Project RAP: Reaching Adolescents for Prevention

RAP: Reaching Adolescents for Prevention - A Randomized Trial of a Brief Negotiated Interview and Active Referral to Reduce Alcohol Related Morbidity Among Youth and Young Adults in the Pediatric Emergency Department

The purpose of the study is to determine if a brief motivational interview in the context of an emergency health care visit will reduce high-risk drinking and drug-taking and associated health consequences among adolescents ages 14-21 years old.

Study Overview

Detailed Description

Many studies have shown that a brief motivational interview in the context of a routine or emergency health care visit may assist adults to reduce high-risk drinking and drug-taking. Center researchers are conducting a 1,400-person, randomized clinical trial involving teen patients at the Boston Medical Center Pediatric Emergency Department in order to determine if a similar approach will be effective with youth. All patients aged 14 to 21 get a brief alcohol and drug screen, and those whose scores indicate they drink or use marijuana are invited to participate in the study. One-third of the enrollees will receive an assessment, a brief motivational interview performed by a trained peer counselor, direct referrals to community-based resources for adolescents, and a 10-day follow-up phone call. One-third will receive only the assessment and a list of community resources; and the final third will receive only the list of resources. All participants will be followed over time and re-screened to measure the impact of the initial brief intervention on their drinking and drug-taking. The key hypothesis is that individuals who receive the brief motivational interview in the emergency department setting will have lower rates of alcohol and illicit drug use and fewer health consequences over time.

Study Type

Interventional

Enrollment (Anticipated)

1400

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Recruiting
        • Boston Medical Center Pediatric Emergency Department
        • Contact:
        • Principal Investigator:
          • Edward Bernstein, MD
        • Principal Investigator:
          • Judith Bernstein, RNC, PhD
        • Sub-Investigator:
          • David Dorfman, MD
      • Boston, Massachusetts, United States, 02118
        • Recruiting
        • Boston University School of Public Health - Youth Alcohol Prevention Center
        • Contact:
        • Sub-Investigator:
          • David Rosenbloom, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pediatric emergency department patients
  • Aged 14-21
  • An Alcohol Use Disorders Identification Test (AUDIT) score above selected cut-point for age or with history of alcohol-related consequences

Exclusion Criteria:

  • Not resident in area or able to provide contact information for 12 month follow-up
  • Medically unstable
  • Not oriented to person, time and place

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Patients will receive an assessment, a brief motivational interview performed by a trained peer counselor, direct referrals to community-based resources for adolescents, and a 10-day follow-up phone call.
One-third of the enrollees will receive an assessment, a brief motivational interview performed by a trained peer counselor, direct referrals to community-based resources for adolescents, and a 10-day follow-up phone call. All participants will be followed over time and re-screened to measure the impact of the initial brief intervention on their drinking and drug-taking. The key hypothesis is that individuals who receive the brief motivational interview in the emergency department setting will have lower rates of alcohol and illicit drug use and fewer health consequences over time.
Active Comparator: 2
Patients will receive an assessment and a list of community resources
One-third will receive only the assessment and a list of community resources. All participants will be followed over time and re-screened to measure the impact of the initial brief intervention on their drinking and drug-taking. The key hypothesis is that individuals who receive the brief motivational interview in the emergency department setting will have lower rates of alcohol and illicit drug use and fewer health consequences over time.
Active Comparator: 3
Patients will receive only the list of resources.
All patients aged 14 to 21 get a brief alcohol and drug screen, and those whose scores indicate they drink or use marijuana are invited to participate in the study. One-third of the enrollees will receive only a list of resources. All participants will be followed over time and re-screened to measure the impact of the initial brief intervention on their drinking and drug-taking. The key hypothesis is that individuals who receive the brief motivational interview in the emergency department setting will have lower rates of alcohol and illicit drug use and fewer health consequences over time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction in drinking
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Reduction in alcohol associated health consequences
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Edward Bernstein, MD, Boston University School of Public Health - Youth Alcohol Prevention Center
  • Principal Investigator: Judith Bernstein, RNC, PhD, Boston University School of Public Health - Youth Alcohol Prevention Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Anticipated)

December 1, 2009

Study Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

February 13, 2009

Last Update Submitted That Met QC Criteria

February 12, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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