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Completed

NCT Number: NCT01482975

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.

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Key information

Conditions

Prevention Harmful Effects Behavior Motor Activity

Age range

10 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rhode Island

Kingston, Rhode Island, 02881, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tailored computer based intervention

Other

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

Tailored computer intervention

Other

Best practices for TTM tailored communication with two types of feedback: normative - compared to peer and ipsative - self compared to previous assessment

Primary outcomes

  1. Smoking Prevention

    Time frame: 36 months

    Percent reporting being smoke-free at 36 months

  2. Alcohol Use Prevention

    Time frame: 36 months

    Percent reporting being alcohol-free at 36 months

  3. 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).

  4. 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).

Sponsors and collaborators

Lead sponsor

University of Rhode Island

Other

Registry information

Acronym: Project BEST

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Dec 1, 2011
Registry last updated
May 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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