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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03051633
Other study ID # R01DA035141
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 15, 2014
Est. completion date May 16, 2018

Study information

Verified date July 2020
Source Colorado State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 528
Est. completion date May 16, 2018
Est. primary completion date May 16, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 11 Years to 14 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Be Under Your Own Influence
School based anti-drug use communications campaign

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Colorado State University

Outcome

Type Measure Description Time frame Safety issue
Primary Alcohol Initiation The number of students who self-reported initiated alcohol for the first time during the study period 18 months
Primary Alcohol Intoxication Initiation Number of participants self-reporting first-time alcohol intoxication initiation during the study period. 18 months
Primary Marijuana Initiation Number of participants who self-reported first-time marijuana use initiation during the study period 18 months
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