Family Spirit Strengths

Part of paid clinical trials in Chinle, Arizona.

Sponsor
Johns Hopkins Bloomberg School of Public Health
Study ID
NCT05836090
Status
Recruiting
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Conditions

  • Anxiety Disorders and Symptoms
  • Depressive Symptoms
  • Mental Health Issue
  • Substance Use

Eligibility Criteria

Sex
FEMALE
Age
14 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Family Spirit Strengths (FSS) — BEHAVIORAL
    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).
  • Family Spirit Nurture — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Apr 20, 2023
Status verified
Apr 2026
Primary completion
Mar 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
188 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Family Spirit Strengths (FSS)
    FSS 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.
  • Active Comparator: Family Spirit Nurture
    Participants 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.

Primary Outcome Measure

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 [ Time Frame: baseline, 3-4 months post baseline, 6-8 months post baseline ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Johns Hopkins Center for Indigenous HealthChinleArizona86503
Brandy Begay
[email protected]
928-674-6824
Pokagon Health ServicesPokagonMichigan49047
Elizabeth Leffler
[email protected]
269-462-4406
Johns Hopkins Center For Indigenous HealthShiprockNew Mexico87420
Leonela Nelson, MPH
[email protected]

Find similar trials in Chinle, AZ

By condition
Substance use disorder
By specialty
Behavioral healthAddiction medicine
By research site
Johns Hopkins Center for Indigenous Health· Chinle, AZPokagon Health Services· Pokagon, MIJohns Hopkins Center For Indigenous Health· Shiprock, NM

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