Family Spirit Strengths (FSS)

Johns Hopkins Bloomberg School of Public Health

Status: Enrolling

Conditions: Depressive Symptoms; Anxiety Disorders and Symptoms; Substance Use; Mental Health Issue

Treatments: Behavioral: Family Spirit Nurture; Behavioral: Family Spirit Strengths (FSS)

Study type: Interventional

Funder types: Other

Identifiers

NCT05836090

IRB00023017

Details and patient eligibility

About

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.

Enrollment: 188 estimated patients

Sex: Female

Ages: 14+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

188 participants in 2 patient groups

Family Spirit Strengths (FSS)

Experimental group

Description:

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.

Treatment:

Behavioral: Family Spirit Strengths (FSS)

Family Spirit Nurture

Active Comparator group

Description:

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.

Treatment:

Behavioral: Family Spirit Nurture