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CompletedNCT05734014Updated Nov 21, 2025Results posted

Strengthening Healthy Relationships Among Apsaalooke Youth

An interventional study of Connectedness Activities in Youth Engagement, sponsored by Montana State University. Completed at 1 site in United States. Open to participants aged 10 Years to 13 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-21.

Sponsored by Montana State University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
10 Years to 13 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Youth Engagement
03

In context

Lead sponsor

Montana State University is the lead sponsor of 41 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 13 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Intervention

    Youth Sessions focused on respect, communication, and relationally.

    Behavioral: Connectedness Activities

Interventions

  • BehavioralConnectedness Activities

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

06

What researchers measure

Primary outcomes

  1. Crow Knowledge

    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.

    Time frame: 2 week

07

Results

Posted Nov 21, 2025

Participant flow

5th and 6th grade Youth; recruited through flyers and social media

Participant flow — Overall Study
MilestoneIntervention
Started10
Completed10
Not completed0

Outcome measures

PrimaryCrow Knowledge

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.

Time frame:
2 week
Reported as:
Count of participants · Participants
Crow Knowledge
ParticipantsIntervention
Mentioned Crow Stories8
Did not Mention Crow stories2
Statistical analysis
  • Intervention ·

Adverse events

Collected over Through study completion, 2 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Intervention0/10 (0%)0/10 (0%)0/10 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Intervention
<=18 years10
Between 18 and 65 years0
>=65 years0
Sex: Female, Male
Sex: Female, Male(Participants)Intervention
Female5
Male5
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Intervention
American Indian or Alaska Native10
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White0
More than one race0
Unknown or Not Reported0
08

Study locations

1 site
  • Vanessa Simonds
    Bozeman, Montana 59717, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Apr 29, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05734014
Lead sponsor
Montana State University
Responsible party
Sponsor
First posted
Feb 17, 2023
Start date
May 1, 2024
Primary completion
Jun 30, 2024
Completion
Jun 30, 2024
Results posted
Nov 21, 2025
Last update
Nov 21, 2025

Study contacts

Vanessa Simonds, ScD
principal investigator · Montana State University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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