Adolescent Substance UseNCT03051633
Substance Use Prevention Campaign for American Indian Youth
A study testing Be Under Your Own Influence in people with Adolescent Substance Use, run by Colorado State University.
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. Read more about this study
- Who is it for?
- Ages 11 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Substance Use
- What is being tested?
- Be Under Your Own Influence
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 528 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2014to 16 May 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Attend 7th grade in targeted schools that are on or near American Indian reservation and have received parental consent
Who cannot join
- No parental consent
About this study
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.
Read the 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.
- Conditions
- Adolescent Substance Use
- Being tested
- Be Under Your Own Influence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Be Under Your Own InfluenceBehavioural
School based anti-drug use communications campaign
| Study group | Role | What they receive |
|---|---|---|
| Be Under Your Own Influence Intervention | Experimental | School-based anti-substance use communications campaign Receives: Behavioral: Be Under Your Own Influence |
| Control | No intervention | Assessment only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol Initiation
The number of students who self-reported initiated alcohol for the first time during the study period
Measured: 18 months
Alcohol Intoxication Initiation
Number of participants self-reporting first-time alcohol intoxication initiation during the study period.
Measured: 18 months
Marijuana Initiation
Number of participants who self-reported first-time marijuana use initiation during the study period
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2017
- Study start15 Apr 2014
- Primary completion16 May 2018
- Study completion16 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adolescent Substance UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 528 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Randall Swaim, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03051633
- Sponsor's protocol ID
- R01DA035141
- Status last verified
- Jul 2020
- First submitted
- 8 Feb 2017
- Last updated
- 3 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Substance Use Prevention Campaign for American Indian Youth
- ClinicalTrials.gov ID
- NCT03051633
- Acronym / sponsor ID
- R01DA035141
- Conditions
- Adolescent Substance Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 528 participants (actual)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Study start
- 15 Apr 2014 (actual)
- Primary completion
- 16 May 2018 (actual)
- Study completion
- 16 May 2018 (actual)
- First posted
- 14 Feb 2017 (actual)
- Results
- Posted 3 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Be Under Your Own Influence Intervention | Experimental | Behavioral: Be Under Your Own InfluenceSchool-based anti-substance use communications campaign |
| Control | No intervention | –Assessment only |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Attend 7th grade in targeted schools that are on or near American Indian reservation and have received parental consent
Key exclusion criteria (1 listed)
- No parental consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Be Under Your Own InfluenceSchool based anti-drug use communications campaign | Behavioural | Be Under Your Own Influence Intervention |
Primary outcome
Alcohol Initiation
Time frame: 18 months
The number of students who self-reported initiated alcohol for the first time during the study period
Alcohol Intoxication Initiation
Time frame: 18 months
Number of participants self-reporting first-time alcohol intoxication initiation during the study period.
Marijuana Initiation
Time frame: 18 months
Number of participants who self-reported first-time marijuana use initiation during the study period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Be Under Your Own Influence in people with Adolescent Substance Use, run by Colorado State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol Initiation (time frame: 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2020.