Recruiting

Caring Connections

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT07167615

Conditions

Suicide

Suicide Prevention

Suicide Ideation

Suicide Attempt

Eligibility Criteria

Sex: All

Age: 13+

Healthy Volunteers: Not accepted

Interventions

Caring Connections

Treatment as Usual (TAU)

Study Details

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:

1. Is Caring Connections feasible to use for suicidal high-risk youth?
2. 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.

Conditions

Suicide

Suicide Prevention

Suicide Ideation

Suicide Attempt

Study ID

NCT07167615

Start date

Aug 14, 2025

Status verified date

Sep, 2025

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Experimental: Caring Connections

Caring Connections is a 90-day culturally adapted LINC intervention developed with and for youth. The Caring Connection intervention 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 Caring Connections intervention incorporates culturally promotive factors, empowerment, and motivational strategies to support, enhance strengths, promote hope, improve family relationships, and reinforce caring messages. This consumer-, community-, and theory-driven care coordination intervention is designed to reduce suicide ideation and behavior (SIB) by improving service engagement and delivery standards. Caring Connections is implemented by Peer Support Specialists and Community Health Workers assigned to mental health "hubs" in Faith-Based Organizations (FBOs) to facilitate standardization and access to care.

active comparator: Active Comparator: Treatment as Usual

The treatment-as-usual arm includes care coordination services provided by Peer Support Specialists and Community Health Workers in the faith-based organization mental health hubs. This condition includes screening to determine youth suicide risk (high vs. low). Youth presenting with high risk are typically referred to an inpatient treatment facility. Youth presenting with low risk may be referred to a local outpatient provider. Mental health hub staff may attempt to follow up with families (typically not more than a one-time check-in) to ensure they are connected to the referral source. Following initial referrals, mental health hubs typically continue to provide crisis response and referral services to youth and caregivers as needed.

Interventions

Caring Connections

Participants receive the Caring Connections intervention.

Treatment as Usual (TAU)

Participants receive treatment as usual.

Primary outcome measure

  • Change in Suicide Ideation Severity [ Time Frame: Baseline, 30 days, 90 days, 180 days ]
  • Reported Suicide Attempts [ Time Frame: Baseline, 30 days, 90 days, 180 days ]

Central Contacts and Locations

Central contacts

Sonyia Richardson, Ph.D.

919-445-1235Sonyia.Richardson@unc.edu

Margaret Phipps, MSW

marp@unc.edu

Locations

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27514

Contacts

Sonyia Richardson, Ph.D.

704-941-7751Sonyia.Richardson@unc.edu

Sonyia.Richardson@unc.edu

Principal Investigator:

Sonyia Richardson, Ph.D.

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

Sep 11, 2025

Last verified

Sep, 2025

Keywords

  • youth
  • suicide prevention
  • care coordination
  • suicide intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2025-09-11.