Screening and Brief Advice to Reduce Teen Substance Use

Study Overview
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Brief Summary
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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: 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; 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; 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.

Detailed Description
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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.

Official Title
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Screening and Brief Advice to Reduce Teen Substance Use

Conditions
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Substance Related Disorders

Intervention / Treatment
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* Behavioral: cSBA - New England, USA
* Behavioral: cSBA - Prague, CZR


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control - New England, USA<br>Control participants will receive care as usual from their provider | |
| Experimental: cSBA - New England, USA<br>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<br>* 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.<br>* Other names: SBIRT;|
| No Intervention: Control - Prague, CZR<br>Control participants will receive care as usual from their provider | |
| Experimental: cSBA - Prague, CZR<br>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<br>* 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.<br>* Other names: SBIRT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Past-90-day Substance Use at 3 Months Among Baseline Substance Users - New England, USA | 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. | Past-90-days at 3 months post-baseline | 
| Past-90-day Substance Use at 3 Months Among Baseline Substance Non-Users, New England, USA | 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. | Past-90-days at 3 months post-baseline | 
| Past-12-month Substance Use at 12 Months Among Baseline Substance Users, New England, USA | 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 | Past-12-months at 12 months post-baseline | 
| Past-12-month Substance Use at 12 Months, Baseline Substance Non-Users, New England, USA | 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 | Past-12-months at 12 months post-baseline | 
| Past-90-day Substance Use at 3 Months Among Baseline Substance Users - Prague, CZR | 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 | Past-90-days at 3 months post-baseline | 
| Past-90-day Substance Use at 3 Months Among Baseline Substance Non-Users - Prague, CZR | 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 | Past-90-days at 3 months post-baseline | 
| Past-12-Month Substance Use at 12 Months Among Baseline Substance Users - Prague, CZR | 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 | Past-12-months at 12 months post-baseline | 
| Past-12-Month Substance Use at 12 Months Among Baseline Substance Non-Users - Prague, CZR | 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 | Past-12-months at 12 months post-baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any Risky Riding or Driving at 3 Months - New England, USA | 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 | Past-90-days at 3 months post-baseline | 
| Any Risky Riding or Driving at 12 Months - New England, USA | 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 | Past-90-days at 12 months post-baseline | 
| Any Risky Riding or Driving at 3 Months - Prague, CZR | 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 | Past-90-days at 3 months post-baseline | 
| Any Risky Riding or Driving at 12 Months - Prague, CZR | 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 | Past-90-days at 12 months post-baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alcohol abuse, substance abuse, substance related disorders