Clinical trial NCT03661255: Promoting Community Conversations About Research to End Native Youth Suicide in Rural Alaska
Official title: Promoting Community Conversations About Research to End Native Youth Suicide in Rural Alaska
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Suicide
Keywords: Suicide Prevention
Alaska Native
Community Intervention
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: University of Nebraska Lincoln
name: Norton Sound Health Corporation
name: National Institute of Mental Health (NIMH)
First posted: 2018-09-07
Enrollment: 1491
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* lives or works in village
* at least 15 years old

Primary outcomes:
measure: Change in Behaviors related to suicide prevention
timeFrame: 6 times over approximately 3 year period
measure: Change in Knowledge related to suicide prevention
timeFrame: 6 times over approximately 3 year period
measure: Change in Attitudes related to suicide prevention
timeFrame: 6 times over approximately 3 year period
Secondary outcomes:
measure: Community level impact of PC CARES (type of interactions)
timeFrame: Pre and post intervention (2 times over approximately 3 year period)
measure: Community level impact of PC CARES (number of interactions)
timeFrame: Pre and post intervention (2 times over approximately 3 year period)
measure: 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.
timeFrame: Pre and post intervention (2 times over approximately 3 year period)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Lisa Wexler, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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