Efficacy-Implementation Study for PC CARES in Rural Alaska

Not Applicable

Recruiting

• Conditions: Suicide Prevention

• Registration Number: NCT06658808
• Lead Sponsor: University of Michigan

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).

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.

Study Timeline

• Status Verified: 2024-05
• Study Start: 2024-09-12
• Study First Submitted: 2024-10-18
• Study First Submitted QC: 2024-10-23
• Study First Posted: 2024-10-26
• Last Update Submitted: 2024-10-30
• Last Update Posted: 2024-11-04
• Primary Completion: 2029-12
• Study Completion: 2031-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1075

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Suicide Prevention Knowledge	Baseline; monthly after each LC, assessed over 5 months; follow-up at 1 month and 6 month after the last LC	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.
Change in Self-Efficacy	Baseline; monthly after each LC, assessed over 5 months; follow-up at 1 month and 6 month after the last LC	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.
Change in Youth Connectedness	Baseline; monthly after each LC, assessed over 5 months; and 1 month follow up	Youth connectedness is measured using a 4-point Agreement Scale (11 survey questions).; Youth connectedness is measured in youth participants.
Change in Community Protective Factors	Baseline; monthly after each LC, assessed over 5 months; and 1 month follow up	Community protective factors are measured using a 7-point Agreement Scale (9 survey questions). Community protective factors is measured in youth participants.
Change in Community of Practice (CoP)	Baseline; monthly after each LC, assessed over 5 months; follow-up at 1 month and 6 month after the last LC	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.
Change in Self-Reported Supportive Interactions with Adults	Baseline; monthly after each LC, assessed over 5 months; and 1 month follow up	Self-reported supportive interactions are measured using a 6-point Frequency Scale (10 survey questions).; Self-reported supportive interactions are measured in youth participants.
Change in Perceived Social Support	Baseline; monthly after each LC, assessed over 5 months; and 1 month follow up	Perceived social support is measured using a 7-point Agreement Scale (11 survey questions). Perceived social support is measured in youth participants.
Change in Suicide Prevention-Oriented Behaviors	Baseline; monthly after each LC, assessed over 5 months; follow-up at 1 month and 6 month after the last LC	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.

Trial Locations

Locations (2)

Rural Human Services Program; 🇺🇸 Fairbanks, Alaska, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States