Tailored Interventions to Prevent Substance Abuse

Prevention Harmful Effects Clinical Trial

— Project BEST  

Official title:

Tailored Interventions to Prevent Substance Abuse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01482975
• Other study ID #: DA020112
• Status: Completed
• Phase: N/A
• First received: November 29, 2011
• Last updated: November 29, 2011
• Start date: September 2007
• Est. completion date: June 2011

Study information

• Verified date: November 2011
• Source: University of Rhode Island
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4158
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Years to 14 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Prevention Harmful Effects

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	University of Rhode Island	Kingston	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
University of Rhode Island

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking Prevention	Percent reporting being smoke-free at 36 months	36 months	No
Primary	Alcohol Use Prevention	Percent reporting being alcohol-free at 36 months	36 months	No
Primary	Exercise	Percentage of baseline at-risk participants who reach the Regular Exercise criteria (60 minutes a day/five days per week).	36 months	No
Primary	Diet	Percentage of at-risk participants at baseline who reach Diet Criteria (five or more a day servings of fruits and vegetables).	36 months	No

External Links

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