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NCT05836090: FSS

Family Spirit Strengths

Recruiting now NA Last updated 13 April 2026
What this trial tests

NA trial testing Family Spirit Strengths (FSS) in Depressive Symptoms in 188 participants. Currently enrolling.

Timeline
20 April 2023
Primary endpoint
30 March 2028
30 June 2028

Quick facts

Lead sponsorJohns Hopkins Bloomberg School of Public Health
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment188
Start date20 April 2023
Primary completion30 March 2028
Estimated completion30 June 2028
Sites3 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Johns Hopkins Bloomberg School of Public Health

Who can join

14 and older, female only, with Depressive Symptoms or Anxiety Disorders and Symptoms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Testing the effectiveness of Family Spirit Strengths (FSS) - a culturally informed intervention designed to prevent mental health and substance misuse for indigenous families through home visiting.
    Nelson L, Lopez LM, Archuleta S, Van Wyk SS, et al · · 2026 · PMID 41749230 · DOI 10.1186/s12889-026-26593-0

Verify or expand the search:

Other recruiting trials for Depressive Symptoms

Currently open trials in the same condition.

Other Johns Hopkins Bloomberg School of Public Health trials

Trials by the same sponsor.

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing