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Project RAP: Reaching Adolescents for Prevention
This study is currently recruiting participants.
Verified by National Institute on Alcohol Abuse and Alcoholism (NIAAA), February 2009
First Received: September 12, 2005   Last Updated: February 12, 2009   History of Changes
Sponsored by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier: NCT00183157
  Purpose

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.


Condition Intervention Phase
Alcohol Related Morbidity
Alcohol Dependence
Behavioral: Brief Motivational Intervention
Behavioral: Assessment and list of resources
Behavioral: Referral to Community Resources
Phase II

MedlinePlus related topics: Alcoholism
Drug Information available for: Ethanol
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Primary Outcome Measures:
  • Reduction in drinking [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction in alcohol associated health consequences [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1400
Study Start Date: October 2004
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
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.
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.
2: Active Comparator
Patients will receive an assessment and a list of community resources
Behavioral: 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.
3: Active Comparator
Patients will receive only the list of resources.
Behavioral: 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.

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.

  Eligibility

Ages Eligible for Study:   14 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00183157

Contacts
Contact: Barbara Cole 617-638-4600 barbcole@bu.edu

Locations
United States, Massachusetts
Boston Medical Center Pediatric Emergency Department Recruiting
Boston, Massachusetts, United States, 02118
Contact: Barbara Cole     617-638-4600     barbcole@bu.edu    
Principal Investigator: Edward Bernstein, MD            
Principal Investigator: Judith Bernstein, RNC, PhD            
Sub-Investigator: David Dorfman, MD            
Boston University School of Public Health - Youth Alcohol Prevention Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Barbara Cole     617-638-4600     barbcole@bu.edu    
Sub-Investigator: David Rosenbloom, PhD            
Sponsors and Collaborators
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
  More Information

Additional Information:
No publications provided

Responsible Party: Boston University School of Public Health - Youth Alcohol Prevention Center ( Edward Bernstein, MD/Judith Bernstein, RNC, PhD )
Study ID Numbers: NIAAABER13759, NIH 5P60 AA13759
Study First Received: September 12, 2005
Last Updated: February 12, 2009
ClinicalTrials.gov Identifier: NCT00183157     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):
High risk drinking
Alcohol dependence
Alcohol related injury

Study placed in the following topic categories:
Mental Disorders
Alcoholism
Substance-Related Disorders
Disorders of Environmental Origin
Emergencies
Alcohol-Related Disorders
Ethanol

Additional relevant MeSH terms:
Mental Disorders
Alcoholism
Substance-Related Disorders
Disorders of Environmental Origin
Alcohol-Related Disorders

ClinicalTrials.gov processed this record on May 07, 2009