- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05734014
Strengthening Healthy Relationships Among Apsaalooke Youth
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Purpose: The purpose of this study is to conduct a feasibility and acceptability of a pilot intervention to promote relationality among Apsáalooke youth. This formative study is grounded in community-based participatory efforts to build locally relevant educational programming for youth and support the development of future evidence-based programming for youth.
Participants and Inclusion Citeria:
Participants in this study consisted youth who are a maximum of 13 years old who are enrolled in 5th-6th grade at the time of the study. Eligibility criteria included youth that live on or near the Crow Reservation in Montana and have parental or guardian consent to participate. Recruitment efforts were conducted in partnership with local schools, educational liaisons, and community champions. Information about the program was shared through school announcements, flyers sent home with students and presentations during school-based and community events. Interested families received informational packets and consent forums outlining the purpose, procedures and voluntary nature of participants. Informed consent was also obtained from parents and assent from each youth participant. The recruitment spanned from May 2024 through June 2024. A total of 10 participants were recruited and enrolled in the study.
Data Collection Methods
Data for this feasibility study consisted of process evaluation data and qualitative, art-based reflections. The primary data collected included recruitment and retention metrics: Researchers tracked the number of students recruited, consented, and retained during the program. Session Observations: Trained facilitators and researchers documented implementation fidelity, student engagement, and logistical issues during sessions. Observational field notes were compiled systematically and informed the overall assessment of feasibility.
Arts-based qualitative reflections. At the conclusion of each session, students participated in a reflective activity using paper and markers to draw or write about their experiences. Prompts included: "What did you like best today?" "What did you learn?" "What would you like to share with your family?" The creative responses provided insight into the youth's internalization of key messages and their personal engagement with the content. Following the acidity, students voluntarily shared their drawing and narratives with the group. Researchers took detailed notes during these sharing moments to record accurate explanations.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Montana
-
Bozeman, Montana, United States, 59717
- Vanessa Simonds
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria: Students who are entering the fifth and sixth grade and who live on or near the Crow reservation will be invited to participate in the summer camp.
Exlcusion Criteria: Youth not enrolled in fifth or sixth grade, and who did not obtain parental or guardian consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
Youth Sessions focused on respect, communication, and relationally.
|
Indigenous Connectedness: Promoting respect, listening to elders, understanding Crow cultural values.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Crow Knowledge
Time Frame: 2 week
|
Arts-based open-ended question for youth to describe what they liked, what was challenging or what they learned.
We examined whether they mentioned the clan system (Crow Relationally), or the Creation Story.
|
2 week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Vanessa Simonds, ScD, Montana State University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 4W8808
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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