RECRUITING

Caring Connections Youth Suicide Prevention Care Coordination Study

Conditions

Suicide Suicide Prevention Suicide Ideation Suicide Attempt youth care coordination suicide intervention

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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: 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.

Official Title

CA-LINC Caring Connections Randomized Control Trial Study

Quick Facts

Study Start:2025-08-14

Study Completion:2026-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07167615

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.

Ages Eligible for Study:13 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 * 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 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 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	* 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 * Not meeting the inclusion criteria listed above. * Not meeting the inclusion criteria listed above.

Inclusion Criteria

Exclusion 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
* 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 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 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

* 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
* Not meeting the inclusion criteria listed above.
* Not meeting the inclusion criteria listed above.

Contacts and Locations

Study Contact

Sonyia Richardson, Ph.D.

CONTACT

919-445-1235

Sonyia.Richardson@unc.edu

Margaret Phipps, MSW

CONTACT

marp@unc.edu

Principal Investigator

Sonyia Richardson, Ph.D.

PRINCIPAL_INVESTIGATOR

UNC Chapel Hill

Study Locations (Sites)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514

United States

Collaborators and Investigators

Sponsor: University of North Carolina, Chapel Hill

Sonyia Richardson, Ph.D., PRINCIPAL_INVESTIGATOR, UNC Chapel Hill

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 Registration Dates

Study Start Date2025-08-14

Study Completion Date2026-10

Study Record Updates

Study Start Date2025-08-14

Study Completion Date2026-10

Terms related to this study

Keywords Provided by Researchers

youth
suicide prevention
care coordination
suicide intervention

Additional Relevant MeSH Terms

Suicide
Suicide Prevention
Suicide Ideation
Suicide Attempt