| NCT ID | NCT05836090 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Johns Hopkins Bloomberg School of Public Health |
| Condition | Depressive Symptoms |
| Study Type | INTERVENTIONAL |
| Enrollment | 188 participants |
| Start Date | 2023-04-20 |
| Primary Completion | 2028-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 188 participants in total. It began in 2023-04-20 with a primary completion date of 2028-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Emily Haroz
PRINCIPAL INVESTIGATOR
Johns Hopkins Bloomberg School of Public Health
Frequently Asked Questions
Who can join the NCT05836090 clinical trial?
This trial is open to female participants only, aged 14 Years or older, studying Depressive Symptoms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05836090 currently recruiting?
Yes, NCT05836090 is actively recruiting participants. Contact the research team at eharoz1@jhu.edu for enrollment information.
Where is the NCT05836090 trial being conducted?
This trial is being conducted at Chinle, United States, Pokagon, United States, Shiprock, United States.
Who is sponsoring the NCT05836090 clinical trial?
NCT05836090 is sponsored by Johns Hopkins Bloomberg School of Public Health. The principal investigator is Emily Haroz at Johns Hopkins Bloomberg School of Public Health. The trial plans to enroll 188 participants.