A program to support mental health in American Indian and Alaska Native communities
Official title: Family Spirit Strengths
Run by Johns Hopkins Bloomberg School of Public Health · NCT05836090 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 14 Years and up |
| Sex | Women only |
| Enrollment | 188 (estimated) |
| Sponsor | Johns Hopkins Bloomberg School of Public Health Academic / other |
| Locations | 3 sites (Chinle, Arizona and 2 other locations) |
| Status | Recruiting |
| Started | April 20, 2023 |
| Main results expected | March 30, 2028 |
| Study ends | June 30, 2028 |
| Registry record updated | October 19, 2026 |
| Trial ID | NCT05836090 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown success with culturally tailored interventions for mental health in Indigenous populations, suggesting potential for this approach.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.