Caring Connections Youth Suicide Detection and Intervention Study (CA-LINC)

March 13, 2026 updated by: University of North Carolina, Chapel Hill

CA-LINC Randomized Control Trial Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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,

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Margaret Phipps-Bennett, M.S.W.
  • Phone Number: 919-445-1235
  • Email: marp@unc.edu

Study Locations

  • United States
    • North Carolina
      • Charlotte, North Carolina, United States, 28223
        • Recruiting
        • The University of North Carolina at Charlotte
        • Principal Investigator:
          • Sonyia C Richardson, PhD
        • Contact:
        • Contact:
          • Margaret Phipps-Bennett, M.S.W.
          • Phone Number: 919-445-1235
          • Email: marp@unc.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: Caring Connections
Participants received 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.
Behavioral: Treatment as Usual
Participants received Treatment as Usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Suicide Ideation Severity
Time Frame: Baseline, 30 days, 90 days, 180 days
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
Time Frame: Baseline, 30 days, 90 days, 180 days
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Treatment Acceptability
Time Frame: 30 days, 90 days
The Treatment Evaluation Inventory Short Form (TEI-SF) is a 14-item, reliable, and valid measure that has been modified to assess the acceptability of CA-LINC. The total score ranges from 9 to 45, with higher scores indicating greater acceptability of the treatment.
30 days, 90 days
Change in Therapeutic Alliance
Time Frame: 30 days, 90 days
The Therapeutic Alliance Scales for Adolescents (TASA) is a reliable, valid 12-item scale slightly modified to assess the helping relationship between the youth/care coordinator. Scores range from 12 to 48, with higher scores indicating a stronger therapeutic alliance.
30 days, 90 days
Change in Cultural Humility
Time Frame: 30 days, 90 days
The Cultural Humility Scale (CHS) a reliable, valid 12-item scale to determine youth perceived cultural humility within the youth-care coordinator relationship. Scores range from 12 to 60, where higher scores indicate greater cultural humility.
30 days, 90 days
Change in Family Relationships
Time Frame: Baseline, 30 days, 90 days, 180 days
The Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Family Relationship is a reliable, valid 47-item measure to assess youth's perceptions of family relationships. The measure provides a standardized T-score, where 50 represents the average for the general population, and scores are interpreted based on whether they are above (better family relationships) or below this average (worse family relationships).
Baseline, 30 days, 90 days, 180 days
Change in Engagement Behaviors
Time Frame: 30 days, 90 days
The Engagement Behaviors Scale (EBS) is a 17-item measure, adapted from the Adolescent Alliance-Building Scale to assess helping behaviors of care coordinators. The scores range from 0 to 85, with higher scores indicating strong engagement behaviors.
30 days, 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

National Institute of Mental Health (NIMH)
Robert Wood Johnson Foundation

Investigators

  • Principal Investigator: Sonyia C Richardson, Ph.D., University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 14, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

April 2, 2024

First Submitted That Met QC Criteria

April 2, 2024

First Posted (Actual)

April 9, 2024

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 13, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-2167a
  • IRB-23-0746 (Other Identifier: UNC-Charlotte)
  • R34MH129782 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication, provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

IPD Sharing Time Frame

The data will become available beginning 9 to 36 months following publication.

IPD Sharing Access Criteria

See the 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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