Clinical trial NCT05836090: Family Spirit Strengths
Official title: Family Spirit Strengths
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depressive Symptoms
Anxiety Disorders and Symptoms
Substance Use
Mental Health Issue
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
First posted: 2023-05-01
Enrollment: 188
Sex: FEMALE
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
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
timeFrame: baseline, 3-4 months post baseline, 6-8 months post baseline
Secondary outcomes:
measure: Change in Substance Use as measure by the Timeline Follow Back for Substance Use
timeFrame: baseline, 3-4 months post baseline, 6-8 months post baseline
measure: Change in depressive symptoms as measured by the Centers for Epidemiological Research Revised 10 item scale (CESDR-10)
timeFrame: baseline, 3-4 months post baseline, 6-8 months post baseline
measure: Change in anxiety symptoms as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) short form
timeFrame: baseline, 3-6 months post baseline, 6-8 months post baseline
Other outcomes:
Locations:
city: Chinle
country: United States
facility: Johns Hopkins Center for Indigenous Health
state: Arizona
city: Pokagon
country: United States
facility: Pokagon Health Services
state: Michigan
city: Shiprock
country: United States
facility: Johns Hopkins Center For Indigenous Health
state: New Mexico
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Emily Haroz
role: PRINCIPAL_INVESTIGATOR
References: