Tailored Interventions to Prevent Substance Abuse (Project BEST)

May 10, 2016 updated by: Wayne F. Velicer, University of Rhode Island
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

4158

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Kingston, Rhode Island, United States, 02881
        • University of Rhode Island

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 14 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Smoking Prevention
Time Frame: 36 months
Percent reporting being smoke-free at 36 months
36 months
Alcohol Use Prevention
Time Frame: 36 months
Percent reporting being alcohol-free at 36 months
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).
36 months
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).
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rhode Island

Investigators

  • Principal Investigator: Wayne F Velicer, PhD, Univeristy of Rhode Island

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

November 29, 2011

First Submitted That Met QC Criteria

November 29, 2011

First Posted (Estimate)

December 1, 2011

Study Record Updates

Last Update Posted (Estimate)

May 12, 2016

Last Update Submitted That Met QC Criteria

May 10, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DA020112

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prevention Harmful Effects

Clinical Trials on Tailored computer based intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Japan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe