Promoting Community Conversations About Research to End Native Youth Suicide in Rural Alaska (PC CARES)
Primary Purpose
Suicide
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PC CARES
Sponsored by
About this trial
This is an interventional prevention trial for Suicide focused on measuring Suicide Prevention, Alaska Native, Community Intervention
Eligibility Criteria
Inclusion Criteria:
- lives or works in village
- at least 15 years old
Sites / Locations
- University of MichiganRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
PC CARES Intervention
No intervention
Arm Description
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.
This group will not attend the PC CARES sessions. Investigators will collect data from this group at baseline and follow-up
Outcomes
Primary Outcome Measures
Change in Behaviors related to suicide prevention
Behaviors (12 survey questions) related to suicide prevention will be measured at baseline, after each PC CARES session, and at follow up for participants (intervention group) and at baseline and followup only for non-participants (No intervention group).
Change in Knowledge related to suicide prevention
Knowledge (7 survey questions) related to suicide prevention will be measured at baseline, after each PC CARES session, and at follow up for participants (intervention group) and at baseline and followup only for non-participants (No intervention group).
Change in Attitudes related to suicide prevention
Attitudes (20 survey questions) related to suicide prevention will be measured at baseline, after each PC CARES session, and at follow up for participants (intervention group) and at baseline and followup only for non-participants (No intervention group).
Secondary Outcome Measures
Community level impact of PC CARES (type of interactions)
Investigators will document the community level impact of PC CARES by tracking the type of interactions aimed at preventing youth suicide and promoting wellness in participating villages
Community level impact of PC CARES (number of interactions)
Investigators will document the community level impact of PC CARES by tracking the number of interactions aimed at preventing youth suicide and promoting wellness in participating villages
Community level impact of PC CARES through social network analysis by describing changes in the supportive social networks of young people before and after the intervention.
Document the Community level impact of PC CARES by describing changes in the supportive social networks of young people before and after the intervention.
Full Information
NCT ID
NCT03661255
First Posted
July 12, 2018
Last Updated
October 20, 2023
Sponsor
University of Michigan
Collaborators
University of Nebraska Lincoln, Norton Sound Health Corporation, National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT03661255
Brief Title
Promoting Community Conversations About Research to End Native Youth Suicide in Rural Alaska
Acronym
PC CARES
Official Title
Promoting Community Conversations About Research to End Native Youth Suicide in Rural Alaska
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 12, 2019 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
University of Nebraska Lincoln, Norton Sound Health Corporation, National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
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.
Also due to COVID-related restrictions, we began to send PC CARES Care packages to community members who 'opted in' to receive them. Care packages contained brief information about what research shows community members can do to prevent suicide and promote wellness in their community. They will also contain small gifts that community members can use in their wellness promotion/suicide prevention, such as "You Matter" cards that have affirming messages that they can share with others in their community. Over 2 years, PC CARES sent Care Packages to 493 recipients in 49 communities in Alaska, with a total number of 1319 packages sent. Each care package contained a survey with a self-addressed stamped envelope. Participants who sent the survey back to researchers or filled it out online were entered into a raffle to win a prize worth $50. After each care package, we also randomly selected 5 Care package recipients to be invited to participate in a brief interview to collect additional data about how they are using the Care package information and items and to help us make the Care packages more useful to them over time. Interview participants received a $20 gift card as an incentive to participate. According to recipient feedback, the Care Packages helped build connections and goodwill between PC CARES and participants during COVID-19 pandemic, and were welcomed and well-used by recipients.
As a supplement to the original grant and the virtual adaptation, we initiated an implementation-focused small study. In this additional project, a cohort of students in the Rural Human Services Certificate Program at University of Alaska-Fairbanks, Kuskokwim campus will fulfill their practicum requirement by facilitating PC CARES Learning Circles in their home communities in rural remote western Alaska. Students who consent to participate in the study will complete 3 surveys (Pre-Training, Post-Training, and 6-Month Follow Up). In addition, we asked for consent to take field notes during the facilitator training and during the monthly facilitator support calls. These field notes focus on what kinds of questions are raised by trainees, what challenges and success they have as facilitators, and other information related to the experience of being a facilitator.
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.
Our expected recruitment numbers evolved as the ramifications of the COVID pandemic hit and our strategy had to change. Pre-pandemic, we were able to recruit 496 participants who completed a Baseline Steps toward Prevention Survey, however, we shifted our research strategy to hold virtual learning circles based in the schools in 2 remote Alaskan regions. With this revised scope, we aimed to recruit 700 and in actuality, we recruited 774.
Also due to COVID, we instated the PC CARES at Home Care Package program and we had 117 participants.
In our efforts to research further the experiences of PC CARES facilitators, we planned to recruit 20 students from the UAF-Bethel Rural Human Services program, and 24 of them have enrolled.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide
Keywords
Suicide Prevention, Alaska Native, Community Intervention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study will have a stepped wedge design with 3 cohorts (in successive years) of 3 villages each. 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. Intervention participants will be self-selecting.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1491 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PC CARES Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
This group will not attend the PC CARES sessions. Investigators will collect data from this group at baseline and follow-up
Intervention Type
Behavioral
Intervention Name(s)
PC CARES
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Behaviors related to suicide prevention
Description
Behaviors (12 survey questions) related to suicide prevention will be measured at baseline, after each PC CARES session, and at follow up for participants (intervention group) and at baseline and followup only for non-participants (No intervention group).
Time Frame
6 times over approximately 3 year period
Title
Change in Knowledge related to suicide prevention
Description
Knowledge (7 survey questions) related to suicide prevention will be measured at baseline, after each PC CARES session, and at follow up for participants (intervention group) and at baseline and followup only for non-participants (No intervention group).
Time Frame
6 times over approximately 3 year period
Title
Change in Attitudes related to suicide prevention
Description
Attitudes (20 survey questions) related to suicide prevention will be measured at baseline, after each PC CARES session, and at follow up for participants (intervention group) and at baseline and followup only for non-participants (No intervention group).
Time Frame
6 times over approximately 3 year period
Secondary Outcome Measure Information:
Title
Community level impact of PC CARES (type of interactions)
Description
Investigators will document the community level impact of PC CARES by tracking the type of interactions aimed at preventing youth suicide and promoting wellness in participating villages
Time Frame
Pre and post intervention (2 times over approximately 3 year period)
Title
Community level impact of PC CARES (number of interactions)
Description
Investigators will document the community level impact of PC CARES by tracking the number of interactions aimed at preventing youth suicide and promoting wellness in participating villages
Time Frame
Pre and post intervention (2 times over approximately 3 year period)
Title
Community level impact of PC CARES through social network analysis by describing changes in the supportive social networks of young people before and after the intervention.
Description
Document the Community level impact of PC CARES by describing changes in the supportive social networks of young people before and after the intervention.
Time Frame
Pre and post intervention (2 times over approximately 3 year period)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
lives or works in village
at least 15 years old
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Wexler, PhD
Phone
734-764-7806
Email
lwexler@umich.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Suzanne Rataj, MPH
Phone
413-545-4532
Email
srataj@umass.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Wexler, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suzanne Rataj, MPH
Phone
413-824-1190
Email
srataj@umass.edu
First Name & Middle Initial & Last Name & Degree
Tara Schmidt, MPH
Email
pccares@umich.edu
First Name & Middle Initial & Last Name & Degree
Lisa Wexler, PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
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 with collaborating 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.
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Citation
Wexler L, Schmidt T, White L, Wells CC, Rataj S, Moto R, Kirk T, McEachern D. Collaboratively adapting culturally-respectful, locally-relevant suicide prevention for newly participating Alaska Native communities. Journal for Social Action in Counseling and Psychology. 2022; 14(1): 124-151. https://doi.org/10.33043/JSACP.14.1.124-151
Results Reference
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Links:
URL
http://www.pc-cares.org/
Description
Site describing the PC CARES philosophy, curriculum, team, and how people can get involved
Learn more about this trial
Promoting Community Conversations About Research to End Native Youth Suicide in Rural Alaska
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