Recruiting

Family Spirit Strengths

ClinicalTrials.gov IDNCT05836090

PhaseNA

Enrollment188

SponsorJohns Hopkins Bloomberg School of Public Health

Age14 Years

SexFEMALE

I'm interested View official listing

Conditions studied

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

About this study

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.

Interventions

Behavioral: Family Spirit Strengths (FSS) — 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).
Behavioral: Family Spirit Nurture — 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.

Primary outcomes

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 (baseline, 3-4 months post baseline, 6-8 months post baseline)

Eligibility information

Inclusion Criteria: * Self-identify as female; and * Pregnant or be a primary caregiver of a child that is 24 months or younger; and * 14 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. Exclusion Criteria: * 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.

Study locations

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

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.