Caring Connections Youth Suicide Prevention Care Coordination Study

NCT ID: NCT07167615

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-14
• Study Completion Date: 2026-10-31

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.

Detailed Description

Linking Individuals Needing Care (LINC) is a consumer- and theory-driven care coordination intervention designed to reduce suicidal ideations and behaviors by improving service engagement and delivery standards. However, LINC has not been culturally adapted to meet the specific needs of all youth and caregivers, nor has it been integrated with communities whose help-seeking behaviors are often facilitated through non-behavioral health supports. Caring Connections is a proposed adaptation of LINC to meet the specific needs of youth and families by incorporating input from communities whose help-seeking behaviors are often facilitated through non-behavioral health supports such as faith-based organizations. This study has the potential to improve service delivery standards and reduce suicide risk among youth.

Caring Connections is implemented by Peer Support Specialists and Community Health Workers assigned to mental health "hubs" in Faith-Based Organizations (FBOs) that facilitate standardization and access to care for youth/families regardless of religious affiliation. FBOs effectively mobilize communities to promote positive health behaviors.

The aims of this study are the following: (1) Assess stakeholder perceptions on the acceptability/appropriateness of the adapted intervention, (2) Assess provider and community stakeholder perceptions on the practicality and integration of implementing and sustaining Caring Connections using existing community resources/infrastructure, (3) Evaluate the feasibility of study procedures for screening, recruitment, and randomization, (4) Evaluate treatment adherence, fidelity, and study retention, (5) Examine effect size estimates for differences in primary outcomes (suicide ideation and behaviors (SIB) among youth randomly assigned to Caring Connections vs. Treatment as Usual (TAU), (6) Examine differences in potential change mechanisms (i.e., therapeutic alliance, service utilization, cultural humility, family relationships, engagement behaviors, and participation barriers) between Caring Connections and TAU.

All participants will participate in a care coordination intervention aimed at linking them to resources and decreasing their risk for suicide. For the randomized control trial, investigators will enroll 180 participants, including 80 youth ages 13-19 with recent suicidal ideation and behaviors (<90 days), 80 Caregivers of youth meeting inclusion criteria, and 20 Care Coordinators, Providers, or Community Stakeholders with experience working with youth. Upon consent, the measures/data collection will occur at baseline, 30, 90, and 180 days. Measures will be administered by IRB-compliant university research assistants (blinded to group assignment in the RCT).

This pilot will inform the feasibility, usability, and implementation of a novel care coordination approach aimed at addressing the lack of culturally responsive interventions for reducing youth suicide risk. Caring Connections will assess elements of feasibility (acceptability, practicality, integration) aimed to facilitate rapid uptake and sustainability within existing mental health "hubs'' embedded in FBOs. This study has potential for improving service delivery standards, reducing suicide risk among diverse youth populations,

Conditions

Suicide; Suicide Prevention; Suicide Ideation; Suicide Attempt

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Caring Connections

Intervention Type: BEHAVIORAL

Participants receive the Caring Connections intervention.

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.

Group Type: ACTIVE_COMPARATOR

Treatment as Usual (TAU)

Intervention Type: BEHAVIORAL

Participants receive treatment as usual.

Interventions

Caring Connections

Participants receive the Caring Connections intervention.

Intervention Type: BEHAVIORAL

Treatment as Usual (TAU)

Participants receive treatment as usual.

Intervention Type: BEHAVIORAL

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:

• 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

Parents/Legal Guardians/Caregivers:

Mental Healthcare and/or Healthcare Providers and/or Community Stakeholders:

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

• Minimum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Village Heartbeat, Inc.

UNKNOWN

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sonyia Richardson, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

UNC Chapel Hill

Locations

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sonyia Richardson, Ph.D.

Role: CONTACT

Sonyia.Richardson@unc.edu

919-445-1235

Margaret Phipps, MSW

Role: CONTACT

marp@unc.edu

Facility Contacts

Sonyia Richardson, Ph.D.

Role: primary

Sonyia.Richardson@unc.edu

704-941-7751

Role: backup

Sonyia.Richardson@unc.edu

Other Identifiers

24-2167

Identifier Type: -

Identifier Source: org_study_id