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Family Spirit Strengths

Study acronym: FSS
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Re-verified, no change to tracked fieldsv9
  2. Notable Primary completion date: Apr 2025 to Mar 30, 2028
    • Study completion date: Dec 2028 to Jun 30, 2028
    v8
  3. Minor Study completion date: Dec 2025 to Dec 2028v7
  4. Minor Site details revised at 2 of 3 sitesv6
  5. Minor Study sites: 1 to 3
    • Secondary endpoints: details revised at 1 of 3 entries
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Minor Secondary endpoints: details revised at 3 of 3 entriesv4
  2. Minor Eligibility criteria expanded, about 8 wordsv3
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 1, 2023 to Apr 20, 2023
    • Site details revised
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT05836090
Lead Sponsor Johns Hopkins Bloomberg School of Public Health
Conditions
(from sponsor)
Depressive Symptoms, Anxiety Disorders and Symptoms, Substance Use, Mental Health Issue
Related terms Anxiety Disorders, Depression, Substance-Related Disorders
Enrollment 188 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov