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Substance Use Prevention Campaign for American Indian Youth

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ClinicalTrials.gov Identifier: NCT03051633
Recruitment Status : Completed
First Posted : February 14, 2017
Results First Posted : August 3, 2020
Last Update Posted : August 3, 2020
Sponsor:
Information provided by (Responsible Party):
Randall Swaim, Colorado State University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Adolescent Substance Use Behavioral: Be Under Your Own Influence Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 528 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Substance Use Prevention Campaign for American Indian Youth
Actual Study Start Date : April 15, 2014
Actual Primary Completion Date : May 16, 2018
Actual Study Completion Date : May 16, 2018
Arms and Interventions
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Arm Intervention/treatment
Experimental: Be Under Your Own Influence Intervention
School-based anti-substance use communications campaign
 Behavioral: Be Under Your Own Influence
School based anti-drug use communications campaign
No Intervention: Control
Assessment only


Outcome Measures
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Primary Outcome Measures :
  1. Alcohol Initiation [ Time Frame: 18 months ]
    The number of students who self-reported initiated alcohol for the first time during the study period

  2. Alcohol Intoxication Initiation [ Time Frame: 18 months ]
    Number of participants self-reporting first-time alcohol intoxication initiation during the study period.

  3. Marijuana Initiation [ Time Frame: 18 months ]
    Number of participants who self-reported first-time marijuana use initiation during the study period


Eligibility Criteria
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Ages Eligible for Study:   11 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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No Contacts or Locations Provided
  Study Documents (Full-Text)

Documents provided by Randall Swaim, Colorado State University:
Study Protocol and Statistical Analysis Plan  [PDF] May 21, 2020

More Information
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Responsible Party: Randall Swaim, Senior Research Scientist, Colorado State University
ClinicalTrials.gov Identifier: NCT03051633    
Other Study ID Numbers: R01DA035141 ( U.S. NIH Grant/Contract )
First Posted: February 14, 2017    Key Record Dates
Results First Posted: August 3, 2020
Last Update Posted: August 3, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No