Intertribal Talking Circle for the Prevention of Substance Abuse in Native Youth

NCT ID: NCT03086434

Last Updated: 2020-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 630 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2019-09-29

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.

Conditions

Substance Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Culturally Tailored Intervention

Intervention Type: OTHER

School-based substance use prevention

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.

Group Type: ACTIVE_COMPARATOR

Standard Substance Abuse Education

Intervention Type: OTHER

Class room program

Interventions

Culturally Tailored Intervention

School-based substance use prevention

Intervention Type: OTHER

Standard Substance Abuse Education

Class room program

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• AIl students enrolled in the 6th grade at each of the 3 regions
• Active parental consent

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northern Arizona University

OTHER

Sponsor Role: collaborator

Choctaw Nation of Oklahoma

UNKNOWN

Sponsor Role: collaborator

University of North Carolina

OTHER

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: collaborator

Florida State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Lowe, PhD

Role: PRINCIPAL_INVESTIGATOR

Florida State University

Other Identifiers

2017.19687

Identifier Type: -

Identifier Source: org_study_id