Brief Voluntary Alcohol and Drug Intervention for Middle School Youth (CHOICE)
Primary Purpose
Alcohol Drinking, Cigarette Smoking, Marijuana Smoking
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Project CHOICE
Sponsored by
About this trial
This is an interventional prevention trial for Alcohol Drinking focused on measuring adolescent, middle school, prevention, alcohol, cigarettes, marijuana
Eligibility Criteria
Inclusion Criteria: Adolescents between the ages of 11 and 15 who are currently attending one of 16 selected middle schools across Los Angeles, Torrance, and Santa Monica -
Exclusion Criteria: None
-
Sites / Locations
- 16 middle schools in Torrance, Santa Monica, and Los Angeles
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Project CHOICE
No Project CHOICE
Arm Description
Middle school receives Project CHOICE
Middle school does not receive Project CHOICE
Outcomes
Primary Outcome Measures
Alcohol, cigarette, and marijuana use
Secondary Outcome Measures
Substance use-related cognitions
Full Information
NCT ID
NCT01081119
First Posted
March 3, 2010
Last Updated
July 9, 2014
Sponsor
RAND
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT01081119
Brief Title
Brief Voluntary Alcohol and Drug Intervention for Middle School Youth
Acronym
CHOICE
Official Title
Brief Voluntary Alcohol and Drug Intervention for Middle School Youth
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RAND
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
We are currently working in 16 middle schools across Los Angeles, Santa Monica and Torrance to test out a voluntary after school program called Project CHOICE, which focuses on helping students decrease their alcohol and drug use. We are conducting surveys in all schools over three years and providing the intervention in 8 schools in the 2008-2009 school year and in the other 8 schools in the 2011-2012 school year. This is a program we have provided before in middle schools and we found that it was effective in curbing alcohol and drug use among students who voluntarily attended and among all students at the intervention school.
Detailed Description
The middle school years are peak years for initiation of alcohol and marijuana (Johnston et al., 2007). Unfortunately, most youth who engage in substance use and experience problems are unlikely to voluntarily make use of formal prevention services (D'Amico, 2005; Johnson et al., 2001; Wu et al., 2003). A small body of recent research suggests that youth may benefit from less formal programs that are brief, voluntary, and easily accessible (Brown, 2001; D'Amico et al., 2005). However, very few intervention programs of this type have been developed (Little and Harris, 2003). Thus, while this approach shows promise, the impact of intervention programs that younger teens may choose to attend has not been extensively examined. One such intervention, Project CHOICE, was developed and tested by the PI using NIAAA funding for developmental work (R21AA13284). Project CHOICE is the only voluntary intervention that has been tested for middle school youth and our small quasi-experimental study has demonstrated its efficacy in one school setting (D'Amico and Edelen, in press; D'Amico et al., 2005). The Project CHOICE intervention addresses several critical gaps in the field, including beginning to understand voluntary service utilization among this age group and assessing how this type of program may impact school-wide use of alcohol and other drugs (AOD). The main objective of the proposed 5-year longitudinal study is to build on our initial work by conducting a more rigorous test of Project CHOICE. The study will include 16 middle schools, located in the ethnically diverse Southern California cities of Los Angeles, Santa Monica, and Torrance. These schools will be randomly assigned as intervention (n= 8) or control (n = 8). We will first examine individual-level effects by testing whether Project CHOICE affects AOD-related outcomes among students who participate in the intervention. We will then examine school-level effects by testing whether AOD rates among all students in the intervention schools are affected, regardless of participation. We assume that these school-level effects will be due to changes in the school environment (e.g., Project CHOICE advertising, discussion of Project CHOICE among students, changes in social norms). In anticipation of this school-level impact, a secondary objective of this study is to gain a better understanding of who participates in Project CHOICE, as well as how these participants and changes in the school environment may influence the attitudes and behaviors of those who do not participate. This research incorporates a novel methodology for AOD involvement, as it emphasizes personal self-change efforts and natural recovery and is appealing to both using and non-using youth. The work proposed in this application represents the important next step in this line of research: to more critically evaluate Project CHOICE and its potential impact on both school-wide and individual outcomes with a larger population of youth.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking, Cigarette Smoking, Marijuana Smoking
Keywords
adolescent, middle school, prevention, alcohol, cigarettes, marijuana
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6455 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Project CHOICE
Arm Type
Experimental
Arm Description
Middle school receives Project CHOICE
Arm Title
No Project CHOICE
Arm Type
No Intervention
Arm Description
Middle school does not receive Project CHOICE
Intervention Type
Behavioral
Intervention Name(s)
Project CHOICE
Intervention Description
Voluntary after school program offered 1 day per week for 30 minutes
Primary Outcome Measure Information:
Title
Alcohol, cigarette, and marijuana use
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Substance use-related cognitions
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adolescents between the ages of 11 and 15 who are currently attending one of 16 selected middle schools across Los Angeles, Torrance, and Santa Monica -
Exclusion Criteria: None
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth J. D'Amico, PhD
Organizational Affiliation
RAND
Official's Role
Principal Investigator
Facility Information:
Facility Name
16 middle schools in Torrance, Santa Monica, and Los Angeles
City
Los Angeles
State/Province
California
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Brief Voluntary Alcohol and Drug Intervention for Middle School Youth
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