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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program called the CA-LINC Intervention, designed to assist Black youth who have experienced thoughts of suicide or self-harm. The study will compare two groups: one will receive the usual care, while the other will participate in a special 90-day program focusing on culturally tailored support, including safety planning and community care. The program aims to reduce suicide-related thoughts and behaviors by improving access to and engagement with mental health services. Black youth aged 14-19 who have recently had suicidal thoughts or behaviors may be eligible to participate. As an unphased trial, this study offers a unique opportunity to access innovative support tailored to cultural needs.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that safety planning interventions, like those in the CA-LINC program, generally reduce suicidal thoughts and behaviors. Evidence suggests these interventions can significantly lower suicide rates. For instance, one study found a 25% drop in suicide rates in an area where a similar program was implemented.

The CA-LINC program builds on these strategies by providing culturally tailored support for Black youth. It focuses on engaging participants and following up with them to monitor suicide risks and improve access to mental health services. While specific safety data for CA-LINC isn't detailed, using safety planning as part of mental health care has shown promise in other settings.

No negative side effects have been reported for the CA-LINC program so far. This suggests it is well-tolerated, especially since it uses established methods known to be safe and effective in similar programs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

CA-LINC is unique because it is specifically designed for Black youth, integrating culturally adapted strategies to address suicide prevention. Unlike standard care that primarily relies on referrals and crisis response, CA-LINC offers a comprehensive 90-day intervention that includes continuous engagement, monitoring, and personalized safety planning. It emphasizes community involvement by leveraging African-centered principles, empowerment, and motivational strategies to strengthen family relationships and create supportive care networks. Researchers are excited about this approach because it combines community-driven care with culturally tailored methods, potentially leading to more effective engagement and reduced suicide ideation and behavior in this underserved population.

What evidence suggests that this trial's treatments could be effective for suicide prevention in Black youth?

Research has shown that programs like CA-LINC, which participants in this trial may receive, are tailored to fit cultural needs and can help reduce suicidal thoughts and actions. A key part of CA-LINC is safety planning, which has proven to decrease suicidal behavior and thoughts. Studies have found that similar programs can lower suicide rates by up to 25% in specific areas. This method emphasizes building support networks and strengthening family relationships, which are important for better mental health. Early results suggest that including cultural and community aspects increases participation and can make the program more effective for Black youth. ^{1 4 5 6 7}

Who Is on the Research Team?

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

Marc Karver, PhD

Principal Investigator

University of South Florida

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06353711

CA-LINC Black Youth Suicide Detection and Intervention ... Examine effect size estimates for differences in primary outcomes (suicide ideation and behaviors (SIB) measured by the Suicidal Ideation Questionnaire among ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10189833/

Effectiveness of Suicide Safety Planning Interventions Evidence across a range of studies indicates that SSP is effective for reducing suicide behavior (SB) and ideation (SI).

3. sciencedirect.com sciencedirect.com/science/article/pii/S016517812400088X

The effectiveness of a suicide prevention program in ... The suicide rate in the intervention area decreased by 25% following the intervention. Implementation of the LinkPC-PH intervention was associated with ...

4. jamanetwork.com jamanetwork.com/journals/jamapediatrics/fullarticle/2834286

Safety Planning Interventions for Suicide Prevention in ... This systematic review and meta-analysis investigates the effectiveness of safety planning as a standalone intervention for suicide ...

5. psychiatryonline.org psychiatryonline.org/doi/full/10.1176/appi.focus.20220078

Implementing Evidence-Based Suicide Prevention ... In studies to date, CAMS has shown a positive effect on suicidal ideation (d=0.25) and distress (d=0.29), but so far has not demonstrated an ...

6. ctv.veeva.com ctv.veeva.com/study/ca-linc-black-youth-suicide-detection-and-intervention-study

CA-LINC Black Youth Suicide Detection and Intervention Study The CA-LINC intervention integrates engagement and follow-up strategies to assess/monitor suicide risk, facilitate service use referrals/ ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12090068/

Safety Planning Interventions for Suicide Prevention in ... This systematic review and meta-analysis investigates the effectiveness of safety planning as a standalone intervention for suicide prevention in children and ...