Clinical trial NCT03086434: Intertribal Talking Circle for the Prevention of Substance Abuse in Native Youth
Official title: Intertribal Talking Circle for the Prevention of Substance Abuse in Native Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use
Keywords: Culturally tailored intervention
American Indian early adolescents
Prevention of substance use
Lead sponsor: Florida State University
Sponsor class: OTHER
Collaborators: name: Northern Arizona University
name: Choctaw Nation of Oklahoma
name: University of North Carolina
name: University of Minnesota
First posted: 2017-03-22
Enrollment: 630
Sex: ALL
Minimum age (years): 10
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Inclusion criteria for youth participants include:
* 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.

Exclusion Criteria:

* Exclusion criteria include students who are not identified as American Indian, no active parental consent, and no signed assent.

Primary outcomes:
measure: Substance Use
timeFrame: Change overtime at baseline, 6 months, 12 months
Secondary outcomes:
measure: Native Self-Reliance
timeFrame: Change overtime at baseline, 6 months, 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Florida State University
name: John Lowe, PhD
role: PRINCIPAL_INVESTIGATOR
References: