NCT06353711 · University of North Carolina, Chapel Hill
Caring Connections Youth Suicide Detection and Intervention Study
(CA-LINC)
What this study is about
The goal of this pilot randomly assigned 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 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.
Where
- Charlotte, North Carolina
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 7, 2026 · Source of record for eligibility and locations