PC CARES for Suicide Prevention in Rural Alaska Youth

(PC CARES Trial)

Overseen By Suzanne Rataj, MPH

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 9

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how effectively the PC CARES program (Promoting Community Conversations About Research to End Suicide) can prevent suicide in rural Alaskan villages. The program includes conversations and sessions designed to raise awareness and change behaviors related to suicide prevention. Individuals living or working in these villages who are at least 15 years old can participate. Participants will either attend PC CARES sessions or join a group that does not, and their experiences will be compared to assess the program's impact. As an unphased trial, this study allows participants to contribute to important research that could lead to meaningful change in their communities.

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

The trial protocol does not specify whether you need to stop taking your current medications.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that the PC CARES intervention is safe for participants?

Research shows that PC CARES is a community health program designed to prevent suicide by encouraging conversations and actions in rural areas. Studies have not identified any major safety concerns with this program. Since PC CARES emphasizes education and community involvement, it is generally well-received. Reports have not indicated harmful effects from participation, suggesting it is safe for participants. However, because the program addresses sensitive topics, some emotional reactions are normal when discussing mental health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about PC CARES for suicide prevention in rural Alaska youth because it offers a community-based approach that is different from traditional individual therapy sessions or medication. Unlike standard treatments, which often involve direct patient interventions, PC CARES focuses on educating and empowering community members, including family and friends, to support at-risk youth. This method fosters a supportive network that can be crucial in remote areas where access to mental health professionals is limited. By integrating education with community involvement, PC CARES aims to create a sustainable support system that could have a lasting impact on youth mental health in rural settings.

What evidence suggests that the PC CARES intervention is effective for suicide prevention in rural Alaska youth?

Research shows that the PC CARES program, available to participants in this trial, helps communities unite to discuss suicide and find prevention methods. The program emphasizes sharing prevention ideas and promoting community action. Studies have found that this approach builds partnerships among community members and local service providers, which is crucial for suicide prevention. Early results suggest that involving community members in these discussions raises awareness and leads to proactive steps to address the issue. By empowering local leaders, PC CARES aims to create lasting prevention strategies tailored to the specific needs of rural Alaskan villages. Meanwhile, another group in this trial will not attend the PC CARES sessions, allowing for a comparison of outcomes. ^{1 2 3 6 7}

Who Is on the Research Team?

Lisa Wexler, PhD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for people who live or work in remote rural Alaskan villages and are at least 15 years old. It aims to involve community members in discussions about preventing youth suicide.

Inclusion Criteria

I am at least 15 years old.

lives or works in village

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Data Collection

Pre-intervention data collection involving surveys on demographics, knowledge, skills, attitudes, and behaviors related to suicide prevention

4 weeks

1 visit (virtual)

PC CARES Intervention

Participants attend 1-7 sessions of the PC CARES curriculum, either virtually or in-person, focusing on suicide prevention strategies

6 months

7 sessions (virtual or in-person)

Follow-up

Participants are monitored for changes in attitudes, knowledge, and behaviors related to suicide prevention

1 month

1 visit (virtual)

Care Package Program

Distribution of care packages containing information and small gifts to promote wellness and suicide prevention

2 years

What Are the Treatments Tested in This Trial?

Interventions

• PC CARES

Trial Overview The study tests the PC CARES program, which involves a curriculum of five sessions designed to foster community conversations on ending youth suicide. The effectiveness will be measured by comparing participant behavior before and after the program with those who did not participate.

How Is the Trial Designed?

Group I: PC CARES Intervention Experimental Treatment 1 Intervention

Experimental: PC CARES Intervention Participants will attend 1-7 sessions of the PC CARES curriculum, either virtually or in-person. Investigators will collect data from this group at baseline, after each session they attend, and at follow-up.

Group II: No intervention Active Control 1 Intervention

This group will not attend the PC CARES sessions. Investigators will collect data from this group at baseline and follow-up

PC CARES is already approved in United States for the following indications:

Approved in United States as PC CARES for:

• Suicide prevention in rural Alaska Native communities

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

University of Nebraska Lincoln

Collaborator

Trials

40

Recruited

13,200+

Norton Sound Health Corporation

Collaborator

Trials

5

Recruited

4,500+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

The Helping Hands Program, developed by the Bristol Bay Area Health Corporation, has significantly increased the percentage of Alaska Natives dying at home from 33% in 1997 to 77% in 2001 by providing culturally sensitive, volunteer-based palliative care in remote communities.

This program combines traditional cultural practices with modern palliative care, and its success has led to interest from larger health organizations in Alaska to expand similar initiatives to improve end-of-life care across the state.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Establishing a culturally sensitive palliative care program in rural Alaska Native American communities. DeCourtney, CA., Jones, K., Merriman, MP., et al.[2022]

The Caring Contacts intervention, a suicide prevention program, showed high acceptability among American Indian/Alaska Native (AI/AN) communities, with 92% of participants reporting a positive experience during initial assessments.

Adaptations made during the study's Phase 1, such as broadening eligibility criteria and incorporating locally-informed methods of self-harm, significantly increased participant recruitment and allowed for a more comprehensive understanding of suicidal behaviors in these communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Keep up the messages, sometimes it was a lifesaver": Effects of cultural adaptation on a suicide prevention clinical trial in American Indian/Alaska Native communities. Bogic, M., Hebert, LE., Evanson, A., et al.[2023]

Youth suicide rates in Indigenous communities in North America are alarmingly high, a trend that has emerged over the last 50 to 100 years due to factors like intergenerational trauma and socio-economic changes.

The article introduces the Promoting Community Conversations About Research to End Suicide (PC CARES) approach, which emphasizes decolonization and community engagement to foster learning and action for suicide prevention and health promotion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creating a Community of Practice to Prevent Suicide Through Multiple Channels: Describing the Theoretical Foundations and Structured Learning of PC CARES. Wexler, L., McEachern, D., DiFulvio, G., et al.[2022]

The PC CARES intervention successfully engaged 535 participants in rural Alaskan communities through 59 learning circles, demonstrating its feasibility and effectiveness in promoting discussions about suicide prevention research.

Participants reported significant improvements in their knowledge, skills, and attitudes towards suicide prevention, and the intervention positively influenced the preventive actions of their social networks, indicating a broader community impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community mobilization for rural suicide prevention: Process, learning and behavioral outcomes from Promoting Community Conversations About Research to End Suicide (PC CARES) in Northwest Alaska. Wexler, L., Rataj, S., Ivanich, J., et al.[2023]

A text messaging program developed by the Maniilaq Association sent supportive messages to about 100 young Alaska Native participants each month, which were reported to improve mood and feelings of worth among recipients.

Participants suggested enhancements for the program, such as incorporating more culturally relevant content and increasing the frequency of messages, indicating a positive reception and potential for broader community impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a Supportive Text Messaging Intervention in Northwest Alaska. Edwards, A., Ozer, F., Cueva, K.[2023]

The study involved in-depth interviews with 15 Alaska Native and American Indian individuals aged 15-56, revealing that strong social connections and awareness of the impact of suicide on loved ones are crucial for building resilience against suicide risk.

Participants emphasized the importance of knowing and using available health services, highlighting that access to support can significantly influence their help-seeking behavior and overall mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lived Experiences of Suicide Risk and Resilience among Alaska Native and American Indian People. Shaw, JL., Beans, JA., Comtois, KA., et al.[2020]

A study analyzing electronic health records from 2012 to 2015 identified significant factors associated with suicide-related visits among Alaska Native and American Indian populations, including a high prevalence of poisoning or overdose, emergency department visits, and hospitalizations.

Using electronic health records for risk detection can help identify individuals at risk for suicide who might not engage in traditional screening methods, potentially improving prevention efforts and addressing health disparities in these communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using the electronic health record to identify suicide risk factors in an Alaska Native Health System. Schaefer, KR., Muller, CJ., Smith, JJ., et al.[2022]

The PC CARES intervention trained 32 facilitators from 11 Northwest Alaska communities to implement culturally responsive suicide prevention strategies, demonstrating feasibility and community engagement.

Facilitators successfully hosted 54 learning circles with 309 community members, showing effective dissemination of research evidence and positive reflections on the program's impact in addressing youth suicide in rural Alaska Native communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting Community Conversations About Research to End Suicide: learning and behavioural outcomes of a training-of-trainers model to facilitate grassroots community health education to address Indigenous youth suicide prevention. Wexler, L., Trout, L., Rataj, S., et al.[2023]

Palliative care is a newly recognized area of focus for over 4 million American Indians and Alaskan Natives who primarily receive healthcare from federal Indian Health Service or tribal health programs.

The Indian Health Service has initiated programs to address the needs and barriers to palliative care in these communities, highlighting several successful initiatives that are currently being developed and implemented.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative care: an emerging issue for American Indians and Alaskan Natives. Kitzes, JA., Domer, T.[2022]

Caring Contacts, a suicide prevention intervention, was positively received by 189 participants across four diverse American Indian and Alaska Native communities, indicating its potential for reducing suicide ideation and attempts in these populations.

Adaptations to the Caring Contacts intervention were suggested by community members, focusing on message frequency, timing, and cultural relevance, which may enhance its effectiveness in addressing suicide-related health disparities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Culturally Adapting Caring Contacts for Suicide Prevention in Four Alaska Native and American Indian Communities. Jansen, KJ., Shaw, JL., Comtois, KA., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28762305/

learning and behavioural outcomes of a training-of-trainers ... Promoting Community Conversations About Research to End Suicide: learning and behavioural outcomes of a training-of-trainers model to facilitate grassroots ...

2. pc-cares.org pc-cares.org/

PC CARES PC CARES is a community health intervention that translates research into community solutions, sharing prevention ideas, and sparking action on multiple levels.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06658808

Efficacy-Implementation Study for PC CARES in Rural Alaska This participatory, pragmatic efficacy-implementation trial evaluates the impact of Promoting Community Conversations About Research to End Suicide (PC ...

4. pc-cares.org pc-cares.org/research-participation

Details about research participation The PC CARES study aims to increase suicide prevention in rural Alaska Native communities, focusing on adults and their youth, and aims to create practical, ...

5. clearinghouse.helpandhopewv.org clearinghouse.helpandhopewv.org/program/promoting-community-conversations-about-research-to-end-suicide-pc-cares/

Promoting Community Conversations About Research to ... By sparking regular community conversations, PC CARES builds partnerships among community members and providers in order to effectively prevent suicide and ...

6. tandfonline.com tandfonline.com/doi/full/10.1080/22423982.2017.1345277

learning and behavioural outcomes of a training-of-trainers ... PC CARES represents a practical community education and mobilisation approach to Indigenous youth suicide prevention that displays preliminary success in ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0277953619302928

Community mobilization for rural suicide prevention This study evaluates the process and preliminary outcomes of Promoting Community Conversations About Research to End Suicide (PC CARES).