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

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ClinicalTrials.gov Identifier: NCT03086434
Recruitment Status : Enrolling by invitation
First Posted : March 22, 2017
Last Update Posted : August 23, 2018
Sponsor:
Collaborators:
Northern Arizona University
Choctaw Nation of Oklahoma
University of North Carolina
University of Minnesota - Clinical and Translational Science Institute
Information provided by (Responsible Party):
Florida State University

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.


Condition or disease Intervention/treatment Phase
Substance Use Other: Culturally Tailored Intervention Other: Standard Substance Abuse Education Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 630 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Intertribal Talking Circle for the Prevention of Substance Abuse in Native Youth
Actual Study Start Date : May 2014
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Arm Intervention/treatment
Experimental: 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.
Other: Culturally Tailored Intervention
School-based substance use prevention

Active Comparator: 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.
Other: Standard Substance Abuse Education
Class room program




Primary Outcome Measures :
  1. Substance Use [ Time Frame: Change overtime at baseline, 6 months, 12 months ]
    Self-report to substance use


Secondary Outcome Measures :
  1. Native Self-Reliance [ Time Frame: Change overtime at baseline, 6 months, 12 months ]
    Cultural identity



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03086434


Sponsors and Collaborators
Florida State University
Northern Arizona University
Choctaw Nation of Oklahoma
University of North Carolina
University of Minnesota - Clinical and Translational Science Institute
Investigators
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Principal Investigator: John Lowe, PhD Florida State University

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Responsible Party: Florida State University
ClinicalTrials.gov Identifier: NCT03086434     History of Changes
Other Study ID Numbers: 2017.19687
First Posted: March 22, 2017    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: This study and project will be presented to the other researchers and at national conferences and submitted for publication after study completion.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Florida State University:
Culturally tailored intervention
American Indian early adolescents
Prevention of substance use

Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders