New program aims to prevent depression and substance use in native communities
NCT ID NCT05836090
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a program called Family Spirit Strengths (FSS) designed to help American Indian and Alaska Native mothers and caregivers cope with stress, build skills, and connect with their culture. About 188 participants will either receive FSS or a nutrition education program. Researchers will measure changes in mental health days and substance use over six months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Family Spirit Strengths (FSS) – a behavioral skills program
- What this could lead to
- If it works, this could provide an effective, culturally grounded way to prevent depression, anxiety, and substance use in Indigenous communities.
- What could go wrong
- This is a relatively small trial (188 participants) and compares the program to nutrition education, so results may not apply broadly. The program is behavioral, so effects may vary.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 188 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2023
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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14 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Johns Hopkins Center For Indigenous Health
RECRUITINGShiprock, New Mexico, 87420, United States
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Johns Hopkins Center for Indigenous Health
RECRUITINGChinle, Arizona, 86503, United States
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Pokagon Health Services
RECRUITINGPokagon, Michigan, 49047, United States
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