Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 18 of 34 for:    tribe

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03086434
Recruitment Status : Completed
First Posted : March 22, 2017
Last Update Posted : February 7, 2020
Sponsor:
Collaborators:
Northern Arizona University
Choctaw Nation of Oklahoma
University of North Carolina
University of Minnesota
Information provided by (Responsible Party):
Florida State University

Tracking Information
First Submitted Date  ICMJE March 2, 2017
First Posted Date  ICMJE March 22, 2017
Last Update Posted Date February 7, 2020
Actual Study Start Date  ICMJE May 2014
Actual Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2017)
Substance Use [ Time Frame: Change overtime at baseline, 6 months, 12 months ]
Self-report to substance use
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2017)
Native Self-Reliance [ Time Frame: Change overtime at baseline, 6 months, 12 months ]
Cultural identity
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intertribal Talking Circle for the Prevention of Substance Abuse in Native Youth
Official Title  ICMJE Intertribal Talking Circle for the Prevention of Substance Abuse in Native Youth
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Substance Use
Intervention  ICMJE
  • Other: Culturally Tailored Intervention
    School-based substance use prevention
  • Other: Standard Substance Abuse Education
    Class room program
Study Arms  ICMJE
  • 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.
    Intervention: Other: Culturally Tailored Intervention
  • 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.
    Intervention: Other: Standard Substance Abuse Education
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 15, 2017)
630
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 29, 2019
Actual Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 55 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03086434
Other Study ID Numbers  ICMJE 2017.19687
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.
Responsible Party Florida State University
Study Sponsor  ICMJE Florida State University
Collaborators  ICMJE
  • Northern Arizona University
  • Choctaw Nation of Oklahoma
  • University of North Carolina
  • University of Minnesota
Investigators  ICMJE
Principal Investigator: John Lowe, PhD Florida State University
PRS Account Florida State University
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP