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OpenTrials
Completed

NCT Number: NCT03086434

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

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.

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Key information

Age range

10 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Culturally Tailored Intervention

Other

School-based substance use prevention

Standard Substance Abuse Education

Other

Class room program

Primary outcomes

  1. Substance Use

    Time frame: Change overtime at baseline, 6 months, 12 months

    Self-report to substance use

Secondary outcomes

  1. Native Self-Reliance

    Time frame: Change overtime at baseline, 6 months, 12 months

    Cultural identity

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Collaborators

  • Choctaw Nation of Oklahoma
  • Northern Arizona University
  • University of Minnesota
  • University of North Carolina

Registry information

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Mar 22, 2017
Registry last updated
Feb 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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