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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
Colorado State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Adolescent Substance Use

Eligibility Criteria

11 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

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

    First Posted
    February 8, 2017
    Last Updated
    July 20, 2020
    Sponsor
    Colorado State University
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    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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