NCT06353711 Caring Connections Youth Suicide Detection and Intervention Study
| NCT ID | NCT06353711 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of North Carolina, Chapel Hill |
| Condition | Suicide |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2025-08-14 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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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 180 participants in total. It began in 2025-08-14 with a primary completion date of 2027-05-31.
⚠ 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
The goal of this pilot randomized control trial (RCT) is to test the feasibility of Caring Connections, a Culturally Adapted Linking Individuals Needing Care (CA-LINC) suicide prevention care coordination intervention for high-risk suicidal youth. This consumer-, community-, and theory-driven care coordination intervention is designed to reduce suicide ideation and behavior (SIB) by improving service engagement. Connections is a 90-day intervention that integrates engagement and follow-up strategies to assess/monitor suicide risk, facilitate service use referrals/linkages, develop/refine safety plans, and create villages of care. The intervention incorporates cultural promotive factors, empowerment, and motivational strategies aimed at supporting youth, enhancing strengths, promoting hope, improving family relationships, and reinforcing caring messages. Primary research questions include: Is Caring Connections feasible to use for suicidal high-risk youth? Does Caring Connections have the potential to reduce suicide ideation and behaviors among high-risk suicidal youth? For the pilot RCT, 80 youth participants ages 13-19 who meet the inclusion criteria will be randomly assigned to one of two conditions: Caring Connections (n=40) or Treatment as Usual (n=40). Additionally, investigators will enroll 80 caregivers of youth meeting inclusion criteria and 20 Mental Healthcare, Healthcare Providers, Community Stakeholders, and/or Care Coordinators with experience working with suicidal youth. Researchers will compare those receiving Caring Connections with treatment as usual to see if suicidal ideation and behaviors, and engagement.
Eligibility Criteria
Inclusion Criteria: Youth: * 13 - 19 years old * Current or recent history (\<90 days) of suicide ideation, planning, or attempts or nonsuicidal self-injurious behaviors per youth or caregiver self-report or positive screen on the Patient Health Questionnaire Adolescent (PHQ-A), C-SSRS, or Ask Suicide-Screening Questions (ASQ). * Able to fluently speak and read English * Youth with a prior history of difficulty accessing services. * Written assent to participate in the study (\<18 years old) * Written consent from a parent/legal guardian/caregiver to participate in the study (\<18 years old) * Written consent if the youth is ages 18-19 Parents/Legal Guardians/Caregivers: * The primary caregiver of a youth who meets the above inclusion criteria for the study * Over the age of 18 * Able to fluently speak and read English * Without intellectual disabilities * Provide written consent to participate Mental Healthcare and/or Healthcare Providers and/or Community Stakeholders: * Mental Health, behavioral health, substance use and/or health-related professionals who screen/assess for mental health and/or suicide risk or provide referrals, treatment, or follow-up care to youth with a prior history of difficulty accessing services in the surrounding treatment areas based on this risk or community stakeholder (i.e., faith-based leaders, agency directors, advocates, school administrators, hospital/crisis directors, topical experts, etc.). * Over the age of 18 * Able to fluently speak and read English * Without intellectual disabilities * Provide written consent to participate Care Coordinators: * Care coordinators who screen/assess for mental health and/or suicide risk or provide referrals, treatment, or follow-up care to underserved youth in the surrounding treatment areas. * Over the age of 18 * Able to fluently speak and read English * Without intellectual disabilities Exclusion Criteria: Youth: * Youth at imminent suicide risk (reported verbally and/or indicated on C-SSRS) * Youth who exhibit severe cognitive, language, or developmental delays * Youth not meeting inclusion criteria Parents/Legal Guardians/Caregivers: * Not meeting the inclusion criteria listed above. Mental Healthcare and/or Healthcare Providers and/or Community Stakeholders: * Not meeting the inclusion criteria listed above.
Contact & Investigator
Sonyia C Richardson, Ph.D.
PRINCIPAL INVESTIGATOR
University of North Carolina, Chapel Hill
Frequently Asked Questions
Who can join the NCT06353711 clinical trial?
This trial is open to participants of all sexes, aged 13 Years or older, studying Suicide. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06353711 currently recruiting?
Yes, NCT06353711 is actively recruiting participants. Contact the research team at sonyia.richardson@unc.edu for enrollment information.
Where is the NCT06353711 trial being conducted?
This trial is being conducted at Charlotte, United States.
Who is sponsoring the NCT06353711 clinical trial?
NCT06353711 is sponsored by University of North Carolina, Chapel Hill. The principal investigator is Sonyia C Richardson, Ph.D. at University of North Carolina, Chapel Hill. The trial plans to enroll 180 participants.