SuicidePC CARESNCT03661255
Promoting Community Conversations About Research to End Native Youth Suicide in Rural Alaska
A study testing PC CARES in people with Suicide, run by University of Michigan at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Suicide
- What is being tested?
- PC CARES
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,427 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2019to 12 Dec 2025
- Phase
- Interventional
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 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- lives or works in village
- at least 15 years old
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
This intervention study will measure the outcomes of the PC CARES (Promoting Community Conversations about Research to End Suicide) curriculum implemented in 9 rural Alaskan villages and remotely during COVID pandemic years (2020-2022). It will compare pre-post data from intervention participants to non-participants, and will analyze social networks related to suicide prevention behavior in each village. Researchers worked with local service providers and other partners to recruit participants who have access to the internet for virtual sessions. Pilot research by the investigators produced a roster of social ecological roles within the village (hereafter: 'network positions') that are relevant to suicide prevention. These network positions include organizational affiliations: individuals interacting with young people as a function of their position in schools, health care facilities, mental health services, social services, religious institutions, tribal governments, city governments (including law enforcement). The roster also includes family roles: Elder; parent; a sibling or cousin who is close; other adult family member who is also a mentor: or friend. Mainly school-based personnel and clinic-based staff were recruited to attend the 7 virtual PC CARES sessions.
Baseline data collection:
For pre-intervention data collection, investigators recruited widely in each village, focusing on those who occupy organizationally-affiliated network positions, and youth ages 15-24. Data collection will involve a survey in which they will be asked about demographics, Knowledge about reducing suicide, Skills in making positive community changes, Attitudes toward suicide prevention, and Behavior related to suicide prevention. Questions about Behavior included follow up questions asking with whom they've done the behavior (which of the listed network positions) and 'How Often?'
The study's original Interrupted Time Series design had 3 cohorts, with the opportunity for all villages in the Bering Strait region of Alaska to participate. However, the COVID-19 pandemic led to modifications to: 1) the intervention delivery method, 2) audience, and 3) content. After the first cohort of in-person learning circles was halted to follow health authority guidelines, PC CARES pivoted to 1) online, remote synchronous delivery (live Zoom sessions) with 2) school and clinic staff in any of the Bering Strait region and Northwest Arctic region communities (27 villages total), with 3) additional sessions regarding school-specific suicide prevention strategies. Schools are some of the best-resourced institutions in the villages, with existing infrastructure like wireless Internet and spaces for community use, and school staff are well-positioned to make impacts on youth wellness.
During COVID, we offered online, all-staff 'one time' inservice trainings for Bering Strait School District and Northwest Arctic School District staff on what they can do (and the school as a whole can do) to prevent suicide among their students. Afterward, interested staff and community members were invited to participate in on-going virtual learning circles hosted by PC CARES curriculum trainers aimed at developing a suicide prevention and postvention plan for their school and/or district. School staff who were at least 18 years old, and who participated in any level of training will have the option to participate in 3 online surveys (emailed to them) to assess their changes in Attitudes, Skills, Behavior, Knowledge and Community of Practice related to suicide prevention: 1) before any trainings are offered, 2) soon after the inservice, and 3) at the end of the school year.
Participants in the Virtual PC CARES training filled out a registration form to indicate their interest in attending PC CARES. The registration form included a description of the research and consent form. If they gave their informed consent, participants were brought to the Virtual PC CARES Baseline Survey, which mirrors the Steps Toward Prevention Survey, with a few questions that pertain to the school context added. We also added some answer choices for school-specific network roles such as Teacher, Administrator, Coach, Administrative Assistant/Front Desk, Classroom Aide, Other school staff (including janitor/cafeteria worker), Student, Parent of student. Participants in the virtual sessions were asked for their consent to use the notes from PC CARES sessions as part of the research. Students who did not consent were excluded from note-taking.
Follow Up data collection:
For data collection approximately 1 month after the intervention concluded, investigators recruited all those who attended PC CARES and those who completed the baseline survey. This survey was identical to the Baseline Survey, and participants' responses were paired to their baseline data via anonymous IDs. By starting with those who attended PC CARES sessions, investigators hope to document diffusion effects-to learn how PC CARES impacts those who attend the learning circles, people close to them and others in the community.
This study maximizes rigor through a multiple baseline, multi-method approach, and carefully tracks the process indicators, moderating variables, and mechanisms leading to our hypothesized proximal, intermediate and ultimate outcomes of youth support to reduce suicidal behavior. Most community-based suicide studies measure only changes in participants' knowledge, attitudes and intentions to act. This study goes further by documenting changes in participants' prevention behavior over time, and assessing its impact on protective interactions within the community.
Integrating key lessons from the pilot research, investigators use multilevel growth modeling to track the factors likely to affect these outcomes, namely participation at community (cross- sector) and individual (dosage) levels, and the formal/institutional or informal/community social role of participants. Using innovative social network methods, investigators also investigate the intervention's impact on prevention-oriented interactions, help- giving and seeking, and health promoting exchanges within the community.
By documenting the level and type of preventive and supportive interactions taking place among people in various roles (including youth) within the village before and after PC CARES, investigators can assess the effectiveness of the intervention at initiating community-level change among PC CARES participants and those who did not participate: allowing investigators to measure diffusion effects. This data informs investigators of the scalability of the approach. This analysis considers the moderating effects of key variables such as the degree of closeness between youth and PC CARES participants, level of collaboration between formal-informal supporters, interactions across age groups, and level of participation. Building on the infrastructure of schools and tribal health clinics in each rural and remote community and leveraging our prior work, our scalable model translates scientific prevention research onto practice, enabling people who are in the daily lives of Alaska Native youth to purposefully reduce suicide risk factors, and increase safety, help-seeking and support to prevent suicide and promote health.
- Conditions
- Suicide
- Being tested
- PC CARES
- Keywords
- Suicide Prevention, Alaska Native, Community Intervention
- Medical subject headings
- Suicide, Suicide Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PC CARESBehavioural
PC CARES trains local residents to deliver the PC CARES curriculum in their own community. These facilitators will attend a 40 hour training, and then will deliver the 4 session PC CARES curriculum in their home village. To aid local facilitators, each session follows the same structure after a beginning ritual:(1) agreements/safe talk, (2)'small wins', (3)'what do we know?' (facilitator shares current research on suicide prevention or wellness) (4)'what do we think?' (participants have an opportunity to discuss their thoughts on the research presented), and (5)'what we want to do?' (participants identify what steps they can take in their village to make positive change).The content of learning circles (LCs) includes community-level conditions, evidence-based approaches, risk and protective factors that can prevent suicide and promote well-being.Each LC includes both primary and secondary prevention strategies.Teaching tools include charts, short films, and case studies.
| Study group | Role | What they receive |
|---|---|---|
| PC CARES Intervention | Experimental | Experimental: PC CARES Intervention Participants will attend 1-7 sessions of the PC CARES curriculum. Investigators will collect data from this group at baseline, after each session they attend, and at follow-up. Receives: Behavioral: PC CARES |
| No intervention | No intervention | This group will not attend the PC CARES sessions. Investigators will collect data from this group at baseline and follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wellness Self-Efficacy
The Wellness Self-Efficacy scale includes two items:
- I know how I can make positive changes for school wellness
- There are things I can do to promote wellness here
Items were measured on a 7-point Likert scale with response options ranging from Strongly Disagree (1) to Strongly Agree (7) with a neutral midpoint.
Responses to the two items are averaged to calculate a composite Wellness Self-Efficacy score ranging from 1 to 7. The reported outcome measure is the mean (standard deviation) of the composite score. Higher scores indicate greater self-efficacy for promoting school wellness.
Measured: At follow up, an average of 7 months
Community of Practice
The Community of Practice scale includes three items:
- Many people in this community work together for suicide prevention/wellness.
- I have regular opportunities to work with others to increase wellness.
- I have many people to work with in my community to prevent suicide.
Items were measured on a 7-point Likert scale with response options ranging from Strongly Disagree (1) to Strongly Agree (7) with a neutral midpoint.
Responses to the three items are averaged to calculate a composite Community of Practice score ranging from 1 to 7. The reported outcome measure is the mean (standard deviation) of the composite score. Higher scores indicate a stronger community of practice for suicide prevention and wellness.
Measured: At follow up, an average of 7 months
Suicide Prevention Self-Efficacy
The Suicide Prevention Self-Efficacy scale includes three items:
- I know how to talk safely about suicide, in ways that help with prevention
- I know how to decrease suicide risk for others by the way I talk about suicide
- I feel confident that I can do things to prevent suicide
Items were measured on a 7-point Likert scale with response options ranging from Strongly Disagree (1) to Strongly Agree (7) with a neutral midpoint.
Responses to the three items are averaged to calculate a composite Suicide Prevention Self-Efficacy score ranging from 1 to 7. The reported outcome measure is the mean (standard deviation) of the composite score. Higher scores indicate greater self-efficacy for engaging in suicide prevention.
Measured: At follow up, an average of 7 months
Working Together
The Working Together scale includes six items:
- I asked someone for help doing prevention/wellness work when I needed it
- I spoke up about what the school can do to reduce the risk of youth suicide
- I talked with others about wellness
- I worked with others to increase wellness in the school community
- I worked with others to prevent suicide
- I let others know what resources are available for prevention. Participants were asked if they had completed the action in the past few months (Y/N), resulting in a count of the types of actions taken.
Measured: At follow up, an average of 7 months
Interpersonal Support
The Interpersonal Support measure included 7 items:
- I spent time listening to a teen or child who just wanted to talk about their experience
- I trusted others in the school community to hear what I have to say
- I reached out to a child who was hurting (alone, sad, angry)
- I helped a youth (child/teen) who was feeling down get help (Behavioral Health Services, Alaska Careline, etc.)
- I reminded someone that just listening to someone can be more supportive than giving advice
- I quietly listened to a youth (child or teen) who had a problem, reflecting back to them what I heard
- I encouraged others to offer small acts of kindness when someone was having a hard time.
Participants were asked if they had completed the action in the past few months (Y/N), resulting in a count of the types of actions taken.
Measured: At follow up, an average of 7 months
Postvention
The Postvention Behavior measure includes five items:
- I shared only the basic facts of a suicide (avoiding details)
- I spoke to someone about how to talk safely after a suicide
- I talked about how suicide is no one's fault
- I shared that it can be harmful to honor someone who died by suicided more than is done for other deaths
- I talked about how we can help prevent further harm after a suicide happens Participants were asked if they had completed the action in the past few months (Y/N), resulting in a count of the types of actions taken.
Measured: At follow up, an average of 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start12 Sep 2019
- Primary completion18 Feb 2025
- Study completion12 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (39)Papers the sponsor has linked to this study.
- Other trials for SuicideStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- This intervention study will measure the outcomes of the PC CARES (Promoting Community Conversations about Research to End Suicide) curriculum implemented remotely during COVID pandemic years (2020-2022). It will compare pre-post data from intervention participants to non-participants, and will analyze social networks related to suicide prevention behavior in each village. Researchers worked with local service providers and other partners to recruit participants who have access to the internet for virtual sessions. Intervention participants will be self-selecting.
- Masking
- None (open label)
- Enrolment
- 1,427 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nebraska Lincoln, Norton Sound Health Corporation, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Lisa Wexler, University of Michigan
- Investigators
- Lisa Wexler, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03661255
- Sponsor's protocol ID
- HUM00161969
- Other IDs
- 1R01MH112458-01A1
- Acronym
- PC CARES
- Status last verified
- May 2026
- First submitted
- 12 Jul 2018
- Last updated
- 19 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Final data will be shared through peer-reviewed publications and presentations, community presentations and tribal reports. Raw data will be considered for sharing under the following rules. Raw datasets released for sharing will not contain identifiers. Data and associated documentation will be made available to users only under a signed and properly executed data-sharing agreement that provides specific criteria under which the data will be used, including but not limited to: (1) a commitment to secure the data using appropriate computer technology, (2) a commitment to using the data for research purposes that are in accordance withcollaborating tribes' priorities, (3) that the data is not used to identify individual participants and conforms to all privacy protections indicated in the participants' informed consent, and (4) a commitment to destroying or returning the data after analyses are completed.
Publications
Wexler L, Trout L, Rataj S, Kirk T, Moto R, McEachern D. 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. Int J Circumpolar Health. 2017;76(1):1345277. doi: 10.1080/22423982.2017.1345277.
PubMed 28762305Wexler 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 26880738Lee HW, Gauthier GR, Ivanich JD, Wexler L, Khan B, & Dombrowski K. A method for assessing the success and failure of community-level interventions in the presence of network diffusion, social reinforcement, and related social effects. ArXiv180108612 Phys. January 2018. http://arxiv.org/abs/1801.08612. Accessed February 8, 2018.
Palinkas LA, Holloway IW, Rice E, Brown CH, Valente TW, Chamberlain P. Influence network linkages across implementation strategy conditions in a randomized controlled trial of two strategies for scaling up evidence-based practices in public youth-serving systems. Implement Sci. 2013 Nov 14;8:133. doi: 10.1186/1748-5908-8-133.
PubMed 24229373Gest SD, Osgood DW, Feinberg ME, Bierman KL, Moody J. Strengthening prevention program theories and evaluations: contributions from social network analysis. Prev Sci. 2011 Dec;12(4):349-60. doi: 10.1007/s11121-011-0229-2.
PubMed 21728069Tseng V. The uses of research in policy and practice. Sharing Child and Youth Development Knowledge 26(2):1-16, 2012.
Rogers EM. Diffusion of Innovations. NY, NY Simon and Schuster, 2010.
Dombrowski K, Khan B, Moses J, Channell E, & Dombrowski N. Network sampling of social divisions in a rural Inuit community. Identities 21(2):134-151, 2014.
Wexler LM. Inupiat youth suicide and culture loss: Changing community conversations for prevention. Soc Sci Med. 2006 Dec;63(11):2938-48. doi: 10.1016/j.socscimed.2006.07.022. Epub 2006 Sep 6.
PubMed 16952416Wexler L, Goodwin B. Youth and adult community member beliefs about Inupiat youth suicide and its prevention. Int J Circumpolar Health. 2006 Dec;65(5):448-58. doi: 10.3402/ijch.v65i5.18146.
PubMed 17319089Hill R, Perkins R, Wexler L. An analysis of hospital visits during the 12 months preceding suicide death in Northern Alaska. Alaska Med. 2007 Jan-Mar;49(1):16-21.
PubMed 17479732Wexler L, Hill R, Bertone-Johnson E, Fenaughty A. Correlates of Alaska Native fatal and nonfatal suicidal behaviors 1990-2001. Suicide Life Threat Behav. 2008 Jun;38(3):311-20. doi: 10.1521/suli.2008.38.3.311.
PubMed 18611129Wexler L. Identifying colonial discourses in Inupiat young people's narratives as a way to understand the no future of Inupiat youth suicide. Am Indian Alsk Native Ment Health Res. 2009;16(1):1-24. doi: 10.5820/aian.1601.2009.1.
PubMed 19340763Wexler L. Behavioral health services "Don't work for us": cultural incongruities in human service systems for Alaska Native communities. Am J Community Psychol. 2011 Mar;47(1-2):157-69. doi: 10.1007/s10464-010-9380-3.
PubMed 21052820Ulturgasheva O, Wexler L, Kral M, Allen J, Mohatt GV, Nystad K; CIPA Team. Navigating International, Interdisciplinary, and Indigenous Collaborative Inquiry: Phase 1 in the Circumpolar Indigenous Pathways to Adulthood Project. J Community Engagem Scholarsh. 2011 Jun 19;4(1):50-59.
PubMed 22866196