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Tailored Interventions to Prevent Substance Abuse (Project BEST)

Primary Purpose

Prevention Harmful Effects

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tailored computer based intervention
Tailored computer intervention
Sponsored by
University of Rhode Island
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prevention Harmful Effects focused on measuring tobacco, alcohol, diet, exercise

Eligibility Criteria

10 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Rhode Island

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Smoking and Alcohol Prevention

Diet and Exercise

Arm Description

TTM expert system

TTM expert system

Outcomes

Primary Outcome Measures

Smoking Prevention
Percent reporting being smoke-free at 36 months
Alcohol Use Prevention
Percent reporting being alcohol-free at 36 months
Exercise
Percentage of baseline at-risk participants who reach the Regular Exercise criteria (60 minutes a day/five days per week).
Diet
Percentage of at-risk participants at baseline who reach Diet Criteria (five or more a day servings of fruits and vegetables).

Secondary Outcome Measures

Full Information

First Posted
November 29, 2011
Last Updated
May 10, 2016
Sponsor
University of Rhode Island
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1. Study Identification

Unique Protocol Identification Number
NCT01482975
Brief Title
Tailored Interventions to Prevent Substance Abuse
Acronym
Project BEST
Official Title
Tailored Interventions to Prevent Substance Abuse
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rhode Island

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prevention Harmful Effects
Keywords
tobacco, alcohol, diet, exercise

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
4158 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Smoking and Alcohol Prevention
Arm Type
Experimental
Arm Description
TTM expert system
Arm Title
Diet and Exercise
Arm Type
Active Comparator
Arm Description
TTM expert system
Intervention Type
Other
Intervention Name(s)
Tailored computer based intervention
Other Intervention Name(s)
Tailored computer based interventions
Intervention Description
Best practices for TTM tailored communication with two types of feedback: normative - compared to peer and ipsative - self compared to previous assessment.
Intervention Type
Other
Intervention Name(s)
Tailored computer intervention
Intervention Description
Best practices for TTM tailored communication with two types of feedback: normative - compared to peer and ipsative - self compared to previous assessment
Primary Outcome Measure Information:
Title
Smoking Prevention
Description
Percent reporting being smoke-free at 36 months
Time Frame
36 months
Title
Alcohol Use Prevention
Description
Percent reporting being alcohol-free at 36 months
Time Frame
36 months
Title
Exercise
Description
Percentage of baseline at-risk participants who reach the Regular Exercise criteria (60 minutes a day/five days per week).
Time Frame
36 months
Title
Diet
Description
Percentage of at-risk participants at baseline who reach Diet Criteria (five or more a day servings of fruits and vegetables).
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wayne F Velicer, PhD
Organizational Affiliation
Univeristy of Rhode Island
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rhode Island
City
Kingston
State/Province
Rhode Island
ZIP/Postal Code
02881
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Tailored Interventions to Prevent Substance Abuse

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