No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
14 and older
Sex
Female
Study type
Interventional
Purpose
Prevention
Participants needed
188 (estimated)
Sponsor
Johns Hopkins Bloomberg School of Public Health · Other
Who this trial is looking for
This trial is looking for women who are pregnant or caring for a young child and have concerns about their mental health or substance use. Participants will receive support through the Family Spirit Strengths program, aimed at helping them build skills and connections.
Are You a Good Fit for This Trial?
You may be able to join if
I identify as female.
I am pregnant or the main caregiver of a child who is 24 months or younger.
I am 14 years or older.
I have a family history of high-risk substance use or I personally have high-risk substance use.
I have symptoms of depression or anxiety.
I am part of the service population at one of the study sites.
You may not be able to join if
I have a profound disability that limits my ability to participate.
I am unlikely to be living in or near the research service area for the next 6 months.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 p…
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.
Trial Locations
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City
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Status
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
* Ha…
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.
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