NCT05734014

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2022

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 17, 2023

Completed
1.2 years until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

November 21, 2025

Completed
Last Updated

November 21, 2025

Status Verified

November 1, 2025

Enrollment Period

2 months

First QC Date

September 30, 2022

Results QC Date

May 22, 2025

Last Update Submit

November 10, 2025

Conditions

Outcome Measures

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.

    2 week

Study Arms (1)

Intervention

EXPERIMENTAL

Youth Sessions focused on respect, communication, and relationally.

Behavioral: Connectedness Activities

Interventions

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

Intervention

Eligibility Criteria

Age10 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanessa Simonds

Bozeman, Montana, 59717, United States

Location

Results Point of Contact

Title
Vanessa Simonds
Organization
Montana State University

Study Officials

  • Vanessa Simonds, ScD

    Montana State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: The feasibility study includes pilot testing activities and an evaluation of the activities. This study focused on developing the lessons that would promote cultural connectedness.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2022

First Posted

February 17, 2023

Study Start

May 1, 2024

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

November 21, 2025

Results First Posted

November 21, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations