Tailored Interventions to Prevent Substance Abuse
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Rhode Island
- Enrollment
- 4,158
- Locations
- 2
- Primary Endpoint
- Alcohol Use Prevention
Study Overview
Brief Summary
The overarching objective of this research is to prevent substance use in early adolescents through the use of innovative interactive interventions tailored to each individual's particular risk profile for using cigarettes and alcohol. The specific aims are: (1) To test the effectiveness of the computer-based profile-based tailored interventions to keep early adolescents smoke-free compared to a comparison group; (2) To test the effectiveness of the computer-based profile-based tailored interventions to keep early adolescents from using alcohol compared to a comparison group; and (3) To replicate findings that the tailored diet and physical activity interventions will be effective in reducing these two high risk behaviors as part of the comparison condition.
Detailed Description
Research across age groups (elementary, middle and high school), populations (U.S., U.K., and Israel), and substances (tobacco, alcohol and other drugs) has consistently identified four clusters of non-users who vary in their risks for substance use: (1) Most Protected from substance use; (2) High Risk to use substances; (3) Ambivalent about staying substance free; and (4) Risk Denial about substance use. These profiles have demonstrated both internal and external validity as well as good ability to predict future substance use and, therefore, provide an opportunity to develop a new approach to prevention. These profiles will be employed as the basis for designing two innovative computer-based interventions to prevent substance abuse by adolescents. The two new tailored interventions (smoking prevention and alcohol prevention) will be developed and tested in a school-based clinical trial. The comparison group will receive two previously developed and tested tailored health behavior interventions (diet and physical activity).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 10 Years to 14 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •6th grade student in one of 20 participating Middle Schools in RI
- •English speaking
- •Student Assent
Exclusion Criteria
- •Parent refusal for child to participate
Outcomes
Primary Outcomes
Alcohol Use Prevention
Time Frame: 36 months
Percent reporting being alcohol-free at 36 months
Exercise
Time Frame: 36 months
Percentage of baseline at-risk participants who reach the Regular Exercise criteria (60 minutes a day/five days per week).
Diet
Time Frame: 36 months
Percentage of at-risk participants at baseline who reach Diet Criteria (five or more a day servings of fruits and vegetables).
Smoking Prevention
Time Frame: 36 months
Percent reporting being smoke-free at 36 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Wayne F. Velicer
Professor
University of Rhode Island