RecruitingNot ApplicableNCT05836090

Family Spirit Strengths


Sponsor

Johns Hopkins Bloomberg School of Public Health

Enrollment

188 participants

Start Date

Apr 20, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 14 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a home-visiting support program called Family Spirit Strengths for pregnant women and young mothers who face mental health challenges and a family history of substance use. The program is designed to build resilience, address depression and anxiety, and reduce risk of substance use disorder through culturally tailored coaching visits. **You may be eligible if...** - You identify as female - You are pregnant or are the primary caregiver of a child 24 months old or younger - You are 14 or older at the time of enrollment - You have a family history of high-risk substance use OR have concerning levels of personal substance use - You have elevated symptoms of depression, anxiety, or risk of substance use disorder - You are part of the community served by one of the participating sites **You may NOT be eligible if...** - You have a profound disability that prevents you from participating in study activities - You are unlikely to remain in the area for the next 6 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALFamily 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).

BEHAVIORALFamily 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.


Locations(3)

Johns Hopkins Center for Indigenous Health

Chinle, Arizona, United States

Pokagon Health Services

Pokagon, Michigan, United States

Johns Hopkins Center For Indigenous Health

Shiprock, New Mexico, United States

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NCT05836090


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