BSFT: Brief Strategic Family Therapy for Adolescent Drug Abusers

• Sponsor: University of Miami (Other)
• Overall Status: Completed
• CT.gov ID: NCT00095303
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH), Oregon Research Institute (Other)
• Enrollment: 480
• Locations: 8
• Arms: 2
• Duration (Months): 84
• Patients Per Site: 60
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

The purpose of this study is to compare Brief Strategic Family Therapy (BSFT) for Adolescent Drug Abusers to treatment as usual (TAU).

An additional follow up assessment, funded by an American Recovery & Reinvestment Act (ARRA) grant, was completed 5 years post randomization in order to examine the long term effects of outpatient treatments for illicit drug using adolescents.

Condition or Disease	Intervention/Treatment	Phase
Substance Abuse	Behavioral: Brief Strategic Family Therapy (BSFT); Behavioral: Treatment as Usual	Phase 3

Detailed Description

Adolescent drug abuse continues to be one of the most pressing public health issues in the United States-our nation's teenagers continue to use illicit drugs at a worrisome rate. Broad reviews of the treatment outcome literature indicate that family interventions in general, and Brief Strategic Family Therapy (BSFT) in particular, are effective with drug using youth. This study is designed to compare BSFT to treatment as usual (TAU). The researchers believe that BSFT will be much more effective than TAU in reducing adolescent drug use. They will also examine which of these treatment approaches does a better job of engaging adolescents and family members in treatment, decreasing problem behaviors, decreasing sexually risky behaviors, increasing pro-social activities (e.g., school, work), and improving the functioning of the family.

With the addition of the extended follow up, we have the opportunity to examine the sustainability of study outcomes into early adulthood, filling a gap in the treatment research literature about the long-term effects of adolescent substance abuse treatment. The follow up study examined the long term effectiveness of BSFT compared to TAU in the rates of substance use, number of arrests and externalizing behaviors, in youth who received study treatments at the time when they were adolescents.

Study Design

• Study Type: Interventional
• Actual Enrollment: 480 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Brief Strategic Family Therapy for Adolescent Drug Abusers
• Study Start Date: Aug 1, 2004
• Actual Primary Completion Date: Jan 1, 2008
• Actual Study Completion Date: Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Brief Strategic Family Therapy (BSFT) BSFT is a family therapy approach that consists of 12 to 16 sessions (each 1 to 1.5 hours long) over a 4-month period during the Main Study, and up to 8 "booster" sessions. Interventions are delivered to adolescents and relevant family members in non-restrictive community settings (e.g., clinics, homes, school).	Behavioral: Brief Strategic Family Therapy (BSFT); BSFT is a family therapy approach that consists of 12 to 16 sessions (each 1 to 1.5 hours long) over a 4-month period during the Main Study, and up to 8 "booster" sessions. Interventions are delivered to adolescents and relevant family members in non-restrictive community settings (e.g., clinics, homes, school).; Other Names: BSFT
Active Comparator: Treatment as Usual (TAU) TAU varies depending on site, however each will offer services that include at least 1 therapy session (individual or group therapy) per week during the Main Study, as well as participation in ancillary services (e.g., case management, self help groups, etc.) over a four month period.	Behavioral: Treatment as Usual; TAU varies depending on site, however each will offer services that include at least 1 therapy session (individual or group therapy) per week during the Main Study, as well as participation in ancillary services (e.g., case management, self help groups, etc.) over a four month period.; Other Names: TAU

Outcome Measures

Primary Outcome Measures

1. Main Study, Adolescent Drug Use [Number of self reported drug use days from 28 days prior to baseline]

   Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.

2. Main Study, Adolescent Drug Use [Number of self reported drug use days from day 1-28]

   Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.

3. Main Study, Adolescent Drug Use [Number of self reported drug use days in days 29-56]

   Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.

4. Main Study, Adolescent Drug Use [Number of self reported drug use days from day 57-84]

   Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.

5. Main Study, Adolescent Drug Use [Number of self reported drug use days from day 85-112]

   Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.

6. Main Study, Adolescent Drug Use [Number of self reported drug use days from day 113-140]

   Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.

7. Main Study, Adolescent Drug Use [Number of self reported drug use days from day 141 - 168]

   Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.

8. Main Study, Adolescent Drug Use [Number of self reported drug use days from day 169-196]

   Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.

9. Main Study, Adolescent Drug Use [Number of self reported drug use days from day 197-224]

   Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.

10. Main Study, Adolescent Drug Use [Number of self reported drug use days from day 225-252]

    Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.

11. Main Study, Adolescent Drug Use [Number of self reported drug use days from day 253-280]

    Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.

12. Main Study, Adolescent Drug Use [Number of self reported drug use from days 281-308]

    Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.

13. Main Study, Adolescent Drug Use [Number of self reported drug use days from day 309-336]

    Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.

14. Main Study, Adolescent Drug Use [Number of self reported drug use days from day 337-364]

    Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.

15. Follow Up Study, Drug Use [Number of self reported drug use days 90 days prior assessment]

    Timeline Follow Back (TLFB) measured drug use. For the Follow Up Study, the TLFB was used to identify drug use in the 90 day period that preceded the assessment. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use over the past 90 days. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use.The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 90 days.

16. Follow Up Study, Drug Use [Number of self reported drug use days 90 days prior to assessment]

    Timeline Follow Back (TLFB) measured drug use. For the Follow Up Study, the TLFB was used to identify drug use in the 90 day period that preceded the assessment. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use over the past 90 days. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use.The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 90 days.

Secondary Outcome Measures

1. Main Study, Externalizing Behaviors at Baseline [Baseline]

   For the Main study, an equally weighted composite of the following standardized scales was used to assess externalizing behaviors: 'Total Delinquency' from the National Youth Survey; 'Oppositional Defiant Disorder' and 'Conduct Problems' from the Diagnostic Interview Schedule for Children-Predictive Scales, 'Externalizing Scale' from the Youth Self-Report. This composite was then transformed to a z-score using the mean and standard deviation of the baseline in the entire sample. Adolescent externalizing behaviors were assessed at 4-, 8-, and 12-months post randomization.This hypothesis analyzed using hierarchical linear models. Scores ranged from -1.6 to 3.0. The higher the score, the more externalizing behavior.

2. Main Study, Externalizing Behavior at 4 Months Post Randomization [4 months post randomization]

   For the Main study, an equally weighted composite of the following standardized scales was used to assess externalizing behaviors: 'Total Delinquency' from the National Youth Survey; 'Oppositional Defiant Disorder' and 'Conduct Problems' from the Diagnostic Interview Schedule for Children-Predictive Scales, 'Externalizing Scale' from the Youth Self-Report. This composite was then transformed to a z-score using the mean and standard deviation of the baseline in the entire sample. Adolescent externalizing behaviors were assessed at 4-, 8-, and 12-months post randomization.This hypothesis analyzed using hierarchical linear models. Scores ranged from -1.6 to 3.8. The higher the score, the more externalizing behavior.

3. Main Study, Externalizing Behavior at 8 Months Post Randomization [8 months post randomization]

   For the Main study, an equally weighted composite of the following standardized scales was used to assess externalizing behaviors: 'Total Delinquency' from the National Youth Survey; 'Oppositional Defiant Disorder' and 'Conduct Problems' from the Diagnostic Interview Schedule for Children-Predictive Scales, 'Externalizing Scale' from the Youth Self-Report. This composite was then transformed to a z-score using the mean and standard deviation of the baseline in the entire sample. Adolescent externalizing behaviors were assessed at 4-, 8-, and 12-months post randomization.This hypothesis analyzed using hierarchical linear models. Scores ranged from -1.6 to 3.5. The higher the score, the more externalizing behavior.

4. Main Study, Externalizing Behavior at 12 Months Post Randomization [12 months post randomization]

   For the Main study, an equally weighted composite of the following standardized scales was used to assess externalizing behaviors: 'Total Delinquency' from the National Youth Survey; 'Oppositional Defiant Disorder' and 'Conduct Problems' from the Diagnostic Interview Schedule for Children-Predictive Scales, 'Externalizing Scale' from the Youth Self-Report. This composite was then transformed to a z-score using the mean and standard deviation of the baseline in the entire sample. Adolescent externalizing behaviors were assessed at 4-, 8-, and 12-months post randomization.This hypothesis analyzed using hierarchical linear models. Scores ranged from -1.6 to 3.4. The higher the score, the more externalizing behavior.

5. Follow Up Study, Externalizing Behavior [90 days prior to assessment]

   For the follow up study, externalizing behavior for the 90 days prior to the follow up was assessed using the externalizing composite of the Adult Self Report (ASR). The ASR is a 123 item self report scale designed for 18 to 59 year-old to describe their own functioning. Items are on a 3 point likert type scale (0= not true, 1=somewhat true, 2=very true or often true). The externalizing scale is comprised by the aggressive, rule braking and intrusive syndromes. The problem syndromes have been normed by sex and age (18 to 35, or 36 to 59), using a nationally representative sample. Scores were square-root transformed to more closely approximate a normal distribution. Scores ranged from 0 to 7.2. The higher the score, the more externalizing behavior. Participants were also asked to self report arrests in the past year . Externalizing was analyzed using regression

6. Main Study, Level of Family Functioning at Baseline [Baseline]

   The four components of the 'Parenting Practices Inventory' used to create a composite for use in this analysis. The four component scales from the Parenting Practices Inventory are 'Positive Parenting', 'Discipline Effectiveness,' 'Avoidance of Discipline' and 'Monitoring' scales from the Pittsburgh Youth Survey. the family functioning composite was standardized by the full sample standard deviation at baseline. Scores ranged from -3.0 to 1.8. The higher the score, the better outcome of family functioning.

7. Main Study, Level of Family Functioning at 4 Months Post Randomization [4 months post randomization]

   The four components of the 'Parenting Practices Inventory' used to create a composite for use in this analysis. The four component scales from the Parenting Practices Inventory are 'Positive Parenting', 'Discipline Effectiveness,' 'Avoidance of Discipline' and 'Monitoring' scales from the Pittsburgh Youth Survey. the family functioning composite was standardized by the full sample standard deviation at baseline. Scores ranged from -2.9 to 1.8. The higher the score, the better outcome of family functioning.

8. Main Study, Level of Family Functioning at 8 Months Post Randomization [8 months post randomization]

   The four components of the 'Parenting Practices Inventory' used to create a composite for use in this analysis. The four component scales from the Parenting Practices Inventory are 'Positive Parenting', 'Discipline Effectiveness,' 'Avoidance of Discipline' and 'Monitoring' scales from the Pittsburgh Youth Survey. the family functioning composite was standardized by the full sample standard deviation at baseline.Scores ranged from -2.8 to 2.0. The higher the score, the better outcome of family functioning.

9. Main Study, Level of Family Functioning at 12 Months Post Randomization [12 months post randomization]

   The four components of the 'Parenting Practices Inventory' used to create a composite for use in this analysis. The four component scales from the Parenting Practices Inventory are 'Positive Parenting', 'Discipline Effectiveness,' 'Avoidance of Discipline' and 'Monitoring' scales from the Pittsburgh Youth Survey. the family functioning composite was standardized by the full sample standard deviation at baseline.Scores ranged from -2.6 to 2.0. The higher the score, the better outcome of family functioning.

10. Follow Up Study, Level of Family Functioning [90 days prior assessment]

    For the follow up study, family functioning was measured by a composite of the Cohesion and Conflict scales of the Family Environment Scale. Scores ranged from 1.0 to 18.0. The higher the value, the better the level of family functioning outcome.

11. Main Study, Risky Sexual Behaviors at Baseline [Baseline]

    For the Main Study, the total score of the 'HIV/Sex Risk Behaviors' measure was used as the outcome. Scores ranged from -0.5 to 8.7. The higher the score, the more risky sexual behavior.

12. Main Study, Risky Sexual Behaviors at 4 Months Post Randomization [4 months post randomization]

    For the Main Study, the total score of the 'HIV/Sex Risk Behaviors' measure was used as the outcome. Scores ranged from -0.5 to 10.4. The higher the score, the more risky sexual behavior.

13. Main Study, Risky Sexual Behaviors at 8 Months Post Randomization [8 months post randomization]

    For the Main Study, the total score of the 'HIV/Sex Risk Behaviors' measure was used as the outcome. Scores ranged from -0.5 to 6.8. The higher the score, the more risky sexual behavior.

14. Main Study, Risky Sexual Behaviors at 12 Months Post Randomization [12 months post randomization]

    For the Main Study, the total score of the 'HIV/Sex Risk Behaviors' measure was used as the outcome. Scores ranged from -0.5 to 6.7. The higher the score, the more risky sexual behavior.

15. Follow Up Study, Risky Sexual Behaviors [90 days prior assessment]

    For the Follow Up Study, sexual risk behavior was measured by examining the number of unprotected sexual acts and the number of partners and number of sex acts that included substance use the in the 90 day period that preceded the assessment; a latent factor using structural equation modeling will be used created from the Behavioral Risk Assessment. Scores ranged from -0.5 to 11.7. The higher the score, the more risky sexual behavior.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Main Study:

Inclusion Criteria:

• adolescents ages 12 to 17

• used any illicit drugs (other than alcohol and tobacco) in the 30-day period

• live with or intend to live with a formal or informal family

Exclusion Criteria:

• suicidal or homicidal ideation.

Follow Up Study:

Inclusion Criteria:

• youth must have signed consent during the main study to be approached for future research

• currently 18 years old or older

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	La Frontera Center	Tucson	Arizona	United States	85713
2	Tarzana Treatment Center	Tarzana	California	United States	91356
3	Arapahoe House	Thornton	Colorado	United States	80260
4	Gateway Community Services	Jacksonville	Florida	United States	32224
5	The Villiage	Miami	Florida	United States	33137
6	Daymark	Concord	North Carolina	United States	28025
7	The Crossroads Center	Cincinnati	Ohio	United States	45219
8	Centro de Salud Mental de la Comunidad de Bayamsn	Bayamon		Puerto Rico	00960

Sponsors and Collaborators

• University of Miami
• National Institute on Drug Abuse (NIDA)
• Oregon Research Institute

Investigators

• Principal Investigator: Jose Szapocznik, Ph.D., University of Miami

Study Documents (Full-Text)

None provided.

More Information

Publications

• Horigian VE, Robbins MS, Dominguez R, Ucha J, Rosa CL. Principles for defining adverse events in behavioral intervention research: lessons from a family-focused adolescent drug abuse trial. Clin Trials. 2010 Feb;7(1):58-68. doi: 10.1177/1740774509356575.
• Robbins MS, Alonso E, Horigian VE, Bachrach K, Burlew K, Carrión IS, Hodgkins CC, Miller M, Schindler E, VanDeMark N, Henderson C, Szapocznik J. Transporting clinical research to community settings: designing and conducting a multisite trial of brief strategic family therapy. Addict Sci Clin Pract. 2010 Dec;5(2):54-61.
• Robbins MS, Feaster DJ, Horigian VE, Puccinelli MJ, Henderson C, Szapocznik J. Therapist adherence in brief strategic family therapy for adolescent drug abusers. J Consult Clin Psychol. 2011 Feb;79(1):43-53. doi: 10.1037/a0022146.

• Responsible Party: Jose Szapocznik, Chair, Department of Epidemiology and Public Health, University of Miami
• ClinicalTrials.gov Identifier: NCT00095303
• Other Study ID Numbers: 20090698; U10DA013720; 5RC2DA028864
• First Posted: Nov 3, 2004
• Last Update Posted: Jul 7, 2015
• Last Verified: Jun 1, 2015

• Keywords provided by Jose Szapocznik, Chair, Department of Epidemiology and Public Health, University of Miami: BSFT; Family Therapy; Adolescents; Substance Abuse
• Additional relevant MeSH terms: Substance-Related Disorders

Study Results

Participant Flow

Recruitment Details	Main Study: Adolescents who self-reported illicit drug use in the 30-days before baseline assessment or had to be referred from an institution for the treatment of drug abuse. Extended Follow Up Study: Participants from the Main Study who agreed to be contacted in the future, regardless of Main completion, were recruited to complete the assessment.

Arm/Group Title	BSFT	Treatment as Usual
Arm/Group Description	Brief Strategic Family Therapy For Adolescent Drug Abusers : BSFT is a family therapy approach that consists of 12 to 16 sessions (each 1 to 1.5 hours long) over a 4-month period, and up to 8 "booster" sessions. Interventions are delivered to adolescents and relevant family members in non-restrictive community settings (e.g., clinics, homes, school).	Treatment as Usual : TAU varies depending on site, however each will offer services that include at least 1 therapy session per week (individual or group therapy) as well as participation in ancillary services (e.g., case management, self help groups, etc.) over a four month period.
Period Title: Main Study
STARTED	245	235
COMPLETED	154	148
NOT COMPLETED	91	87
Period Title: Main Study
STARTED	199	179
COMPLETED	140	121
NOT COMPLETED	59	58

Baseline Characteristics

Arm/Group Title	BSFT	TAU- Treatment as Usual	Total
Arm/Group Description	BSFT: Brief Strategic Family Therapy. 12-16 sessions, ranging from 8 to 24 as full dose Sessions include adolescents and family members	TAU: Treatment As Usual. Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT Typically services include individual, group, and family therapy sessions as well as case management	Total of all reporting groups
Overall Participants	245	235	480
Age (Count of Participants)
<=18 years	245 100%	235 100%	480 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Age (participants in follow up study) [Number]
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	140 57.1%	121 51.5%	261 54.4%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	50 20.4%	53 22.6%	103 21.5%
Male	195 79.6%	182 77.4%	377 78.5%
Gender (participants in follow up study) [Number]
Female	26 10.6%	27 11.5%	53 11%
Male	114 46.5%	94 40%	208 43.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	107 43.7%	106 45.1%	213 44.4%
Not Hispanic or Latino	133 54.3%	125 53.2%	258 53.8%
Unknown or Not Reported	5 2%	4 1.7%	9 1.9%
Ethnicity (NIH/OMB) (participants in follow up study) [Number]
Hispanic or Latino	62 25.3%	53 22.6%	115 24%
Not Hispanic or Latino	78 31.8%	68 28.9%	146 30.4%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Main Study, Adolescent Drug Use
Description	Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.
Time Frame	Number of self reported drug use days from 28 days prior to baseline

Outcome Measure Data

Analysis Population Description

The number of participants analyzed represents the number of participants that completed the baseline time point, assessing for the past 28 days. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.

Arm/Group Title	BSFT	TAU- Treatment as Usual
Arm/Group Description	BSFT: 12-16 sessions, ranging from 8 to 24 as full dose Sessions include adolescents and family members	TAU: Treat As Usual Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT Typically services include individual, group, and family therapy sessions as well as case management
Measure Participants	245	234
Median (Inter-Quartile Range) [days of drug use 28 days prior baseline]	3	3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BSFT, TAU- Treatment as Usual
	Comments	Null Hypothesis: BSFT will be significantly more effective than TAU in reducing adolescent drug abuse, defined as the percentage of drug use days in 28-day periods. The outcome variable is the percentage of days of drug use within a 28-day period. This variable constructed from the Timeline-Follow-back instrument and measured as the sum of the number of days with positive use in 28-day increments. Hypothesis tested using hierarchical linear models.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.27
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	slope of linear trajectory of drug use
	Estimated Value	.05
	Confidence Interval	(2-Sided) 95%; -.04 to .14
	Parameter Dispersion	Type: Value:
	Estimation Comments	The parameter estimated is the regression coefficient on the interaction of the BSFT treatment assignment and the linear time trend.

2. Primary Outcome

Title	Main Study, Adolescent Drug Use
Description	Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.
Time Frame	Number of self reported drug use days from day 1-28

Outcome Measure Data

Analysis Population Description

The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 1-28. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.

Arm/Group Title	BSFT	TAU- Treatment as Usual
Arm/Group Description	BSFT: 12-16 sessions, ranging from 8 to 24 as full dose Sessions include adolescents and family members	TAU: Treat As Usual Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT Typically services include individual, group, and family therapy sessions as well as case management
Measure Participants	219	201
Median (Inter-Quartile Range) [days of drug use from day 1-28]	1	2

3. Secondary Outcome

Title	Main Study, Externalizing Behaviors at Baseline
Description	For the Main study, an equally weighted composite of the following standardized scales was used to assess externalizing behaviors: 'Total Delinquency' from the National Youth Survey; 'Oppositional Defiant Disorder' and 'Conduct Problems' from the Diagnostic Interview Schedule for Children-Predictive Scales, 'Externalizing Scale' from the Youth Self-Report. This composite was then transformed to a z-score using the mean and standard deviation of the baseline in the entire sample. Adolescent externalizing behaviors were assessed at 4-, 8-, and 12-months post randomization.This hypothesis analyzed using hierarchical linear models. Scores ranged from -1.6 to 3.0. The higher the score, the more externalizing behavior.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

The number of participants analyzed represents the number of participants that completed this time point, assessing externalizing behaviors at baseline. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.

Arm/Group Title	BSFT	TAU- Treatment as Usual
Arm/Group Description	BSFT: 12-16 sessions, ranging from 8 to 24 as full dose Sessions include adolescents and family members	TAU: Treat As Usual Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT Typically services include individual, group, and family therapy sessions as well as case management
Measure Participants	245	235
Mean (Standard Deviation) [units on a scale]	-.004 (1.01)	.004 (1.03)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BSFT, TAU- Treatment as Usual
	Comments	Null hypothesis: It is hypothesized that BSFT will be significantly more effective than TAU in decreasing adolescent externalizing problem behaviors
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.26
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	-0.10
	Confidence Interval	(2-Sided) 95%; -0.28 to 0.08
	Parameter Dispersion	Type: Value:
	Estimation Comments	The parameter estimated is the regression coefficient on the interaction of BSFT treatment assignment and the linear time trend.

4. Secondary Outcome

Title	Main Study, Externalizing Behavior at 4 Months Post Randomization
Description	For the Main study, an equally weighted composite of the following standardized scales was used to assess externalizing behaviors: 'Total Delinquency' from the National Youth Survey; 'Oppositional Defiant Disorder' and 'Conduct Problems' from the Diagnostic Interview Schedule for Children-Predictive Scales, 'Externalizing Scale' from the Youth Self-Report. This composite was then transformed to a z-score using the mean and standard deviation of the baseline in the entire sample. Adolescent externalizing behaviors were assessed at 4-, 8-, and 12-months post randomization.This hypothesis analyzed using hierarchical linear models. Scores ranged from -1.6 to 3.8. The higher the score, the more externalizing behavior.
Time Frame	4 months post randomization

Outcome Measure Data

Analysis Population Description

The number of participants analyzed represents the number of participants that completed this time point, assessing for externalizing behavior at 4 months post randomization. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.

Arm/Group Title	BSFT	TAU- Treatment as Usual
Arm/Group Description	BSFT: 12-16 sessions, ranging from 8 to 24 as full dose Sessions include adolescents and family members	TAU: Treat As Usual Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT Typically services include individual, group, and family therapy sessions as well as case management
Measure Participants	191	185
Mean (Standard Deviation) [units on a scale]	-.36 (.89)	-.21 (1.07)

5. Primary Outcome

Title	Main Study, Adolescent Drug Use
Description	Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.
Time Frame	Number of self reported drug use days in days 29-56

Outcome Measure Data

Analysis Population Description

The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 29-56. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.

Arm/Group Title	BSFT	TAU- Treatment as Usual
Arm/Group Description	BSFT: 12-16 sessions, ranging from 8 to 24 as full dose Sessions include adolescents and family members	TAU: Treat As Usual Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT Typically services include individual, group, and family therapy sessions as well as case management
Measure Participants	211	192
Median (Inter-Quartile Range) [days of drug use in days 29-56]	2	1

6. Secondary Outcome

Title	Main Study, Externalizing Behavior at 8 Months Post Randomization
Description	For the Main study, an equally weighted composite of the following standardized scales was used to assess externalizing behaviors: 'Total Delinquency' from the National Youth Survey; 'Oppositional Defiant Disorder' and 'Conduct Problems' from the Diagnostic Interview Schedule for Children-Predictive Scales, 'Externalizing Scale' from the Youth Self-Report. This composite was then transformed to a z-score using the mean and standard deviation of the baseline in the entire sample. Adolescent externalizing behaviors were assessed at 4-, 8-, and 12-months post randomization.This hypothesis analyzed using hierarchical linear models. Scores ranged from -1.6 to 3.5. The higher the score, the more externalizing behavior.
Time Frame	8 months post randomization

Outcome Measure Data

Analysis Population Description

The number of participants analyzed represents the number of participants that completed this time point, assessing for externalizing behavior at 8 months post randomization. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.

Arm/Group Title	BSFT	TAU- Treatment as Usual
Arm/Group Description	BSFT: 12-16 sessions, ranging from 8 to 24 as full dose Sessions include adolescents and family members	TAU: Treat As Usual Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT Typically services include individual, group, and family therapy sessions as well as case management
Measure Participants	168	162
Mean (Standard Deviation) [units on a scale]	-.45 (.81)	-.39 (.99)

7. Secondary Outcome

Title	Main Study, Externalizing Behavior at 12 Months Post Randomization
Description	For the Main study, an equally weighted composite of the following standardized scales was used to assess externalizing behaviors: 'Total Delinquency' from the National Youth Survey; 'Oppositional Defiant Disorder' and 'Conduct Problems' from the Diagnostic Interview Schedule for Children-Predictive Scales, 'Externalizing Scale' from the Youth Self-Report. This composite was then transformed to a z-score using the mean and standard deviation of the baseline in the entire sample. Adolescent externalizing behaviors were assessed at 4-, 8-, and 12-months post randomization.This hypothesis analyzed using hierarchical linear models. Scores ranged from -1.6 to 3.4. The higher the score, the more externalizing behavior.
Time Frame	12 months post randomization

Outcome Measure Data

Analysis Population Description

The number of participants analyzed represents the number of participants that completed this time point, assessing for externalizing behavior at 12 months post randomization. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.

Arm/Group Title	BSFT	TAU- Treatment as Usual
Arm/Group Description	BSFT: 12-16 sessions, ranging from 8 to 24 as full dose Sessions include adolescents and family members	TAU: Treat As Usual Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT Typically services include individual, group, and family therapy sessions as well as case management
Measure Participants	164	153
Mean (Standard Deviation) [units on a scale]	-.45 (.93)	-.52 (.87)

8. Primary Outcome

Title	Main Study, Adolescent Drug Use
Description	Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.
Time Frame	Number of self reported drug use days from day 57-84

Outcome Measure Data

Analysis Population Description

The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 57-84. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.

Arm/Group Title	BSFT	TAU- Treatment as Usual
Arm/Group Description	BSFT: 12-16 sessions, ranging from 8 to 24 as full dose Sessions include adolescents and family members	TAU: Treat As Usual Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT Typically services include individual, group, and family therapy sessions as well as case management
Measure Participants	208	185
Median (Inter-Quartile Range) [days of drug use from day 57-84]	1	1

9. Primary Outcome

Title	Main Study, Adolescent Drug Use
Description	Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.
Time Frame	Number of self reported drug use days from day 85-112

Outcome Measure Data

Analysis Population Description

The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 85-112. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.

Arm/Group Title	BSFT	TAU- Treatment as Usual
Arm/Group Description	BSFT: 12-16 sessions, ranging from 8 to 24 as full dose Sessions include adolescents and family members	TAU: Treat As Usual Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT Typically services include individual, group, and family therapy sessions as well as case management
Measure Participants	194	179
Median (Inter-Quartile Range) [days of drug use from day 85-112]	1	2

10. Primary Outcome

Title	Main Study, Adolescent Drug Use
Description	Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.
Time Frame	Number of self reported drug use days from day 113-140

Outcome Measure Data

Analysis Population Description

The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 113-140. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.

Arm/Group Title	BSFT	TAU- Treatment as Usual
Arm/Group Description	BSFT: 12-16 sessions, ranging from 8 to 24 as full dose Sessions include adolescents and family members	TAU: Treat As Usual Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT Typically services include individual, group, and family therapy sessions as well as case management
Measure Participants	186	176
Median (Inter-Quartile Range) [days of drug use from days 113-140]	1	1

11. Primary Outcome

Title	Main Study, Adolescent Drug Use
Description	Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.
Time Frame	Number of self reported drug use days from day 141 - 168

Outcome Measure Data

Analysis Population Description

The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 141-168. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.

Arm/Group Title	BSFT	TAU- Treatment as Usual
Arm/Group Description	BSFT: 12-16 sessions, ranging from 8 to 24 as full dose Sessions include adolescents and family members	TAU: Treat As Usual Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT Typically services include individual, group, and family therapy sessions as well as case management
Measure Participants	187	170
Median (Inter-Quartile Range) [days of drug use from day 141-168]	1	1.5

12. Primary Outcome

Title	Main Study, Adolescent Drug Use
Description	Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.
Time Frame	Number of self reported drug use days from day 169-196

Outcome Measure Data

Analysis Population Description

The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 169-196. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.

Arm/Group Title	BSFT	TAU- Treatment as Usual
Arm/Group Description	BSFT: 12-16 sessions, ranging from 8 to 24 as full dose Sessions include adolescents and family members	TAU: Treat As Usual Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT Typically services include individual, group, and family therapy sessions as well as case management
Measure Participants	173	162
Median (Inter-Quartile Range) [days of drug use from day 169-196]	1	1

13. Primary Outcome

Title	Main Study, Adolescent Drug Use
Description	Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.
Time Frame	Number of self reported drug use days from day 197-224

Outcome Measure Data

Analysis Population Description

The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 197-224. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.

Arm/Group Title	BSFT	TAU- Treatment as Usual
Arm/Group Description	BSFT: 12-16 sessions, ranging from 8 to 24 as full dose Sessions include adolescents and family members	TAU: Treat As Usual Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT Typically services include individual, group, and family therapy sessions as well as case management
Measure Participants	173	162
Median (Inter-Quartile Range) [days of drug use from day 197-224]	1	1

14. Primary Outcome

Title	Main Study, Adolescent Drug Use
Description	Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.
Time Frame	Number of self reported drug use days from day 225-252

Outcome Measure Data

Analysis Population Description

The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 225-252. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.

Arm/Group Title	BSFT	TAU- Treatment as Usual
Arm/Group Description	BSFT: 12-16 sessions, ranging from 8 to 24 as full dose Sessions include adolescents and family members	TAU: Treat As Usual Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT Typically services include individual, group, and family therapy sessions as well as case management
Measure Participants	165	161
Median (Inter-Quartile Range) [days of drug use from day 225-252]	2	2

15. Primary Outcome

Title	Main Study, Adolescent Drug Use
Description	Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.
Time Frame	Number of self reported drug use days from day 253-280

Outcome Measure Data

Analysis Population Description

The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 253-280. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.

Arm/Group Title	BSFT	TAU- Treatment as Usual
Arm/Group Description	BSFT: 12-16 sessions, ranging from 8 to 24 as full dose Sessions include adolescents and family members	TAU: Treat As Usual Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT Typically services include individual, group, and family therapy sessions as well as case management
Measure Participants	170	155
Median (Inter-Quartile Range) [days of drug use from day 253-280]	2	2

16. Primary Outcome

Title	Main Study, Adolescent Drug Use
Description	Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.
Time Frame	Number of self reported drug use from days 281-308

Outcome Measure Data

Analysis Population Description

The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 281-308. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.

Arm/Group Title	BSFT	TAU- Treatment as Usual
Arm/Group Description	BSFT: 12-16 sessions, ranging from 8 to 24 as full dose Sessions include adolescents and family members	TAU: Treat As Usual Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT Typically services include individual, group, and family therapy sessions as well as case management
Measure Participants	169	153
Median (Inter-Quartile Range) [days of drug use from day 281-308]	2	2

17. Primary Outcome

Title	Main Study, Adolescent Drug Use
Description	Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.
Time Frame	Number of self reported drug use days from day 309-336

Outcome Measure Data

Analysis Population Description

The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 309-336. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.

Arm/Group Title	BSFT	TAU- Treatment as Usual
Arm/Group Description	BSFT: 12-16 sessions, ranging from 8 to 24 as full dose Sessions include adolescents and family members	TAU: Treat As Usual Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT Typically services include individual, group, and family therapy sessions as well as case management
Measure Participants	162	149
Median (Inter-Quartile Range) [days of drug use from day 309-336]	2	3

18. Primary Outcome

Title	Main Study, Adolescent Drug Use
Description	Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.
Time Frame	Number of self reported drug use days from day 337-364

Outcome Measure Data

Analysis Population Description

The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 337-364. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.

Arm/Group Title	BSFT	TAU- Treatment as Usual
Arm/Group Description	BSFT: 12-16 sessions, ranging from 8 to 24 as full dose Sessions include adolescents and family members	TAU: Treat As Usual Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT Typically services include individual, group, and family therapy sessions as well as case management
Measure Participants	157	140
Median (Inter-Quartile Range) [days of drug use from day 337-364]	2	3.5

19. Primary Outcome

Title	Follow Up Study, Drug Use
Description	Timeline Follow Back (TLFB) measured drug use. For the Follow Up Study, the TLFB was used to identify drug use in the 90 day period that preceded the assessment. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use over the past 90 days. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use.The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 90 days.
Time Frame	Number of self reported drug use days 90 days prior assessment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BSFT	TAU- Treatment as Usual
Arm/Group Description	BSFT: 12-16 sessions, ranging from 8 to 24 as full dose Sessions include adolescents and family members	TAU: Treat As Usual Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT Typically services include individual, group, and family therapy sessions as well as case management
Measure Participants	140	121
Median (Inter-Quartile Range) [days of drug use 90 days prior assessmen]	19.5	25

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BSFT, TAU- Treatment as Usual
	Comments	Null Hypothesis: BSFT will be significantly more effective than TAU in the rates of drug use, defined as the percentage of drug use days in last 90 days. The primary hypothesis will be evaluated in terms of % of days of drug use in the last 90 days, assessed by the timeline follow-back. The general analytic approach will use generalized estimating equation (GEE) with negative binomial distribution comparing the BSFT and TAU participants
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.21
	Comments
	Method	GEE
	Comments
Method of Estimation	Estimation Parameter	Rate Ratio
	Estimated Value	.94
	Confidence Interval	(2-Sided) 95%; .82 to 1.09
	Parameter Dispersion	Type: Value:
	Estimation Comments

20. Primary Outcome

Title	Follow Up Study, Drug Use
Description	Timeline Follow Back (TLFB) measured drug use. For the Follow Up Study, the TLFB was used to identify drug use in the 90 day period that preceded the assessment. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use over the past 90 days. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use.The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 90 days.
Time Frame	Number of self reported drug use days 90 days prior to assessment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BSFT	TAU- Treatment as Usual
Arm/Group Description	BSFT: 12-16 sessions, ranging from 8 to 24 as full dose Sessions include adolescents and family members	TAU: Treat As Usual Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT Typically services include individual, group, and family therapy sessions as well as case management
Measure Participants	140	121
Median (Inter-Quartile Range) [days of drug use 90 days prior assessmen]	8	10

21. Secondary Outcome

Title	Follow Up Study, Externalizing Behavior
Description	For the follow up study, externalizing behavior for the 90 days prior to the follow up was assessed using the externalizing composite of the Adult Self Report (ASR). The ASR is a 123 item self report scale designed for 18 to 59 year-old to describe their own functioning. Items are on a 3 point likert type scale (0= not true, 1=somewhat true, 2=very true or often true). The externalizing scale is comprised by the aggressive, rule braking and intrusive syndromes. The problem syndromes have been normed by sex and age (18 to 35, or 36 to 59), using a nationally representative sample. Scores were square-root transformed to more closely approximate a normal distribution. Scores ranged from 0 to 7.2. The higher the score, the more externalizing behavior. Participants were also asked to self report arrests in the past year . Externalizing was analyzed using regression
Time Frame	90 days prior to assessment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BSFT	TAU- Treatment as Usual
Arm/Group Description	BSFT: 12-16 sessions, ranging from 8 to 24 as full dose Sessions include adolescents and family members	TAU: Treat As Usual Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT Typically services include individual, group, and family therapy sessions as well as case management
Measure Participants	140	121
Mean (Standard Deviation) [units on a scale]	3.1 (1.5)	3.5 (1.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BSFT, TAU- Treatment as Usual
	Comments	Null hypothesis: It is hypothesized that BSFT will be significantly more effective than TAU in the level of externalizing problem behaviors
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<.006
	Comments
	Method	GEE
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-.42
	Confidence Interval	(2-Sided) 95%; -.71 to -.12
	Parameter Dispersion	Type: Value:
	Estimation Comments

22. Secondary Outcome

Title	Main Study, Level of Family Functioning at Baseline
Description	The four components of the 'Parenting Practices Inventory' used to create a composite for use in this analysis. The four component scales from the Parenting Practices Inventory are 'Positive Parenting', 'Discipline Effectiveness,' 'Avoidance of Discipline' and 'Monitoring' scales from the Pittsburgh Youth Survey. the family functioning composite was standardized by the full sample standard deviation at baseline. Scores ranged from -3.0 to 1.8. The higher the score, the better outcome of family functioning.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BSFT	TAU- Treatment as Usual
Arm/Group Description	BSFT: 12-16 sessions, ranging from 8 to 24 as full dose Sessions include adolescents and family members	TAU: Treat As Usual Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT Typically services include individual, group, and family therapy sessions as well as case management
Measure Participants	245	235
Mean (Standard Error) [units on a scale]	-0.03 (1.01)	0.04 (0.99)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BSFT, TAU- Treatment as Usual
	Comments	Null hypothesis: BSFT will be significantly more effective than TAU in improving family functioning.The four components of the 'Parenting Practices Inventory' will be used to create a composite for use in this analysis. The four component scales from the Parenting Practices Inventory are 'Positive Parenting', 'Discipline Effectiveness,' 'Avoidance of Discipline' and 'Monitoring' scales from the Pittsburgh Youth Survey. Hypothesis will be analyzed as using hierarchical linear models.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.015
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	.12
	Confidence Interval	(2-Sided) 95%; .03 to .22
	Parameter Dispersion	Type: Value:
	Estimation Comments

23. Secondary Outcome

Title	Main Study, Level of Family Functioning at 4 Months Post Randomization
Description	The four components of the 'Parenting Practices Inventory' used to create a composite for use in this analysis. The four component scales from the Parenting Practices Inventory are 'Positive Parenting', 'Discipline Effectiveness,' 'Avoidance of Discipline' and 'Monitoring' scales from the Pittsburgh Youth Survey. the family functioning composite was standardized by the full sample standard deviation at baseline. Scores ranged from -2.9 to 1.8. The higher the score, the better outcome of family functioning.
Time Frame	4 months post randomization

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BSFT	TAU- Treatment as Usual
Arm/Group Description	BSFT: 12-16 sessions, ranging from 8 to 24 as full dose Sessions include adolescents and family members	TAU: Treat As Usual Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT Typically services include individual, group, and family therapy sessions as well as case management
Measure Participants	194	188
Mean (Standard Deviation) [units on a scale]	0.15 (1.02)	0.21 (0.94)

24. Secondary Outcome

Title	Main Study, Level of Family Functioning at 8 Months Post Randomization
Description	The four components of the 'Parenting Practices Inventory' used to create a composite for use in this analysis. The four component scales from the Parenting Practices Inventory are 'Positive Parenting', 'Discipline Effectiveness,' 'Avoidance of Discipline' and 'Monitoring' scales from the Pittsburgh Youth Survey. the family functioning composite was standardized by the full sample standard deviation at baseline.Scores ranged from -2.8 to 2.0. The higher the score, the better outcome of family functioning.
Time Frame	8 months post randomization

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BSFT	TAU- Treatment as Usual
Arm/Group Description	BSFT: 12-16 sessions, ranging from 8 to 24 as full dose Sessions include adolescents and family members	TAU: Treat As Usual Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT Typically services include individual, group, and family therapy sessions as well as case management
Measure Participants	169	164
Mean (Standard Deviation) [units on a scale]	0.31 (0.96)	0.25 (0.97)

25. Secondary Outcome

Title	Main Study, Level of Family Functioning at 12 Months Post Randomization
Description	The four components of the 'Parenting Practices Inventory' used to create a composite for use in this analysis. The four component scales from the Parenting Practices Inventory are 'Positive Parenting', 'Discipline Effectiveness,' 'Avoidance of Discipline' and 'Monitoring' scales from the Pittsburgh Youth Survey. the family functioning composite was standardized by the full sample standard deviation at baseline.Scores ranged from -2.6 to 2.0. The higher the score, the better outcome of family functioning.
Time Frame	12 months post randomization

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BSFT	TAU- Treatment as Usual
Arm/Group Description	BSFT: 12-16 sessions, ranging from 8 to 24 as full dose Sessions include adolescents and family members	TAU: Treat As Usual Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT Typically services include individual, group, and family therapy sessions as well as case management
Measure Participants	169	158
Mean (Standard Deviation) [units on a scale]	0.35 (0.96)	0.14 (0.99)

26. Secondary Outcome

Title	Follow Up Study, Level of Family Functioning
Description	For the follow up study, family functioning was measured by a composite of the Cohesion and Conflict scales of the Family Environment Scale. Scores ranged from 1.0 to 18.0. The higher the value, the better the level of family functioning outcome.
Time Frame	90 days prior assessment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BSFT	TAU- Treatment as Usual
Arm/Group Description	BSFT: 12-16 sessions, ranging from 8 to 24 as full dose Sessions include adolescents and family members	TAU: Treat As Usual Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT Typically services include individual, group, and family therapy sessions as well as case management
Measure Participants	141	121
Mean (Standard Deviation) [units on a scale]	13.2 (4.2)	12.4 (4.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BSFT, TAU- Treatment as Usual
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.12
	Comments
	Method	GEE
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	.68
	Confidence Interval	(2-Sided) 95%; -.18 to 1.54
	Parameter Dispersion	Type: Value:
	Estimation Comments

27. Secondary Outcome

Title	Main Study, Risky Sexual Behaviors at Baseline
Description	For the Main Study, the total score of the 'HIV/Sex Risk Behaviors' measure was used as the outcome. Scores ranged from -0.5 to 8.7. The higher the score, the more risky sexual behavior.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BSFT	TAU- Treatment as Usual
Arm/Group Description	BSFT: 12-16 sessions, ranging from 8 to 24 as full dose Sessions include adolescents and family members	TAU: Treat As Usual Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT Typically services include individual, group, and family therapy sessions as well as case management
Measure Participants	245	235
Least Squares Mean (Standard Error) [units on a scale]	.95 (.14)	1.00 (.12)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BSFT, TAU- Treatment as Usual
	Comments	Null hypothesis: BSFT will be significantly more effective than TAU in decreasing sexually risky behaviors. The total score of the 'HIV/Sex Risk Behaviors' measure will be used as the outcome.Hypothesis analyzed using the hierarchical linear model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.12
	Comments
	Method	GEE
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	.33
	Confidence Interval	(2-Sided) 95%; -.09 to .76
	Parameter Dispersion	Type: Value:
	Estimation Comments	The parameter estimated is the regression coefficient on the interaction of BSFT treatment assignment and the linear time trend.

28. Secondary Outcome

Title	Main Study, Risky Sexual Behaviors at 4 Months Post Randomization
Description	For the Main Study, the total score of the 'HIV/Sex Risk Behaviors' measure was used as the outcome. Scores ranged from -0.5 to 10.4. The higher the score, the more risky sexual behavior.
Time Frame	4 months post randomization

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BSFT	TAU- Treatment as Usual
Arm/Group Description	BSFT: 12-16 sessions, ranging from 8 to 24 as full dose Sessions include adolescents and family members	TAU: Treat As Usual Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT Typically services include individual, group, and family therapy sessions as well as case management
Measure Participants	191	185
Least Squares Mean (Standard Error) [units on a scale]	.89 (.12)	1.18 (.12)

29. Secondary Outcome

Title	Main Study, Risky Sexual Behaviors at 8 Months Post Randomization
Description	For the Main Study, the total score of the 'HIV/Sex Risk Behaviors' measure was used as the outcome. Scores ranged from -0.5 to 6.8. The higher the score, the more risky sexual behavior.
Time Frame	8 months post randomization

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BSFT	TAU- Treatment as Usual
Arm/Group Description	BSFT: 12-16 sessions, ranging from 8 to 24 as full dose Sessions include adolescents and family members	TAU: Treat As Usual Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT Typically services include individual, group, and family therapy sessions as well as case management
Measure Participants	168	163
Least Squares Mean (Standard Error) [units on a scale]	1.01 (.12)	1.32 (.12)

30. Secondary Outcome

Title	Main Study, Risky Sexual Behaviors at 12 Months Post Randomization
Description	For the Main Study, the total score of the 'HIV/Sex Risk Behaviors' measure was used as the outcome. Scores ranged from -0.5 to 6.7. The higher the score, the more risky sexual behavior.
Time Frame	12 months post randomization

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BSFT	TAU- Treatment as Usual
Arm/Group Description	BSFT: 12-16 sessions, ranging from 8 to 24 as full dose Sessions include adolescents and family members	TAU: Treat As Usual Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT Typically services include individual, group, and family therapy sessions as well as case management
Measure Participants	164	154
Least Squares Mean (Standard Error) [units on a scale]	1.30 (.14)	1.44 (.12)

31. Secondary Outcome

Title	Follow Up Study, Risky Sexual Behaviors
Description	For the Follow Up Study, sexual risk behavior was measured by examining the number of unprotected sexual acts and the number of partners and number of sex acts that included substance use the in the 90 day period that preceded the assessment; a latent factor using structural equation modeling will be used created from the Behavioral Risk Assessment. Scores ranged from -0.5 to 11.7. The higher the score, the more risky sexual behavior.
Time Frame	90 days prior assessment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BSFT	TAU- Treatment as Usual
Arm/Group Description	BSFT: 12-16 sessions, ranging from 8 to 24 as full dose Sessions include adolescents and family members	TAU: Treat As Usual Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT Typically services include individual, group, and family therapy sessions as well as case management
Measure Participants	140	121
Least Squares Mean (Standard Error) [units on a scale]	2.06 (.06)	2.20 (.10)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BSFT, TAU- Treatment as Usual
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.23
	Comments
	Method	GEE
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	.14
	Confidence Interval	(2-Sided) 95%; -.09 to .37
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	12 months
Adverse Event Reporting Description	Main Study:Adverse Events (AE) tracked- arrest, school suspension/drop out, runaway, kicked out of home, violence. Serious Adverse Events (SAE) tracked-physical/sexual abuse, suicidal/homicidal behavior, hospitalization, death. Follow Up Study:AE/SAE's not tracked given brief time of involvement in the study/minimal risk in completing assessment.
Arm/Group Title	BSFT		Treatment as Usual
Arm/Group Description	Brief Strategic Family Therapy For Adolescent Drug Abusers: BSFT is a family therapy approach that consists of 12 to 16 sessions (each 1 to 1.5 hours long) over a 4-month period, and up to 8 "booster" sessions. Interventions are delivered to adolescents and relevant family members in non-restrictive community settings (e.g., clinics, homes, school).		Treatment as Usual: TAU varies depending on site, however each will offer services that include at least 1 therapy session per week (individual or group therapy) as well as participation in ancillary services (e.g., case management, self help groups, etc.) over a four month period.
All Cause Mortality
	BSFT		Treatment as Usual
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	BSFT		Treatment as Usual
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	16/245 (6.5%)		16/235 (6.8%)
Social circumstances
Physical/ Sexual Abuse	2/245 (0.8%)		2/235 (0.9%)
Suicidal Behavior	8/245 (3.3%)		5/235 (2.1%)
Homicidal Behavior	3/245 (1.2%)		4/235 (1.7%)
Hospitalization	8/245 (3.3%)		8/235 (3.4%)
Death	0/245 (0%)		1/235 (0.4%)
Other Unexpected SAE	0/245 (0%)		1/235 (0.4%)
Other (Not Including Serious) Adverse Events
	BSFT		Treatment as Usual
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	144/245 (58.8%)		133/235 (56.6%)
Social circumstances
Arrest	85/245 (34.7%)		79/235 (33.6%)
Runaway	34/245 (13.9%)		45/235 (19.1%)
Kicked out of home	6/245 (2.4%)		4/235 (1.7%)
School suspension	72/245 (29.4%)		71/235 (30.2%)
Violence	31/245 (12.7%)		23/235 (9.8%)
Other Unexpected Adverse Event	12/245 (4.9%)		3/235 (1.3%)

Limitations/Caveats

Main Study: Low rates self-reported drug use leading to only examination of prevention of relapse/escalation of drug use Follow Up Study: Variability between the time of participation in main and follow up, so no direct casuality could be concluded

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.