Caring Connections Youth Suicide Detection and Intervention Study

Официальное название

CA-LINC Randomized Control Trial Study

Обзор

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.

Подробное описание

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,

Вмешательства

• Поведенческое Caring Connections
  Participants received the Caring Connections Intervention.
• Поведенческое Treatment as Usual
  Participants received Treatment as Usual

Первичные конечные точки

• Change in Suicide Ideation Severity [Срок оценки: Baseline, 30 days, 90 days, 180 days]
• Reported Suicide Attempts [Срок оценки: Baseline, 30 days, 90 days, 180 days]

Критерии участия

Критерии включения

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

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• The University of North Carolina at Charlotte — Charlotte

Публикации

• 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 38095815

Идентификаторы

NCT: NCT06353711 · 24-2167a · R34MH129782 · IRB-23-0746

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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