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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00383838
Other study ID # R21AA13284-01
Secondary ID
Status Completed
Phase N/A
First received March 20, 2006
Last updated October 2, 2006
Start date September 2002
Est. completion date June 2005

Study information

Verified date October 2006
Source RAND
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Alcohol use among youth continues to be a major concern for this nation, with a large proportion of adolescents increasing their alcohol consumption as they transition from the 6th to the 8th grade. Although many adolescents experience alcohol-related problems, few actually seek help or treatment. This may be because traditional intervention approaches are not well suited for this age group. It is important to understand where adolescents turn to when they want to get help. The current project focuses on developing an alcohol intervention program for younger adolescents. We will conduct biannual surveys at two middle schools to assess alcohol and drug use patterns over three years. In years 2 and 3, we will implement an intervention in one of the schools.We will examine whether the intervention has an impact on subsequent alcohol use.


Description:

Alcohol use among youth continues to be a major concern for this nation, with a large proportion of adolescents increasing their alcohol consumption as they transition from the 6th to the 8th grade. Although many adolescents experience alcohol-related problems, few actually seek help or treatment. This may be because traditional intervention approaches are not well suited for this age group. The aims of this project are to assess factors that impact younger adolescents’ alcohol-related help-seeking behavior and to develop and standardize a developmentally sensitive self-change facilitation program. We will also preliminarily test the efficacy of the program in modifying the alcohol involvement (e.g., initiation, use, and problems) of middle school students. The focus of this grant is on younger adolescents (e.g., 12-15 years old), as they are particularly vulnerable to initiating alcohol use due to unique developmental issues. For example, peer conformity peaks during 6tn, 7th and 8th grade and declines thereafter. In addition, this age group is less likely to consider future consequences in the decision making process. Biannual surveys at two middle schools will assess alcohol and drug use patterns, help-seeking behavior and preferences, self-change efforts, and level of motivation for change. Year 1 data will be used to develop a voluntary brief intervention program that targets a variety of youth, including those who are just beginning to experiment with alcohol and those who may have experienced some problems due to their use. Primary objectives are: 1) to explore barriers and facilitative factors that promote/hinder younger adolescents’ use of services, 2) use detailed survey information to design and pilot a self-change program, 3) examine alcohol involvement in relation to program utilization, and 4) preliminarily evaluate the efficacy of the intervention and overall patterns of service use. This study will extend facilitation of self-change research, as this program will be one of the first voluntary alcohol focused intervention programs to target middle school students.


Recruitment information / eligibility

Status Completed
Enrollment 1200
Est. completion date June 2005
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 11 Years to 16 Years
Eligibility Inclusion Criteria:

- middle school student

Exclusion Criteria:

Study Design

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


Related Conditions & MeSH terms


Intervention

Behavioral:
brief, voluntary substance use intervention


Locations

Country Name City State
n/a

Sponsors (2)

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

Outcome

Type Measure Description Time frame Safety issue
Primary alcohol, tobacco, drug use
Primary alcohol and drug consequences
Primary self-change efforts
Primary perceived peer use
Primary positive and negative outcome expectancies
Primary all measures taken biannually over a three year period
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