Efficacy-Implementation Study for PC CARES in Rural Alaska

NCT06658808 | Recruiting

• 2 other identifiers: HUM002474581R01MH136768-01
• Study Type: interventional
• Target: 1,075
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Suicide Prevention

Keywords

Suicide Prevention; Alaska Native; Community Intervention; Community-Based Participatory Research

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (2)

PC CARES Intervention

EXPERIMENTAL

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

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).

Interventions

Promoting Community Conversations About Research to End Suicide BEHAVIORAL

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.

PC CARES Intervention

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• University of Michigan: lead
• Yukon Kuskokwim Health Corporation: collaborator
• Norton Sound Health Corporation: collaborator
• Maniilaq Association: collaborator
• University of Alaska Fairbanks: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

Rural Human Services Program

Fairbanks, Alaska, 99775, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Related Publications (6)

• 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.

  PMID: 36047453 BACKGROUND

• 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.

  PMID: 31151026 BACKGROUND

• 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.

  PMID: 35881985 BACKGROUND

• 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.

  PMID: 26880738 BACKGROUND

• 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.

  PMID: 30561803 BACKGROUND

• 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.

  PMID: 35762450 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Suicide Prevention

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Lisa Wexler, PhD

  Univer

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Wexler, PhD

CONTACT

734-764-7806; lwexler@umich.edu

Miriam Midoun, MA, MSc

CONTACT

734-764-8354; mmidoun@umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor, Research Center for Group Dynamics, Institute for Social Research and Professor of Social Work

Model Details: The study will have a stepped wedge design with 3 cycles of implementation (in successive years) across 9-12 villages total, depending on need and feasibility to achieve our needs. In each village, we will collect baseline data and follow-up data on knowledge, attitudes, and behavior related to suicide prevention from participants and non-participants. Participants will also provide data on these topics after each learning circle they attend and non-participants will be given a monthly survey each month for 5 months as the learning circles occur. Intervention participants will be self-selecting.

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: October 26, 2024
• Study Start: September 12, 2024
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): May 1, 2031
• Last Updated: June 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)