Actively Recruiting
Family Spirit Strengths Program to Improve Mental Health in American Indian and Alaska Native Women
Led by Johns Hopkins Bloomberg School of Public Health · Updated on 2026-04-13
188
Participants Needed
3
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the Family Spirit Strengths (FSS) program to address mental and behavioral health challenges among American Indian and Alaska Native communities, where access to culturally appropriate care is limited. This study aims to test the effectiveness of FSS, a skills-based secondary prevention program that combines evidence-based practices and Indigenous cultural elements to help participants build coping skills, self-efficacy, and stronger community ties. The study uses a randomized controlled design comparing FSS with an evidence-based nutrition education program. Participants assigned to the FSS group will receive between 4 and 16 intervention sessions, averaging 6 to 8 visits, tailored to their mental and behavioral health needs based on regular in-session surveys. The comparison group will receive six bi-weekly nutrition education lessons from the Family Spirit Nurture curriculum, promoting healthy early childhood growth over a period of up to four months. Both programs are delivered through home visiting services. During the study, participants will be assessed at baseline, 3 to 4 months, and 6 to 8 months after starting the program. Researchers will measure changes in mental health, including the number of poor mental health days, substance use, depressive symptoms, and anxiety levels using validated scales. The study is sponsored by Johns Hopkins Bloomberg School of Public Health and focuses on culturally tailored interventions for improving mental health outcomes. The total duration of participation varies depending on timing of assessments.
CONDITIONS
Brief Title
Family Spirit Strengths
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Self-identify as female
- Pregnant or primary caregiver of a child 24 months old or younger
- 14 years or older at time of enrollment
- Report family history of high-risk substance use or personal high-risk substance use
- Have elevated symptoms of depression, anxiety, or risk of substance use disorder
- Be part of the service population at one of the participating sites
You will not qualify if you...
- Profound disability limiting ability to participate in assessments or interventions
- Unlikely to reside in or near the research service area for the next 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 months
Participants receive behavioral intervention sessions tailored to their mental and behavioral health needs or nutrition education lessons focused on early childhood healthy growth.
4 to 16 intervention visits for Family Spirit Strengths participants; bi-weekly visits for up to 6 lessons for Family Spirit Nurture participants
Duration - Up to 8 months post baseline
Participants complete follow-up assessments to evaluate changes in mental health, substance use, depressive and anxiety symptoms.
3 visits at baseline, 3-4 months, and 6-8 months post baseline
Trial Site Locations
Total: 3 locations
1
Johns Hopkins Center for Indigenous Health
Chinle, Arizona, United States, 86503
Actively Recruiting
2
Pokagon Health Services
Pokagon, Michigan, United States, 49047
Actively Recruiting
3
Johns Hopkins Center For Indigenous Health
Shiprock, New Mexico, United States, 87420
Actively Recruiting
Research Team
E
Emily Haroz, PhD
L
Leonela Nelson, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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