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

Primary Purpose

Substance Use

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Culturally Tailored Intervention
Standard Substance Abuse Education
Sponsored by
Florida State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Substance Use focused on measuring Culturally tailored intervention, American Indian early adolescents, Prevention of substance use

Eligibility Criteria

10 Years - 55 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Culturally tailored intervention

    Standard Substance Abuse Education

    Arm Description

    The participants of the experimental condition will receive the intervention in a talking circle format. They will meet for 10 weekly 50 minute sessions.

    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.

    Outcomes

    Primary Outcome Measures

    Substance Use
    Self-report to substance use

    Secondary Outcome Measures

    Native Self-Reliance
    Cultural identity

    Full Information

    First Posted
    March 2, 2017
    Last Updated
    February 5, 2020
    Sponsor
    Florida State University
    Collaborators
    Northern Arizona University, Choctaw Nation of Oklahoma, University of North Carolina, University of Minnesota
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03086434
    Brief Title
    Intertribal Talking Circle for the Prevention of Substance Abuse in Native Youth
    Official Title
    Intertribal Talking Circle for the Prevention of Substance Abuse in Native Youth
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2014 (Actual)
    Primary Completion Date
    September 2019 (Actual)
    Study Completion Date
    September 29, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Florida State University
    Collaborators
    Northern Arizona University, Choctaw Nation of Oklahoma, University of North Carolina, University of Minnesota

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Substance Use
    Keywords
    Culturally tailored intervention, American Indian early adolescents, Prevention of substance use

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    630 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Culturally tailored intervention
    Arm Type
    Experimental
    Arm Description
    The participants of the experimental condition will receive the intervention in a talking circle format. They will meet for 10 weekly 50 minute sessions.
    Arm Title
    Standard Substance Abuse Education
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Culturally Tailored Intervention
    Intervention Description
    School-based substance use prevention
    Intervention Type
    Other
    Intervention Name(s)
    Standard Substance Abuse Education
    Intervention Description
    Class room program
    Primary Outcome Measure Information:
    Title
    Substance Use
    Description
    Self-report to substance use
    Time Frame
    Change overtime at baseline, 6 months, 12 months
    Secondary Outcome Measure Information:
    Title
    Native Self-Reliance
    Description
    Cultural identity
    Time Frame
    Change overtime at baseline, 6 months, 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    John Lowe, PhD
    Organizational Affiliation
    Florida State University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    This study and project will be presented to the other researchers and at national conferences and submitted for publication after study completion.

    Learn more about this trial

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

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