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Substance Use Prevention Campaign for American Indian Youth

Substance Use Prevention Campaign for American Indian Youth

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03051633
Enrollment
528
Registered
2017-02-14
Start date
2014-04-15
Completion date
2018-05-16
Last updated
2020-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent Substance Use

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.

Interventions

BEHAVIORALBe Under Your Own Influence

School based anti-drug use communications campaign

Sponsors

Colorado State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
11 Years to 14 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Alcohol Initiation18 monthsThe number of students who self-reported initiated alcohol for the first time during the study period
Alcohol Intoxication Initiation18 monthsNumber of participants self-reporting first-time alcohol intoxication initiation during the study period.
Marijuana Initiation18 monthsNumber of participants who self-reported first-time marijuana use initiation during the study period

Participant flow

Participants by arm

ArmCount
Be Under Your Own Influence Intervention
School-based anti-substance use communications campaign Be Under Your Own Influence: School based anti-drug use communications campaign
342
Control
Assessment only
186
Total528

Baseline characteristics

CharacteristicBe Under Your Own Influence InterventionControlTotal
Age, Categorical
<=18 years
342 Participants186 Participants528 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Continuous12.5 Years
STANDARD_DEVIATION 0.57
12.5 Years
STANDARD_DEVIATION 0.65
12.5 Years
STANDARD_DEVIATION 0.59
Ethnicity (NIH/OMB)
Hispanic or Latino
18 Participants47 Participants65 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
324 Participants139 Participants463 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
American Indian
321 Participants176 Participants497 Participants
Sex: Female, Male
Female
188 Participants91 Participants279 Participants
Sex: Female, Male
Male
151 Participants95 Participants246 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 3420 / 186
other
Total, other adverse events
0 / 3420 / 186
serious
Total, serious adverse events
0 / 3420 / 186

Outcome results

Primary

Alcohol Initiation

The number of students who self-reported initiated alcohol for the first time during the study period

Time frame: 18 months

Population: BUYOI efficacy was tested in a five-year study with two cohorts of middle school students, and five middle schools recruited from the Northern Plains and Southwest regions of the United States, representing a recent sample of American Indian adolescents (grades 7th-8th, age at first assessment = 12.5 years).

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Be Under Your Own Influence InterventionAlcohol Initiation160 Participants
ControlAlcohol Initiation109 Participants
Comparison: Discrete time hazard represents the conditional probability that a student will experience first time alcohol use during a given measurement period, given that students did not use alchohol in a previous measurement period. Thus for each model, we tested the following hypothesis: Controlling for age at first-assessment, students attending BUYOI-assigned schools will have a lower risk of substance use uptake by the end of their eighth-grade year, relative to students attending control schools.p-value: 0.00495% CI: [-0.714, -0.126]Regression, Logistic
Primary

Alcohol Intoxication Initiation

Number of participants self-reporting first-time alcohol intoxication initiation during the study period.

Time frame: 18 months

Population: BUYOI efficacy was tested in a five-year study with two cohorts of middle school students, and five middle schools recruited from the Northern Plains and Southwest regions of the United States, representing a recent sample of American Indian adolescents (grades 7th-8th, age at first assessment = 12.5 years).

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Be Under Your Own Influence InterventionAlcohol Intoxication Initiation90 Participants
ControlAlcohol Intoxication Initiation62 Participants
Comparison: Discrete time hazard represents the conditional probability that a student will experience first time alcohol initiation during a given measurement period, given that students did not become intoxicated in a previous measurement period. Thus, for each model, we tested the following hypothesis: controlling for age at first assessment, students attending BUYOI-assigned schools will have a lower risk of substance use uptake at the end of their eight grade yearp-value: 0.03795% CI: [-0.762, -0.018]Regression, Logistic
Primary

Marijuana Initiation

Number of participants who self-reported first-time marijuana use initiation during the study period

Time frame: 18 months

Population: BUYOI efficacy was tested in a five-year study with two cohorts of middle school students, and five middle schools recruited from the Northern Plains and Southwest regions of the United States, representing a recent sample of American Indian adolescents (grades 7th-8th, age at first assessment = 12.5 years).

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Be Under Your Own Influence InterventionMarijuana Initiation183 Participants
ControlMarijuana Initiation97 Participants
Comparison: Discrete time hazard represents the conditional probability that a student will experience first time marijuana use during a given measurement period, given that students did not use marijuana in a previous measurement period. Thus for each model, we tested the following hypothesis: Controlling for age at first-assessment, students attending BUYOI-assigned schools will have a lower risk of marijuana use uptake by the end of their eighth-grade year, relative to students attending control schools.p-value: 0.22895% CI: [-0.104, 0.444]Regression, Logistic

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026