Clinical Trials Logo

Clinical Trial Summary

The Culturally Adapted Linking Individuals Needing Care (CA-LINC) study will recruit a sample of Black youth to participate in a two-arm parallel-comparison single-blinded pilot randomized control trial (RCT). For the pilot RCT, 68 Black youth participants ages 14-19 who meet the inclusion criteria will be randomly assigned to one of two conditions: CA-LINC (n=34) or TAU (n=34). CA-LINC is a 90-day culturally adapted LINC intervention developed with and for Black youth. The CA-LINC 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 CA-LINC intervention incorporates African-centered principles and empowerment and motivational strategies aimed 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. CA-LINC is implemented by Peer Support Specialists and Community Health Workers assigned to mental health "hubs" in Black Faith-Based Organizations (FBOs) that facilitate standardization and access to care for Black youth/families regardless of religious affiliation. Black FBOs effectively mobilize Black communities to promote positive health behaviors. The RCT will explore the "fit" of the culturally adapted intervention (CA-LINC) in Black communities in Charlotte, North Carolina, and inform a scalable RCT for a future study.


Clinical Trial Description

Specific Aims: Aim 1 (Phase 1): Adapt the LINC intervention to address practical, systemic, linguistic, cultural, and developmental needs of Black youth and caregivers. Tasks include: - Identify/assess stakeholder (youth, caregiver, provider, community) perceptions and needs to enhance suicide risk detection, service referrals/linkages, and service engagement using focus groups. - Conduct focus groups to obtain provider perceptions and feedback on clinical workflow processes (e.g., screening, eligibility protocol, warm hand-off referrals) and implementation strategies (e.g., assessment, contact sessions). - Adapt service delivery components and workflow and implementation strategies using an iterative process. Aim 2 (Phase 2): Evaluate the feasibility and assess outcomes of CA-LINC via an open trial and small-scale pilot RCT. Tasks include: - Assess stakeholder perceptions on the acceptability/appropriateness of the adapted intervention. - Assess provider and community stakeholder perceptions on the practicality and integration of implementing and sustaining CA-LINC using existing community resources/infrastructure. - Evaluate the feasibility of study procedures for screening, recruitment, and randomization. - Evaluate treatment adherence, fidelity, and study retention. - Examine effect size estimates for differences in primary outcomes (suicide ideation and behaviors (SIB) measured by the Suicidal Ideation Questionnaire among Black youth randomly assigned to CA-LINC vs. Treatment as Usual (TAU). - Examine differences in potential change mechanisms (i.e., therapeutic alliance, service utilization, cultural humility, family relationships, engagement behaviors, and participation barriers) between LINC and TAU. Protocol/Procedures: Participants will participate in a care coordination intervention aimed at linking them to resources and decreasing their risk for suicide. Screening: Youth participants (14-19) will be screened for participation in the study by a Research Assistant to verify a reported history of suicide ideation and/or behavior based on agency and/or school screeners (i.e., Patient Health Questionnaire- Adolescent [PHQ-A], Columbia-Suicide Severity Rating Scale [C-SSRS], or Ask Suicide-Screening Questions [ASQ]) or as indicated via self-report. This information will be documented on the Youth CA-LINC Screening Form. Of particular note is that the screening process for youth requires safety protocols to offer additional protections for participants based on their responses to the initial eligibility screeners. In particular, the research team involved with screening prospective participants will be trained to follow suicide crisis protocols (i.e., the Assessment of Suicidality Protocol) developed by the study's PIs, Drs. Gryglewicz and Karver. The protocol includes conducting a brief suicide risk assessment, triaging care, de-escalating the crisis, and/or immediately contacting mobile crisis support or 911 for emergency assistance. Study Measures: Upon consent, the measures/data collection will occur at baseline, 30, 90, and 180 days for the RCT. Measures will be administered by IRB-compliant university research assistants (blinded to group assignment in the RCT only). Baseline measures will be administered in person or online via phone or Zoom prior to randomization to CA-LINC or TAU. RAs will administer the same study measures during (30 days) and immediately after the intervention (90 days), and at the 6-month follow-up from baseline (in person, phone, online). A 30-day benchmark was chosen to capture potential change mechanisms influencing treatment engagement, dropout, and/or youth outcomes. A 6-month follow-up is added to the study timeline to assess the feasibility of collecting longitudinal data with Black youth and evaluate change over time. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06353711
Study type Interventional
Source University of North Carolina, Charlotte
Contact Sonyia C Richardson, PhD
Phone 7046877935
Email srichardson@charlotte.edu
Status Not yet recruiting
Phase N/A
Start date August 2024
Completion date May 2025

See also
  Status Clinical Trial Phase
Completed NCT04127292 - Impact of Clinician Virtual Human Interaction Training in Emotional Self-Awareness on Patients Suicidal Ideation and Suicide Crisis Syndrome N/A
Recruiting NCT06079853 - Nurse Suicide: Physiologic Sleep Health Promotion Trial N/A
Recruiting NCT05423483 - Developing an Intervention to Promote Lethal Means Safety in Suicidal Adolescents Phase 2
Completed NCT03272048 - Identifying Effective Approaches to Counseling on Firearm Safety N/A
Completed NCT05514587 - Meaning of Life Questionnaire (MLQ) in Patients Admitted to the Crisis Centre (MSVCAC)
Enrolling by invitation NCT05639426 - Preventing Youth Violence Through Building Equitable Communities N/A
Completed NCT03703128 - Suicide in People Aged 45-60: A Case-control Psychological Autopsy Study
Completed NCT03646903 - Reducing Help-Seeking Stigma in Young Adults at Elevated Suicide Risk N/A
Not yet recruiting NCT05558332 - Youth Nominated Support Team N/A
Not yet recruiting NCT06349915 - A Pilot Evaluation of a Digital Peer Support Intervention for Suicidal Adolescents N/A
Completed NCT02718248 - Ottawa Suicide Prevention in Men Pilot Study N/A
Completed NCT02094898 - Ketamine for Depression and Suicide Risk Phase 2
Completed NCT01594138 - Linguistic Characteristics of Suicidal Patients in the Emergency Department N/A
Completed NCT01360736 - A Brief Intervention to Reduce Suicide Risk in Military Service Members and Veterans - Study 2 (SAFEMIL) N/A
Completed NCT02228044 - Alcohol, Suicide and HIV Prevention for Teens in Mental Health Treatment N/A
Completed NCT00604097 - Preventing Youth Suicide in Primary Care: A Family Model Phase 3
Completed NCT00387855 - An Evaluation of the SOS (Suicide Prevention) Program N/A
Recruiting NCT03519802 - Evaluation of Cognitive Function in a Suicidal Crisis
Completed NCT05580757 - Pharmacists as Gate Keepers in Suicide Prevention: Needs of Pharmacists
Recruiting NCT03030924 - Wearable Suicidal Early Warning System for Adolescents