Culturally Adapted Compass for Courage for Melancholia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Rocky Boy Reservation, Box Elder, MT
Melancholia+2 More
Culturally Adapted Compass for Courage - Behavioral
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

Native Americans (NA) are at greater risk for anxiety and depression early in life with 10-39% of NA youth reporting clinical levels of anxiety or depression. This is concerning given potential negative effects of these conditions across the lifespan (substance use, suicide). Available culturally adapted prevention and early interventions (PEIs) for anxiety and depression in NA youth are limited. Two are indicated for at-risk youth (e.g., trauma), one universal PEI was not efficacious, community stakeholders served as consultants with no youth or parents involved, and evaluation used minimal mixed methods. Thus, there is a critical need for the development and evaluation of a culturally consonant, brief prevention and early intervention (PEI) for anxiety and depression in NA youth using a CBPR approach that include youth and parents and mixed method evaluation. The investigators' short-term goal is to provide the community with a potentially successful PEI to mitigate Rocky Boy youth's anxiety and depression that integrates culture and traditions for delivery in schools. The Specific Aims of the proposed research are to 1) culturally adapt COMPASS for Courage for NA youth (chosen by the CAB), 2) evaluate the feasibility and acceptability of the culturally-adapted COMPASS with NA Rocky Boy youth, and 3) estimate effect size changes in anxiety and depressive symptoms of the culturally adapted COMPASS with NA youth. The investigators propose to build upon the investigators' strong community relationships and CBPR methods to achieve these aims. The investigators will partner with the CAB to culturally adapt COMPASS for NA youth in year 1 within a CBPR framework, including Rocky Boy youth and parents. In year 2, The investigators will train three NA Rocky Boy providers and pilot test the adapted PEI among 30 Rocky Boy 8-12-year-olds in two schools serving youth from the reservation in Years 2 and 3. The investigators will evaluate feasibility and acceptability using mixed methods including focus groups of key stakeholders (youth, parents, and teachers) and estimate effect sizes of changes in anxiety and depressive symptoms using a pre-post, single group design. The investigators hypothesize Rocky Boy youth will find the adapted COMPASS intervention to be acceptable, enjoyable, and culturally appropriate and there will be pre- to post-intervention reductions in anxiety and depressive symptoms. The long-term goal is to continue refining and tailoring the adapted COMPASS intervention and evaluate its efficacy and sustainability. The investigators plan to submit an R01 (Clinical Trial) in response to the FOA, Intervention Research to Improve Native American Health (PAR-20-238), in Year 3 for a full-scale clinical trial that will be informed by the study's findings.

Eligible Conditions

  • Melancholia
  • Anxiety Disorders

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 5-10 minutes

5 minutes
Anxiety Control Questionnaire for Children
Child Response Style Questionnaire - Rumination Scale
Revised Child Anxiety and Depression Scale - Short Version
5-10 minutes
Post-Intervention Usability Survey
The Child and Youth Resilience Measure

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Culturally Adapted Compass for Courage
1 of 1
Experimental Treatment

130 Total Participants · 1 Treatment Group

Primary Treatment: Culturally Adapted Compass for Courage · No Placebo Group · N/A

Culturally Adapted Compass for Courage
Behavioral
Experimental Group · 1 Intervention: Culturally Adapted Compass for Courage · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 5-10 minutes
Closest Location: Rocky Boy Reservation · Box Elder, MT
Photo of montana 1Photo of montana 2Photo of montana 3
N/AFirst Recorded Clinical Trial
0 TrialsResearching Melancholia
0 CompletedClinical Trials

Who is running the clinical trial?

Montana State UniversityLead Sponsor
37 Previous Clinical Trials
1,042,381 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are a teacher of 8-12 year-old youth.
You are an elder residing on the reservation.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.