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. 2025 Jun 23;46:101511. doi: 10.1016/j.conctc.2025.101511

Study protocol for a randomized controlled effectiveness trial of THRIVE group and peer coaching to promote suicide recovery in crisis stabilization centers☆☆☆☆☆☆☆☆☆☆☆☆☆☆☆

Jennifer D Lockman a,b,⁎, Anthony R Pisani c,d, M Alexis Kirk e, Kimberly A Van Orden c, Ian J Cero c, Margaret E Balfour f,g, Kristina Mossgraber h, David Jacobowitz c, Kenneth R Conner c
PMCID: PMC12272113  PMID: 40688062

Abstract

Crisis Stabilization Centers (CSCs) offer a person-centered, community-based alternative to Emergency Departments for suicide prevention. CSCs may facilitate the expansion of the 988 Suicide Prevention Lifeline by providing callers with places to go in communities to receive treatment. However, new, recovery-focused psychological interventions for suicide prevention that can be rapidly implemented in CSCs are needed to be effective. This pilot study examines the feasibility, acceptability, and target engagement of the Toward Recovery, Hope, Interpersonal Connection, Values, and Engagement (i.e., THRIVE) for CSCs. THRIVE includes a psychotherapy group and peer-led recovery coaching calls after discharge. This project consists of three phases to adapt, pilot, and test THRIVE in CSCs in preparation for a full-scale effectiveness trial. In phase I, we will use the Model for Implementation Design and Impact (i.e., MADI) to adapt THRIVE to CSCs’ implementation needs (n = 25). In phase II, we will assess the feasibility and acceptability of THRIVE through CSC Stakeholder feedback and completing a pilot trial of THRIVE with CSC guests (n = 20). In phase III, we will complete a pilot randomized effectiveness trial of THRIVE (n = 162) to test the effectiveness of THRIVE on treatment initiation. We will also examine target engagement (i.e., as thwarted belongingness, and perceived burdensomeness) of the THRIVE intervention. Participants will be randomized to (a) Thrive + Discharge & Safety Planning as Usual (i.e., Intervention Arm): or (b) Discharge & Safety Planning as Usual (i.e., Control Arm). Participants complete assessments at baseline, discharge, 1 month, and 3 months. This protocol demonstrates strategies for involving community-based practice partners in research and is the first randomized controlled trial in a CSC sponsored by the National Institute of Mental Health (NIMH).

Keywords: Model for adaptation design and impact, Participatory action research, Suicide prevention, Suicide recovery, Peer support, Crisis stabilization centers, THRIVE

There is a critical need for brief, effective, recovery-focused psychological treatments for suicide prevention in the United States that can be adopted and scaled quickly [1]; U.S. Department of Health and Human Services [2]. In 2021, 12.3 million adults considered suicide, 3.5 million adults made a suicide plan, 1.7 million adults attempted suicide, and 48,000 adults died by suicide [3]. To increase access to suicide prevention services, the U.S. Department of Health and Human Services rolled out “988” as the new, easy-to-recall phone number for mental health emergencies in 2022 [4]. More than 200 million dollars in federal funding is currently dedicated to expanding 988 and related crisis stabilization center services for community-based treatment (SAMHSA, n.d.). With 988 expanding, there is an increased need for diverting suicidal persons in urgent need of treatment away from emergency departments (i.e., EDs) that are overcrowded and ill-equipped to provide suicide-specific care [[5], [6], [7]].

Crisis Stabilization Centers (CSCs) are community-based crisis walk-in centers staffed by interdisciplinary teams that can provide suicide prevention services and are an alternative to EDs [[8], [9], [10]]. However, research on CSCs is scarce and has mixed support [[11], [12], [13]]. Challenges associated with CSCs include role differentiation in interdisciplinary treatment models and difficulties with re-admissions and community-based treatment engagement after discharge [14,15]. Although CSCs employ peer-support specialists with lived experiences of suicide, there are no existing evidence-based treatments for their peer role. To date, there have been no published outcomes from randomized controlled trials for suicide prevention, suicide recovery, or after-discharge treatment engagement in CSCs. For CSCs to become a mainstream alternative to EDs, brief, effective, recovery-focused suicide-specific interventions that can be rapidly adopted and scaled are needed but do not exist.

Toward Hope, Recovery, Interpersonal Connection, Values, and Engagement (i.e., THRIVE) consists of a collection of recovery-focused psychological interventions tailored to community-based staff and workflows. THRIVE targets components of the Interpersonal Theory of Suicide (e.g., thwarted belongingness, perceived burdensomeness, hopelessness, self-hate, [16]; Fig. 1) and recovery (e.g., through meaning made of stress, [17,18]). THRIVE was initially pilot-tested in a large, multi-state nonprofit community mental health center in the United States but has not yet been tailored to the unique cultures and workflows of CSCs.

Fig. 1.

Fig. 1

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Interpersonal theory of suicide: Life events (distal) Lead to suicide to the extent that they impact belonging and perceived burden (proximal).

1. Method

1.1. Overarching study design and ethical approval

We describe this protocol according to the SPIRIT guidelines for reporting clinical intervention trials [20]. This study was approved by the WCG Connexus Institutional Review Board and is registered with clinicaltrials.gov (NCT05637203).

1.2. Study setting and population

This study will be conducted at two CSC units at Connections Health Solutions in Phoenix, AZ. Connections Health Solutions is one of the leading CSC centers in the nation and has contributed directly to national standards in crisis care [7,21]. Connections Health Solutions sees approximately 9676 persons at risk for suicide in Phoenix, AZ, each year. We will recruit CSC stakeholders across the United States to provide feedback on the feasibility and acceptability of THRIVE.

1.3. THRIVE intervention

THRIVE is a collection of novel, interpersonal, recovery-oriented interventions that were developed by the first author (Lockman). THRIVE draws on the Interpersonal Theory of Suicide [16,22] by targeting the two interpersonal factors proposed to function as drivers of suicide - thwarted (or low) belonging and perceived burden on others. We anticipate individuals who have greater levels of belongingness and perceived contribution to others (i.e., opposite burdensomeness) will be more motivated to engage in treatment to resolve their suicidal ideation and promote recovery. THRIVE facilitates recovery through narrative meaning-making, a values-driven meaningful living plan, and social-justice advocacy to address social determinants of health. THRIVE was previously piloted as a crisis follow-up program in five adult cohorts receiving suicide prevention services through SAMHSA grants. In this protocol, we are studying the THRIVE Belonging and Giving psychotherapy group (THRIVE-group) and the THRIVE peer-support phone program (THRIVE-peer). THRIVE-group is a psychotherapy group co-led by a mental health counselor and peer support specialist offered during the CSC stay. THRIVE-peer consists of up to four caring phone calls after CSC discharge to facilitate the care transition to outpatient services (i.e., a period of heightened risk for suicidal behavior [23,24]. THRIVE includes an optional mobile app with a meaningful living plan, community-based resources to promote care engagement, and a 1-touch contact button for 988 crisis support. All participants will have the app downloaded on their phone and we will track the number of impressions and frequency of use to assess feasibility and acceptability, along with qualitative items to gauge user feedback. We anticipate directly targeting ITS mechanisms of change will promote recovery, treatment initiation, and engagement in outpatient settings after CSC discharge.

1.4. Phase I: Adapt THRIVE to CSCs using MADI. Create an adapted THRIVE manual

The first phase of this study involves using the MADI [19] to tailor THRIVE to the unique culture, staffing, and clinical workflows of CSCs. THRIVE will be adapted to include peer-support specialists, which is a new frontier for suicide-specific care in rural and urban community-based settings in need of cost-effective, accessible, feasible, and scalable interventions (Fortuna et al., 2022).Specifically, we will recruit and consent ten clinical staff and administrators from Community Mental Health Centers and CSCs who have used THRIVE and 15 “naïve” staff from Connections Health Solutions CSC who have no prior experience with THRIVE to participate in the MADI adaptation. The MADI (i.e., Fig. 2) is a rapid adaptation procedure that includes the following steps: (a) identify the core functions and forms of the THRIVE intervention; (b) identify key context differences between inpatient/EDs, community mental health and CSCs using a modified Delphi approach where 85 % or greater consensus is reached to achieve recommendation for adaptation (Fig. 3); (c) select adaptations that preserve the core functions of THRIVE and improve fit with CSCs. We will revise the THRIVE intervention manual to include MADI-informed adaptations and intervention strategies.

Fig. 2.

Fig. 2

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Madi rapid adaptation process for Thrive.

Fig. 3.

Fig. 3

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MADI Decision Tree for Selecting Treatment Adaptations for THRIVE.

1.5. Phase II: test feasibility, acceptability, and appropriateness of THRIVE for CSCs

1.5.1. Study design

In phase two, we will test the feasibility, acceptability, and appropriateness of THRIVE for CSCs while assessing the utility of the MADI adaptations [25]. We will recruit up to 19 Connections Health Solutions Staff and up to 30 CSC national stakeholders working in CSCs across the United States to participate in a series of focus groups, live demos, and quantitative surveys to examine its feasibility and acceptability. We will use the Pragmatic Context Assessment Tool (PCAT; [26]) to identify implementation facilitators, barriers, and possible implementation mechanisms of change according to the CFIR. We will use the Intervention Scalability Assessment Tool (i.e., ISAT; [27]) to map and measure national implementation thresholds for THRIVE. We will conduct a pilot trial of THRIVE with 20 CSC guests to examine its feasibility and acceptability.

1.5.2. Participants

CSC Local Stakeholders. We will recruit up to two study therapists and up to two peer specialists to deliver the THRIVE intervention. Inclusion criteria for THRIVE study personnel include: (a) 18 years or older; (b) experience delivering THRIVE; and (c) English-speaking. The exclusion criterion for THRIVE study personnel is less than one year of experience working in a CSC.

CSC National Stakeholders. We will recruit up to 30 CSC national leaders and stakeholders who do not work for Connections Health Solutions and are naïve to THRIVE. Inclusion criteria for CSC National Stakeholders include: (a) 18 years or older; (b) no training or experience in THRIVE; (c) English-speaking. The exclusion criterion for CSC National Stakeholders is less than one year of experience.

CSC Guests. Approximately 20 adults from Connections Health Solutions’ CSC will participate in a pilot trial of THRIVE. Inclusion criteria include: (a) Admission to CSC with suicidal crisis, as defined by active suicidal ideation ascertained via the Columbia Suicide Severity Rating Scale and (b) ability and willingness to provide information and permission for at least one person in case of emergency or inability to reach the participant for follow-up. Exclusion criteria include (a) Under age 18; (b) inability to communicate with the researcher in English (c) acute psychiatric instability (e.g., psychotic symptoms);: as determined by clinical judgement of the onsite psychiatrist or nurse practitioner; (d) not having a phone for phone follow-up. Most patients with acute psychiatric instability are transferred to a higher level of care (e.g., inpatient), such that we do not anticipate many exclusions on this criterion.

1.5.3. Recruitment, consent, study Participation

CSC Local Stakeholders. THRIVE study personnel will be asked to sign an e-consent form agreeing to complete implementation measures for the study and to submit audio recordings for fidelity coding. THRIVE study personnel will be prompted to participate in a survey rating the feasibility, acceptability, and implementation potential of THRIVE and one focus group after phase 2. Local stakeholders naïve to THRIVE will be recruited via an email with an online link to view and sign the electronic consent form and will participate in one focus group.

CSC National Stakeholders. CSC National Stakeholders will be recruited via Connections Health Solutions Leadership meetings, the Crisis Residential Association list-serve and email list, and the National Consortium for Crisis Innovation (i.e., Learning-Action Community-based Coalition Co-directed by the first author and TBD Solutions, Inc.). Participants will be asked to sign an electronic consent form online and then provided a link to the online study materials. After providing e-consent, participants will be provided a written, brief description of THRIVE or invited to attend one of three “live” events where the intervention can be demonstrated. Participants will then be immediately directed to an electronic survey asking them to rate the feasibility, acceptability, adaptation utility, and implementation potential of THRIVE.

CSC Guests. Study staff trained in human subjects procedures and supervised by one of the PIs will conduct the recruitment and consent procedure onsite. Potentially eligible participants are identified via a review of the medical record to determine which guests were admitted for suicide risk. Potential participants receive medical clearance and are approached with information about the study. Potential participants sign a research interest form, are screened for eligibility, and then are approached for consent via a University-provided tablet and Adobe sign. Consented participants are provided a full research assessment battery. Participants participate in the THRIVE-group while at the CSC. After discharge, participants complete up to four weeks of THRIVE-peer calls led by a THRIVE peer specialist. Participants are asked to complete a baseline survey, an after-THRIVE survey (before CSC discharge), and a 1-week follow-up survey with a qualitative interview.

1.5.4. Assessments

The research assessment battery is provided in Table 1. Measures included in this study have established psychometric properties and have been used previously in suicide research and implementation science.

Table 1.

Data collection measures.

Domain Phase Measure Participants Type Purpose Schedule
Tailor THRIVE to CSCs using MADI 1 Modified Delphi survey according to the Model for Adaptation Design and Impact (MADI) [19] CSC local stakeholders 18 items Intervention Adaptation 1x at end of phase 1.
Demographics 1–3 Age, sex, gender identity, sexual orientation, race, ethnicity, education status, employment, housing status, socioeconomic status CSC local and national stakeholders and guests 24 items Descriptive CSC stakeholders - 1x in initial survey. CSC guests - Baseline.
THRIVE Adaptation Effectiveness, Implementation Facilitators and Barriers, Implementation Mechanisms 2 MADI focus group including the Pragmatic Context Assessment Tool (PCAT; [26]) CSC local stakeholders Focus group Implementation Thresholds; Exploratory Outcome 1x. Administered at end of phase 2
Scalability 2 The Intervention Scalability Assessment Tool (ISAT; [27]) CSC national stakeholders 20 Items Scale Thresholds; Exploratory Outcome 1x. Administered at the end of phase 2
Feasibility/Acceptability/Appropriateness 2 Feasibility of Intervention Measure (FIM); Acceptability of Intervention Measure (AIM); Intervention Appropriateness Measure (IAM) [39] CSC national stakeholders and guests 12 items Feasibility/Acceptability/Appropriateness CSC stakeholders - 1x at end of phase 2; CSC guests - before discharge & at follow-up
Acceptability 2 Intervention Rating Profile adapted for CSCs (IRP; [40]) CSC stakeholders and guests 20 items Acceptability CSC stakeholders - 1x at end of phase 2; CSC guests - before discharge & at follow-up
Satisfaction 2 Client Satisfaction Questionnaire- 8 (CSQ-8; [41]) CSC guests 8 items Satisfaction CSC stakeholders - 1x at end of phase 2; CSC guests - before discharge & at follow-up
Fidelity 2–3 THRIVE Fidelity Measure - Adherence, Competence CSC interventionists & guests 34 items per encounter Primary Outcome Continuous ratings
Group Cohesion 2–3 Group Therapy Experience Questionnaire [42] CSC guests 10 items Moderator 1x; CSC discharge survey
Perceived Burdensomeness/Thwarted Belongingness 3 Interpersonal Needs Questionnaire-10 (INQ-10; [32]) CSC guests 10 items Mechanism Baseline, follow-ups
Social Isolation/Loneliness 3 System-Social Isolation (PROMIS-SI [43]; CSC guests 8 items Mechanism Baseline, follow-ups
Recovery - Orientation 3 Recovery Assessment Scale (RAS; [44]). CSC guests 24 items Secondary Outcome Baseline, follow-ups
Recovery - Coping 3 Brief Resilient Coping Scale (B-RCS; [45]) CSC guests 4 items Secondary Outcome Baseline, follow-ups
Recovery - Readiness for Living 3 Living Ladder [46] CSC guests 1 item Secondary Outcome Baseline, follow-ups
Depression 3 PROMIS CAT Depression [43] CSC guests 8 items Moderator Baseline, follow-ups
Alcohol Use 3 AUDIT -10 [47] CSC guests 10 items Moderator Baseline, follow-ups
Substance Use 3 DAST-10 [48] CSC guests 10 items Moderator Baseline, follow-ups
Suicide ideation and attempts 2–3 Columbia Suicide Severity Rating Scale [49] CSC guests 6 items Exploratory Outcome Screen, Baseline, follow-ups
Suicide Resolved Plans and Preparations 3 Suicide Resolved Plans and Preparations subscale of the Suicide Ideation Scale (SIS; [50]) CSC guests 7 items Exploratory Outcome Baseline, follow-ups
Treatment Initiation/Engagement 3 Psychological Problem Area subscale of the Treatment Services Review[51]; EMR chart review CSC guests 8 items Primary Outcome Baseline, follow-ups
Mobile Phone App Engagement 2–3 Demographic information on persons who use app; number of digital impressions per user per activity CSC guests Logged by mobile app Descriptive Throughout trial
Peer Interventions 2–3 Number, type, content focus of peer-led interventions CSC guests Qualitative Descriptive THRIVE Transcripts coded using Consensual Qualitative Analysis
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1.5.5. Fidelity

Fidelity to the THRIVE Intervention will be assessed using the THRIVE fidelity scale developed by the first author. We will rate 25 % of group and phone follow-up calls during the pilot trial. The THRIVE fidelity scale assesses fidelity by measuring study therapists’ “adherence” (i.e., completion of intervention components) and “competence” (i.e., quality of implementation) to the study intervention [28,29]. The items are scored and summed by the fidelity rater to generate summary percentages (0–100 %) of therapist competence and adherence [30]. Study staff will re-train and receive supervision on two sessions if fidelity falls below 75 % during the trial.

1.5.6. Analysis

We will examine descriptive statistics to understand the feasibility, acceptability, and implementation fidelity of THRIVE. For qualitative data collected, we will use the framework method in the context of consensual qualitative analysis to understand peer's interactions with guests in the THRIVE–peer follow-up program and how CSC guests pursue recovery post-discharge [[31], [32], [33]]. Implementation data collected in focus groups and post-survey interviews will be coded using a classical content analysis approach [34] using codes developed from the Consensual Framework for Implementation Research (CFIR; [35]).

1.5.7. Ethical considerations, safety, and withdrawal

Local and national stakeholders participating in this study are healthy volunteers who can work and maintain employment independently. For CSC Guests, THRIVE is provided by licensed mental health counselors and trained peer-support specialists who work within a CSC. Study therapists and peers have experience working with individuals at risk for suicide. Connections Health Solutions is nationally recognized for implementing existing suicide prevention best practices and can follow-up with persons as needed to ensure safety of subjects.

Subjects may be removed from the study without their consent if they appear harmed by participating. If withdrawn, subjects in both conditions can continue care as usual. Subjects will complete a withdrawal form to withdraw from the study.

During the follow-up phase of the study, THRIVE study staff will follow a risk management protocol developed by Holloway, Linehan and Beck, for a study titled “Post Admission Cognitive Therapy (PACT) for the Inpatient Treatment of Military Personnel with Suicidal Behaviors; A Multi-Site Randomized Controlled Trial.” We will follow the sections of this risk management protocol applicable to our study. We have used this protocol effectively in our currently active RCT that follows suicide attempt survivors with phone follow-up for 18 months. A Data Safety Monitoring Board (DSMB) will meet annually to provide oversight and advice.

1.6. Phase III: pilot randomized effectiveness trial to test the effectiveness THRIVE on treatment initiation

1.6.1. Study design

We will conduct a pilot randomized effectiveness clinical trial to assess the effect of THRIVE on rates of treatment initiation. We will also examine the target mechanisms of THRIVE (i.e., thwarted belongingness, perceived burdensomeness) according to the Interpersonal Theory of Suicide [22]. We hypothesize that CSC guests who receive THRIVE + Discharge & Safety Planning as Usual vs. Discharge & Safety Planning as Usual alone will have (a) H1: Higher rates of treatment initiation at 1 month and 3 months from CSC discharge and (b) H2. Increased belongingness and decreased burdensomeness at 1 month and 3 months from discharge. We will explore the effect of the intervention on treatment initiation acute care psychiatric readmissions (number of readmissions to ED, CSC, or inpatient within 3 months), and suicidal ideation and suicidal behavior over the 3-month follow-up period.

1.6.2. Participants and recruitment

Approximately 260 adults from the Connections Health Solutions’ CSC will be assessed for eligibility to randomize 162. The recruitment and consent procedure is the same as described above in Phase II. Individuals who consent are provided a full research assessment battery. Participants then receive Thrive + Discharge & Safety Planning as Usual (i.e., Intervention Arm) or Discharge & Safety Planning as Usual (i.e., Control Arm) according to the pre-set weekly randomization schedule. The inclusion and exclusion criteria above are the same as in Phase 2.

1.6.3. Study conditions

Participants will be randomized to one of two groups (a) Thrive + Discharge & Safety Planning as Usual (i.e., Intervention Arm): or (b) Discharge &Safety Planning as Usual (i.e., Control Arm). The THRIVE interventions are described above (see “Intervention”) and will include adaptations to CSC workflows developed during Phase 1 and examined in Phase 2. The Discharge & Safety Planning as Usual condition includes planning for outpatient care, community linkages, a written safety plan, and one follow-up phone call within 30 days. The safety plan template includes all written elements of the Stanley & Brown Safety Plan.

1.6.4. Randomization

Conditions will be randomized by calendar week (e.g., Tx, Tx, Ctrl, Tx, Ctrl, Ctrl, Tx) prior to the start of the trial. All participants arriving in a given week will be assigned to that week's pre-randomized study condition. Individual random assignment is not feasible in this CSCs' clinical context. Our clinical partners could not offer a group on their unit that only allowed select guests into the group (i.e., those who had been randomized to it).

1.6.5. Blinding

The study PIs are blinded to study conditions and will not participate in data analysis. Research associates will be blind to study conditions during the recruitment, consent, and data collection procedures. Participants are instructed not to communicate their treatment group to staff who complete research assessments. Research assistants will participate in a brief survey to determine if blinding was successful. Provider blinding, which might be compromised if they were aware of the alternating-week assignment, is impossible since providers deliver the group themselves. To address this pragmatic issue, we will collect data on operational factors (e.g., therapist delivering intervention, number of patients on the unit and in group) to include in the analyses.

1.6.6. Assessments

The research assessment battery is provided in Table 1. Measures included in this study have established psychometric properties and have been used previously in suicide research.

1.6.7. Fidelity

Fidelity will be assessed using a THRIVE fidelity scale developed by the first author. We will rate 50 % of group sessions and 20 % of phone sessions throughout the clinical trial. We will determine which sessions to rate using a random number generator in Microsoft Excel. The THRIVE fidelity scale assesses fidelity by measuring key elements of study therapists’ “adherence” (i.e., completion of intervention components) and “competence” (i.e., quality of implementation) to the study intervention [28,29]. The items are scored and summed by the fidelity rater to generate summary percentages (0–100 %) of therapist competence and adherence to the intervention [30]. Fidelity ratings will be provided to study therapists throughout the trial using a brief video with a standardized script. If individual study therapists fall below 75 % fidelity during the trial, they will complete a brief online refresher training and receive direct supervision on their subsequent two THRIVE sessions.

1.6.8. Power analysis

We examined sample sizes necessary to detect the range of effect sizes observed in pilot work (70 %–90 %) initiating treatment in the intervention vs. an expected 40 % in controls; INQ belongingness, Cohen's D of .65–.75) at .80 power with .05 alpha on two-sided tests. The most conservative sample size estimate occurred for .80 power to detect a treatment initiation difference of .70 vs.40 (N = 122 or 61 per group). We also conservatively estimate attrition at roughly 25 %. Thus, a total sample size of 162 will allow us to detect the most conservative effect size estimate, accounting for a conservative attrition rate.

1.6.9. Data analysis

Prior to analysis, we will examine graphical distributions and descriptive statistics. We will examine group balance across demographic and psychological factors and whether imbalanced covariates are also associated with outcomes. We will pay special attention to operational factors and site factors. Imbalanced factors also associated with the outcomes will be included as covariates in models of treatment effects.

For Phase 3, we will test treatment effects on INQ scores at 1 and 3 months using a mixed effects linear regression with a similar model specification, including a random intercept. Mixed models are attractive because they incorporate all repeated measures and provide consistent estimates when missing data depends on observed factors (missing at random). Non-differential attrition across groups, for instance, is easily observable and an informative outcome in and of itself. By contrast, missingness dependent on unobserved factors is difficult to ascertain. To examine this possibility, however, we will conduct a sensitivity analysis estimating treatment effects with a pattern mixture model and compare the results to standard analyses. Finally, while the trial is not powered for or intended to identify treatment moderators given that the early stage of this work, secondary analysis will examine potential theory-based moderators (substance use, history of suicide attempt, suicide ideation/behavior) in an exploratory fashion using the False Discovery Rate. Our goal with these analyses is largely hypothesis generating rather than hypothesis testing. While developing and refining interventions, we have found that it is useful to be cognizant of any patient factors potentially linked to intervention response.

We will use the framework method [31] in the context of consensual qualitative analysis within teams [33,36] to understand peers’ interactions with guests in the post-follow-up calls and how guests define and pursue recovery-based meaningful living post-discharge.

1.6.10. Ethical considerations, Participant withdrawal, and safety monitoring

We will follow the same protocol for participant withdrawal and safety monitoring in our phase 3 randomized clinical effectiveness trial as our phase 2 trial.

2. Discussion

In 2016, the National Action Alliance (NAA) Crisis Services Taskforce identified principles for crisis care and CSCs including embracing recovery, being trauma-informed, providing a role for peers support and specialists, and a focus on community linkage. Yet, existing evidence-based psychological interventions for suicide identified for CSCs by the NAA do not fully incorporate all these principles and are not brief enough to be provided in CSCs. Moreover, implementation factors that can assist in rapid implementation of suicide-specific interventions in CSCs have not yet been identified or studied. The national launch of 988 funding for the CSC expansion provides an opportunity to rapidly build and deploy novel, recovery-focused, suicide-specific psychological interventions that may save lives in community-based settings.

2.1. Trial status

We worked with Connections Health Solutions to complete the MADI refinement process for THRIVE between October 2023 and April 2024. We are currently recruiting for the open trial of THRIVE (aim 2), with sixteen CSC guest participants recruited as of November 18, 2024.

2.2. Protocol strengths and limitations

This study will advance our understanding of treatment science specific to suicide recovery in CSCs. Through engaging our community-based practice partners in research through the MADI process, we anticipate we will test the version of THRIVE in our pilot randomized controlled trial that maximizes capacity for future implementation in CSCs. Including community-based practice partners in intervention refinement and testing is critical to ensuring interventions can be implemented quickly in intended settings [37,38]. Regarding limitations, the generalizability of study outcomes may be limited to individuals who have reliable access to a phone, which is a challenge in conducting research in community-based populations. Use of a single focus heterogeneous group with CSC Stakeholders may introduce the risk of contamination or “group think”, potentially affecting the generalizability of the qualitative data collected. The exclusion of non-English speakers is an additional limitation, and use of an interpreter/translation services to increase diversity in research samples of novel interventions is an important direction for future research. Implementation data collected from national CSC stakeholders may have limited generalizability due to convenience sampling and small sample size.

2.3. Ethics and dissemination plan

This study is co-led by the first and second authors of this paper (i.e., Lockman, Pisani) according to a multiple principal investigator leadership plan. This study was approved by the WCG IRB Board with additional institutional IRBs (i.e., University of Alabama at Birmingham, University of Rochester) submitting reliance agreements to the WCG IRB. All investigators and research staff completed training in human subjects protections training. This study uses a Data Safety Monitoring Board (DSMB), which meets annually, to ensure safety for human subjects. Results from this study will be presented at scientific conferences, published in peer-reviewed academic journals, and disseminated through dissemination briefs that are community practice-partner oriented.

3. Conclusion

This study adapts and tests THRIVE, a novel group and peer-led follow-up intervention for CSCs. THRIVE uses the Interpersonal Theory of Suicide [16] as a framework to bolster social connectedness and counter perceived burdensomeness, coupled with a meaning and social justice oriented recovery focus (Lockman & Servaty-Seib, 2017). THRIVE will be tailored to CSCs’ culture, workflows, and implementation needs through the MADI process to integrate practice-partner feedback and national CSC stakeholder data. This is the first randomized controlled clinical trial of a recovery-oriented group and peer-led follow-up program in CSCs. At the end of the study, THRIVE for CSCs will be ready to test in a fully-powered hybrid effectiveness trial for preventing suicidal behavior.

CRediT authorship contribution statement

Jennifer D. Lockman: Writing – review & editing, Writing – original draft, Project administration, Methodology, Investigation, Formal analysis, Funding acquisition, Conceptualization. Anthony R. Pisani: Writing – review & editing, Project administration, Methodology, Funding acquisition, Conceptualization. M. Alexis Kirk: Writing – review & editing, Writing – original draft, Project administration, Methodology, Funding acquisition, Conceptualization. Kimberly A. Van Orden: Writing – review & editing, Resources, Funding acquisition, Conceptualization. Ian J. Cero: Writing – review & editing, Methodology, Formal analysis. Margaret E. Balfour: Writing – review & editing, Project administration, Methodology, Conceptualization. Kristina Mossgraber: Writing – review & editing, Methodology, Conceptualization. David Jacobowitz: Writing – review & editing, Project administration, Conceptualization. Kenneth R. Conner: Writing – review & editing, Methodology, Funding acquisition, Conceptualization.

Protocol objectives and specific aims

The purpose of this paper is to describe the study protocol for “THRIVE: A Study about Group and Phone Follow-up in Crisis Stabilization Centers.” This study is funded by the National Institute of Mental Health (i.e., NIMH) and was responsive to the Notice of Special Interest NOT-MH-22-10. The objective of the current protocol is to adapt THRIVE to CSCs’ implementation needs and obtain data on its effectiveness. This project consists of three phases. In phase I, we will use the Model for Adaptation Design and Impact (MADI; [19]) to adapt THRIVE to the unique cultures and workflows of CSCs. In phase II, we will conduct a pilot trial of THRIVE while collecting data on the feasibility and acceptability of THRIVE from local and national CSC stakeholders. In phase III, we will test the preliminary effectiveness of THRIVE in a randomized pilot effectiveness trial. Taken together, these three phases will address three study aims: (a) Aim 1: Adapt THRIVE and complete a CSC-specific manual; (b) Aim 2: Test the feasibility, acceptability, and appropriateness of THRIVE for CSCs (c) Aim 3: Complete a randomized pilot effectiveness trial of THRIVE to test the effect of THRIVE on treatment initiation. We will also examine THRIVE target engagement (i.e.,thwarted belongingness, burdensomeness). In Aim 3, we hypothesize that CSC guests who receive THRIVE + Discharge & Safety Planning as Usual vs. Discharge & Safety Planning as Usual alone will have: (a) H1: Higher rates of treatment initiation at 1 and 3 months from CSC discharge and (b) H2: Increased belongingness and burdensomeness at 1 and 3 months after discharge.

Declaration of competing interest

The authors declare the following financial interests/personal relationships which may be considered as potential competing interests:

Dr. Lockman independently owns the intellectual property rights to THRIVE (previously, RELATE), which is licensed to outside entities. She has no financial conflict of interest to disclose.

Dr. Balfour holds equity in Connections Health Solutions, where she is also employed.

National Institutes of Mental Health (R34MH131914-01) supported this work. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Mental Health.

Footnotes

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This study was registered with ClinicalTrials.gov (NCT05637203).

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Dr. Lockman independently owns the intellectual property rights to THRIVE (previously, RELATE), which is licensed to outside entities. She has no financial conflict of interest to disclose.

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Dr. Balfour holds equity in Connections Health Solutions, where she is also employed.

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National Institute of Mental Health (R34MH131914-01) supported this work. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute of Mental Health.

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We would like to thank Bre Banks-Angerer, PhD for editorial assistance in the peer review revision process.

Data availability

No data was used for the research described in the article.

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Data Availability Statement

No data was used for the research described in the article.

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