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Suicide PreventionNCT06658808

Efficacy-Implementation Study for PC CARES in Rural Alaska

A study testing Promoting Community Conversations About Research to End Suicide in people with Suicide Prevention, run by University of Michigan at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 12 years and olderHealthy volunteers can take part
Conditions the study is for
Suicide Prevention
What is being tested?
Promoting Community Conversations About Research to End Suicide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,075 participants
Where
2 sitesUnited States
Study dates
12 Sep 2024to May 2031
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

None listed.

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Rural Human Services Program

    Fairbanks, Alaska, 99775

Other trials in United States

About this study

Official title: 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).

Read the 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.

Being tested
Promoting Community Conversations About Research to End Suicide
Keywords
Suicide Prevention, Alaska Native, Community Intervention, Community-Based Participatory Research
Medical subject headings
Suicide Prevention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Promoting Community Conversations About Research to End SuicideBehavioural

    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.

Study groups in NCT06658808
Study groupRoleWhat they receive
PC CARES InterventionExperimentalPC 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.
Receives: Behavioral: Promoting Community Conversations About Research to End Suicide
No InterventionNo interventionThis 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline; monthly after each LC, assessed over 5 months; follow-up at 1 month and 6 month after the last LC

  2. 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.

    Measured: Baseline; monthly after each LC, assessed over 5 months; follow-up at 1 month and 6 month after the last LC

  3. 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.

    Measured: Baseline; monthly after each LC, assessed over 5 months; follow-up at 1 month and 6 month after the last LC

  4. Change in Youth Connectedness

    Youth connectedness is measured using a 4-point Agreement Scale (11 survey questions).

    Youth connectedness is measured in youth participants.

    Measured: Baseline; monthly after each LC, assessed over 5 months; and 1 month follow up

  5. 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.

    Measured: Baseline; monthly after each LC, assessed over 5 months; and 1 month follow up

  6. 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.

    Measured: Baseline; monthly after each LC, assessed over 5 months; and 1 month follow up

  7. 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.

    Measured: Baseline; monthly after each LC, assessed over 5 months; and 1 month follow up

  8. 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.

    Measured: Baseline; monthly after each LC, assessed over 5 months; follow-up at 1 month and 6 month after the last LC

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2024
  2. Study start12 Sep 2024
  3. Primary completionDec 2029 (estimated)
  4. Study completionMay 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
1,075 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06658808
Sponsor's protocol ID
HUM00247458
Other IDs
1R01MH136768-01
Status last verified
Jun 2026
First submitted
18 Oct 2024
Last updated
2 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: It is not appropriate for our study and would require additional tribal approvals.

Publications

  • 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.

    PubMed 36047453
  • 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.

    PubMed 31151026
  • 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.

    PubMed 35881985
  • 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.

    PubMed 26880738
  • 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.

    PubMed 30561803
  • 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.

    PubMed 35762450

Questions about this trial

What is this clinical trial studying?

A study testing Promoting Community Conversations About Research to End Suicide in people with Suicide Prevention, run by University of Michigan at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Community of Practice (CoP) (time frame: Baseline; monthly after each LC, assessed over 5 months; follow-up at 1 month and 6 month after the last LC). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06658808, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.

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Clinical Trial NCT06658808 | AzTrials