Family Spirit Strengths

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

188 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-20

Study Completion Date

2028-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Depressive Symptoms Anxiety Disorders and Symptoms Substance Use Mental Health Issue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Family Spirit Strengths (FSS)

Intervention Type BEHAVIORAL

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

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.

Group Type ACTIVE_COMPARATOR

Family Spirit Nurture

Intervention Type BEHAVIORAL

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.

Interventions

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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).

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

14 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No