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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05734014
Other study ID # 4W8808
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 1, 2023
Est. completion date August 30, 2023

Study information

Verified date April 2023
Source Montana State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This pilot project proposes to build upon these cultural strengths, including the clan system, to test the feasibility of a translational research intervention to promote healthy relationships and prevent dating violence among Apsáalooke youth. Community Advisory Board members identified 5th grade as an important age to establish healthy dating norms. The feasibility study includes a one-group pre/post intervention that includes 10-hour long sessions with youth to promote healthy relationship knowledge, volition, and communication skills. Elders and near-peer (young adults) will assist during these sessions sharing advice and serving as role models for youth. In addition, to promote the connectedness between youth and their community, there are 3 monthly clan feeds.


Description:

This project builds upon long-standing community-based participatory research partnerships between Montana State University and the Crow Nation. Through these partnerships, Apsáalooke community members prioritized healthy relationships among youth as a critical area for intervention. Through interviews and focus groups with Apsaalooke community members a strength-based strategy to promote healthy relationships among youth has emerged. This pilot project proposes to build upon these cultural strengths, including the clan system, to test the feasibility of a translational research intervention to promote healthy relationships and prevent dating violence among Apsáalooke youth. Community Advisory Board members identified 5th grade as an important age to establish healthy dating norms. The feasibility study includes a one-group pre/post intervention that includes 10-hour long sessions with youth to promote healthy relationship knowledge, volition, and communication skills. Elders and near-peer (young adults) will assist during these sessions sharing advice and serving as role models for youth. In addition, to promote the connectedness between youth and their community, there are 3 monthly clan feeds. Using a participatory approach, our project will accomplish the following aims: 1. Using a participatory research approach, finish adapting and localizing the curriculum. 2. Test the feasibility of pilot intervention among Apsáalooke youth and their families. 3. Refine pilot intervention and design an appropriate translational intervention (R01) for promoting healthy relationship skills among Apsáalooke youth.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date August 30, 2023
Est. primary completion date August 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years to 13 Years
Eligibility Inclusion Criteria: - Youth residing on or near the Crow Reservation 5th grade Exclusion Criteria: - Those without parental consent

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Healthy Relationship
The feasibility study includes a one-group pre/post intervention that includes 10-hour long sessions with youth to promote healthy relationship knowledge, volition, and communication skills. Elders and near-peer (young adults) will assist during these sessions sharing advice and serving as role models for youth. In addition, to promote the connectedness between youth and their community, there are 3 monthly clan feeds.

Locations

Country Name City State
United States Vanessa Simonds Bozeman Montana

Sponsors (1)

Lead Sponsor Collaborator
Montana State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Healthy Relationship Knowledge Using 7 true/false items that test knowledge, we will evaluate each item individually and as a combined score ranging from 0-7. Patterns of non-response will be examined. We will compare treating them as incorrect versus removing them and re-weighting the answered questions. up to 3 months
Primary Change in Volition A central concept to curriculum,21 volition, will be measured using the statement, I stand up for what I believe. Youth will be asked to rate their agreement with the statement using a 4-point Likert scale. up to 3 months
Primary Change in Self-efficacy to resist peer pressure: This scale focuses on peer pressure with youth providing ratings that range from 1 (definitely would not do this) to 4 (definitely would do this). Scales are reverse coded so that the higher numbers reflect greater self-efficacy based on a mean score across items. Three-item, 4-point Likert scale (Cronbach's a = .85).23 up to 3 months
Primary Change in Communication, Decision Making and Problem-Solving scale (CDP-Child Version This scale includes three items that make up the Problem-Solving Skills subscale, 4 items that make up the Decision-Making Skills subscale, and 4 items that make up the Communication Skills subscale. Response options include a 5-point Likert scale with total scores across all subscales ranging from 11 to 55 (Cronbach's a = 0.87).61 Higher scores indicate better communication, decision-making, and problem-solving skills. Subscale scores range from 1 to 5 and are derived by summing items for each subscale and then dividing by the number of items for that subscale. up to 3 months
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