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Tailored Interventions to Prevent Substance Abuse (Project BEST)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wayne F. Velicer, University of Rhode Island
ClinicalTrials.gov Identifier:
NCT01482975
First received: November 29, 2011
Last updated: NA
Last verified: November 2011
History: No changes posted
  Purpose

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.


Condition Intervention
Prevention Harmful Effects
 Other: Tailored computer based intervention
Other: Tailored computer intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Tailored Interventions to Prevent Substance Abuse

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Rhode Island:

Primary Outcome Measures:
  • Smoking Prevention [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Percent reporting being smoke-free at 36 months

  • Alcohol Use Prevention [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Percent reporting being alcohol-free at 36 months

  • Exercise [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Percentage of at-risk participants at baseline who reach Diet Criteria (five or more a day servings of fruits and vegetables).


Enrollment: 4158
Study Start Date: September 2007
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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
Other Name: Tailored computer intervention

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).

  Eligibility

Ages Eligible for Study:   10 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01482975

Locations
United States, Rhode Island
University of Rhode Island
Kingston, Rhode Island, United States, 02881
Sponsors and Collaborators
University of Rhode Island
Investigators
Principal Investigator: Wayne F Velicer, PhD Univeristy of Rhode Island
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Wayne F. Velicer, Professor, University of Rhode Island
ClinicalTrials.gov Identifier: NCT01482975     History of Changes
Other Study ID Numbers: DA020112
Study First Received: November 29, 2011
Last Updated: November 29, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rhode Island:
tobacco
alcohol
diet
exercise

Additional relevant MeSH terms:
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 21, 2013