Substance Use Prevention Campaign for American Indian Youth
Primary Purpose
Adolescent Substance Use
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Be Under Your Own Influence
Sponsored by
About this trial
This is an interventional prevention trial for Adolescent Substance Use
Eligibility Criteria
Inclusion Criteria:
- Attend 7th grade in targeted schools that are on or near American Indian reservation and have received parental consent
Exclusion Criteria:
- No parental consent
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Be Under Your Own Influence Intervention
Control
Arm Description
School-based anti-substance use communications campaign
Assessment only
Outcomes
Primary Outcome Measures
Alcohol Initiation
The number of students who self-reported initiated alcohol for the first time during the study period
Alcohol Intoxication Initiation
Number of participants self-reporting first-time alcohol intoxication initiation during the study period.
Marijuana Initiation
Number of participants who self-reported first-time marijuana use initiation during the study period
Secondary Outcome Measures
Full Information
NCT ID
NCT03051633
First Posted
February 8, 2017
Last Updated
July 20, 2020
Sponsor
Colorado State University
1. Study Identification
Unique Protocol Identification Number
NCT03051633
Brief Title
Substance Use Prevention Campaign for American Indian Youth
Official Title
Substance Use Prevention Campaign for American Indian Youth
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
April 15, 2014 (Actual)
Primary Completion Date
May 16, 2018 (Actual)
Study Completion Date
May 16, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Colorado State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this project is to test the effectiveness of a successful anti-drug communications campaign (Be Under your Own Influence) to lower substance use among AI 7th graders. The campaign uses messages that support youths' personal autonomy and future aspirations, and these messages are delivered to 7th graders using high school students. Our goal is to develop a turnkey package for the broader population of AI youth and schools and to develop components that can incorporate flexibility and creativity in their delivery.
Detailed Description
Substance use is a particularly dangerous risk to middle-school youth, and American Indian (AI) youth are at increased risk. We have found over the course of more than three decades that substance use among AI youth is consistently higher than that of other ethnic/racial groups.
Schools are often the site for adolescent drug prevention efforts, but results from these efforts are often modest or even disappointing. This intervention adapts an existing campaign (Be Under Your Own Influence; BUYOI) that has been found to be effective in reducing substance use and that uses campaign messages that are congruent with AI culture. The intervention will be adapted using significant contributions from tribal members, including youth, teachers, parents, elders, and other community members. This proposal includes active involvement of local advisory boards, hiring of a local AI liaison, focus groups, a youth photo voice component, and use of AI staff from our Center and from the Native American Cultural Center at our university.
The adapted anti-drug and alcohol use communications campaign will be delivered by selected high school students to 7th grade students. A distinguishing feature of the BUYOI campaign is a message that targets outcome expectations related to aspirations, autonomy, and physical harms. The campaign will use multiple channels of communication including print (e.g., posters and fliers), video and audio spots, presentations, and social media to deliver messages that are designed to alter outcome expectancies, intentions, and ultimately substance use among targeted youth.
The campaign will be delivered to two cohorts of 7th graders, with 4 longitudinal measurement occasions for each cohort. Five middle schools (and their corresponding high schools) have been recruited for the study, where three of these will be randomly assigned to the intervention condition and two to the control condition. Multilevel data analysis will test for effects of campaign exposure on autonomy, aspirations, perceived harm, and intentions to use.
Because of the heavy involvement of the school and community in the development and delivery of the intervention, we will be able to incorporate sustainability into the design of all integrated components. Ultimately, our goal is to develop a turnkey package for the broader population of reservation-based AI youth and schools and to develop components that can incorporate flexibility and creativity in their delivery. For example, a school or local group may implement the campaign in its original form or they may modify aspects to make them more pertinent to their community.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Substance Use
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
528 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Be Under Your Own Influence Intervention
Arm Type
Experimental
Arm Description
School-based anti-substance use communications campaign
Arm Title
Control
Arm Type
No Intervention
Arm Description
Assessment only
Intervention Type
Behavioral
Intervention Name(s)
Be Under Your Own Influence
Intervention Description
School based anti-drug use communications campaign
Primary Outcome Measure Information:
Title
Alcohol Initiation
Description
The number of students who self-reported initiated alcohol for the first time during the study period
Time Frame
18 months
Title
Alcohol Intoxication Initiation
Description
Number of participants self-reporting first-time alcohol intoxication initiation during the study period.
Time Frame
18 months
Title
Marijuana Initiation
Description
Number of participants who self-reported first-time marijuana use initiation during the study period
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Attend 7th grade in targeted schools that are on or near American Indian reservation and have received parental consent
Exclusion Criteria:
No parental consent
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Substance Use Prevention Campaign for American Indian Youth
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