AzTrials
AzTrials

SuicideCA-LINCNCT06353711

Caring Connections Youth Suicide Detection and Intervention Study

A study testing Caring Connections and Treatment as Usual in people with Suicide and Suicide Prevention, run by University of North Carolina, Chapel Hill at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 13 years and older
Conditions the study is for
Suicide, Suicide Prevention, Suicide Ideation
What is being tested?
Caring Connections and Treatment as Usual
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteUnited States
Study dates
14 Aug 2025to 31 May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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)
Show all 25Show fewer
  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sonyia C Richardson, Ph.D. contact

919-445-1235

sonyia.richardson@unc.edu

Margaret Phipps-Bennett, M.S.W. contact

919-445-1235

marp@unc.edu

United States1 site, 1 recruiting
  • The University of North Carolina at Charlotte

    Charlotte, North Carolina, 28223

    Sonyia C Richardson, Ph.D., 919-445-1235, Sonyia.Richardson@unc.edu

    Margaret Phipps-Bennett, M.S.W., 919-445-1235, marp@unc.edu

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the 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 cultural adaptation of LINC that incorporates input from communities whose help-seeking behaviors are often facilitated through non-behavioral health supports. 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,

Being tested
Caring Connections, Treatment as Usual
Keywords
Black youth, suicide, ideation, attempts
Medical subject headings
Suicide, Suicide Prevention, Suicide, Attempted

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Caring ConnectionsBehavioural

    Participants received the Caring Connections Intervention.

  • Treatment as UsualBehavioural

    Participants received Treatment as Usual

Study groups in NCT06353711
Study groupRoleWhat they receive
Caring ConnectionsExperimentalCaring 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.
Receives: Behavioral: Caring Connections
Treatment as UsualActive comparatorThe 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.
Receives: Behavioral: Treatment as Usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in suicidal ideation

    The Suicide Ideation Questionnaire (SIQ) is a reliable, valid 30-item self-report scale to screen for the frequency of suicidal thoughts and cognitions in adolescents. Scores range from 0 to 180, with higher scores indicating greater frequency and severity of suicidal ideation.

    Measured: Baseline, 30 days, 90 days, 180 days

  2. Change in suicidal behaviors

    The Self-Harm Behavior Questionnaire (SHBQ) is a 32-item valid and reliable measure to assess suicidal behaviors among diverse youth. Scores range from 0 to 78, with higher scores indicating higher severity of suicidal behaviors.

    Measured: Baseline, 30 days, 90 days, 180 days

Secondary outcomes (2)
  1. 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)

    Measured: Baseline, 30 days, 90 days, 180 days

  2. 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.

    Measured: Baseline, 30 days, 90 days, 180 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2024
  2. Study start14 Aug 2025
  3. Primary completion31 May 2027 (estimated)
  4. Study completion31 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06353711
Sponsor's protocol ID
24-2167a
Other IDs
R34MH129782, IRB-23-0746
Acronym
CA-LINC
Status last verified
Mar 2026
First submitted
2 Apr 2024
Last updated
4 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Richardson SC, Phipps-Bennett M, Gryglewicz K, Vance M, Williams JA, Bey I, Herbert R, Dennis S, Karver MS. Making deep-structure adaptations: A community-engaged qualitative study for culturally adapting suicide prevention interventions for Black youth. Cultur Divers Ethnic Minor Psychol. 2026 Jul;32(3):628-638. doi: 10.1037/cdp0000770. Epub 2025 Sep 1.

    PubMed 40892589
  • Richardson SC, Gryglewicz K, Williams JA, Phipps-Bennett M, Dennis S, Browne N, Trujillo A, Carlisle C, Nail M, Karver M. The Pursuit of Radical Hope: Suicidal Help-Seeking Behaviors Among Black Adolescents and Caregivers. J Clin Child Adolesc Psychol. 2026 Mar-Apr;55(2):345-359. doi: 10.1080/15374416.2025.2579278. Epub 2025 Nov 20.

    PubMed 41264369
  • Vance MM, Gryglewicz K, Nam E, Richardson S, Borntrager L, Karver MS. Exploring Service Use Disparities among Suicidal Black Youth in a Suicide Prevention Care Coordination Intervention. J Racial Ethn Health Disparities. 2023 Oct;10(5):2231-2243. doi: 10.1007/s40615-022-01402-7. Epub 2022 Sep 13.

    PubMed 36100810
  • Gryglewicz K, Peterson A, Nam E, Vance MM, Borntrager L, Karver MS. Caring Transitions - A Care Coordination Intervention to Reduce Suicide Risk Among Youth Discharged From Inpatient Psychiatric Hospitalization. Crisis. 2023 Jan;44(1):7-13. doi: 10.1027/0227-5910/a000795. Epub 2021 Jun 15.

    PubMed 34128700
  • Richardson SC, Gunn LH, Phipps M, Azasu E. Factors Associated with Suicide Risk Behavior Outcomes Among Black High School Adolescents. J Community Health. 2024 Jun;49(3):466-474. doi: 10.1007/s10900-023-01312-7. Epub 2023 Dec 14.

    PubMed 38095815

Questions about this trial

What is this clinical trial studying?

A study testing Caring Connections and Treatment as Usual in people with Suicide and Suicide Prevention, run by University of North Carolina, Chapel Hill at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sonyia C Richardson, Ph.D. (919-445-1235, sonyia.richardson@unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in suicidal ideation (time frame: Baseline, 30 days, 90 days, 180 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06353711, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in