Project RAP: Reaching Adolescents for Prevention

Alcohol Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00183157
• Other study ID #: NIAAABER13759
• Secondary ID: NIH 5P60 AA13759
• Status: Recruiting
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: February 12, 2009
• Start date: October 2004
• Est. completion date: December 2009

Study information

• Verified date: February 2009
• Source: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Contact: Barbara Cole
• Phone: 617-638-4600
• Email: barbcole[@]bu.edu
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1400
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 21 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcohol Related Morbidity
• Alcoholism

Intervention

Behavioral:
• Brief Motivational Intervention
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.
• Assessment and list of 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.
• Referral to Community 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.

Locations

Country	Name	City	State
United States	Boston Medical Center Pediatric Emergency Department	Boston	Massachusetts
United States	Boston University School of Public Health - Youth Alcohol Prevention Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in drinking		12 months	No
Secondary	Reduction in alcohol associated health consequences		12 months	No

External Links

•   Reaching Adolescents for Prevention (RAP), Boston University School of Public Health