Recruiting

Observational Study

Sponsor:

Johns Hopkins Bloomberg School of Public Health

Code:

NCT05836090

Conditions

Depressive Symptoms

Anxiety Disorders and Symptoms

Substance Use

Mental Health Issue

Eligibility Criteria

Sex: Female

Age: 14+

Healthy Volunteers: Not accepted

Interventions

Family Spirit Strengths (FSS)

Family Spirit Nurture

Study Details

Brief 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

Study ID

NCT05836090

Start date

Apr 20, 2023

Status verified date

Apr, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Mar 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 14+

Healthy Volunteers: Not accepted

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 Design

Enrollment

188 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

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).

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 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 and Locations

Central contacts

Emily Haroz, PhD

410-449-0051eharoz1@jhu.edu

Leonela Nelson, MPH

505-368- 4234lnelso32@jhu.edu

Locations

Johns Hopkins Center for Indigenous Health

Recruiting

Chinle, Arizona, United States, 86503

Contacts

Brandy Begay

928-674-6824bbegay4@jh.edu

Pokagon Health Services

Recruiting

Pokagon, Michigan, United States, 49047

Contacts

Elizabeth Leffler

269-462-4406Elizabeth.Leffler@pokagonband-nsn.gov

Johns Hopkins Center For Indigenous Health

Recruiting

Shiprock, New Mexico, United States, 87420

Contacts

Leonela Nelson, MPH

lnelso32@jhu.edu

More Information

Sponsor

Johns Hopkins Bloomberg School of Public Health

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins Bloomberg School of Public Health on 2026-04-13.