Substance UseNCT03086434
Intertribal Talking Circle for the Prevention of Substance Abuse in Native Youth
A study testing Culturally Tailored Intervention and Standard Substance Abuse Education in people with Substance Use, run by Florida State University.
Trial summary
This project will evaluate an after-school substance abuse prevention intervention, compared to a standard substance abuse education program, targeting 6th grade AI youth in three AI communities: Ojibwe/Chippewa in Minnesota, Choctaw in Oklahoma, and Lumbee in North Carolina. Read more about this study
- Who is it for?
- Ages 10 to 55 years
- Conditions the study is for
- Substance Use
- What is being tested?
- Culturally Tailored Intervention and Standard Substance Abuse Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 630 participants
- Where
- No sites listed yet
- Study dates
- May 2014to 29 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 10 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- AIl students enrolled in the 6th grade at each of the 3 regions
- Active parental consent
- Student willingness to participate and signed assent. Inclusion criteria for adult participants include: adults over 18 years of age currently employed as personnel, educators, and counselors at tribal schools among the three regions.
Who cannot join
- Exclusion criteria include students who are not identified as American Indian, no active parental consent, and no signed assent.
About this study
This project will evaluate an after-school substance abuse prevention intervention, compared to a standard substance abuse education program, targeting 6th grade AI youth in three AI communities: Ojibwe/Chippewa in Minnesota, Choctaw in Oklahoma, and Lumbee in North Carolina.
A community-based participatory research approach will be used to culturally and technologically adapt the intervention. A two-condition controlled study will evaluate the efficacy of the intervention to increase AI youth Native self-reliance while decreasing AI youth substance use involvement. An adult training program second level intervention study will also be implemented to train tribal personnel from the three regional tribes on how to implement the intervention as a tribal program beyond the study period.
Effectiveness will be determined by a small partial cross-over randomized trial comparing the intervention to a wait-list control condition. Process evaluations will focus on the future adoption and implementation of the intervention, and recommendations for sustainable adaptations.
Read the detailed description
The proposed study will consist of a 5-year plan: Year 1 has been completed and consisted of strengthening and extending community partnerships in each community and collecting data that will inform the cultural adaptation and tailoring of the intervention; Years 2, 3, and 4 will entail implementation by using a two-condition controlled study in which the culturally competent intervention is compared to standard care; and Year 5 will consist of final data collection, analysis of results, dissemination of results to local communities, and finalization of a sustainability plan for each Tribe.
Participants in the proposed study will consist of 540 male and female American Indian 6th grade students who represent at least three different Tribes - Choctaw, Ojibwe/ Chippewa, and Lumbee, in three different regions of the U.S. Participants will also include 70 tribal personnel (adults 18 and over) who be trained to implement the intervention in Years 3 \& 4 of the project. Finally, 15-20 stakeholders and community partnership members will be interviewed at various stages of this project.
- Conditions
- Substance Use
- Being tested
- Culturally Tailored Intervention, Standard Substance Abuse Education
- Keywords
- Culturally tailored intervention, American Indian early adolescents, Prevention of substance use
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culturally Tailored InterventionOther
School-based substance use prevention
Standard Substance Abuse EducationOther
Class room program
| Study group | Role | What they receive |
|---|---|---|
| Culturally tailored intervention | Experimental | The participants of the experimental condition will receive the intervention in a talking circle format. They will meet for 10 weekly 50 minute sessions. Receives: Other: Culturally Tailored Intervention |
| Standard Substance Abuse Education | Active comparator | The control condition participants are assigned to the standard substance abuse education program which is delivered in a classroom format format. They will meet for 10 weekly 50 minute classroom sessions. Receives: Other: Standard Substance Abuse Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Substance Use
Self-report to substance use
Measured: Change overtime at baseline, 6 months, 12 months
Secondary outcomes (1)
Native Self-Reliance
Cultural identity
Measured: Change overtime at baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study startMay 2014
- Primary completionSep 2019
- Study completion29 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance UseStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 630 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- Northern Arizona University, Choctaw Nation of Oklahoma, University of North Carolina, University of Minnesota
- Responsible party
- Sponsor
- Investigators
- John Lowe, PhD, Principal investigator, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03086434
- Sponsor's protocol ID
- 2017.19687
- Other IDs
- 2017
- Status last verified
- Aug 2018
- First submitted
- 2 Mar 2017
- Last updated
- 7 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This study and project will be presented to the other researchers and at national conferences and submitted for publication after study completion.
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intertribal Talking Circle for the Prevention of Substance Abuse in Native Youth
- ClinicalTrials.gov ID
- NCT03086434
- Acronym / sponsor ID
- 2017.19687
- Conditions
- Substance Use
- Keywords
- Culturally tailored intervention, American Indian early adolescents, Prevention of substance use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 630 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- Northern Arizona University, Choctaw Nation of Oklahoma, University of North Carolina, University of Minnesota
- Study start
- May 2014 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- 29 Sep 2019 (actual)
- First posted
- 22 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project will evaluate an after-school substance abuse prevention intervention, compared to a standard substance abuse education program, targeting 6th grade AI youth in three AI communities: Ojibwe/Chippewa in Minnesota, Choctaw in Oklahoma, and Lumbee in North Carolina.
A community-based participatory research approach will be used to culturally and technologically adapt the intervention. A two-condition controlled study will evaluate the efficacy of the intervention to increase AI youth Native self-reliance while decreasing AI youth substance use involvement. An adult training program second level intervention study will also be implemented to train tribal personnel from the three regional tribes on how to implement the intervention as a tribal program beyond the study period.
Effectiveness will be determined by a small partial cross-over randomized trial comparing the intervention to a wait-list control condition. Process evaluations will focus on the future adoption and implementation of the intervention, and recommendations for sustainable adaptations.
Detailed description
The proposed study will consist of a 5-year plan: Year 1 has been completed and consisted of strengthening and extending community partnerships in each community and collecting data that will inform the cultural adaptation and tailoring of the intervention; Years 2, 3, and 4 will entail implementation by using a two-condition controlled study in which the culturally competent intervention is compared to standard care; and Year 5 will consist of final data collection, analysis of results, dissemination of results to local communities, and finalization of a sustainability plan for each Tribe.
Participants in the proposed study will consist of 540 male and female American Indian 6th grade students who represent at least three different Tribes - Choctaw, Ojibwe/ Chippewa, and Lumbee, in three different regions of the U.S. Participants will also include 70 tribal personnel (adults 18 and over) who be trained to implement the intervention in Years 3 \& 4 of the project. Finally, 15-20 stakeholders and community partnership members will be interviewed at various stages of this project.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Culturally tailored intervention | Experimental | Other: Culturally Tailored InterventionThe participants of the experimental condition will receive the intervention in a talking circle format. They will meet for 10 weekly 50 minute sessions. |
| Standard Substance Abuse Education | Active comparator | Other: Standard Substance Abuse EducationThe control condition participants are assigned to the standard substance abuse education program which is delivered in a classroom format format. They will meet for 10 weekly 50 minute classroom sessions. |
Who may qualify
- Ages
- 10 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- AIl students enrolled in the 6th grade at each of the 3 regions
- Active parental consent
- Student willingness to participate and signed assent. Inclusion criteria for adult participants include: adults over 18 years of age currently employed as personnel, educators, and counselors at tribal schools among the three regions.
Key exclusion criteria (1 listed)
- Exclusion criteria include students who are not identified as American Indian, no active parental consent, and no signed assent.
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 |
|---|---|---|
| Culturally Tailored InterventionSchool-based substance use prevention | Other | Culturally tailored intervention |
| Standard Substance Abuse EducationClass room program | Other | Standard Substance Abuse Education |
Primary outcome
Substance Use
Time frame: Change overtime at baseline, 6 months, 12 months
Self-report to substance use
1 secondary outcome
Native Self-Reliance
Time frame: Change overtime at baseline, 6 months, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
- Individual participant dataSharing planned: Yes. This study and project will be presented to the other researchers and at national conferences and submitted for publication after study completion.
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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.
John Lowe, PhD principal investigator
Florida State University
Questions about this trial
What is this clinical trial studying?
A study testing Culturally Tailored Intervention and Standard Substance Abuse Education in people with Substance Use, run by Florida 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 3 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 7 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Substance Use (time frame: Change overtime at baseline, 6 months, 12 months). 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 7 Feb 2020.