Family Spirit Strengths
FSS
1 other identifier
interventional
188
1 country
3
Brief Summary
This project addresses the disproportionate morbidity and mortality associated with mental and behavioral health problems in American Indian and Alaska Native communities. Access to culturally competent and effective behavioral health services is limited in many of these communities. The investigators aim to address this gap by testing the effectiveness of a trans-diagnostic secondary prevention program, Family Spirit Strengths (FSS) that can be embedded within home visiting services. The FSS program is a skills-based program that incorporates elements of evidence-based practice, the Common Elements Treatment Approach (CETA), and materials informed and developed based on an Indigenous advisory group. The FSS program aims to help participants build self-efficacy and coping skills, as well as build stronger connections to others, the participants' community, and cultural resources. The investigators will use a randomized controlled trial, whereby half of the participants will receive FSS and the other half will receive an evidence-based nutrition education program. The investigators' study is grounded in participatory processes and led by a team of Indigenous and allied researchers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2023
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 18, 2023
CompletedStudy Start
First participant enrolled
April 20, 2023
CompletedFirst Posted
Study publicly available on registry
May 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2028
April 13, 2026
April 1, 2026
4.9 years
April 18, 2023
April 10, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Difference in number of poor mental health days in last 30 days as assessed by a single item on the Health-Related Quality of Life (HRQOL) measure
As measured by the single item on the Health-Related Quality of Life (HRQOL) which asks responders to identify how many days in the past 30 day they experience bad or poor mental health. Scores may range from 0-30 where 0 indicates the participant did not experience any poor mental health days in the last 30 days and 30 indicates the participant experienced a poor mental health day every day in the last 30 days. A difference in mean for the past 30 days will be calculated at the 6 month follow-up timepoint.
baseline, 3-4 months post baseline, 6-8 months post baseline
Secondary Outcomes (3)
Change in Substance Use as measure by the Timeline Follow Back for Substance Use
baseline, 3-4 months post baseline, 6-8 months post baseline
Change in depressive symptoms as measured by the Centers for Epidemiological Research Revised 10 item scale (CESDR-10)
baseline, 3-4 months post baseline, 6-8 months post baseline
Change in anxiety symptoms as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) short form
baseline, 3-6 months post baseline, 6-8 months post baseline
Study Arms (2)
Family Spirit Strengths (FSS)
EXPERIMENTALFSS participants will receive 4-16 (average of 6-8) intervention visits covering topics related to their mental and behavioral health. The number of sessions each participant receives varies and depends on their unique needs. To guide this process, all intervention participants will take a brief, in-session survey to screen for current challenges they may be facing. Their answers will help determine the content and dose of future sessions.
Family Spirit Nurture
ACTIVE COMPARATORParticipants enrolled in nutrition education comparison group will receive 6 educational lessons related to promoting early childhood healthy growth. Lessons will be delivered bi-weekly for no longer than 4-months total. The lessons are from the evidence-based Family Spirit Nurture curriculum.
Interventions
The FSS intervention consists of psychoeducational components that emphasize the importance of mental and emotional health as part of overall wellness, and seek to normalize experiences of stress, to de-stigmatize help-seeking, and to build hope. Core content focuses on awareness of the connections between thoughts, feelings, behaviors, and spirituality, and imparts related self-help skills. It also specifically builds in connection to culture, land and others as coping strategies. The FSS lessons were developed based on culturally adapting the Common Elements Treatment Approach (CETA).
The active control Family Spirit Nurture, is an evidence-based nutrition education curriculum that has been previously tested with Navajo communities which focuses on age-appropriate parental feeding practices, including snack routines, avoidance of sugar-sweetened beverages (SSB) and promotion of water consumption.
Eligibility Criteria
You may qualify if:
- Self-identify as female; and
- Pregnant or be a primary caregiver of a child that is 24 months or younger; and
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Johns Hopkins Center for Indigenous Health
Chinle, Arizona, 86503, United States
Pokagon Health Services
Pokagon, Michigan, 49047, United States
Johns Hopkins Center For Indigenous Health
Shiprock, New Mexico, 87420, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emily Haroz
Johns Hopkins Bloomberg School of Public Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 18, 2023
First Posted
May 1, 2023
Study Start
April 20, 2023
Primary Completion (Estimated)
March 30, 2028
Study Completion (Estimated)
June 30, 2028
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share