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

1491 Participants Needed

Trial Summary

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 data supports the idea that PC CARES for Suicide Prevention in Rural Alaska Youth is an effective treatment?

The available research shows that PC CARES is a promising treatment for suicide prevention in rural Alaska. In one study, 32 facilitators from 11 village communities were trained to implement the program, and 20 of them hosted 54 learning circles involving 309 community members. The facilitators reported positive experiences, indicating that the program is feasible and potentially impactful. This suggests that PC CARES effectively translates research into practice in under-resourced communities. Compared to other treatments like supportive text messaging, which improved mood and feelings of self-worth among participants, PC CARES involves more direct community engagement and education, which may lead to more sustainable outcomes. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment PC CARES for suicide prevention in rural Alaska youth?

PC CARES shows promise as a community-based approach to prevent suicide by training local facilitators to share research and spark community efforts. Early results suggest it is feasible and potentially impactful in rural Alaska, with positive feedback from facilitators and community members. ^{1 2 3 4 5}

What safety data exists for PC CARES in suicide prevention for rural Alaska youth?

The available research on PC CARES, also known as Promoting Community Conversations About Research to End Suicide, indicates that it is a feasible and acceptable intervention for suicide prevention in rural Alaska Native communities. The studies highlight its potential impact through community mobilization and education, with positive feedback from facilitators and participants. However, specific safety data or adverse effects are not detailed in the provided abstracts. ^{1 2 3 4 6}

Is PC CARES safe for use in humans?

The available research on PC CARES, a community-based intervention for suicide prevention, suggests it is feasible and well-received in rural Alaska Native communities, with no reported safety concerns. ^{1 2 3 4 6}

Is PC CARES a promising treatment for preventing suicide among rural Alaska youth?

Yes, PC CARES is a promising treatment because it brings community members together to discuss and apply suicide prevention strategies, creating a supportive network that encourages practical actions to prevent suicide. ^{2 7 8 9 10}

How is the PC CARES treatment different from other treatments for suicide prevention?

PC CARES is unique because it focuses on community involvement and education, bringing together local stakeholders to discuss and implement suicide prevention strategies. It emphasizes decolonization and uses popular education methods to create a supportive community of practice, which is particularly tailored for rural and indigenous communities in Alaska. ^{2 7 8 9 10}

What is the purpose of this trial?

This intervention study measures the outcomes of the PC CARES (Promoting Community Conversations about Research to End Suicide) project implemented in remote rural Alaskan villages. Researchers worked with local service providers and other partners to recruit facilitators who were trained to implement the 5-session PC CARES curriculum. The study will compare pre-post data from intervention participants to non-participants, and will analyze social networks related to suicide prevention behavior in each village.

Research Team

Lisa Wexler, PhD

Principal Investigator

University of Michigan

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

References

1. England 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. [2023]

2. England 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. [2023]

3. United States 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. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility of a Supportive Text Messaging Intervention in Northwest Alaska. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Lived Experiences of Suicide Risk and Resilience among Alaska Native and American Indian People. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Using the electronic health record to identify suicide risk factors in an Alaska Native Health System. [2022]

7. United States 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. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Establishing a culturally sensitive palliative care program in rural Alaska Native American communities. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Palliative care: an emerging issue for American Indians and Alaskan Natives. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Culturally Adapting Caring Contacts for Suicide Prevention in Four Alaska Native and American Indian Communities. [2023]