PRIDE-P: Therapeutic Substance Abuse Treatment in Pregnancy - 1

• Sponsor: Yale University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00227903
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 168
• Locations: 2
• Arms: 2
• Duration (Months): 71
• Patients Per Site: 84
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

The purpose of this study is... To assess whether a behavioral treatment that combines motivational enhancement and cognitive skills training therapy (MET-CBT) is more effective than brief advice in: 1) decreasing use of a full range of psychoactive substances (e.g. marijuana, cocaine, methamphetamines, alcohol, nicotine, opioids) in pregnant substance using and dependent women; 2) decreasing HIV risk behavior; 3) improving birth outcomes (longer gestations and greater birth weight).

Condition or Disease	Intervention/Treatment	Phase
Alcohol Abuse; Cocaine Abuse; Marijuana Abuse	Behavioral: MI-CBT; Behavioral: Brief Advice	Phase 2

Detailed Description

We propose an integrated system of counseling services onsite in primary care obstetrical clinics, comparing a manualized brief advice (closely approximating "treatment as usual") to manualized motivationally enhanced cognitive behavioral therapy. Treatment providers are obstetrical nurses. Therapy patients are taught skill sets designed to enhance motivation to abstain from drugs of abuse, as well as designed to prevent relapse during the perinatal period. It is our hypothesis that therapy patients will be more successful at achieving stated study aims than those receiving brief advice.

Study Design

• Study Type: Interventional
• Actual Enrollment: 168 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Psychosocial Research to Improve Drug Treatment in Pregnancy (PRIDE-P)
• Study Start Date: Sep 1, 2004
• Actual Primary Completion Date: Aug 1, 2010
• Actual Study Completion Date: Aug 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MI-CBT Motivationally-enhanced cognitive behavioral skills counseling	Behavioral: MI-CBT; Motivationally-enhanced cognitive behavioral skills counseling
Active Comparator: Brief Advice Advice and education	Behavioral: Brief Advice; Advice and education

Outcome Measures

Primary Outcome Measures

1. Percentage of Days Used Drugs or Alcohol [intake to delivery, an average of 21 weeks]

2. Percentage of Days Used Drugs or Alcohol [delivery to 3 months post-delivery]

3. Percentage of Days That Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol [intake to delivery, an average of 21 weeks]

4. Percentage of Days That Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol [Delivery to 3 months post-delivery]

5. Percentage of Days That Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol [intake to delivery, an average of 21 weeks]

6. Percentage of Days That Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol [Delivery to 3 months post-delivery]

Secondary Outcome Measures

1. Incidence of Preterm Births [At delivery]

2. Incidence of Low Birth Weight [At delivery]

3. Proportion of Participants Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report [intake to delivery, an average of 21 weeks]

4. Proportion of Participants Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report [Delivery to 3 months post-delivery]

5. Proportion of Participants Abstinent From Drugs (i.e., Marijuana, Cocaine or Opioids) According to Urine [intake to delivery, an average of 21 weeks]

6. Proportion of Participants Abstinent From Drugs According to Urine [Delivery to 3 months post-delivery]

   Based on urine tests for marijuana, cocaine, or opioids

7. Proportion of Participants Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine [intake to delivery, an average of 21 weeks]

   Based on urine tests for marijuana, cocaine or opioids.

8. Proportion of Participants Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine [Delivery to 3 months post-delivery]

   Based on urine tests for marijuana, cocaine, or opioids.

9. Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report [intake to delivery, an average of 21 weeks]

10. Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report [Delivery to 3 months post-delivery]

11. Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report [intake to delivery, an average of 21 weeks]

12. Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report [Delivery to 3 months post-delivery]

13. Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine [intake to delivery, an average of 21 weeks]

    Based on urine tests for marijuana, cocaine or opioids.

14. Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine [Delivery to 3 months post-delivery]

    Based on urine tests for marijuana, cocaine or opioids.

15. Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine [intake to delivery, an average of 21 weeks]

    Based on urine tests for marijuana, cocaine or opioids.

16. Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine [Delivery to 3 months post-delivery]

    Based on urine tests for marijuana, cocaine or opioids.

17. Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine [intake to delivery, an average of 21 weeks]

    Based on urine tests for marijuana, cocaine or opioids.

18. Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine [Delivery to 3 months post-delivery]

    Based on urine tests for marijuana, cocaine or opioids

19. Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine [intake to delivery, an average of 21 weeks]

    Based on urine tests for marijuana, cocaine or opioids

20. Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine [Delivery to 3 months post-delivery]

    Based on urine tests for marijuana, cocaine or opioids

Other Outcome Measures

1. Adequacy of Received Services [After prenatal care initiation]

   Based on prenatal care attendance: the percent of visits attended after prenatal care initiation, accounting for time of delivery. Attendance was rated according to the Kotelchuck Adequacy of Prenatal Care Index. Only the normally scheduled prenatal car visits were included.

2. Attendance of Treatment Outside the Study [30 days prior to assessment]

   The number of patients who attended outside treatment in the 30 days prior to each assessment.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Pregnant women, age 16 or older, alcohol or illicit drug use in the past 30 days -

Exclusion Criteria:

Nonfluent in English or Spanish, pending incarceration, psychotic, cognitively unable to give informed consent, actively suicidal or homicidal, already engaged in addictions treatment, primarily addicted to nicotine or heroin.

-

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bridgeport Hospital	Bridgeport	Connecticut	United States	06106
2	Yale-New Haven Hospital	New Haven	Connecticut	United States	06510

Sponsors and Collaborators

• Yale University
• National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Kimberly A Yonkers, M.D., Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

• Hine CE, Howell HB, Yonkers KA. Integration of medical and psychological treatment within the primary health care setting. Soc Work Health Care. 2008;47(2):122-34. doi: 10.1080/00981380801970244. Review.
• Quesada O, Gotman N, Howell HB, Funai EF, Rounsaville BJ, Yonkers KA. Prenatal hazardous substance use and adverse birth outcomes. J Matern Fetal Neonatal Med. 2012 Aug;25(8):1222-7. doi: 10.3109/14767058.2011.602143. Epub 2012 May 11.
• Yonkers KA, Gotman N, Kershaw T, Forray A, Howell HB, Rounsaville BJ. Screening for prenatal substance use: development of the Substance Use Risk Profile-Pregnancy scale. Obstet Gynecol. 2010 Oct;116(4):827-833. doi: 10.1097/AOG.0b013e3181ed8290.
• Yonkers KA, Howell HB, Allen AE, Ball SA, Pantalon MV, Rounsaville BJ. A treatment for substance abusing pregnant women. Arch Womens Ment Health. 2009 Aug;12(4):221-7. doi: 10.1007/s00737-009-0069-2. Epub 2009 Apr 7.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT00227903
• Other Study ID Numbers: 0402026466; R01DA019135
• First Posted: Sep 28, 2005
• Last Update Posted: Apr 15, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Marijuana Abuse; Alcoholism; Cocaine-Related Disorders

Study Results

Participant Flow

Recruitment Details	Recruitment occurred between June 2006 and September 2009, with follow-up concluding in July 2010. Women were screened and recruited while attending obstetrical appointments in two hospital-based reproductive health clinics in New Haven and Bridgeport, CT.
Pre-assignment Detail	13 women who were consented to the trial and provisionally were found to be eligible either declined or failed to complete intake, 1 had an incomplete intake and 1 was found to be ineligible at intake

Arm/Group Title	Brief Advice	MI-CBT
Arm/Group Description	Advice and education	Motivationally-enhanced cognitive behavioral skills counseling
Period Title: Overall Study
STARTED	91	92
Received ≥ 1 Follow-up Assessment	86	82
COMPLETED	86	82
NOT COMPLETED	5	10

Baseline Characteristics

Arm/Group Title	Brief Advice	MI-CBT	Total
Arm/Group Description	Advice and education	Motivationally-enhanced cognitive behavioral skills counseling	Total of all reporting groups
Overall Participants	86	82	168
Age, Customized (participants) [Number]
<20 years	13 15.1%	16 19.5%	29 17.3%
20-34 years	65 75.6%	61 74.4%	126 75%
>35 years	8 9.3%	5 6.1%	13 7.7%
Sex: Female, Male (Count of Participants)
Female	86 100%	82 100%	168 100%
Male	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (participants) [Number]
White	17 19.8%	19 23.2%	36 21.4%
Black	47 54.7%	42 51.2%	89 53%
Hispanic	24 27.9%	19 23.2%	43 25.6%
Other	1 1.2%	2 2.4%	3 1.8%
Region of Enrollment (participants) [Number]
United States	86 100%	82 100%	168 100%
Education (years) (participants) [Number]
<12	26 30.2%	32 39%	58 34.5%
12	31 36%	35 42.7%	66 39.3%
13-15	23 26.7%	14 17.1%	37 22%
16+	6 7%	1 1.2%	7 4.2%
Parity (Count of Participants)
0	35 40.7%	31 37.8%	66 39.3%
1	27 31.4%	25 30.5%	52 31%
2+	24 27.9%	26 31.7%	50 29.8%
Gestational age at intake (participants) [Number]
Weeks 1-8	5 5.8%	3 3.7%	8 4.8%
Weeks 9-16	25 29.1%	28 34.1%	53 31.5%
Weeks 17-24	31 36%	27 32.9%	58 34.5%
Weeks 25 or later	25 29.1%	24 29.3%	49 29.2%
Prenatal care initiation (participants) [Number]
Weeks 1-8	21 24.4%	23 28%	44 26.2%
Weeks 9-16	47 54.7%	40 48.8%	87 51.8%
Weeks 17-24	13 15.1%	10 12.2%	23 13.7%
Week 25 or later	4 4.7%	5 6.1%	9 5.4%
Unknown	1 1.2%	4 4.9%	5 3%
Site (participants) [Number]
Bridgeport Hospital	22 25.6%	25 30.5%	47 28%
Yale New Haven Hospital	64 74.4%	57 69.5%	121 72%
MINI drug or alcohol abuse or dependence (participants) [Number]
Participants diagnosed with abuse or dependence	28 32.6%	19 23.2%	47 28%
Participants without such a diagnosis	58 67.4%	63 76.8%	121 72%
Past-month use (participants) [Number]
Alcohol (any)	33 38.4%	19 23.2%	52 31%
Alcohol (intoxication)	7 8.1%	9 11%	16 9.5%
Heroin	1 1.2%	3 3.7%	4 2.4%
Methadone	5 5.8%	8 9.8%	13 7.7%
Opiates (excluding methadone)	6 7%	4 4.9%	10 6%
Barbiturates	0 0%	0 0%	0 0%
Sedatives	5 5.8%	1 1.2%	6 3.6%
Cocaine	11 12.8%	7 8.5%	18 10.7%
Amphetamines	1 1.2%	0 0%	1 0.6%
Marijuana	40 46.5%	34 41.5%	74 44%
Hallucinogens	2 2.3%	1 1.2%	3 1.8%
Inhalants	0 0%	0 0%	0 0%
Primary Drug (participants) [Number]
Alcohol	25 29.1%	26 31.7%	51 30.4%
Cocaine	15 17.4%	14 17.1%	29 17.3%
Marijuana	40 46.5%	37 45.1%	77 45.8%
Other	6 7%	5 6.1%	11 6.5%

Outcome Measures

1. Primary Outcome

Title	Percentage of Days Used Drugs or Alcohol
Time Frame	intake to delivery, an average of 21 weeks

Outcome Measure Data

Analysis Population Description

all randomized participants

Arm/Group Title	Brief Advice	MI-CBT
Arm/Group Description	Advice and education	Motivationally-enhanced cognitive behavioral skills counseling
Measure Participants	86	82
Intake	18 (27)	21 (34)
Delivery	6 (17)	7 (22)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Brief Advice, MI-CBT
	Comments	We estimated that 110 people with 10% attrition would provide 80% power
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.88
	Comments	Not corrected for multiple comparison
	Method	Mixed Models Analysis
	Comments	2 degrees of freedom

2. Secondary Outcome

Title	Incidence of Preterm Births
Time Frame	At delivery

Outcome Measure Data

Analysis Population Description

A singleton live birth occurred in 163 subjects, and 5 had twins. Data was collected from the 84 women of the Brief Advice category and the 79 women of the MI-CBT category who had singleton live births.

Arm/Group Title	Brief Advice	MI-CBT
Arm/Group Description	Advice and education	Motivationally-enhanced cognitive behavioral skills counseling
Measure Participants	84	79
Number [preterm births]	17	8

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Brief Advice, MI-CBT
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.08
	Comments
	Method	Fisher Exact
	Comments

3. Primary Outcome

Title	Percentage of Days Used Drugs or Alcohol
Time Frame	delivery to 3 months post-delivery

Outcome Measure Data

Analysis Population Description

all randomized participants with data from delivery and 3 months post-delivery

Arm/Group Title	Brief Advice	MI-CBT
Arm/Group Description	Advice and education	Motivationally-enhanced cognitive behavioral skills counseling
Measure Participants	83	80
Delivery	6 (17)	7 (22)
3 months post-delivery	14 (25)	13 (24)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Brief Advice, MI-CBT
	Comments	We estimated that 110 people with 10% attrition would provide 80% power.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.88
	Comments	Not corrected for multiple comparison.
	Method	Mixed Models Analysis
	Comments	2 degrees of freedom

4. Secondary Outcome

Title	Incidence of Low Birth Weight
Time Frame	At delivery

Outcome Measure Data

Analysis Population Description

Only singleton live births, which occurred in 163 subjects, were analyzed. Three of the women in the MI-CBT group had an infant of unknown birth weight, and were not included in analysis.

Arm/Group Title	Brief Advice	MI-CBT
Arm/Group Description	Advice and education	Motivationally-enhanced cognitive behavioral skills counseling
Measure Participants	84	76
Number [low weight births]	17	11

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Brief Advice, MI-CBT
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.41
	Comments
	Method	Fisher Exact
	Comments

5. Secondary Outcome

Title	Proportion of Participants Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report
Time Frame	intake to delivery, an average of 21 weeks

Outcome Measure Data

Analysis Population Description

All randomized participants

Arm/Group Title	Brief Advice	MI-CBT
Arm/Group Description	Advice and education	Motivationally-enhanced cognitive behavioral skills counseling
Measure Participants	86	82
Intake	0.41 0.5%	0.49 0.6%
Delivery	0.75 0.9%	0.76 0.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Brief Advice, MI-CBT
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.79
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	.77
	Confidence Interval	(2-Sided) 95%; 0.36 to 1.67
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Proportion of Participants Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report
Time Frame	Delivery to 3 months post-delivery

Outcome Measure Data

Analysis Population Description

All randomized participants with data available from the time frame.

Arm/Group Title	Brief Advice	MI-CBT
Arm/Group Description	Advice and education	Motivationally-enhanced cognitive behavioral skills counseling
Measure Participants	83	80
Delivery	0.75 0.9%	0.76 0.9%
3 months post-delivery	0.38 0.4%	0.41 0.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Brief Advice, MI-CBT
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.79
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.05
	Confidence Interval	(2-Sided) 95%; 0.42 to 2.62
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	Proportion of Participants Abstinent From Drugs (i.e., Marijuana, Cocaine or Opioids) According to Urine
Time Frame	intake to delivery, an average of 21 weeks

Outcome Measure Data

Analysis Population Description

All randomized participants for whom urine test data was available.

Arm/Group Title	Brief Advice	MI-CBT
Arm/Group Description	Advice and education	Motivationally-enhanced cognitive behavioral skills counseling
Measure Participants	80	81
Intake	0.54 0.6%	0.56 0.7%
Delivery	0.84 1%	0.84 1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Brief Advice, MI-CBT
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.88
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.96
	Confidence Interval	(2-Sided) 95%; 0.34 to 2.72
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Secondary Outcome

Title	Proportion of Participants Abstinent From Drugs According to Urine
Description	Based on urine tests for marijuana, cocaine, or opioids
Time Frame	Delivery to 3 months post-delivery

Outcome Measure Data

Analysis Population Description

All randomized participants for whom urine data was available during the time frame.

Arm/Group Title	Brief Advice	MI-CBT
Arm/Group Description	Advice and education	Motivationally-enhanced cognitive behavioral skills counseling
Measure Participants	51	55
Delivery	0.84 1%	0.84 1%
3 months post-delivery	0.52 0.6%	0.59 0.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Brief Advice, MI-CBT
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.88
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.21
	Confidence Interval	(2-Sided) 95%; 0.57 to 2.57
	Parameter Dispersion	Type: Value:
	Estimation Comments

9. Secondary Outcome

Title	Proportion of Participants Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine
Description	Based on urine tests for marijuana, cocaine or opioids.
Time Frame	intake to delivery, an average of 21 weeks

Outcome Measure Data

Analysis Population Description

All randomized participants with both self-report and urine data available.

Arm/Group Title	Brief Advice	MI-CBT
Arm/Group Description	Advice and education	Motivationally-enhanced cognitive behavioral skills counseling
Measure Participants	80	81
Intake	0.33 0.4%	0.43 0.5%
Delivery	0.76 0.9%	0.75 0.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Brief Advice, MI-CBT
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.50
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.77
	Confidence Interval	(2-Sided) 95%; 0.32 to 1.84
	Parameter Dispersion	Type: Value:
	Estimation Comments

10. Primary Outcome

Title	Percentage of Days That Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol
Time Frame	intake to delivery, an average of 21 weeks

Outcome Measure Data

Analysis Population Description

All randomized participants without a baseline diagnosis of drug use or dependence.

Arm/Group Title	Brief Advice	MI-CBT
Arm/Group Description	Advice and education	Motivationally-enhanced cognitive behavioral skills counseling
Measure Participants	58	63
Intake	14 (25)	15 (27)
Delivery	4 (11)	6 (20)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Brief Advice, MI-CBT
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.10
	Comments
	Method	Mixed Models Analysis
	Comments

11. Primary Outcome

Title	Percentage of Days That Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol
Time Frame	Delivery to 3 months post-delivery

Outcome Measure Data

Analysis Population Description

All randomized participants without a baseline diagnosis for drug abuse or dependence with data available for time frame.

Arm/Group Title	Brief Advice	MI-CBT
Arm/Group Description	Advice and education	Motivationally-enhanced cognitive behavioral skills counseling
Measure Participants	55	62
Delivery	4 (11)	6 (20)
3 months post-delivery	11 (20)	14 (27)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Brief Advice, MI-CBT
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.10
	Comments
	Method	Mixed Models Analysis
	Comments

12. Primary Outcome

Title	Percentage of Days That Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol
Time Frame	intake to delivery, an average of 21 weeks

Outcome Measure Data

Analysis Population Description

All randomized participants with a baseline diagnosis for drug abuse or dependence.

Arm/Group Title	Brief Advice	MI-CBT
Arm/Group Description	Advice and education	Motivationally-enhanced cognitive behavioral skills counseling
Measure Participants	28	19
Intake	27 (29)	40 (45)
Delivery	10 (25)	13 (28)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Brief Advice, MI-CBT
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.10
	Comments
	Method	Mixed Models Analysis
	Comments

13. Primary Outcome

Title	Percentage of Days That Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol
Time Frame	Delivery to 3 months post-delivery

Outcome Measure Data

Analysis Population Description

All randomized participants with a baseline diagnosis of drug abuse or dependence and data available for the time frame.

Arm/Group Title	Brief Advice	MI-CBT
Arm/Group Description	Advice and education	Motivationally-enhanced cognitive behavioral skills counseling
Measure Participants	28	18
Delivery	10 (25)	13 (28)
3 months post-delivery	18 (32)	8 (8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Brief Advice, MI-CBT
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.10
	Comments
	Method	Mixed Models Analysis
	Comments

14. Secondary Outcome

Title	Proportion of Participants Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine
Description	Based on urine tests for marijuana, cocaine, or opioids.
Time Frame	Delivery to 3 months post-delivery

Outcome Measure Data

Analysis Population Description

All randomized participants with both self-report and urine data available during the time frame.

Arm/Group Title	Brief Advice	MI-CBT
Arm/Group Description	Advice and education	Motivationally-enhanced cognitive behavioral skills counseling
Measure Participants	51	55
Delivery	0.76 0.9%	0.75 0.9%
3 months post-delivery	0.34 0.4%	0.33 0.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Brief Advice, MI-CBT
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.50
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.76
	Confidence Interval	(2-Sided) 95%; 0.27 to 2.11
	Parameter Dispersion	Type: Value:
	Estimation Comments

15. Secondary Outcome

Title	Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report
Time Frame	intake to delivery, an average of 21 weeks

Outcome Measure Data

Analysis Population Description

All randomized participants without a baseline diagnosis of drug abuse or dependence.

Arm/Group Title	Brief Advice	MI-CBT
Arm/Group Description	Advice and education	Motivationally-enhanced cognitive behavioral skills counseling
Measure Participants	58	63
Intake	0.50 0.6%	0.52 0.6%
Delivery	0.76 0.9%	0.81 1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Brief Advice, MI-CBT
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.07
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.18
	Confidence Interval	(2-Sided) 95%; 0.44 to 3.14
	Parameter Dispersion	Type: Value:
	Estimation Comments

16. Secondary Outcome

Title	Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report
Time Frame	Delivery to 3 months post-delivery

Outcome Measure Data

Analysis Population Description

All randomized participants without a baseline diagnosis of drug abuse or dependence with data available for the time frame.

Arm/Group Title	Brief Advice	MI-CBT
Arm/Group Description	Advice and education	Motivationally-enhanced cognitive behavioral skills counseling
Measure Participants	55	62
Delivery	0.76 0.9%	0.81 1%
3 months post-delivery	0.28 0.3%	0.44 0.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Brief Advice, MI-CBT
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.07
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.46
	Confidence Interval	(2-Sided) 95%; 0.47 to 4.52
	Parameter Dispersion	Type: Value:
	Estimation Comments

17. Secondary Outcome

Title	Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report
Time Frame	intake to delivery, an average of 21 weeks

Outcome Measure Data

Analysis Population Description

All randomized participants with a baseline diagnosis of drug abuse or dependence.

Arm/Group Title	Brief Advice	MI-CBT
Arm/Group Description	Advice and education	Motivationally-enhanced cognitive behavioral skills counseling
Measure Participants	28	19
Intake	0.21 0.2%	0.37 0.5%
Delivery	0.71 0.8%	0.61 0.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Brief Advice, MI-CBT
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.07
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.28
	Confidence Interval	(2-Sided) 95%; 0.08 to 1.02
	Parameter Dispersion	Type: Value:
	Estimation Comments

18. Secondary Outcome

Title	Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report
Time Frame	Delivery to 3 months post-delivery

Outcome Measure Data

Analysis Population Description

All randomized participants with a baseline diagnosis of drug abuse or dependence and data available for the time frame.

Arm/Group Title	Brief Advice	MI-CBT
Arm/Group Description	Advice and education	Motivationally-enhanced cognitive behavioral skills counseling
Measure Participants	28	18
Delivery	0.71 0.8%	0.61 0.7%
3 months post-delivery	0.54 0.6%	0.31 0.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Brief Advice, MI-CBT
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.07
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.62
	Confidence Interval	(2-Sided) 95%; 0.10 to 3.90
	Parameter Dispersion	Type: Value:
	Estimation Comments

19. Secondary Outcome

Title	Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine
Description	Based on urine tests for marijuana, cocaine or opioids.
Time Frame	intake to delivery, an average of 21 weeks

Outcome Measure Data

Analysis Population Description

All randomized participants without a baseline diagnosis for drug abuse or dependence and with urine data.

Arm/Group Title	Brief Advice	MI-CBT
Arm/Group Description	Advice and education	Motivationally-enhanced cognitive behavioral skills counseling
Measure Participants	52	62
Intake	0.56 0.7%	0.60 0.7%
Delivery	0.82 1%	0.85 1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Brief Advice, MI-CBT
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.91
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.15
	Confidence Interval	(2-Sided) 95%; 0.32 to 4.20
	Parameter Dispersion	Type: Value:
	Estimation Comments

20. Secondary Outcome

Title	Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine
Description	Based on urine tests for marijuana, cocaine or opioids.
Time Frame	Delivery to 3 months post-delivery

Outcome Measure Data

Analysis Population Description

All randomized participants without a baseline diagnosis of drug abuse or dependence and urine data during the time frame.

Arm/Group Title	Brief Advice	MI-CBT
Arm/Group Description	Advice and education	Motivationally-enhanced cognitive behavioral skills counseling
Measure Participants	33	46
Delivery	0.82 1%	0.85 1%
3 months post-delivery	0.46 0.5%	0.58 0.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Brief Advice, MI-CBT
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.91
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.33
	Confidence Interval	(2-Sided) 95%; 0.35 to 5.07
	Parameter Dispersion	Type: Value:
	Estimation Comments

21. Secondary Outcome

Title	Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine
Description	Based on urine tests for marijuana, cocaine or opioids.
Time Frame	intake to delivery, an average of 21 weeks

Outcome Measure Data

Analysis Population Description

All randomized participants with a baseline diagnosis of drug abuse or dependence and urine data.

Arm/Group Title	Brief Advice	MI-CBT
Arm/Group Description	Advice and education	Motivationally-enhanced cognitive behavioral skills counseling
Measure Participants	28	19
Intake	0.50 0.6%	0.42 0.5%
Delivery	0.89 1%	0.78 1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Brief Advice, MI-CBT
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.91
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.85
	Confidence Interval	(2-Sided) 95%; 0.14 to 5.23
	Parameter Dispersion	Type: Value:
	Estimation Comments

22. Secondary Outcome

Title	Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine
Description	Based on urine tests for marijuana, cocaine or opioids.
Time Frame	Delivery to 3 months post-delivery

Outcome Measure Data

Analysis Population Description

All randomized participants with a baseline diagnosis of drug abuse or dependence and urine data.

Arm/Group Title	Brief Advice	MI-CBT
Arm/Group Description	Advice and education	Motivationally-enhanced cognitive behavioral skills counseling
Measure Participants	18	9
Delivery	0.89 1%	0.78 1%
3 months post-delivery	0.60 0.7%	0.63 0.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Brief Advice, MI-CBT
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.91
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.23
	Confidence Interval	(2-Sided) 95%; 0.21 to 7.12
	Parameter Dispersion	Type: Value:
	Estimation Comments

23. Secondary Outcome

Title	Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine
Description	Based on urine tests for marijuana, cocaine or opioids.
Time Frame	intake to delivery, an average of 21 weeks

Outcome Measure Data

Analysis Population Description

All randomized participants without a baseline diagnosis of drug abuse or dependence, and with both self-report and urine data.

Arm/Group Title	Brief Advice	MI-CBT
Arm/Group Description	Advice and education	Motivationally-enhanced cognitive behavioral skills counseling
Measure Participants	52	62
Intake	0.42 0.5%	0.47 0.6%
Delivery	0.76 0.9%	0.76 0.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Brief Advice, MI-CBT
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	.04
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.28
	Confidence Interval	(2-Sided) 95%; 0.46 to 3.55
	Parameter Dispersion	Type: Value:
	Estimation Comments

24. Secondary Outcome

Title	Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine
Description	Based on urine tests for marijuana, cocaine or opioids
Time Frame	Delivery to 3 months post-delivery

Outcome Measure Data

Analysis Population Description

All randomized participants without a baseline diagnosis of drug abuse or dependence, and with both self-report and urine data for the time frame.

Arm/Group Title	Brief Advice	MI-CBT
Arm/Group Description	Advice and education	Motivationally-enhanced cognitive behavioral skills counseling
Measure Participants	33	46
Delivery	0.76 0.9%	0.76 0.9%
3 months post-delivery	0.23 0.3%	0.35 0.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Brief Advice, MI-CBT
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.04
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.21
	Confidence Interval	(2-Sided) 95%; 0.35 to 4.17
	Parameter Dispersion	Type: Value:
	Estimation Comments

25. Secondary Outcome

Title	Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine
Description	Based on urine tests for marijuana, cocaine or opioids
Time Frame	intake to delivery, an average of 21 weeks

Outcome Measure Data

Analysis Population Description

All randomized participants with a baseline diagnosis for drug abuse or dependence, and with both self-report and urine data.

Arm/Group Title	Brief Advice	MI-CBT
Arm/Group Description	Advice and education	Motivationally-enhanced cognitive behavioral skills counseling
Measure Participants	28	19
Intake	0.14 0.2%	0.32 0.4%
Delivery	0.78 0.9%	0.67 0.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Brief Advice, MI-CBT
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.04
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.25
	Confidence Interval	(2-Sided) 95%; 0.04 to 1.63
	Parameter Dispersion	Type: Value:
	Estimation Comments

26. Secondary Outcome

Title	Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine
Description	Based on urine tests for marijuana, cocaine or opioids
Time Frame	Delivery to 3 months post-delivery

Outcome Measure Data

Analysis Population Description

All randomized participants with a baseline diagnosis of drug abuse or dependence, and with both self-report and urine data for the time frame.

Arm/Group Title	Brief Advice	MI-CBT
Arm/Group Description	Advice and education	Motivationally-enhanced cognitive behavioral skills counseling
Measure Participants	18	9
Delivery	0.78 0.9%	0.67 0.8%
3 months post-delivery	0.52 0.6%	0.25 0.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Brief Advice, MI-CBT
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.04
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.40
	Confidence Interval	(2-Sided) 95%; 0.04 to 3.74
	Parameter Dispersion	Type: Value:
	Estimation Comments

27. Other Pre-specified Outcome

Title	Adequacy of Received Services
Description	Based on prenatal care attendance: the percent of visits attended after prenatal care initiation, accounting for time of delivery. Attendance was rated according to the Kotelchuck Adequacy of Prenatal Care Index. Only the normally scheduled prenatal car visits were included.
Time Frame	After prenatal care initiation

Outcome Measure Data

Analysis Population Description

All randomized participants, 6 women had unkown attendance.

Arm/Group Title	Brief Advice	MI-CBT
Arm/Group Description	Advice and education	Motivationally-enhanced cognitive behavioral skills counseling
Measure Participants	86	82
Inadequate (0-49% attendance)	2 2.3%	2 2.4%
Intermediate (50%-79% attendance)	7 8.1%	13 15.9%
Adequate (80%-109% attendance)	24 27.9%	33 40.2%
Adequate plus (110+%)	51 59.3%	30 36.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Brief Advice, MI-CBT
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.01
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

28. Other Pre-specified Outcome

Title	Attendance of Treatment Outside the Study
Description	The number of patients who attended outside treatment in the 30 days prior to each assessment.
Time Frame	30 days prior to assessment

Outcome Measure Data

Analysis Population Description

all randomized participants with data availabe at time frames

Arm/Group Title	Brief Advice	MI-CBT
Arm/Group Description	Advice and education	Motivationally-enhanced cognitive behavioral skills counseling
Measure Participants	86	82
Participants who attended prior to delivery	4 4.7%	6 7.3%
Participants who attended prior to 3 months post	9 10.5%	6 7.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Brief Advice, MI-CBT
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Chi-squared
	Comments

Adverse Events

Arm/Group Title	Brief Advice		MI-CBT
Arm/Group Description	Advice and education		Motivationally-enhanced cognitive behavioral skills counseling
All Cause Mortality
	Brief Advice		MI-CBT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Brief Advice		MI-CBT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/86 (0%)		0/82 (0%)
Other (Not Including Serious) Adverse Events
	Brief Advice		MI-CBT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/86 (0%)		0/82 (0%)

Limitations/Caveats

Did not acheive desired sample size; results were averaged across substances; women were not seeking substance abuse treatment (i.e. they were attending for prenatal care); treatment was brief

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.