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

Substance Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03086434
• Other study ID #: 2017.19687
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: September 29, 2019

Study information

• Verified date: August 2018
• Source: Florida State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 630
• Est. completion date: September 29, 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Substance Use
• Substance-Related Disorders

Intervention

Other:
• Culturally Tailored Intervention
School-based substance use prevention
• Standard Substance Abuse Education
Class room program

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Florida State University	Choctaw Nation of Oklahoma, Northern Arizona University, University of Minnesota, University of North Carolina

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Substance Use	Self-report to substance use	Change overtime at baseline, 6 months, 12 months
Secondary	Native Self-Reliance	Cultural identity	Change overtime at baseline, 6 months, 12 months