Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06353711
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-04-02
Brief Title:
CA-LINC Black Youth Suicide Detection and Intervention Study
Sponsor:
University of North Carolina Charlotte
Organization:
University of North Carolina Charlotte
Study Overview
Official Title:
CA-LINC A Culturally Adapted Care Coordination Suicide Detection and Intervention Model for Black Youth
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CA-LINC
Brief 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 n34 or TAU n34
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 assessmonitor suicide risk facilitate service use referralslinkages developreļ¬ne 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 youthfamilies 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
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 assessmonitor suicide risk facilitate service use referralslinkages developreļ¬ne 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 youthfamilies 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
Detailed 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
Identifyassess stakeholder youth caregiver provider community perceptions and needs to enhance suicide risk detection service referralslinkages and service engagement using focus groups
Conduct focus groups to obtain provider perceptions and feedback on clinical workflow processes eg screening eligibility protocol warm hand-off referrals and implementation strategies eg 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 acceptabilityappropriateness of the adapted intervention
Assess provider and community stakeholder perceptions on the practicality and integration of implementing and sustaining CA-LINC using existing community resourcesinfrastructure
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 ie therapeutic alliance service utilization cultural humility family relationships engagement behaviors and participation barriers between LINC and TAU
ProtocolProcedures 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 andor behavior based on agency andor school screeners ie 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 ie the Assessment of Suicidality Protocol developed by the studys PIs Drs Gryglewicz and Karver The protocol includes conducting a brief suicide risk assessment triaging care de-escalating the crisis andor immediately contacting mobile crisis support or 911 for emergency assistance
Study Measures Upon consent the measuresdata 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 andor 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
Aim 1 Phase 1 Adapt the LINC intervention to address practical systemic linguistic cultural and developmental needs of Black youth and caregivers Tasks include
Identifyassess stakeholder youth caregiver provider community perceptions and needs to enhance suicide risk detection service referralslinkages and service engagement using focus groups
Conduct focus groups to obtain provider perceptions and feedback on clinical workflow processes eg screening eligibility protocol warm hand-off referrals and implementation strategies eg 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 acceptabilityappropriateness of the adapted intervention
Assess provider and community stakeholder perceptions on the practicality and integration of implementing and sustaining CA-LINC using existing community resourcesinfrastructure
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 ie therapeutic alliance service utilization cultural humility family relationships engagement behaviors and participation barriers between LINC and TAU
ProtocolProcedures 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 andor behavior based on agency andor school screeners ie 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 ie the Assessment of Suicidality Protocol developed by the studys PIs Drs Gryglewicz and Karver The protocol includes conducting a brief suicide risk assessment triaging care de-escalating the crisis andor immediately contacting mobile crisis support or 911 for emergency assistance
Study Measures Upon consent the measuresdata 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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R34MH129782 | NIH | None | httpsreporternihgovquickSearchR34MH129782 |