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
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
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
NCT ID
NCT03086434
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
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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