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New program aims to prevent depression and substance use in native communities

NCT ID NCT05836090

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 188 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2023

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

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

14 years and older

Sex

Female participants only

Healthy volunteers

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

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.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Johns Hopkins Center For Indigenous Health

    RECRUITING

    Shiprock, New Mexico, 87420, United States

  • Johns Hopkins Center for Indigenous Health

    RECRUITING

    Chinle, Arizona, 86503, United States

  • Pokagon Health Services

    RECRUITING

    Pokagon, Michigan, 49047, United States

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