Screening and Brief Advice to Reduce Teen Substance Use

• Sponsor: Boston Children's Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00227877
• Collaborator: Cambridge Health Alliance (Other), Concord Hospital (Other), Fallon Clinic (Industry), Tufts Medical Center (Other), University of Vermont (Other)
• Enrollment: 2,695
• Locations: 6
• Arms: 4
• Actual Duration (Months): 50
• Patients Per Site: 449.2
• Patients Per Site Per Month: 9

Study Details

Study Description

Brief Summary

The purpose of this study is to test the effectiveness of a brief intervention for alcohol and drug use in adolescents that a primary care doctor can give in his/her office. The study will be conducted in nine primary care offices in three New England states, and in ten pediatric offices in Prague, Czech Republic (CZR).

We hypothesize that:

1. Among 12-18 year old well care patients who screen positive for drug/alcohol use, the experimental intervention administered by trained primary care providers will be more effective than standard care in decreasing drug and alcohol use;

2. Among 12-18 year old well care patients who screen negative for drug/alcohol use, the experimental intervention administered by trained primary care providers will be more effective than standard care in decreasing initiation of drug and alcohol use as measured by self-reports of substance use;

3. Among 12-18 year old well care patients who are at risk for riding with an impaired driver or driving while impaired, the experimental intervention administered by trained primary care providers will be more effective than standard care in decreasing Riding/Driving risk behavior as measured by a standardized scale.

Condition or Disease	Intervention/Treatment	Phase
Substance Related Disorders	Behavioral: cSBA - New England, USA; Behavioral: cSBA - Prague, CZR	N/A

Detailed Description

We are trying to find out the best way for doctors to talk with their adolescent patients about alcohol and drug use. Adolescents 12-18 who are coming to their doctor's office for a routine well-care or follow-up visit will be invited to participate in the study. Participants do not have to have ever used alcohol or drugs. All participants will answer a computerized questionnaire about alcohol and drug use three times. The first one will be at the time of a doctor's visit. The second time will be three months later and the third time a year later. Adolescents who agree to be in the study during the first year will be in the 'control' group. Their doctor will talk to them about drugs and alcohol the same as he/she usually does for all his/her patients. Those who agree to be in the study during the second year will be in the 'intervention' group. Everyone in the 'intervention' group will receive some advice on the computer about their alcohol and drug use. Their doctor will also give them some specific advice about drug and alcohol use. The researchers have chosen what that advice will be, and all doctors involved in the study will give advice according to the study protocol. Participants and their parents will also be given educational information about alcohol and drugs. We will test the effectiveness of the intervention by comparing drug and alcohol use between those who are in the 'control' group, and those who are in the 'intervention' group.

We we will also validate the Czech version of the CRAFFT screen before conducting the effectiveness trial outlined above in the Czech Republic.

Study Design

• Study Type: Interventional
• Actual Enrollment: 2695 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: In this before-/after- quasi-experimental trial, all sites first completed a treatment-as-usual phase with assessments only, followed by all sites undergoing training and completing a subsequent intervention phase.In this before-/after- quasi-experimental trial, all sites first completed a treatment-as-usual phase with assessments only, followed by all sites undergoing training and completing a subsequent intervention phase.
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Screening and Brief Advice to Reduce Teen Substance Use
• Actual Study Start Date: Dec 1, 2005
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Feb 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control - New England, USA Control participants will receive "care as usual" from their provider
Experimental: cSBA - New England, USA Participants who are in the experimental arm will complete the CRAFFT screen on the computer and receive information on the computer regarding the health effects of substance use. Their provider will be given the results of their CRAFFT screen and a list of suggested "talking points" which they will use to guide a discussion with the patient about drug and alcohol use. Participants and their families will also receive educational brochures about substance use.	Behavioral: cSBA - New England, USA; Participants who are in the experimental arm will complete the CRAFFT screen on the computer and receive information on the computer regarding the health effects of substance use. Their provider will be given the results of their CRAFFT screen and a list of suggested "talking point" which they will use to guide a discussion with the patient about drug and alcohol use. Participants and their families will also receive educational brochures about substance use.; Other Names: SBIRT
No Intervention: Control - Prague, CZR Control participants will receive "care as usual" from their provider
Experimental: cSBA - Prague, CZR Participants who are in the experimental arm will complete the CRAFFT screen on the computer and receive information on the computer regarding the health effects of substance use. Their provider will be given the results of their CRAFFT screen and a list of suggested "talking points" which they will use to guide a discussion with the patient about drug and alcohol use. Participants and their families will also receive educational brochures about substance use.	Behavioral: cSBA - Prague, CZR; Participants who are in the experimental arm will complete the CRAFFT screen on the computer and receive information on the computer regarding the health effects of substance use. Their provider will be given the results of their CRAFFT screen and a list of suggested "talking point" which they will use to guide a discussion with the patient about drug and alcohol use. Participants and their families will also receive educational brochures about substance use.; Other Names: SBIRT

Outcome Measures

Primary Outcome Measures

1. Past-90-day Substance Use at 3 Months Among Baseline Substance Users - New England, USA [Past-90-days at 3 months post-baseline]

   Among the 12-18 year old primary care patients who reported past-12-month drug or alcohol use at baseline in New England, USA, this analysis reports the number who subsequently reported past-90-day drug or alcohol use at the 3 months post-baseline assessment.

2. Past-90-day Substance Use at 3 Months Among Baseline Substance Non-Users, New England, USA [Past-90-days at 3 months post-baseline]

   Among the 12-18 year old primary care patients who did NOT report past-12-month drug or alcohol use at baseline in New England, USA, this analysis reports the number who subsequently reported past-90-day drug or alcohol use at the 3 months post-baseline assessment.

3. Past-12-month Substance Use at 12 Months Among Baseline Substance Users, New England, USA [Past-12-months at 12 months post-baseline]

   Of those participants who reported past-12-month drug or alcohol use at baseline,the number reporting past-90-day drug or alcohol use at 12 months post-baseline assessment in New England, USA

4. Past-12-month Substance Use at 12 Months, Baseline Substance Non-Users, New England, USA [Past-12-months at 12 months post-baseline]

   Of those participants who reported NO past-12-month drug or alcohol use at baseline,the number reporting past-90-day drug or alcohol use at 12 months post-baseline assessment in New England, USA

5. Past-90-day Substance Use at 3 Months Among Baseline Substance Users - Prague, CZR [Past-90-days at 3 months post-baseline]

   Of those participants who reported past-12-month drug or alcohol use at baseline,the number reporting past-90-day drug or alcohol use at 3 months post-baseline assessment in Prague, Czech Republic

6. Past-90-day Substance Use at 3 Months Among Baseline Substance Non-Users - Prague, CZR [Past-90-days at 3 months post-baseline]

   Of those participants who reported NO past-12-month drug or alcohol use at baseline,the number reporting past-90-day drug or alcohol use at 3 months post-baseline assessment in Prague, Czech Republic

7. Past-12-Month Substance Use at 12 Months Among Baseline Substance Users - Prague, CZR [Past-12-months at 12 months post-baseline]

   Of those participants who reported past-12-month drug or alcohol use at baseline,the number reporting past-12-month drug or alcohol use at 12 months post-baseline assessment in Prague, Czech Republic

8. Past-12-Month Substance Use at 12 Months Among Baseline Substance Non-Users - Prague, CZR [Past-12-months at 12 months post-baseline]

   Of those participants who reported past-12-month drug or alcohol use at baseline,the number reporting past-12-month drug or alcohol use at 12 months post-baseline assessment in Prague, Czech Republic

Secondary Outcome Measures

1. Any Risky Riding or Driving at 3 Months - New England, USA [Past-90-days at 3 months post-baseline]

   Any past-90-day self-reported Riding with a driver who had used alcohol or other drugs or Driving after having used alcohol or other drugs at 3 months post-baseline assessment - New England

2. Any Risky Riding or Driving at 12 Months - New England, USA [Past-90-days at 12 months post-baseline]

   Any past-90-day self-reported Riding with a driver who had used alcohol or other drugs or Driving after having used alcohol or other drugs at 12 months post-baseline assessment - New England

3. Any Risky Riding or Driving at 3 Months - Prague, CZR [Past-90-days at 3 months post-baseline]

   Any past-90-day self-reported Riding with a driver who had used alcohol or other drugs or Driving after having used alcohol or other drugs at 3 months post-baseline assessment - Prague, Czech Republic

4. Any Risky Riding or Driving at 12 Months - Prague, CZR [Past-90-days at 12 months post-baseline]

   Any past-90-day self-reported Riding with a driver who had used alcohol or other drugs or Driving after having used alcohol or other drugs at 12 months post-baseline assessment - Prague, Czech Republic

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

12-18 year old patients coming for well care or follow-up visits to one of the study sites, All levels of substance use, Able to read and understand English

Exclusion Criteria:

Will not be available for 12 month follow-up period, Medically unstable at the time of the visit

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tufts-New England Medical Center	Boston	Massachusetts	United States	02111
2	Cambridge Pediatrics	Cambridge	Massachusetts	United States	02139
3	Fallon Clinic	Worcester	Massachusetts	United States	01605
4	Capital Region Family Health Center	Concord	New Hampshire	United States	03301
5	Milton Family Practice	Milton	Vermont	United States	05468
6	Center for the Evaluation, Prevention, and Research of Substance Abuse	Prague		Czechia

Sponsors and Collaborators

• Boston Children's Hospital
• Cambridge Health Alliance
• Concord Hospital
• Fallon Clinic
• Tufts Medical Center
• University of Vermont

Investigators

• Principal Investigator: John R Knight, M.D., Boston Children's Hospital

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• This is the web site of the Center for Adolescent Substance Use and Addiction Research (CeASAR) at Children's Hospital Boston. CeASAR is the research center funded to direct this project.

Publications

• Knight JR, Harris SK, Sherritt L, Van Hook S, Lawrence N, Brooks T, Carey P, Kossack R, Kulig J. Adolescents' preference for substance abuse screening in primary care practice. Subst Abus. 2007;28(4):107-17.
• Knight JR, Harris SK, Sherritt L, Van Hook S, Lawrence N, Brooks T, Carey P, Kossack R, Kulig J. Prevalence of positive substance abuse screen results among adolescent primary care patients. Arch Pediatr Adolesc Med. 2007 Nov;161(11):1035-41.
• Knight JR, Sherritt L, Shrier LA, Harris SK, Chang G. Validity of the CRAFFT substance abuse screening test among adolescent clinic patients. Arch Pediatr Adolesc Med. 2002 Jun;156(6):607-14.
• Knight JR, Shrier LA, Bravender TD, Farrell M, Vander Bilt J, Shaffer HJ. A new brief screen for adolescent substance abuse. Arch Pediatr Adolesc Med. 1999 Jun;153(6):591-6.
• Van Hook S, Harris SK, Brooks T, Carey P, Kossack R, Kulig J, Knight JR; New England Partnership for Substance Abuse Research. The "Six T's": barriers to screening teens for substance abuse in primary care. J Adolesc Health. 2007 May;40(5):456-61. Epub 2007 Feb 15.

• Responsible Party: John R Knight, MD, Associate Professor of Pediatrics, Harvard Medical School, Boston Children's Hospital
• ClinicalTrials.gov Identifier: NCT00227877
• Other Study ID Numbers: NIDA-R01DA0118848; NCT00592878; NCT00592956
• First Posted: Sep 28, 2005
• Last Update Posted: Aug 14, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by John R Knight, MD, Associate Professor of Pediatrics, Harvard Medical School, Boston Children's Hospital: alcohol abuse; substance abuse; substance related disorders
• Additional relevant MeSH terms: Substance-Related Disorders

Study Results

Participant Flow

Recruitment Details	Quasi-experimental, asynchronous study design with each site as its own control. From 2005 to 2008, 12- to 18-year-olds arriving for routine care at 9 medical offices in New England (n= 2096, 58% females) and 10 in Prague, Czech Republic (n = 589, 47% females) were recruited. Medically/emotionally stable, able to read, and available for follow-ups.

Arm/Group Title	Control - New England	cSBA - New England	Control - Czech Republic	cSBA - Czech Republic
Arm/Group Description	Control participants received "care as usual" from their provider	Computer screen & brief physician advice: Participants in the experimental arm completed a computerized CRAFFT screen and received information on the computer regarding the health effects of substance use. Their provider was given the results of their CRAFFT screen and a list of suggested "talking points" which guided a discussion with the patient about drug and alcohol use.	Control participants received "care as usual" from their provider	Computer screen & brief physician advice: Participants in the experimental arm completed a computerized CRAFFT screen and received information on the computer regarding the health effects of substance use. Their provider was given the results of their CRAFFT screen and a list of suggested "talking points" to guide a discussion with the patient about drug and alcohol use.
Period Title: Pre-visit Assessment
STARTED	1075	1031	297	292
COMPLETED	1068	1028	297	292
NOT COMPLETED	7	3	0	0
Period Title: Pre-visit Assessment
STARTED	1068	1028	297	292
COMPLETED	1044	1015	296	292
NOT COMPLETED	24	13	1	0
Period Title: Pre-visit Assessment
STARTED	1068	1028	297	292
COMPLETED	755	761	245	271
NOT COMPLETED	313	267	52	21
Period Title: Pre-visit Assessment
STARTED	1068	1028	297	292
COMPLETED	758	765	266	266
NOT COMPLETED	310	263	31	26

Baseline Characteristics

Arm/Group Title	Control - New England	Computer Screen & Brief Physician Advice - New England	Control - Czech Republic	Computer Screen & Brief Physician Advice - Czech Republic	Total
Arm/Group Description	Control participants will receive "care as usual" from their provider	Participants who are in the experimental arm will complete the CRAFFT screen on the computer and receive information on the computer regarding the health effects of substance use. Their provider will be given the results of their CRAFFT screen and a list of suggested "talking points" which they will use to guide a discussion with the patient about drug and alcohol use. Participants and their families will also receive educational brochures about substance use. Computer screen & brief physician advice: Participants who are in the experimental arm will complete the CRAFFT screen on the computer and receive information on the computer regarding the health effects of substance use. Their provider will be given the results of their CRAFFT screen and a list of suggested "talking point" which they will use to guide a discussion with the patient about drug and alcohol use. Participants and their families will also receive educational brochures about substance use.	Control participants will receive "care as usual" from their provider	Participants who are in the experimental arm will complete the CRAFFT screen on the computer and receive information on the computer regarding the health effects of substance use. Their provider will be given the results of their CRAFFT screen and a list of suggested "talking points" which they will use to guide a discussion with the patient about drug and alcohol use. Participants and their families will also receive educational brochures about substance use. Computer screen & brief physician advice: Participants who are in the experimental arm will complete the CRAFFT screen on the computer and receive information on the computer regarding the health effects of substance use. Their provider will be given the results of their CRAFFT screen and a list of suggested "talking point" which they will use to guide a discussion with the patient about drug and alcohol use. Participants and their families will also receive educational brochures about substance use.	Total of all reporting groups
Overall Participants	1068	1028	297	292	2685
Age (years) [Mean (Standard Deviation) ]
Age	15.9 (2.0)	15.6 (2.0)	15.0 (1.6)	15.0 (1.6)	15.8 (2.0)
Sex: Female, Male (Count of Participants)
Female	659 61.7%	561 54.6%	139 46.8%	139 47.6%	1498 55.8%
Male	409 38.3%	467 45.4%	158 53.2%	153 52.4%	1187 44.2%
Race/Ethnicity, Customized (Count of Participants)
White non-Hispanic	689 64.5%	664 64.6%	297 100%	292 100%	1942 72.3%
Hispanic	106 9.9%	124 12.1%	0 0%	0 0%	230 8.6%
Asian non-Hispanic	77 7.2%	74 7.2%	0 0%	0 0%	151 5.6%
Black non-Hispanic	100 9.4%	117 11.4%	0 0%	0 0%	217 8.1%
Other non-Hispanic	96 9%	49 4.8%	0 0%	0 0%	145 5.4%
Parents at Home (Count of Participants)
Two parents	703 65.8%	721 70.1%	184 62%	195 66.8%	1803 67.2%
One parent or Other	341 31.9%	294 28.6%	107 36%	97 33.2%	839 31.2%
Parents Highest Education Level (Count of Participants)
College/university degree or higher	451 42.2%	522 50.8%	92 31%	100 34.2%	1165 43.4%
High school/Secondary school graduate	427 40%	405 39.4%	111 37.4%	106 36.3%	1049 39.1%
Did not complete high school/secondary school	46 4.3%	33 3.2%	44 14.8%	46 15.8%	169 6.3%
Don't know	99 9.3%	42 4.1%	43 14.5%	38 13%	222 8.3%
Visit type (Count of Participants)
Yes	851 79.7%	968 94.2%	297 100%	292 100%	2408 89.7%
No	199 18.6%	51 5%	0 0%	0 0%	250 9.3%
Yes	115 10.8%	105 10.2%	0 0%	0 0%	220 8.2%
No	930 87.1%	914 88.9%	0 0%	0 0%	1844 68.7%
Yes	663 62.1%	684 66.5%	263 88.6%	259 88.7%	1869 69.6%
No	391 36.6%	335 32.6%	33 11.1%	33 11.3%	792 29.5%
Parent Substance Use (Count of Participants)
Count of Participants [Participants]	170 15.9%	152 14.8%	32 10.8%	32 11%	386 14.4%
Sibling Substance Abuse (Count of Participants)
Count of Participants [Participants]	205 19.2%	187 18.2%	41 13.8%	36 12.3%	469 17.5%
Peer substance abuse (Count of Participants)
Count of Participants [Participants]	658 61.6%	607 59%	204 68.7%	192 65.8%	1661 61.9%

Outcome Measures

1. Primary Outcome

Title	Past-90-day Substance Use at 3 Months Among Baseline Substance Users - New England, USA
Description	Among the 12-18 year old primary care patients who reported past-12-month drug or alcohol use at baseline in New England, USA, this analysis reports the number who subsequently reported past-90-day drug or alcohol use at the 3 months post-baseline assessment.
Time Frame	Past-90-days at 3 months post-baseline

Outcome Measure Data

Analysis Population Description

12-18 year old primary care patients who report past-12-month drug or alcohol use at baseline in New England, USA

Arm/Group Title	Control - New England, USA	Computer Screen & Brief Physician Advice - New England, USA
Arm/Group Description	Control participants received "care as usual" from their providers	Participants in the experimental arm completed the CRAFFT screen on the computer and received information on the computer regarding the health effects of substance use. Their providers were given the results of their CRAFFT screen and a list of suggested "talking points" which they used to guide a discussion with the patient about drug and alcohol use. Participants and their families also received educational brochures about substance use.
Measure Participants	260	222
Count of Participants [Participants]	162 15.2%	121 11.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control - New England, USA, Computer Screen & Brief Physician Advice - New England, USA
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	< 0.05
	Comments
	Method	Regression, Logistic
	Comments	Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)
Method of Estimation	Estimation Parameter	Adjusted Relative Risk Ratio
	Estimated Value	1.39
	Confidence Interval	(2-Sided) 95%; 1.08 to 1.80
	Parameter Dispersion	Type: Standard Error of the Mean; Value: .18
	Estimation Comments	Risk Ratio: (Intervention Cessation)/(Control Cessation) controlling for age; gender; parent education; number of parents in home; visit type; perceived parent, sibling, and peer substance use; provider gender; and connectedness to provider.

2. Primary Outcome

Title	Past-90-day Substance Use at 3 Months Among Baseline Substance Non-Users, New England, USA
Description	Among the 12-18 year old primary care patients who did NOT report past-12-month drug or alcohol use at baseline in New England, USA, this analysis reports the number who subsequently reported past-90-day drug or alcohol use at the 3 months post-baseline assessment.
Time Frame	Past-90-days at 3 months post-baseline

Outcome Measure Data

Analysis Population Description

12-18 year old primary care patients who did not report past-12-month drug or alcohol use at baseline in New England, USA

Arm/Group Title	Control - New England, USA	cSBA - New England, USA
Arm/Group Description	Control participants received "care as usual" from their provider	Computer Screen & Brief physician Advice: Participants in the experimental arm completed a computerized CRAFFT screen and received information on the computer regarding the health effects of substance use. Their provider was given the results of their CRAFFT screen and a list of suggested "talking points" which guided a discussion with the patient about drug and alcohol use.
Measure Participants	494	539
Count of Participants [Participants]	24 2.2%	15 1.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control - New England, USA, Computer Screen & Brief Physician Advice - New England, USA
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.32
	Comments
	Method	Regression, Logistic
	Comments	Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)
Method of Estimation	Estimation Parameter	Adjusted Relative Risk Ratio
	Estimated Value	0.70
	Confidence Interval	(2-Sided) 95%; 0.34 to 1.42
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.25
	Estimation Comments	Risk Ratio: (Intervention Initiation)/(Control Initiation) controlling for age; gender; parent education; number of parents in home; visit type; perceived parent, sibling, and peer substance use; provider gender; and connectedness to provider.

3. Primary Outcome

Title	Past-12-month Substance Use at 12 Months Among Baseline Substance Users, New England, USA
Description	Of those participants who reported past-12-month drug or alcohol use at baseline,the number reporting past-90-day drug or alcohol use at 12 months post-baseline assessment in New England, USA
Time Frame	Past-12-months at 12 months post-baseline

Outcome Measure Data

Analysis Population Description

12-18 year old primary care patients who reported past-12-month drug or alcohol use at baseline in New England, USA

Arm/Group Title	Control - New England, USA	Computer Screen & Brief Physician Advice - New England, USA
Arm/Group Description	Control participants received "care as usual" from their providers	Participants in the experimental arm completed the CRAFFT screen on the computer and received information on the computer regarding the health effects of substance use. Their providers were given the results of their CRAFFT screen and a list of suggested "talking points" which they used to guide a discussion with the patient about drug and alcohol use. Participants and their families also received educational brochures about substance use.
Measure Participants	257	209
Count of Participants [Participants]	214 20%	172 16.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control - New England, USA, Computer Screen & Brief Physician Advice - New England, USA
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	Regression, Logistic
	Comments	Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)
Method of Estimation	Estimation Parameter	Adjusted Relative Risk Ratio
	Estimated Value	1.80
	Confidence Interval	(2-Sided) 95%; .99 to 3.27
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.55
	Estimation Comments
Other Statistical Analysis		Risk Ratio: (Intervention Cessation)/(Control Cessation) controlling for age; gender; parent education; number of parents in home; visit type; perceived parent, sibling, and peer substance use; provider gender; and connectedness to provider.

4. Primary Outcome

Title	Past-12-month Substance Use at 12 Months, Baseline Substance Non-Users, New England, USA
Description	Of those participants who reported NO past-12-month drug or alcohol use at baseline,the number reporting past-90-day drug or alcohol use at 12 months post-baseline assessment in New England, USA
Time Frame	Past-12-months at 12 months post-baseline

Outcome Measure Data

Analysis Population Description

12-18 year old primary care patients who did not report past-12-month drug or alcohol use at baseline in New England, USA

Arm/Group Title	Control - New England, USA	cSBA - New England, USA
Arm/Group Description	Control participants received "care as usual" from their provider	Computer Screen & Brief physician Advice: Participants in the experimental arm completed a computerized CRAFFT screen and received information on the computer regarding the health effects of substance use. Their provider was given the results of their CRAFFT screen and a list of suggested "talking points" which guided a discussion with the patient about drug and alcohol use.
Measure Participants	500	556
Count of Participants [Participants]	83 7.8%	73 7.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control - New England, USA, Computer Screen & Brief Physician Advice - New England, USA
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.23
	Comments
	Method	Regression, Logistic
	Comments	Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)
Method of Estimation	Estimation Parameter	Adjusted Relative Risk Ratio
	Estimated Value	.79
	Confidence Interval	(2-Sided) 95%; .53 to 1.16
	Parameter Dispersion	Type: Standard Error of the Mean; Value: .16
	Estimation Comments	Risk Ratio: (Intervention Initiation)/(Control Initiation) controlling for age; gender; parent education; number of parents in home; visit type; perceived parent, sibling, and peer substance use; provider gender; and connectedness to provider.

5. Primary Outcome

Title	Past-90-day Substance Use at 3 Months Among Baseline Substance Users - Prague, CZR
Description	Of those participants who reported past-12-month drug or alcohol use at baseline,the number reporting past-90-day drug or alcohol use at 3 months post-baseline assessment in Prague, Czech Republic
Time Frame	Past-90-days at 3 months post-baseline

Outcome Measure Data

Analysis Population Description

12-18 year old primary care patients who reported past-12-month drug or alcohol use at baseline in Prague, CZR

Arm/Group Title	Control - Prague, CZR	cSBA - Prague, CZR
Arm/Group Description	Control participants received "care as usual" from their provider	Computer Screen & Brief physician Advice: Participants in the experimental arm completed a computerized CRAFFT screen and received information on the computer regarding the health effects of substance use. Their provider was given the results of their CRAFFT screen and a list of suggested "talking points" which guided a discussion with the patient about drug and alcohol use.
Measure Participants	157	161
Count of Participants [Participants]	118 11%	114 11.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control - New England, USA, Computer Screen & Brief Physician Advice - New England, USA
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.07
	Comments
	Method	Regression, Logistic
	Comments	Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)
Method of Estimation	Estimation Parameter	Adjusted Relative Risk Ratio
	Estimated Value	1.52
	Confidence Interval	(2-Sided) 95%; .97 to 2.36
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.34
	Estimation Comments	Risk Ratio: (Intervention Cessation)/(Control Cessation) controlling for age and gender.

6. Primary Outcome

Title	Past-90-day Substance Use at 3 Months Among Baseline Substance Non-Users - Prague, CZR
Description	Of those participants who reported NO past-12-month drug or alcohol use at baseline,the number reporting past-90-day drug or alcohol use at 3 months post-baseline assessment in Prague, Czech Republic
Time Frame	Past-90-days at 3 months post-baseline

Outcome Measure Data

Analysis Population Description

12-18 year old primary care patients who did not report past-12-month drug or alcohol use at baseline in Prague, CZR

Arm/Group Title	Control - Prague, CZR	cSBA - Prague, CZR
Arm/Group Description	Control participants received "care as usual" from their provider	Computer Screen & Brief physician Advice: Participants in the experimental arm completed a computerized CRAFFT screen and received information on the computer regarding the health effects of substance use. Their provider was given the results of their CRAFFT screen and a list of suggested "talking points" which guided a discussion with the patient about drug and alcohol use.
Measure Participants	88	110
Count of Participants [Participants]	10 0.9%	13 1.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control - New England, USA, Computer Screen & Brief Physician Advice - New England, USA
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.93
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Adjusted Relative Risk Ratio
	Estimated Value	.96
	Confidence Interval	(2-Sided) 95%; .42 to 2.21
	Parameter Dispersion	Type: Standard Error of the Mean; Value: .41
	Estimation Comments	Risk Ratio: (Intervention Initiation)/(Control Initiation) controlling for age and gender.

7. Primary Outcome

Title	Past-12-Month Substance Use at 12 Months Among Baseline Substance Users - Prague, CZR
Description	Of those participants who reported past-12-month drug or alcohol use at baseline,the number reporting past-12-month drug or alcohol use at 12 months post-baseline assessment in Prague, Czech Republic
Time Frame	Past-12-months at 12 months post-baseline

Outcome Measure Data

Analysis Population Description

12-18 year old primary care patients who reported past-12-month drug or alcohol use at baseline in Prague, CZR

Arm/Group Title	Control - Prague, CZR	cSBA - Prague, CZR
Arm/Group Description	Control participants received "care as usual" from their provider	Computer Screen & Brief physician Advice: Participants in the experimental arm completed a computerized CRAFFT screen and received information on the computer regarding the health effects of substance use. Their provider was given the results of their CRAFFT screen and a list of suggested "talking points" which guided a discussion with the patient about drug and alcohol use.
Measure Participants	163	153
Count of Participants [Participants]	154 14.4%	148 14.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control - New England, USA, Computer Screen & Brief Physician Advice - New England, USA
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.78
	Comments
	Method	Regression, Logistic
	Comments	Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)
Method of Estimation	Estimation Parameter	Adjusted Relative Risk Ratio
	Estimated Value	.85
	Confidence Interval	(2-Sided) 95%; .27 to 2.70
	Parameter Dispersion	Type: Standard Error of the Mean; Value: .50
	Estimation Comments	Risk Ratio: (Intervention Cessation)/(Control Cessation) controlling for age and gender.

8. Primary Outcome

Title	Past-12-Month Substance Use at 12 Months Among Baseline Substance Non-Users - Prague, CZR
Description	Of those participants who reported past-12-month drug or alcohol use at baseline,the number reporting past-12-month drug or alcohol use at 12 months post-baseline assessment in Prague, Czech Republic
Time Frame	Past-12-months at 12 months post-baseline

Outcome Measure Data

Analysis Population Description

12-18 year old primary care patients who did not report past-12-month drug or alcohol use at baseline in Prague, CZR

Arm/Group Title	Control - Prague, CZR	cSBA - Prague, CZR
Arm/Group Description	Control participants received "care as usual" from their provider	Computer Screen & Brief physician Advice: Participants in the experimental arm completed a computerized CRAFFT screen and received information on the computer regarding the health effects of substance use. Their provider was given the results of their CRAFFT screen and a list of suggested "talking points" which guided a discussion with the patient about drug and alcohol use.
Measure Participants	103	111
Count of Participants [Participants]	48 4.5%	38 3.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control - New England, USA, Computer Screen & Brief Physician Advice - New England, USA
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.13
	Comments
	Method	Regression, Logistic
	Comments	Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)
Method of Estimation	Estimation Parameter	Adjusted Relative Risk Ratio
	Estimated Value	.74
	Confidence Interval	(2-Sided) 95%; .51 to 1.09
	Parameter Dispersion	Type: Standard Error of the Mean; Value: .15
	Estimation Comments	Risk Ratio: (Intervention Initiation)/(Control Initiation) controlling for age and gender.

9. Secondary Outcome

Title	Any Risky Riding or Driving at 3 Months - New England, USA
Description	Any past-90-day self-reported Riding with a driver who had used alcohol or other drugs or Driving after having used alcohol or other drugs at 3 months post-baseline assessment - New England
Time Frame	Past-90-days at 3 months post-baseline

Outcome Measure Data

Analysis Population Description

12-18 year old primary care patients in New England, USA

Arm/Group Title	Control - New England, USA	cSBA - New England, USA
Arm/Group Description	Control participants received "care as usual" from their provider	Computer Screen & Brief physician Advice: Participants in the experimental arm completed a computerized CRAFFT screen and received information on the computer regarding the health effects of substance use. Their provider was given the results of their CRAFFT screen and a list of suggested "talking points" which guided a discussion with the patient about drug and alcohol use.
Measure Participants	754	758
Count of Participants [Participants]	150 14%	88 8.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control - New England, USA, Computer Screen & Brief Physician Advice - New England, USA
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.66
	Comments
	Method	Regression, Logistic
	Comments	Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)
Method of Estimation	Estimation Parameter	Adjusted Relative Risk Ratio
	Estimated Value	.66
	Confidence Interval	(2-Sided) 95%; .48 to .91
	Parameter Dispersion	Type: Standard Error of the Mean; Value: .11
	Estimation Comments	Risk Ratio: (Intervention)/(Control) controlling for age; gender; parent education; number of parents in home; visit type; provider gender; connectedness to provider, and baseline DRWI risk.

10. Secondary Outcome

Title	Any Risky Riding or Driving at 12 Months - New England, USA
Description	Any past-90-day self-reported Riding with a driver who had used alcohol or other drugs or Driving after having used alcohol or other drugs at 12 months post-baseline assessment - New England
Time Frame	Past-90-days at 12 months post-baseline

Outcome Measure Data

Analysis Population Description

12-18 year old primary care patients in New England, USA

Arm/Group Title	Control - New England, USA	cSBA - New England, USA
Arm/Group Description	Control participants received "care as usual" from their provider	Computer Screen & Brief physician Advice: Participants in the experimental arm completed a computerized CRAFFT screen and received information on the computer regarding the health effects of substance use. Their provider was given the results of their CRAFFT screen and a list of suggested "talking points" which guided a discussion with the patient about drug and alcohol use.
Measure Participants	756	765
Count of Participants [Participants]	161 15.1%	125 12.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control - New England, USA, Computer Screen & Brief Physician Advice - New England, USA
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.35
	Comments	Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Adjusted Relative Risk Ratio
	Estimated Value	.87
	Confidence Interval	(2-Sided) 95%; .64 to 1.17
	Parameter Dispersion	Type: Standard Error of the Mean; Value: .13
	Estimation Comments	Risk Ratio: (Intervention)/(Control) controlling for age; gender; parent education; number of parents in home; visit type; provider gender; connectedness to provider, and baseline DRWI risk.

11. Secondary Outcome

Title	Any Risky Riding or Driving at 3 Months - Prague, CZR
Description	Any past-90-day self-reported Riding with a driver who had used alcohol or other drugs or Driving after having used alcohol or other drugs at 3 months post-baseline assessment - Prague, Czech Republic
Time Frame	Past-90-days at 3 months post-baseline

Outcome Measure Data

Analysis Population Description

12-18 year old primary care patients in Prague, CZR

Arm/Group Title	Control - Prague, CZR	cSBA - Prague, CZR
Arm/Group Description	Control participants received "care as usual" from their provider	Computer Screen & Brief physician Advice: Participants in the experimental arm completed a computerized CRAFFT screen and received information on the computer regarding the health effects of substance use. Their provider was given the results of their CRAFFT screen and a list of suggested "talking points" which guided a discussion with the patient about drug and alcohol use.
Measure Participants	245	269
Count of Participants [Participants]	245 22.9%	269 26.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control - New England, USA, Computer Screen & Brief Physician Advice - New England, USA
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<.01
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Adjusted Relative Risk Ratio
	Estimated Value	.63
	Confidence Interval	(2-Sided) 95%; .46 to .87
	Parameter Dispersion	Type: Standard Error of the Mean; Value: .10
	Estimation Comments	Risk Ratio: (Intervention)/(Control) controlling for age; gender; connectedness to provider, and baseline DRWI risk.

12. Secondary Outcome

Title	Any Risky Riding or Driving at 12 Months - Prague, CZR
Description	Any past-90-day self-reported Riding with a driver who had used alcohol or other drugs or Driving after having used alcohol or other drugs at 12 months post-baseline assessment - Prague, Czech Republic
Time Frame	Past-90-days at 12 months post-baseline

Outcome Measure Data

Analysis Population Description

12-18 year old primary care patients in Prague, CZR

Arm/Group Title	Control - Prague, CZR	cSBA - Prague, CZR
Arm/Group Description	Control participants received "care as usual" from their provider	Computer Screen & Brief physician Advice: Participants in the experimental arm completed a computerized CRAFFT screen and received information on the computer regarding the health effects of substance use. Their provider was given the results of their CRAFFT screen and a list of suggested "talking points" which guided a discussion with the patient about drug and alcohol use.
Measure Participants	266	263
Count of Participants [Participants]	78 7.3%	61 5.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control - New England, USA, Computer Screen & Brief Physician Advice - New England, USA
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	< 0.05
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Adjusted Relative Risk Ratio
	Estimated Value	.73
	Confidence Interval	(2-Sided) 95%; .54 to .98
	Parameter Dispersion	Type: Standard Error of the Mean; Value: .11
	Estimation Comments	Risk Ratio: (Intervention)/(Control) controlling for age; gender; connectedness to provider, and baseline DRWI risk.

Adverse Events

Time Frame	Through the course of the entire recruitment and follow-up period.
Arm/Group Title	Control - New England		Computer Screen & Brief Physician Advice - New England		Control - Czech Republic		Computer Screen & Brief Physician Advice - Czech Republic
Arm/Group Description	Control participants will receive "care as usual" from their provider		Participants who are in the experimental arm will complete the CRAFFT screen on the computer and receive information on the computer regarding the health effects of substance use. Their provider will be given the results of their CRAFFT screen and a list of suggested "talking points" which they will use to guide a discussion with the patient about drug and alcohol use. Participants and their families will also receive educational brochures about substance use. Computer screen & brief physician advice: Participants who are in the experimental arm will complete the CRAFFT screen on the computer and receive information on the computer regarding the health effects of substance use. Their provider will be given the results of their CRAFFT screen and a list of suggested "talking point" which they will use to guide a discussion with the patient about drug and alcohol use. Participants and their families will also receive educational brochures about substance use.		Control participants will receive "care as usual" from their provider		Participants who are in the experimental arm will complete the CRAFFT screen on the computer and receive information on the computer regarding the health effects of substance use. Their provider will be given the results of their CRAFFT screen and a list of suggested "talking points" which they will use to guide a discussion with the patient about drug and alcohol use. Participants and their families will also receive educational brochures about substance use. Computer screen & brief physician advice: Participants who are in the experimental arm will complete the CRAFFT screen on the computer and receive information on the computer regarding the health effects of substance use. Their provider will be given the results of their CRAFFT screen and a list of suggested "talking point" which they will use to guide a discussion with the patient about drug and alcohol use. Participants and their families will also receive educational brochures about substance use.
All Cause Mortality
	Control - New England		Computer Screen & Brief Physician Advice - New England		Control - Czech Republic		Computer Screen & Brief Physician Advice - Czech Republic
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Control - New England		Computer Screen & Brief Physician Advice - New England		Control - Czech Republic		Computer Screen & Brief Physician Advice - Czech Republic
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1068 (0%)		0/1028 (0%)		0/297 (0%)		0/292 (0%)
Other (Not Including Serious) Adverse Events
	Control - New England		Computer Screen & Brief Physician Advice - New England		Control - Czech Republic		Computer Screen & Brief Physician Advice - Czech Republic
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1068 (0%)		0/1028 (0%)		0/297 (0%)		0/292 (0%)

Limitations/Caveats

Use of non-randomized, asynchronous study design may have confounded results; 2 NE groups not equivalent in baseline substance use (but controlled for in analysis); self-report and interview-collected data prone to recall and social desirability bias

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.