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Clinical Trials/NCT00227877
NCT00227877
Completed
N/A

Screening and Brief Advice to Reduce Teen Substance Use

Boston Children's Hospital6 sites in 2 countries2,695 target enrollmentDecember 2005

Overview

Phase
N/A
Intervention
Not specified
Conditions
Substance Related Disorders
Sponsor
Boston Children's Hospital
Enrollment
2695
Locations
6
Primary Endpoint
Past-12-month Substance Use at 12 Months Among Baseline Substance Users, New England, USA
Status
Completed
Last Updated
6 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
December 2005
End Date
February 2010
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

John R Knight, MD

Associate Professor of Pediatrics, Harvard Medical School

Boston Children's Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Past-12-month Substance Use at 12 Months Among Baseline Substance Users, New England, USA

Time Frame: 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

Past-90-day Substance Use at 3 Months Among Baseline Substance Non-Users, New England, USA

Time Frame: 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.

Past-12-Month Substance Use at 12 Months Among Baseline Substance Users - Prague, CZR

Time Frame: 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

Past-90-day Substance Use at 3 Months Among Baseline Substance Users - New England, USA

Time Frame: 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.

Past-12-month Substance Use at 12 Months, Baseline Substance Non-Users, New England, USA

Time Frame: 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

Past-90-day Substance Use at 3 Months Among Baseline Substance Users - Prague, CZR

Time Frame: 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

Past-90-day Substance Use at 3 Months Among Baseline Substance Non-Users - Prague, CZR

Time Frame: 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

Past-12-Month Substance Use at 12 Months Among Baseline Substance Non-Users - Prague, CZR

Time Frame: 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 Outcomes

  • Any Risky Riding or Driving at 12 Months - New England, USA(Past-90-days at 12 months post-baseline)
  • Any Risky Riding or Driving at 3 Months - New England, USA(Past-90-days at 3 months post-baseline)
  • Any Risky Riding or Driving at 3 Months - Prague, CZR(Past-90-days at 3 months post-baseline)
  • Any Risky Riding or Driving at 12 Months - Prague, CZR(Past-90-days at 12 months post-baseline)

Study Sites (6)

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