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Brief Integrative Alcohol Interventions for Adolescents (Brief)

Primary Purpose

Alcohol Abuse, Drug Abuse

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Brief Prevention Program Using Positive Image

About this trial

This is an interventional prevention trial for Alcohol Abuse focused on measuring Brief, Image, Intervention, Adolescents, School

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Addictive & Health Behaviors Research Institute, University of Florida

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

Consult

Newsletter

Parent Letter

Control

Arm Description

Consult

Newsletter

Parent Letter

Control

Outcomes

Primary Outcome Measures

Change in alcohol, cigarette and marijuana use consumption from baseline to 3 months follow up.

Change in alcohol, cigarette and marijuana use consumption from baseline to 12 months follow up.

Change in alcohol, cigarette and marijuana use consumption from baseline to 18 months follow up.

Secondary Outcome Measures

Change in frequency of health promoting behaviors from baseline to 3 months follow up.

Change in frequency of health promoting behaviors from baseline to 12 months follow up.

Change in frequency of health promoting behaviors from baseline to 18 months follow up.

Full Information

NCT ID

NCT01427465

First Posted

July 22, 2010

Last Updated

November 21, 2011

Sponsor

University of Florida

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

1. Study Identification

Unique Protocol Identification Number

NCT01427465

Brief Title

Brief Integrative Alcohol Interventions for Adolescents

Acronym

Brief

Official Title

Brief Integrative Alcohol Interventions for Adolescents

Study Type

Interventional

2. Study Status

Record Verification Date

November 2011

Overall Recruitment Status

Withdrawn

Why Stopped

PI left University of Florida

Study Start Date

September 2007 (undefined)

Primary Completion Date

September 2010 (Actual)

Study Completion Date

September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Florida

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcohol Abuse, Drug Abuse

Keywords

Brief, Image, Intervention, Adolescents, School

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Consult

Arm Type

Experimental

Arm Description

Consult

Arm Title

Newsletter

Arm Type

Experimental

Arm Description

Newsletter

Arm Title

Parent Letter

Arm Type

Experimental

Arm Description

Parent Letter

Arm Title

Control

Arm Type

Active Comparator

Arm Description

Control

Intervention Type

Behavioral

Intervention Name(s)

Brief Prevention Program Using Positive Image

Other Intervention Name(s)

Consult

Intervention Description

Consult

Intervention Type

Behavioral

Intervention Name(s)

Brief Prevention Program Using Positive Image

Other Intervention Name(s)

Control

Intervention Description

Control - Standard of Care

Intervention Type

Behavioral

Intervention Name(s)

Brief Prevention Program Using Positive Image

Other Intervention Name(s)

Newsletter

Intervention Description

Newsletter

Intervention Type

Behavioral

Intervention Name(s)

Brief Prevention Program Using Positive Image

Other Intervention Name(s)

Parent Letter

Intervention Description

Parent Letter

Primary Outcome Measure Information:

Title

Change in alcohol, cigarette and marijuana use consumption from baseline to 3 months follow up.

Time Frame

Baseline to 3 months follow up

Title

Change in alcohol, cigarette and marijuana use consumption from baseline to 12 months follow up.

Time Frame

Baseline to 12 months follow up

Title

Change in alcohol, cigarette and marijuana use consumption from baseline to 18 months follow up.

Time Frame

Baseline to 18 months follow up

Secondary Outcome Measure Information:

Title

Change in frequency of health promoting behaviors from baseline to 3 months follow up.

Time Frame

Baseline to 3 months follow up

Title

Change in frequency of health promoting behaviors from baseline to 12 months follow up.

Time Frame

Baseline to 12 months follow up

Title

Change in frequency of health promoting behaviors from baseline to 18 months follow up.

Time Frame

Baseline to 18 months follow up

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chudley E Werch, PhD

Organizational Affiliation

Addictive & Health Behaviors Research Institute, University of Florida

Official's Role

Principal Investigator

Facility Information:

Facility Name

Addictive & Health Behaviors Research Institute, University of Florida

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32256

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Brief Integrative Alcohol Interventions for Adolescents

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