Tailored Interventions to Prevent Substance Abuse

Study Overview
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Brief Summary
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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
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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).

Official Title
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Tailored Interventions to Prevent Substance Abuse

Conditions
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Prevention Harmful Effects

Intervention / Treatment
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* Other: Tailored computer based intervention
* Other: Tailored computer intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smoking and Alcohol Prevention<br>TTM expert system | Other: Tailored computer based intervention<br>* Best practices for TTM tailored communication with two types of feedback: normative - compared to peer and ipsative - self compared to previous assessment.<br>* Other names: Tailored computer based interventions;|
| Active Comparator: Diet and Exercise<br>TTM expert system | Other: Tailored computer intervention<br>* Best practices for TTM tailored communication with two types of feedback: normative - compared to peer and ipsative - self compared to previous assessment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking Prevention | Percent reporting being smoke-free at 36 months | 36 months | 
| Alcohol Use Prevention | Percent reporting being alcohol-free at 36 months | 36 months | 
| Exercise | Percentage of baseline at-risk participants who reach the Regular Exercise criteria (60 minutes a day/five days per week). | 36 months | 
| Diet | Percentage of at-risk participants at baseline who reach Diet Criteria (five or more a day servings of fruits and vegetables). | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tobacco, alcohol, diet, exercise