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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

November 29, 2011
November 29, 2011
September 2007
June 2011   (final data collection date for primary outcome measure)
  • 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).
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Tailored Interventions to Prevent Substance Abuse
Tailored Interventions to Prevent Substance Abuse

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.

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).
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Prevention Harmful Effects
  • 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
  • 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
  • Experimental: Smoking and Alcohol Prevention
    TTM expert system
    Intervention: Other: Tailored computer based intervention
  • Active Comparator: Diet and Exercise
    TTM expert system
    Intervention: Other: Tailored computer intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4158
June 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
10 Years to 14 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01482975
DA020112
No
Wayne F. Velicer, University of Rhode Island
University of Rhode Island
Not Provided
Principal Investigator: Wayne F Velicer, PhD Univeristy of Rhode Island
University of Rhode Island
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP