Caring Connections Youth Suicide Prevention Care Coordination Study

NCT07167615 | Recruiting DMC

• 1 other identifier: 24-2167
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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. 1.Is Caring Connections feasible to use for suicidal high-risk youth?
2. 2.Does Caring Connections have the potential to reduce suicide ideation and behaviors among high-risk suicidal youth?

Conditions

Suicide; Suicide Prevention; Suicide Ideation; Suicide Attempt

Keywords

youth; suicide prevention; care coordination; suicide intervention

Outcome Measures

Primary Outcomes (2)

• Change in Suicide Ideation Severity

  Investigators assess the suicide ideation severity using the Columbia-Suicide Severity Rating Scale (C-SSRS), a 6-item validated tool used to assess a person's risk for suicide. Assess suicidal ideation severity (5 items \[yes/no\]; scores range from 0 to 5, with higher scores indicating more severe suicidal ideation)

  Baseline, 30 days, 90 days, 180 days

• Reported Suicide Attempts

  Investigators will assess the presence of suicidal behaviors (yes/no) over the past month. Question #6 from the Columbia-Suicide Severity Rating Scale (C-SSRS) will be used which assesses a person's risk for suicide. A yes response indicates suicidal behaviors.

  Baseline, 30 days, 90 days, 180 days

Secondary Outcomes (5)

• Change in Treatment Acceptability

  30 days, 90 days

• Change in Therapeutic Alliance

  30 days, 90 days

• Change in Cultural Humility

  30 days, 90 days

• Change in Family Relationships

  Baseline, 30 days, 90 days, 180 days

• Change in Engagement Behaviors

  30 days, 90 days

Study Arms (2)

Experimental: Caring Connections

EXPERIMENTAL

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.

Behavioral: Caring Connections

Active Comparator: Treatment as Usual

ACTIVE COMPARATOR

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.

Behavioral: Treatment as Usual (TAU)

Interventions

Caring Connections BEHAVIORAL

Participants receive the Caring Connections intervention.

Experimental: Caring Connections

Treatment as Usual (TAU) BEHAVIORAL

Participants receive treatment as usual.

Active Comparator: Treatment as Usual

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Youth:
• 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:
• 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.).

You may not qualify if:

• Youth
• Youth at imminent suicide risk (reported verbally and/or indicated on C-SSRS)
• Youth who exhibit severe cognitive, language, or developmental delays
• Parents/Legal Guardians/Caregivers:
• Mental Healthcare and/or Healthcare Providers and/or Community Stakeholders:

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Village Heartbeat, Inc.: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

RECRUITING

MeSH Terms

Conditions

Suicide; Suicide Prevention; Suicide, Attempted

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Sonyia Richardson, Ph.D.

  UNC Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sonyia Richardson, Ph.D.

CONTACT

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

Margaret Phipps, MSW

CONTACT

marp@unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: September 11, 2025
• Study Start: August 14, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will become 9 to 36 months following publication and will remain available as long as the principal investigator remains actively working.
• Access Criteria: See Plan Description section above for IRB or similar authorization prior to access. Once those criteria have been met, an interested investigator may contact the study PI by email (sonyia.richardson@unc.edu); the PI would arrange for deidentified data sharing in accordance with university policy.

Locations

US (1)