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NCT05836090 · ClinicalTrials.gov registry record · NA

Family Spirit Strengths

A NA study of Substance Use and Depressive Symptoms, sponsored by Johns Hopkins Bloomberg School of Public Health.

Recruiting
Registry status
NA
Development phase
188
Enrollment target
3
Study locations

NCT05836090: Recruiting NA study of Substance Use and Depressive Symptoms, sponsored by Johns Hopkins Bloomberg School of Public Health.

NCT05836090 is a NA study of Substance Use and Depressive Symptoms that is actively recruiting participants, run by Johns Hopkins Bloomberg School of Public Health. The registered enrollment target is 188 participants, below the 1,258-participant average among 88 other Substance Use trials with a reported enrollment target (85% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05836090, a NA study of Substance Use and Depressive Symptoms, is actively recruiting participants, sponsored by Johns Hopkins Bloomberg School of Public Health.

RECRUITING
Registry status
NA
Development phase
188 participants
Enrollment target
3
Study locations

Study 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.

Primary Outcome

As measured by the single item on the Health-Related Quality of Life (HRQOL) which asks responders to identify how many days in the past 30 day they experience bad or poor mental health. Scores may range from 0-30 where 0 indicates the participant did not experience any poor mental health days in the last 30 days and 30 indicates the participant experienced a poor mental health day every day in the last 30 days. A difference in mean for the past 30 days will be calculated at the 6 month follow-u

Interventions

  • BEHAVIORAL Family Spirit Strengths (FSS)
  • BEHAVIORAL Family Spirit Nurture

Study Locations (3)

Arizona

  • Johns Hopkins Center for Indigenous Health - Chinle

Michigan

  • Pokagon Health Services - Pokagon

New Mexico

  • Johns Hopkins Center For Indigenous Health - Shiprock

Trial Details

FieldValue
Enrollment Target 188 participants
Start Date 2023-04-20
Est. Completion 2028-06-30
Phase NA

What NCT05836090 shows while recruiting

NCT05836090 is an interventional study that assigns participants to a tested intervention. The registered 188 participants enrollment target is mid-sized for trials with a published cap, below the 1,258-participant average among 88 other Substance Use trials with a reported enrollment target (85% lower).

The record links to 4 conditions, with Substance Use appearing as the primary indexed condition, and to 2 interventions - of which Family Spirit Strengths (FSS) is the first listed.

NCT05836090 reports a single indexed study location in Arizona, Michigan, New Mexico.

Frequently Asked Questions

What is clinical trial NCT05836090 about?

NCT05836090 is a clinical study titled "Family Spirit Strengths". 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 investigato...

What is the current status of trial NCT05836090?

This trial is currently recruiting. It is a NA study. The enrollment target is 188 participants. The study started on 2023-04-20. Estimated completion is 2028-06-30.

What conditions does trial NCT05836090 study?

This clinical trial studies the following conditions: Substance Use, Depressive Symptoms, Mental Health Issue, Anxiety Disorders and Symptoms.

What interventions are being tested in trial NCT05836090?

The interventions under investigation include: Family Spirit Strengths (FSS) (BEHAVIORAL), Family Spirit Nurture (BEHAVIORAL).

Who is sponsoring clinical trial NCT05836090?

This trial is sponsored by Johns Hopkins Bloomberg School of Public Health, which has 187 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05836090 being conducted?

This trial has 3 study locations across Arizona, Michigan, New Mexico. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Substance Use

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05836090's enrollment target sits among peer trials

188 50th of 88 higher than 39 of 88 other Substance Use trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Substance Use trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05836090, the US trial registry maintained by the National Library of Medicine. NCT05836090 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.