Strengthening Healthy Relationships Among Apsaalooke Youth

NCT ID: NCT05734014

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2024-06-30

Brief Summary

This pilot project uses community based participatory research principles to build upon cultural strengths to develop a feasibility of intervention to promote relationality and connectedness among Apsáalooke youth. This project worked closely with a Community Advisory Board (CAB) members to develop all stages of the project. The CAB identified 5th grade as an important age to focus. The feasibility study is developing pilot activities related to respecting promoting intergenerational, family, community and land connectedness among Crow youth.

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.

Conditions

Youth Engagement

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention

Youth Sessions focused on respect, communication, and relationally.

Group Type: EXPERIMENTAL

Connectedness Activities

Intervention Type: BEHAVIORAL

Indigenous Connectedness: Promoting respect, listening to elders, understanding Crow cultural values.

Interventions

Connectedness Activities

Indigenous Connectedness: Promoting respect, listening to elders, understanding Crow cultural values.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

Exlcusion Criteria: Youth not enrolled in fifth or sixth grade, and who did not obtain parental or guardian consent.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Montana State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vanessa Simonds, ScD

Role: PRINCIPAL_INVESTIGATOR

Montana State University

Locations

Vanessa Simonds

Bozeman, Montana, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

4W8808

Identifier Type: -

Identifier Source: org_study_id