Brief Integrative Alcohol Interventions for Adolescents

Alcohol Abuse Clinical Trial

— Brief  

Official title:

Brief Integrative Alcohol Interventions for Adolescents

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01427465
• Other study ID #: #2007-U-0085
• Secondary ID: R01AA009283
• Status: Withdrawn
• Phase: N/A
• First received: July 22, 2010
• Last updated: November 21, 2011
• Start date: September 2007
• Est. completion date: September 2010

Study information

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

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Alcohol Abuse
• Drug Abuse

Intervention

Behavioral:
• Brief Prevention Program Using Positive Image
Consult
• Brief Prevention Program Using Positive Image
Control - Standard of Care
• Brief Prevention Program Using Positive Image
Newsletter
• Brief Prevention Program Using Positive Image
Parent Letter

Locations

Country	Name	City	State
United States	Addictive & Health Behaviors Research Institute, University of Florida	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in alcohol, cigarette and marijuana use consumption from baseline to 3 months follow up.		Baseline to 3 months follow up	No
Primary	Change in alcohol, cigarette and marijuana use consumption from baseline to 12 months follow up.		Baseline to 12 months follow up	No
Primary	Change in alcohol, cigarette and marijuana use consumption from baseline to 18 months follow up.		Baseline to 18 months follow up	No
Secondary	Change in frequency of health promoting behaviors from baseline to 3 months follow up.		Baseline to 3 months follow up	No
Secondary	Change in frequency of health promoting behaviors from baseline to 12 months follow up.		Baseline to 12 months follow up	No
Secondary	Change in frequency of health promoting behaviors from baseline to 18 months follow up.		Baseline to 18 months follow up	No