Intertribal Talking Circle for the Prevention of Substance Abuse in Native Youth
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03086434|
Recruitment Status : Enrolling by invitation
First Posted : March 22, 2017
Last Update Posted : August 23, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Substance Use||Other: Culturally Tailored Intervention Other: Standard Substance Abuse Education||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||630 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Intertribal Talking Circle for the Prevention of Substance Abuse in Native Youth|
|Actual Study Start Date :||May 2014|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||April 2019|
Experimental: Culturally tailored intervention
The participants of the experimental condition will receive the intervention in a talking circle format. They will meet for 10 weekly 50 minute sessions.
Other: Culturally Tailored Intervention
School-based substance use prevention
Active Comparator: Standard Substance Abuse Education
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.
Other: Standard Substance Abuse Education
Class room program
- Substance Use [ Time Frame: Change overtime at baseline, 6 months, 12 months ]Self-report to substance use
- Native Self-Reliance [ Time Frame: Change overtime at baseline, 6 months, 12 months ]Cultural identity
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03086434
|Principal Investigator:||John Lowe, PhD||Florida State University|