A program to support mental health in American Indian and Alaska Native communities
Family Spirit Strengths
This study is testing a new program designed to help pregnant women and caregivers in American Indian and Alaska Native communities improve their mental health and coping skills.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 188 (estimated) |
| Ages | 14 Years and up |
| Sex | Female |
| Sponsor | Johns Hopkins Bloomberg School of Public Health Academic / other |
| Locations | 3 sites (Chinle, Arizona and 2 other locations) |
| Trial ID | NCT05836090 on ClinicalTrials.gov |
What this trial studies
This project aims to address the high rates of mental and behavioral health issues in American Indian and Alaska Native communities by implementing the Family Spirit Strengths (FSS) program. The FSS program is a skills-based intervention that integrates evidence-based practices and is tailored to the cultural context of the participants. It focuses on enhancing self-efficacy, coping skills, and community connections among pregnant women and primary caregivers of young children. The effectiveness of the program will be evaluated through a randomized controlled trial, comparing participants receiving FSS to those who do not.
Who should consider this trial
Good fit: Ideal candidates are females aged 14 and older who are pregnant or primary caregivers of children 24 months or younger, with a family history of substance use and elevated symptoms of depression or anxiety.
Not a fit: Patients with profound disabilities that limit their participation or those unlikely to reside in the research area for the next six months may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve mental health outcomes and coping skills for participants in underserved communities.
How similar studies have performed: Other studies have shown success with culturally tailored interventions for mental health in Indigenous populations, suggesting potential for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Self-identify as female; and * Pregnant or be a primary caregiver of a child that is 24 months or younger; and * 14 years or older at time of enrollment; and * Report a family history of high-risk substance use and/or report high-risk levels of personal substance use; and * Have elevated symptoms of depression and/or anxiety and/or risk of substance use disorder; and * Be part of the service population of one of the participating sites. Exclusion Criteria: * Profound disability that limits the ability to participate in assessments or interventions; and * Unlikely to be residing in or near the research service area for the next 6 months.
Where this trial is running
Chinle, Arizona and 2 other locations
- Johns Hopkins Center for Indigenous Health — Chinle, Arizona, United States (Recruiting)
- Pokagon Health Services — Pokagon, Michigan, United States (Recruiting)
- Johns Hopkins Center For Indigenous Health — Shiprock, New Mexico, United States (Recruiting)
Study contacts
- Principal investigator: Emily Haroz — Johns Hopkins Bloomberg School of Public Health
- Study coordinator: Emily Haroz, PhD
- Email: eharoz1@jhu.edu
- Phone: 410-449-0051
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.