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Clinical Trial Details — Status: Withdrawn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Status Withdrawn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Status Withdrawn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


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
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