Family Spirit Strengths

NCT05836090 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2026-04-13

No results posted yet for this study

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.

Conditions

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

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.

Sponsors & Collaborators

  • Johns Hopkins Bloomberg School of Public Health

    lead OTHER

Principal Investigators

  • Emily Haroz · Johns Hopkins Bloomberg School of Public Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-20
Primary Completion
2028-03-30
Completion
2028-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05836090 on ClinicalTrials.gov