Brief Integrative Alcohol Interventions for Adolescents

This study has been withdrawn prior to enrollment.
(PI left University of Florida)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01427465
First received: July 22, 2010
Last updated: November 21, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention
Alcohol Abuse
Drug Abuse
Behavioral: Brief Prevention Program Using Positive Image

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Brief Integrative Alcohol Interventions for Adolescents

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Change in alcohol, cigarette and marijuana use consumption from baseline to 3 months follow up. [ Time Frame: Baseline to 3 months follow up ] [ Designated as safety issue: No ]
  • Change in alcohol, cigarette and marijuana use consumption from baseline to 12 months follow up. [ Time Frame: Baseline to 12 months follow up ] [ Designated as safety issue: No ]
  • Change in alcohol, cigarette and marijuana use consumption from baseline to 18 months follow up. [ Time Frame: Baseline to 18 months follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in frequency of health promoting behaviors from baseline to 3 months follow up. [ Time Frame: Baseline to 3 months follow up ] [ Designated as safety issue: No ]
  • Change in frequency of health promoting behaviors from baseline to 12 months follow up. [ Time Frame: Baseline to 12 months follow up ] [ Designated as safety issue: No ]
  • Change in frequency of health promoting behaviors from baseline to 18 months follow up. [ Time Frame: Baseline to 18 months follow up ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: September 2007
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Consult
Consult
Behavioral: Brief Prevention Program Using Positive Image
Consult
Other Name: Consult
Experimental: Newsletter
Newsletter
Behavioral: Brief Prevention Program Using Positive Image
Newsletter
Other Name: Newsletter
Experimental: Parent Letter
Parent Letter
Behavioral: Brief Prevention Program Using Positive Image
Parent Letter
Other Name: Parent Letter
Active Comparator: Control
Control
Behavioral: Brief Prevention Program Using Positive Image
Control - Standard of Care
Other Name: Control

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01427465

Locations
United States, Florida
Addictive & Health Behaviors Research Institute, University of Florida
Jacksonville, Florida, United States, 32256
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Chudley E Werch, PhD Addictive & Health Behaviors Research Institute, University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01427465     History of Changes
Other Study ID Numbers: #2007-U-0085, R01AA009283
Study First Received: July 22, 2010
Last Updated: November 21, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Brief
Image
Intervention
Adolescents
School

Additional relevant MeSH terms:
Substance-Related Disorders
Alcoholism
Mental Disorders
Alcohol-Related Disorders

ClinicalTrials.gov processed this record on April 22, 2014