CA-LINC Intervention for Suicide Prevention

(CA-LINC Trial)

Overseen By Michelle Vance, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Charlotte

Disqualifiers: Imminent suicide risk, Severe cognitive delays, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 32

Duration: 12 weeks

Trial Summary

What is the purpose of this trial?

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.

Research Team

Marc Karver, PhD

Principal Investigator

University of South Florida

Michelle Vance, PhD

Principal Investigator

North Carolina Agriculture & Technical State University

Kim Gryglewicz, PhD

Principal Investigator

University of Central Florida

Sonyia C Richardson, PhD

Principal Investigator

University of North Carolina at Charlotte

Eligibility Criteria

The CA-LINC study is for Black youth aged 14-19 who may be at risk of suicide. It's designed to help them by providing support and resources through a special program that understands their cultural background. Participants will be involved in activities aimed at reducing suicidal thoughts and behaviors.

Inclusion Criteria

I am under 18 and have given my written agreement to join the study.

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 PHQ-A, C-SSRS, or ASQ

Able to fluently speak and read English

Exclusion Criteria

Youth at imminent suicide risk (reported verbally and/or indicated on C-SSRS)

Youth not meeting inclusion criteria

I have severe learning, speaking, or developmental challenges.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person or virtual)

Treatment

Participants receive the CA-LINC intervention, which includes engagement and follow-up strategies to assess/monitor suicide risk, facilitate service use referrals/linkages, develop/refine safety plans, and create villages of care.

12 weeks

Regular visits (in-person or virtual) at baseline, 30 days, and 90 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 6 months to evaluate change over time.

12 weeks

1 visit (in-person or virtual) at 180 days

Treatment Details

Interventions

• CA-LINC Intervention

Trial Overview This trial tests the CA-LINC intervention against standard treatment. The new approach includes monitoring, referrals, safety planning, and community support within Black Faith-Based Organizations. It aims to see if this culturally tailored method can better reduce suicide risks among Black youth.

Participant Groups

Group I: CA-LINC Intervention Experimental Treatment 1 Intervention

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 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) to facilitate standardization and access to care.

Group II: Treatment as Usual Active Control 1 Intervention

The treatment as usual arm includes care coordination services provided by Peer Support Specialists and Community Health Workers in the FBO 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. MH 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.

Who Is Running the Clinical Trial?

University of North Carolina, Charlotte

Lead Sponsor

Trials

27

Recruited

12,200+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+