Efficacy-Implementation Study for PC CARES in Rural Alaska

Efficacy-Implementation Study for Promoting Community Conversations About Research to End Suicide (PC CARES) in Rural Alaska

This participatory, pragmatic efficacy-implementation trial evaluates the impact of Promoting Community Conversations About Research to End Suicide (PC CARES) to evaluate Learning Circle (LC) participant outcomes (AIM#1), community-wide diffusion effects, and efficacy by tracking youth impact (AIM#2), while finding sustainable ways to scale PC CARES to other Alaska Native (AN) communities (AIM#3).

Study Overview

• Status: Recruiting
• Conditions: Suicide Prevention
• Intervention / Treatment: Behavioral: Promoting Community Conversations About Research to End Suicide

Detailed Description

AIM#1 will assess how (and if) our intervention engages the presumed proximal mechanisms of change: personal (self-efficacy) and collective (CoP) resources and skills (including knowledge) as well as distal outcomes (engagement in suicide prevention behaviors) to address suicide in the participants' own community. Using a multilevel growth model, we examine the changes in proximal outcomes of suicide prevention knowledge, self-efficacy, collaborations for a 'community of practice' (CoP), and distal outcomes of prevention-oriented behaviors of adult PC CARES participants (n=250) over time (7 timepoints), testing for moderating effects of dosage (e.g. #LCs attended), community 'readiness'; cross-sector participation on outcomes to inform future PC CARES implementation (AIM#1). Inclusion criteria for participants in Aim#1 are ages 18 and older who participated in PC CARES learning circles.

AIM#2 focuses on diffusion of learning in six randomly selected communities over the same time period as the first aim. The recruitment criteria for participating in this community-wide data collection is to be a resident of the community and age 12 years or older (youth: ages 12-17, and adults: 18 and older). Our community-wide adult and youth measures assess the community-level mechanisms of change (social diffusion), and track youth outcomes. We hypothesize that PC CARES learning circles will encourage adults to develop collaborative relationships within a CoP to implement upstream suicide prevention best practices (SPBPs) in support of youth in their lives. Using community level social network measures, we document the number and type of interactions reported by adults (n=450) over time, capturing social diffusion by comparing the knowledge, self-efficacy, CoP and prevention-oriented behaviors of (1) PC CARES participants, (2) non-participants who are 'close to' participants and (3) others, unrelated to participants (comparison group). In both the Adult and Youth Follow-up Surveys, we characterize closeness (close associates/youth 'close to' participants versus unrelated adults and youth) by asking respondents (Y/N) if they are close to a list of PC CARES participants from their community (i.e. people who attended 4+ LCs). 'Close to' is defined as someone with whom the participant feels closely connected to and interacts with at least weekly.

To assess youth impact (n=300, ages 12-17), we measure youth-reported supportive adult interactions and connectedness (over 7 time points), and pre-post perceived social support, family and community protective factors, comparing outcomes for youth who are 'close to' LC participants versus 'unrelated' youth (comparison group).

AIM#3 combines community-engaged methodologies and evidence-based implementation science frameworks to examine the barriers and enablers of PC CARES implementation in Alaska Native communities. AIM#3 examines implementation outcomes and contextual determinants to further understand how to successfully support community-driven diffusion of SPBPs in extremely rural and remote AN villages. Our evaluation will blend PC CARES' community-engaged approach with two evidence-based and widely used Implementation Science (IS) frameworks (RE-AIM; CFIR 2.0). Using participatory methods, we will sequentially and iteratively seek insights from our community partners, including: Rural Human Service (RHS) Students, RHS instructional teams (Elders; University of Alaska Fairbanks (UAF) Practicum Faculty, mentors), and Community Steering Committee (CSC) members. All RHS student facilitators will be invited to participate in each stage of research, and if interested will be invited to join the Community Steering Committee (CSC). As the RHS student facilitation teams implement LCs as part of their practicum, biweekly zoom/phone calls will support and track RHS student experiences and insights and offer opportunities for peer and mentor support. Monthly written reports will capture each student's community-based actions (e.g., recruitment process, sharing ideas from LCs with the tribal council), their experience of hosting LCs, including 'what worked' (enablers) and implementation barriers. In these various ways, they will reflect on key contextual determinants they are navigating, and how those affect their implementation of PC CARES. Lessons learned or puzzling findings from each of 5 RHS cohorts will be shared with the LSC to gain further insights and to inform the next wave of data collection and analysis. After each wave of implementation, we will conduct focus groups with RHS student facilitators about their overall experience using semi-structured guides informed by our preliminary RE-AIM outcomes (Reach, Effectiveness, Diffusion, Adoption, Implementation and Maintenance). We will transcribe focus groups recordings verbatim and use Dedoose, a qualitative analytic software, for deductive analysis using the RE(D)-AIM construct structure.

• Study Type: Interventional
• Enrollment (Estimated): 1075
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lisa Wexler, PhD; Phone Number: 734-764-7806; Email: lwexler@umich.edu
• Study Contact Backup: Name: Miriam Midoun, MA, MSc; Phone Number: 734-764-8354; Email: mmidoun@umich.edu

Study Locations

• United States
  • Alaska
    • Fairbanks, Alaska, United States, 99775
      • Recruiting
      • Rural Human Services Program
      • Contact: Diane McEachern, PhD; Phone Number: 907 543 4597; Email: dmmceachern@alaska.edu
      • Sub-Investigator: Diane McEachern, PhD
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
      • Contact: Tara Schmidt, MPH; Email: pccares@umich.edu
      • Principal Investigator: Lisa Wexler, PhD
      • Contact: Miriam Midoun, MSc, MA; Email: mmidoun@umich.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Anyone aged 12 and over who lives or works in the designated communities may participate in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PC CARES Intervention; PC CARES Intervention Participants will attend 1-5 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.	Behavioral: Promoting Community Conversations About Research to End Suicide; Promoting Community Conversations About Research to End Suicide (PC CARES) trains local community health workers to facilitate a series of five 3-hour Learning Circles (LCs) over ~6 months to develop a 'community of practice' (CoP), whereby trusted adults of youth (a) learn about SPBPs; (b) tailor the SPBPs to their culture and community; (c) build cross-sector relationships (parents, teachers, etc.), and (d) do more to prevent suicide. Each session shares evidence-based, actionable ways to enhance social support, reduce harm/risk, and promote help seeking, which participants adapt and apply in their daily interactions with youth.
No Intervention: No Intervention; This group will not attend the PC CARES sessions. Investigators will collect data from adults and youth at baseline, at 5 monthly timepoints as learning circles are being conducted in the community, and at follow-up (after 1 month and 6 months).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Community of Practice (CoP)	Collaborations for a community of practice (CoP) related to wellness promotion and suicide prevention are measured on a 7-point Agreement Scale (3 survey questions). Change in CoP is measured in adult intervention and non-intervention participants.	Baseline; monthly after each LC, assessed over 5 months; follow-up at 1 month and 6 month after the last LC
Change in Suicide Prevention Knowledge	Knowledge related to suicide prevention are measured using a 7-point Agreement Scale (14 survey questions). Suicide prevention knowledge is measured in adult intervention and non-intervention participants.	Baseline; monthly after each LC, assessed over 5 months; follow-up at 1 month and 6 month after the last LC
Change in Self-Efficacy	Self-efficacy related to wellness promotion and suicide prevention are measured on a 7-point Agreement Scale (5 survey questions). Self-efficacy is measured in adult intervention and non-intervention participants.	Baseline; monthly after each LC, assessed over 5 months; follow-up at 1 month and 6 month after the last LC
Change in Youth Connectedness	Youth connectedness is measured using a 4-point Agreement Scale (11 survey questions). Youth connectedness is measured in youth participants.	Baseline; monthly after each LC, assessed over 5 months; and 1 month follow up
Change in Community Protective Factors	Community protective factors are measured using a 7-point Agreement Scale (9 survey questions). Community protective factors is measured in youth participants.	Baseline; monthly after each LC, assessed over 5 months; and 1 month follow up
Change in Self-Reported Supportive Interactions with Adults	Self-reported supportive interactions are measured using a 6-point Frequency Scale (10 survey questions). Self-reported supportive interactions are measured in youth participants.	Baseline; monthly after each LC, assessed over 5 months; and 1 month follow up
Change in Perceived Social Support	Perceived social support is measured using a 7-point Agreement Scale (11 survey questions). Perceived social support is measured in youth participants.	Baseline; monthly after each LC, assessed over 5 months; and 1 month follow up
Change in Suicide Prevention-Oriented Behaviors	Behaviors related to wellness promotion and suicide prevention is measured across four areas: (1) Interpersonal support (9 items); (2) Lethal means reduction (5 items); (3) Postvention (8 items); (4) Working with others to prevent suicide and promote health (19 items). Participants are asked how often they have engaged in these prevention-oriented actions in the last 30 days and with whom using a 7-point frequency scale. Suicide prevention-oriented behaviors are measured in adult intervention and non-intervention participants.	Baseline; monthly after each LC, assessed over 5 months; follow-up at 1 month and 6 month after the last LC

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute of Mental Health (NIMH); University of Alaska Fairbanks; Maniilaq Association; Norton Sound Health Corporation; Yukon Kuskokwim Health Corporation
• Investigators: Principal Investigator: Lisa Wexler, PhD, Univer

Publications and helpful links

General Publications

• Wexler L, Rataj S, Ivanich J, Plavin J, Mullany A, Moto R, Kirk T, Goldwater E, Johnson R, Dombrowski K. 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. Soc Sci Med. 2019 Jul;232:398-407. doi: 10.1016/j.socscimed.2019.05.028. Epub 2019 May 23.
• Wexler L, McEachern D, DiFulvio G, Smith C, Graham LF, Dombrowski K. Creating a Community of Practice to Prevent Suicide Through Multiple Channels: Describing the Theoretical Foundations and Structured Learning of PC CARES. Int Q Community Health Educ. 2016;36(2):115-22. doi: 10.1177/0272684X16630886. Epub 2016 Feb 15.
• White LA, Wexler L, Weaver A, Moto R, Kirk T, Rataj S, Trout L, McEachern D. Implementation beyond the clinic: Community-driven utilization of research evidence from PC CARES, a suicide prevention program. Am J Community Psychol. 2022 Dec;70(3-4):365-378. doi: 10.1002/ajcp.12609. Epub 2022 Jun 28.
• Wells CC, White L, Schmidt T, Rataj S, McEachern D, Wisnieski D, Garnie J, Kirk T, Moto R, Wexler L. Adapting PC CARES to Continue Suicide Prevention in Rural Alaska During the COVID-19 Pandemic: Narrative Overview of an In-Person Community-Based Suicide Prevention Program Moving Online. Am Indian Alsk Native Ment Health Res. 2022;29(2):126-154. doi: 10.5820/aian.2902.2022.126.
• Markowski KL, White L, Harcey SR, Schmidt T, McEachern D, Habecker P, Wexler L. What Kinds of Support are Alaska Native Youth and Young Adults Reporting? An Examination of Types, Quantities, Sources, and Frequencies of Support. Health Promot Pract. 2023 Sep;24(5):863-872. doi: 10.1177/15248399221115065. Epub 2022 Sep 1.
• Trout L, McEachern D, Mullany A, White L, Wexler L. Decoloniality as a Framework for Indigenous Youth Suicide Prevention Pedagogy: Promoting Community Conversations About Research to End Suicide. Am J Community Psychol. 2018 Dec;62(3-4):396-405. doi: 10.1002/ajcp.12293.

Helpful Links

• Description: Site describing the PC CARES philosophy, curriculum, team, and how people can get involved

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2024
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): May 1, 2031

Study Registration Dates

• First Submitted: October 18, 2024
• First Submitted That Met QC Criteria: October 23, 2024
• First Posted (Actual): October 26, 2024

Study Record Updates

• Last Update Posted (Actual): June 15, 2025
• Last Update Submitted That Met QC Criteria: June 11, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Alaska Native; Suicide Prevention; Community-Based Participatory Research; Community Intervention
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide Prevention; Suicide
• Other Study ID Numbers: HUM00247458; 1R01MH136768-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: It is not appropriate for our study and would require additional tribal approvals.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No