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

NCT03086434 | Completed DMC

• 1 other identifier: 2017.19687
• Study Type: interventional
• Target: 630
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Substance Use

Keywords

Culturally tailored intervention; American Indian early adolescents; Prevention of substance use

Outcome Measures

Primary Outcomes (1)

• Substance Use

  Self-report to substance use

  Change overtime at baseline, 6 months, 12 months

Secondary Outcomes (1)

• Native Self-Reliance

  Change overtime at baseline, 6 months, 12 months

Study Arms (2)

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.

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.

Other: Standard Substance Abuse Education

Interventions

Culturally Tailored Intervention OTHER

School-based substance use prevention

Culturally tailored intervention

Standard Substance Abuse Education OTHER

Class room program

Standard Substance Abuse Education

Eligibility Criteria

• Age: 10 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

Sponsors & Collaborators

• Florida State University: lead
• Northern Arizona University: collaborator
• Choctaw Nation of Oklahoma: collaborator
• University of North Carolina: collaborator
• University of Minnesota: collaborator

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• John Lowe, PhD

  Florida State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2017
• First Posted: March 22, 2017
• Study Start: May 1, 2014
• Primary Completion: September 1, 2019
• Study Completion: September 29, 2019
• Last Updated: February 7, 2020

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share