An interventional study of Caring Connections and Treatment as Usual in Suicide, Suicide Prevention and Suicide Ideation, sponsored by University of North Carolina, Chapel Hill. Recruiting at 1 site in United States. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Prevention
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.
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,
186 studies on the registry are indexed under Suicide Prevention; 92 are open to participants now.
This study's planned enrollment of 180 is above the median of 140 across 167 interventional studies indexed under Suicide Prevention.
Browse Suicide Prevention studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,372 studies on the registry; 133 are open to participants now.
Of its 161 completed or terminated interventional studies of FDA-regulated products, 139 (86%) have results posted.
Compared within Suicide Prevention, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Suicide. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Youth:
Parents/Legal Guardians/Caregivers:
Mental Healthcare and/or Healthcare Providers and/or Community Stakeholders:
Care Coordinators:
Exclusion Criteria:
Youth:
Parents/Legal Guardians/Caregivers:
Mental Healthcare and/or Healthcare Providers and/or Community Stakeholders:
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
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 the Caring Connections Intervention.
Participants received Treatment as Usual
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.
Time frame: Baseline, 30 days, 90 days, 180 days
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.
Time frame: Baseline, 30 days, 90 days, 180 days
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)
Time frame: 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.
Time frame: Baseline, 30 days, 90 days, 180 days
Change in Treatment Acceptability
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.
Time frame: 30 days, 90 days
Changes in Barriers to Service Participation
The Barriers to Treatment Participation Scale is a reliable, valid 22-item scale that assesses perceived service barriers among caregivers. Higher scores indicate more severe barriers to service participation. Scores range from 22-110.
Time frame: Baseline, 30 days
Change in Therapeutic Alliance
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.
Time frame: 30 days, 90 days
Change in Cultural Humility
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.
Time frame: 30 days, 90 days
Change in Family Relationships
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).
Time frame: Baseline, 30 days, 90 days, 180 days
Change in Engagement Behaviors
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.
Time frame: 30 days, 90 days
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: The data will become available beginning 9 to 36 months following publication.
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.
Started Aug 2025 (actual). Primary completion is estimated for May 2027, 21 months after the start.
Of 127 non-industry interventional studies with no phase under Suicide Prevention, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 53. This study's planned 21 months is below that.
Counting every sponsor, half of 129 studies reached it within 28 months; a quarter within 12 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
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