Brief Integrative Alcohol Interventions for Adolescents (Brief)

November 21, 2011 updated by: University of Florida
The primary aim of this research is to test the efficacy of innovative, brief alcohol abuse prevention strategies that integrate positive youth development messages and health risk messages for adolescents in high school settings. A secondary aim is to examine these strategies in various combinations as interventions and re-interventions (i.e., boosters) for sustaining or enhancing behavior change over time. These strategies are founded upon an emerging conceptual framework titled the Behavior-Image Model emanating from findings of our recent trials examining multiple behavior health interventions. The long-term objective of this project is to reduce alcohol abuse and problems among older high-risk adolescents for whom alcohol and drug use disparities exist, yet who are often overlooked in prevention research and services.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

A total of 921 adolescents from two diverse high schools in northeast Florida were randomized to receive either the: 1) in-person consult, 2) parent-youth letter, 3) adolescent newsletter, or 4) standard care control . Three-month, one-year and 18-month follow-ups are planned, with interventions to be implemented in rotating fashion as re-interventions immediately after three-month and one-year data collections. Plans for following year include the following: 1) collecting and analyzing 3-month post-intervention data to determine the effects of the initial consult, parent-youth and adolescent print strategies, intervention costs, and assess possible mediators and moderators of outcomes; 2) implementing the first round of re-interventions; 3) collecting and analyzing one-year post-baseline effects of re-interventions, determining costs and cost-effectiveness of the interventions/re-interventions, and assessing possible mediators and moderators of outcomes; and 4) implementing the second round of re-interventions.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Addictive & Health Behaviors Research Institute, University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Can read English
  • 10th and 11th grade high school students at participating sites

Exclusion Criteria:

  • Cannot read English
  • Not in 10th and 11th grade high school students at participating sites

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Behavioral: Brief Prevention Program Using Positive Image
Consult
Other Names:
  • Consult
Behavioral: Brief Prevention Program Using Positive Image
Control - Standard of Care
Other Names:
  • Control
Behavioral: Brief Prevention Program Using Positive Image
Newsletter
Other Names:
  • Newsletter
Behavioral: Brief Prevention Program Using Positive Image
Parent Letter
Other Names:
  • Parent Letter
Experimental: Consult
Behavioral: Brief Prevention Program Using Positive Image
Consult
Other Names:
  • Consult
Behavioral: Brief Prevention Program Using Positive Image
Control - Standard of Care
Other Names:
  • Control
Behavioral: Brief Prevention Program Using Positive Image
Newsletter
Other Names:
  • Newsletter
Behavioral: Brief Prevention Program Using Positive Image
Parent Letter
Other Names:
  • Parent Letter
Experimental: Newsletter
Behavioral: Brief Prevention Program Using Positive Image
Consult
Other Names:
  • Consult
Behavioral: Brief Prevention Program Using Positive Image
Control - Standard of Care
Other Names:
  • Control
Behavioral: Brief Prevention Program Using Positive Image
Newsletter
Other Names:
  • Newsletter
Behavioral: Brief Prevention Program Using Positive Image
Parent Letter
Other Names:
  • Parent Letter
Experimental: Parent Letter
Behavioral: Brief Prevention Program Using Positive Image
Consult
Other Names:
  • Consult
Behavioral: Brief Prevention Program Using Positive Image
Control - Standard of Care
Other Names:
  • Control
Behavioral: Brief Prevention Program Using Positive Image
Newsletter
Other Names:
  • Newsletter
Behavioral: Brief Prevention Program Using Positive Image
Parent Letter
Other Names:
  • Parent Letter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in alcohol, cigarette and marijuana use consumption from baseline to 3 months follow up.
Time Frame: Baseline to 3 months follow up
Baseline to 3 months follow up
Change in alcohol, cigarette and marijuana use consumption from baseline to 12 months follow up.
Time Frame: Baseline to 12 months follow up
Baseline to 12 months follow up
Change in alcohol, cigarette and marijuana use consumption from baseline to 18 months follow up.
Time Frame: Baseline to 18 months follow up
Baseline to 18 months follow up

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in frequency of health promoting behaviors from baseline to 3 months follow up.
Time Frame: Baseline to 3 months follow up
Baseline to 3 months follow up
Change in frequency of health promoting behaviors from baseline to 12 months follow up.
Time Frame: Baseline to 12 months follow up
Baseline to 12 months follow up
Change in frequency of health promoting behaviors from baseline to 18 months follow up.
Time Frame: Baseline to 18 months follow up
Baseline to 18 months follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: Chudley E Werch, PhD, Addictive & Health Behaviors Research Institute, University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

July 22, 2010

First Submitted That Met QC Criteria

August 31, 2011

First Posted (Estimate)

September 1, 2011

Study Record Updates

Last Update Posted (Estimate)

November 22, 2011

Last Update Submitted That Met QC Criteria

November 21, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #2007-U-0085
  • R01AA009283 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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