A Stakeholder-Engaged Process for Adapting an Evidence-Based Intervention for Posttraumatic Stress Disorder for Peer Delivery

Abstract

Purpose

Peer providers represent a growing sector of the U.S. workforce, yet guidance is needed on best practices for adapting behavioral health interventions for peer delivery.

Methods

We utilized the Framework for Reporting Adaptations and Modifications to Evidence-based interventions (FRAME; Wiltsey Stirman et al. 2013, 2019) to describe how we systematically adapted Skills Training in Affective and Interpersonal Regulation (STAIR) for posttraumatic stress disorder (PTSD) for peer delivery. Our process was iterative and relied on engagement of multiple stakeholders, including a work group of organizational leaders (N = 5), peer interventionists (N = 4), intervention experts (N = 2), and trial participants (N = 18). The FRAME was used to guide rapid coding across multiple data sources, including researcher field notes, meeting minutes, and intervention manual documents, and content analysis of semi-structured interviews with peer interventionists and trial participants.

Results

Phase 1 (pre-trial) focused on modifications for fit with the local context and peer model. Key modifications focused on improving intervention design and packaging, removing clinical and stigmatizing language, and addressing peer interventionist training gaps. We used a hybrid approach to delivery, whereby we integrated peer model principles (self-disclosure, mutuality) into a directive approach. Phase 2 (trial) included reactive fidelity-consistent adaptations, such as additional educational resources. Phase 3 (post-trial) focused on adaptations to support roll-out of the intervention at the peer organization (e.g., group format).

Conclusion

Our stakeholder-engaged process may serve as a helpful exemplar to others tailoring interventions for peer delivery. Future research is needed to understand the role of stakeholder engagement and adaptation in implementation success.

Introduction

Access to behavioral health services in the U.S. is limited, with less than half of those with needs receiving any treatment (Substance Abuse & Mental Health Services Administration [SAMHSA], 2019). This gap in care is even wider for low-resourced settings and among marginalized or underserved populations in the U.S., including communities of color, and those experiencing low income, housing insecurity, or substance use (Hahm et al., 2015; Santiago et al., 2013). Despite challenges with access, efficacious and short-term evidence-based interventions (EBIs) have been developed for common mental health disorders including anxiety, depressive, and traumatic stress conditions. EBIs lead to improvements in 50% to 70% of those who receive services (Hofmann et al., 2012; Nathan & Gorman, 2015). However, these treatments are typically developed and tested in highly controlled settings, such as research clinics, and often lack scientific support for effectiveness in community or routine care clinics (Karlin & Cross, 2014), where most individuals in need of behavioral health interventions present for services (Beck et al., 2019; Russell, 2010). Thus, increasing the availability of EBIs in low-resourced settings is needed to improve treatment access.

Strategies proposed to close the gap in care include tailoring EBIs to be delivered by a wider range of interventionists, including peer specialists (paraprofessionals who use their lived experience to support and deliver interventions within a community; Barnett et al., 2018; O’Connell et al., 2017). Benefits of expanding EBI delivery to peers include increasing access to care by easing shortages in mental health professionals in resource-constricted settings (National Council Medical Director Institute, 2017; Puschner et al., 2019). Peer-delivered EBIs may also be cost effective (Chapin et al., 2013; Sledge et al., 2011; Trachtenberg et al., 2013). Yet, peer delivered mental health care continues to be under utilized. Although peer-delivered interventions have demonstrated effectiveness in many low- and middle-income countries (e.g., Ahmad et al., 2020) and are a common practice in substance use programs in the U.S. (Eddie et al., 2019; MacArthur et al., 2016), this mode of care delivery has only recently gained momentum in programs for common mental health disorders in the U.S. (Barnett et al., 2018).

Research has shown that peer providers are capable of learning and delivering behavioral health interventions effectively despite unsubstantiated concerns around their ability to adhere to interventions with fidelity (Chinman et al., 2008; Cook et al., 2012). Further, individuals suffering from behavioral health conditions often prefer care delivered by peers (Kelly et al., 2020; Magidson et al., 2019). One reason for this preference may include mistrust of medical professionals based on negative prior experiences including direct experiences of enacted discrimination and historical mistreatment by medical staff (Kaltman et al., 2014; Valentine et al., 2016). Therefore, the use of peer-delivered EBIs may not only help expand availability of services by increasing the behavioral health workforce, but may also improve engagement and satisfaction with care.

There is a large research gap in processes and best practices for adapting existing EBIs for peer delivery in the U.S. Adapting intervention to balance fidelity to the treatment and flexibility in the new context is key to successful implementation of interventions, included those delivered by peers (Chambers & Norton, 2016; Chambers et al., 2013; Kendall & Frank, 2018; La Bash et al., 2019). Interventions that are carefully adapted to a new context, population, or provider group tend to be more effective (Forehand et al., 2010; Hall et al., 2016; Huey et al., 2014). However, research on adaptation and implementation frameworks seldom report the specific modifications applied to interventions (Escoffery et al., 2018; Shelton et al., 2018). Thorough frameworks reporting on specific modifications are warranted to (a) improve the efficiency of adaptations; and (b) standardize reporting on the process and content of various types of adaptation so that these can be studied empirically (Baumann et al., 2014). One such model is the Framework for Reporting Adaptations and Modifications to EBIs (FRAME; Wiltsey Stirman et al., 2013, 2019). The FRAME encapsulates both modification content and processes (i.e., when and how alterations occurred) and works well to capture the dynamic process of implementing an intervention in a new context, for a new population, for a new provider group, or all three.

Recent research also highlights the importance of stakeholder engagement in the adaptation process. Stakeholder engagement increases the relevance of research, the adoption of interventions in routine practice, and trust within research-community partnerships (Concannon et al., 2014). However, empirical support has lagged behind due to lack of standardization and operationalization of stakeholder engagement. Data that do exist suggest that stakeholder engagement has a positive impact on implementation and effectiveness outcomes (e.g., Boaz et al., 2018; Concannon et al., 2014; Harvey et al., 2011; Jolibert & Wessenlink, 2012). As such, cultivating reciprocal relationships between researchers and stakeholders may be key to reducing the science-to-practice gap and improving patient access and outcomes.

The present study serves to exemplify how the FRAME may be applied to characterize the systematic adaptation of a cognitive behavioral therapy for PTSD for peer-delivery, specifically Skills Training in Affective and Interpersonal Regulation (STAIR) adapted for Primary Care (STAIR-PC). We aim to report on the process and nature of modifications at various stages of an implementation-effectiveness trial (Smith et al., 2020). Our method of adaptation centers on engaging stakeholders, including the intervention developers of STAIR-PC, a community working group made up of organizational leadership from the participating organization, peer specialist providers from the organization, and trial participants all of whom were equal partners through community-based participatory research (Boaz et al., 2018). Our approach aimed to balance fidelity to the original intervention and empirical literature for EBIs with flexibility in the new setting and provider type. We characterize modifications and our decision-making process, which relied on consensus building and careful integration of stakeholder feedback and the best available empirical research.

Methods

Study Setting

In 2017, our research team partnered with a peer-led service organization overseen by the Department of Psychiatry of a large safety-net hospital in the Northeastern U.S. This peer-led organization serves adults living with behavioral health problems by providing individual and group support (including general support and coping skills groups), planning low-cost social activities, and spearheading public health initiatives to destigmatize behavioral health problems.

Selected Intervention

Leaders within the peer-led organization served on a community working group (CWG), who, in conjunction with the research team, selected STAIR-PC as the optimal intervention for their peer specialists to learn and deliver. STAIR is shown to be effective (Cloitre et al., 2002, 2010) in safety-net settings (Trappler & Newville, 2007), when adapted for primary care settings (Cloitre et al., 2016; Jain et al., 2020), and when delivered by non-specialists (MacIntosh et al., 2016).

STAIR-PC is an abbreviated 5-session intervention that integrates PTSD psychoeducation and coping skills to help clients (1) tolerate, understand, and process emotions, particularly those related to past trauma; (2) identify and challenge negative thoughts and beliefs related to past trauma; and (3) understand and change behavior in accordance with their own values. The intervention emphasizes functional improvement, and does not include recounting or exposure to the trauma memory. The first session of STAIR-PC introduces content on the impact of trauma on emotion regulation and relationships, an overview of skills to be covered by the program, and exercises of goal setting and focused breathing. The second session focuses on coping with strong physical sensations for emotion regulation, including exercises such as soothing the senses. The third session centers on examining and altering negative thoughts and the fourth on adaptive behaviors that aid with improved emotion regulation. The last session covers self-compassion, improving relationships, and a plan for continued skill practice following the end of the intervention (Cloitre et al., 2016; Jain et al., 2020).

Participants

We collected feedback at multiple time points across four groups of participating stakeholders: a CWG (N = 5 organizational leaders), intervention developers (N = 2), peer specialist providers who delivered the intervention as part of the trial (N = 4), and trial participants who received the intervention (N = 18). Table 1 provides detail on each of these groups, including roles, timeline for engagement, and summary of data collection, analysis, and integration methods.

Table 1.

Overview of stakeholder groups and data collection, analysis, and integration methods

	N	Role	Data Sources (Phase 1, 2, 3)	Analysis and Integration
Community Working Group (CWG)- Team of executive leadership for the affiliated peer-led organization	5	Intervention selection, pre-trial tailoring of intervention to peer delivery, nomination of peers interventionists, oversight of trial	Detailed Meeting Notes (5 meetings: Phase 1,3) Document Review (Phase 1)	Rapid coding procedurea Itemized list of modifications
Intervention Developers- Psychologists who developed the intervention and training materials	2	Oversight and involvement in adaptation process to retain core components, training and consultation support to researchers	Detailed Meeting Notes (3 meetings: Phase 1,3) Document Review (Phase 1,3)	Rapid coding procedurea Itemized list of modifications
Certified Peer Specialists- Persons with lived experiences of substance use or mental health who were employed by the hospital	4	Study interventionists, post-trial tailoring of intervention for peer delivery in usual care and to meet the needs of participants	Semi-structured individual interviews (Phase 1,3) Consultation Meeting Notes (37 meetings: Phase 2) Focus group. Skill ranking sheets (Phase 3) Fidelity feedback sheets (Phase 2)	Directed content analysisb Rapid coding procedurea Frequencies/descriptives of rankings Itemized list of modifications (proactive and reactive)
Participants- Persons with clinically elevated PTSD symptoms	18	Trial participants, post-trial tailoring of intervention for roll-out in usual care	Semi-structured individual interviews (Phase 1,3)	Directed content analysisb

Phase 1 = pre-trial; Phase 2 = trial; Phase 3 = post-trial

^aNeal et al., 2015.

^b Hseih & Shannon, 2005

Community Working Group (CWG)

The CWG consisted of five members of the executive leadership team who oversee training of and service delivery by peer specialists in the participating peer-led organization. Four of the five members held supervisory roles but had previously worked as peers. The fifth member is a psychiatric nurse who served in an administrative role within the organization and had a leadership role within the hospital administration team. No personal information was collected on demographic characteristics of the CWG members.

Intervention Developers

Dr. Marylene Cloitre, STAIR-PC intervention developer, and Dr. Christie Jackson, director of the STAIR training institute, communicated with the researchers at various phases, pre- and post- trial, to ensure that core components and essential skills that they identified as such were retained as part of the intervention.

Interventionists

Peer interventionists (N = 4) were recommended by the CWG and participated in STAIR-PC training and consultation. All peer interventionists had completed a peer specialist certification program conducted by the partner peer-led organization. In addition, they received a five-hour in-person training on STAIR-PC with both didactic and experiential components and weekly consultation with the PI (SEV). Peer interventionists reported no current difficulties with behavioral health but endorsed previous experiences with substance use or mental health problems; all reported at least one potentially traumatic event. They completed the Life-Events Checklist (LEC-5; Weathers et al., 2013) and noted exposure to an average of 5 types of traumas (range of 4 to 6). The most commonly endorsed trauma was physical assault followed by natural disasters, transportation accidents, unwanted sexual experiences, life threatening illness or injury, and sudden violent death of a close one. Peer interventionists had not undergone STAIR-PC but may have received services at the partner peer-led organization in the past. They predominantly identified as men (n = 3; 75.0%) and White (n = 3; 75.0%) and had a mean age of 64.25 years (SD = 8.06). Two peer interventionists had graduate-level education and the other two attended some college but did not receive a degree. None of the peers were practicing therapists. They each delivered STAIR-PC to a minimum of three trial participants (for further details on the characteristics of peer interventionists, see Smith et al., 2020).

Trial Participants

Participants (N = 18) were recruited through study flyers at the peer-led partner organization and other community-based organizations in the area. The most frequently self-reported diagnoses assigned by a past provider were depression (n = 14), trauma-related (n = 11), and anxiety (n = 10) disorders. Eight participants reported being diagnosed with severe mental illness in the past. No diagnoses were assigned as part of this trial given the culture of the peer-led organization under which diagnoses were seen as stigmatizing. However, the LEC-5 was administered to identify potentially traumatic events that participants may have faced. Participants most frequently endorsed physical assault, sexual assault and unwanted sexual experiences, assault with a weapon, and transportation accidents. Participants identified predominantly as women (n = 12; 66.7%) and Black/African American (n = 8; 44.4%) with a mean age of 51.11 (SD = 9.80) (for further details on the characteristics of trial participants, see Smith et al., 2020).

Procedures

The current paper reports on findings from a process evaluation of data from a hybrid implementation-effectiveness pilot trial of a peer delivered intervention for PTSD. We focus centrally on findings and process details from our systematic and iterative approach to adaptation. Trial methods and primary implementation and clinical outcomes of the trial are published elsewhere (Smith et al., 2020).

Integration of feedback from the four stakeholder groups occurred over three phases: (1) pre-trial (Phase 1) in which the intervention was selected and revised based on input from the CWG, and in which intervention developers approved changes, made additional recommendations based on CWG’s feedback, and adapted the training in conjunction with the research team; (2) trial (Phase 2), in which consultation meeting notes with peer specialists and review of session audio characterized unplanned changes (reactive modifications) to the intervention and its implementation; and (3) post-trial (Phase 3), in which the manual and program implementation design were further revised based on peer specialist feedback from interviews and meeting notes, trial participant feedback from interviews, CWG feedback from meeting notes, and intervention developer feedback (documented in meeting notes).

Adaptation Process

The adaptation process was based on consensus among the stakeholder groups. Adaptations were suggested by the CWG pre- and post-trial and by peer interventionists and trial participants post-trial. In addition, STAIR-PC components were identified as essential by intervention developer, Dr. Marylene Cloitre and director of the STAIR training institute, Dr. Christie Jackson. Consensus between the CWG, intervention developers, and the scope of work proposed to the study funder were prioritized in Phase 1 and 2. In Phase 3, consensus between CWG, peer interventionists, and trial participants were prioritized for adaptations that would benefit the future roll out of STAIR-PC at the partner peer-led organization. In addition, intervention developers were consulted in Phase 3 as a final check to fidelity to core components. Researchers also weighed the extant literature on evidence-based practices to make decisions regarding recommended changes. For example, retaining homework despite reported issues with homework assignment and completion (e.g., Kazantzis et al., 2016).

Collaborative Decision-Making

We leveraged shared decision-making approaches to turn raw feedback from stakeholders into actual adaptations (whether they be implemented or proposed) across all phases. The research team completed the following steps to reach collaborative decisions: (1) consolidated feedback into discrete adaptations, and (2) presented adaptations to the intervention developers for approval.

Data Collection & Analysis

“Data,” as defined in the current report, refers to the itemized adaptations based on the FRAME or revisions made to the intervention manual or implementation design. Data sources for characterizing adaptations made for peer delivery include notes and recordings from meetings with CWG, intervention developers, and peer specialist providers; semi-structured interviews with peer specialist providers and trial participants; and direct comparison of manual and training materials by version. Meetings were conducted by the principal investigator (SEV), a woman clinical psychologist with extensive training in PTSD interventions, and interviews were conducted by the principal investigator (SEV) and research assistant (AMS), a non-binary person with a bachelor of science degree in psychology. See Table 1 for details on data sources by participant group and phase.

Meeting Notes and Recordings

We had four one- to two-hour meetings with the CWG in the pre-trial phase (Phase 1) of adaptation, wherein the CWG assisted with (1) intervention selection, (2) intervention modifications, and (3) the nomination of certified peer specialists to serve as interventionists. The meetings were audio recorded and study staff took detailed meeting minutes. One final meeting was held after the trial (Phase 3), during which study staff took detailed notes. The CWG also provided oversight during trial implementation (Phase 2) although no in-person meetings were held because no issues or concerns arose during the trial. We held two phone meetings with intervention developers, once before the trial (Phase 1) and once again at the end of the trial (Phase 3). Our meeting with intervention developers prior to the trial (Phase 1) focused on presenting CWG recommendations regarding revisions to the manual, program implementation design, and provider training. We held one meeting with intervention developers after the trial (Phase 3) to present additional adaptations to the manual and program implementation. In both meetings, intervention developers were responsible for ensuring that no changes were made to essential components of the intervention. These meetings were two hours in length and were not recorded, although study staff took detailed notes.

Group consultation meetings with peer specialist providers, conducted by the study PI, were held 1 hour per week throughout the trial (Phase 2), to monitor adherence and competence, as well as provide near real-time feedback, in line with fidelity-oriented approaches (Wiltsey Stirman et al., 2019). Study staff took detailed notes at these meetings of all modifications recommended and approved by the study PI. Details on our approach to fidelity monitoring, training, and consultation are published elsewhere (Valentine et al., in press).

A final two-hour focus group style meeting (“Study Closing Meeting”) with all peer specialist providers was held post-trial (Phase 3) in order to (1) present trial results to providers, (2) gain feedback on the skills and content that should be included in the next manual version, and (3) ask what adaptations were needed to implement in peer-led settings. Study staff took detailed notes during this meeting, and providers filled out a sheet wherein they ranked the skills in each session by order of usefulness and usability.

Interviews

Semi-structured interviews were conducted with peer specialist providers and trial participants pre- and post-trial. Interviews were audio-recorded and transcribed. After transcription, we conducted directed content analysis of the interviews guided by the Consolidated Framework for Implementation Research (CFIR; Damschroder et al., 2009). For this paper, we present the subset of relevant and novel findings that informed post-trial manual adaptations (Phase 3). Post-trial interviews consisted of open-ended questions on the views of peer specialists and trial participants toward the benefits or harms of the intervention, their overall satisfaction, and suggestions for improving the intervention, including which skills participants found most/least helpful. Interviews were transcribed, deidentified, and checked for accuracy by study staff.

Peer Specialist Provider Interviews.

Interviews with peer specialist providers were 30 min to one hour in length. Relevant questions, guided by CFIR, asked about the fit of the intervention and program to peer-led services facilitated at our partner organization, usability of the manual, relevance and usefulness of the content and skills to trial participants, and what would be needed to implement the program within the peer-led service organization. Some example questions included: (1) “What kinds of changes or alterations do you think you will need to make to the intervention so it will work effectively in your setting?”; (2) “What is your perception of the quality of the supporting materials, packaging, and bundling of the intervention for implementation?”; and (3) “How confident are you that you will be able to use the intervention?”.

Trial Participant Interviews.

Trial participant interviews were up to 30 min in length. Relevant questions asked about skill usefulness and usability, what the participant liked or did not like about the program, and whether there was anything they would change. Some example questions include: “Is there anything that you would change about the ‘STAIR Program’?” and “Would you recommend the program to a friend? Why or why not?”.

Document Review

Intervention manuals and training slides were reviewed and compared by phase to itemize and confirm adaptations were completed at each step. The STAIR-PC manual includes a session checklist and guide (provider-facing), as well as session materials (i.e., psychoeducation handouts, emotion-thought-behavior worksheets, handouts describing coping skills, and a tool to track skill practice between sessions). To ensure that all modifications were captured, study staff examined and compared each version of the manual and training materials by Phase, and assigned codes guided by the FRAME.

Qualitative Coding

Two types of qualitative data analyses took place as part of this study. First, rapid coding (Neal et al., 2015) was conducted utilizing directed content analysis (Hsieh & Shannon, 2005) for themes from the FRAME. Sources of data for rapid coding, as outlined above, included notes and/or recordings from meetings with CWG, meetings with intervention developers, weekly consultations with peer specialist providers on intervention delivery, and a post-trial focus group with peer interventionists. Additionally, document review and rapid coding included training slides, iterations of the intervention manual by phase, and skill ranking sheets filled out by peer interventionists at the end of treatment. Lastly, interviews from peer interventionists and trial participants (n = 36) were coded with directed content analyses guided by CFIR by two study staff that met regularly and discussed areas of mismatch as well as created new codes as needed. Study staff continued this process until saturation was reached (at n = 10 [5 baseline and 5 postintervention interviews]). In addition, they double coded 8 interviews at which point they achieved an interrater reliability rate above 80% (M = 93.2%). NVivo 12 (QSR International, 2018) was utilized for qualitative data management.

Data Integration

In the current report, “data integration” refers to two distinct processes: (1) collaborative decision-making on implementing adaptations (i.e., how the study team relayed feedback between stakeholder groups to negotiate approval for certain adaptations while holding off on others), and (2) retroactive presentation of adaptation details and process (i.e., how we consolidate our findings as phase-based adaptation summaries and the FRAME-based itemized adaptation lists).

Presentation of Findings

Phase-based Adaptation Summaries

Rapid coding of meeting notes and content analysis of interviews, confirmed with document review of manual and training slides, informed creation of adaptation summaries, which were sorted by phase. We sorted adaptations by three phases: Phase 1 (pre-trial), Phase 2 (trial), and Phase 3 (post-trial). Phase 3 reflects adaptations recommended for program roll-out across our partner organization. Summaries of each phase of adaptations are presented in Table 2.

Table 2.

Overview of research aims and activities by phase

	Phase 1 (Pre-Trial)	Phase 2 (Trial)	Phase 3 (Post-Trial)
Duration:	9 Months	10 Months	5 Months
Focus:	Learn about local context Select intervention and interventionists Tailor intervention to meet peer delivery model	Monitor fidelity and track modifications in real-time Characterize proactive and reactive modifications Characterize fidelity-consistent and – inconsistent modifications	Gather input across various stakeholders regarding need for further adaptation Further tailor intervention to meet peer delivery model, with considerations for usual care roll-out
Coordination:	CWG ensures cultural validity Intervention developers ensure scientific and conceptual validity Researchers serve as bridge between stakeholder groups, and negotiate finalized manual	CWG and intervention developers provide oversight through ongoing meetings and written updates on study progress Real-time modifications are discussed with peer interventionists in consultation	All stakeholder groups provide feedback at this stage, based on presentation of trial data or based on their lived experience of having delivered or received the intervention (summative evaluation) Researchers integrate data and work with CWG and Intervention developers to prepare intervention for community rollout

CWG Community working group

FRAME-Based Itemization

We used the FRAME (Wiltsey Stirman et al., 2013, 2019) to guide rapid coding procedures (to field notes and document review; Neal et al., 2015) and directed content analysis (for interview data; Hseih & Shannon, 2005) across all phases and data sources. We applied a team-based and consensus approach to coding (Patton, 2014). All adaptation codes were reviewed by the principal investigator (SEV), a postdoctoral fellow (AAA), and a bachelor-level research assistant (AMS) and discussed until consensus was reached. An undergraduate research assistant involved during the trial conducted an additional review of fidelity-monitoring documents to code unplanned adaptations from Phase 2 by consensus with principal investigator (SEV) and bachelor-level research assistant (AMS).

Findings

We describe our adaptation process for the STAIR-PC intervention sequentially as it unfolded over time, with a focus on our data-driven and stakeholder engagement decision making. The content and rationale for changes across phases differed, based on adaptation goals and in response to organization, provider, and program recipient needs. We additionally explain our decision-making process, which was informed by multiple stakeholder perspectives. We have organized our main finding according to the FRAME and have provided narrative summaries in text. A full itemized list of FRAME features by phase can be found in Table 3.

Table 3.

Changes made to intervention according to the FRAME model by phase

Process	Phase
	1	2	3
WHEN did modifications occur?
Pre-implementation/planning/ pilot	x	x	x
Were adaptations planned?
Planned/proactive (proactive adaptation)	x		x
Planned/reactive (reactive adaptation)		x
WHO participated in decision to modify?
Program leader	x		x
Program manager	x		x
Intervention developer/purveyor	x		x
Researcher	x	x	x
Individual practitioners (those who deliver it)		x	x
Recipients			x
Researcher made the ultimate decision?	x		x
WHAT is modified?
Content	x	x	x
Contextual	x		x
Training and Evaluation	x		x
At what LEVEL OF DELIVERY (for whom/what is the modification made)?
Individual		x
Target intervention group	x		x
Individual practitioner(s)	x		x
Organization	x		x
Contextual modifications are made to which of the following?
Format			x
Setting			x
Personnel	x
What is the NATURE of the content modification?
Tailoring/tweaking/refining	x		x
Changes in packaging or materials	x		x
Adding elements		x	x
Removing/skipping elements	x	x	x
Shortening/condensing (pacing/timing)	x	x	x
Lengthening/extending (pacing/timing)		x
Reordering of intervention modules or segments	x	x	x
Spreading (breaking up session content over multiple sessions)		x	x
Integrating another treatment into EBP		x
Repeating elements or modules		x
Loosening structure			x
Departing from the intervention (“drift”) followed by a return to protocol within the encounter		x
Drift from protocol without returning		x
Relationship fidelity/core elements?
Fidelity Consistent/Core elements or functions preserved	x		x
Reasons	Phase
	1	2	3
What was the goal?
Increase reach or engagement			x
Improve feasibility	x		x
Improve fit with recipients	x		x
To address cultural factors	x
Sociopolitical
Existing Policies			x
Existing Regulations			x
Historical Context			x
Organizational/Setting
Available Resources (funds, staffing, technology, space)			x
Service structure			x
Location/accessibility			x
Regulatory/compliance			x
Billing constraints			x
Social context (culture, climate, leadership support)	x
Provider
Previous Training and Skills	x	x	x
Preferences	x	x	x
Clinical Judgement		x
Cultural norms, competency	x		x
Recipient
Race; Ethnicity	x
Access to resources	x
Cognitive capacity	x		x
Literacy and education level	x		x
Comorbidity/Multimorbidity			x
Motivation and readiness	x
Mental health stigma*	x

Phase 1 = pre-pilot changes made between researcher, community working group (CWG) and intervention developer; Phase 2 = pilot trial; Phase 3 = post-trial changes based on input from the CWG, interventionists, and trial participants

^*Added to the FRAME list by our team

Pre-trial Adaptations, Phase 1

Community Working Group Input

The first phase consisted of planning and proactive adaptations prior to the start of the pilot of STAIR-PC delivered by peer interventionists. Goals of the first phase were to improve feasibility of peer delivery of STAIR-PC, and tailor the intervention to fit the peer model and to fit the population served by peer programming (i.e., housing-insecure, disabled, and suffering from comorbid severe mental illness). The main recommended modifications in the first phase based on CWG input were in the following three areas of the FRAME model: content, context, and training and evaluation.

Content Modifications.

No modifications were made to core components of STAIR-PC intervention, but several surface level changes were applied. The CWG suggested making some exercises optional (e.g., one of the three exercises aimed at examining thoughts) to reduce the amount of content in each session; however, specifics were decided in consultation with intervention experts. First, several changes were made to STAIR-PC’s “design quality and packaging” (i.e., presentation of intervention elements; Damschroder et al., 2009). The manual was tailored to be more user friendly for both peer providers and trial participants who would receive care. For peer providers, a section of “Tips” was added to the therapist guides and handouts with scripted language to fill in training gaps and explain psychological concepts, especially those unique to cognitive behavioral therapy approaches. Similarly, we added scripts (e.g., overview of session content and agenda) or simplified existing ones for guided mindfulness exercises (e.g., focused breathing, progressive muscle relaxation, self-compassion meditation). Also, outlines of session content with time anchors were added to intervention materials to support adherence. A Mobile App icon was placed by activities in the manual with a corresponding component on the STAIR Coach App (2017). The app was originally developed by the Veterans Health Administration (VHA). Peer specialists could use mobile exercises in session or encourage trial participants to use them outside of sessions. Finally, content was removed from STAIR-PC for VHA that was specific to Veterans, and was replaced with language fitting our intended recipients.

Second, STAIR-PC language and content was tailored for our target intervention group. For example, the CWG noted that some clinical terms had the potential to be perceived as stigmatizing, so we revised the following: (1) from “unhealthy/maladaptive” to “ineffective” coping; (2) “treatment” with “program”; (3) from skill titled “Time out” to “Take a break.” Similarly, all gendered language was removed and replaced with gender neutral terms. We removed references to “therapist” or “client” as peers were not comfortable with these titles. Instead, we referenced care providers as “peer specialists” and clients as “persons served” or “trial participants,” but we note that this language continued to evolve over course of the study across various phases. Next, we revised language throughout the manual to ensure that text was no higher than seventh grade reading level and we simplified several forms (i.e., feelings monitoring form, goal setting forms, compassion worksheet, and self-compassion meditation) to include informal and colloquial language that would be more appealing to the both peer interventionists and trial participants. The last sets of edits we made in the first phase based on CWG meetings were to tailor intervention examples to our target population. Specifically, we added activities that were low or no cost to the pleasant events exercise, and exercises that would be feasible in a homeless shelter or residential facility to the soothing senses exercise.

Contextual Modifications.

Several changes were made for overall style of intervention delivery in the first phase. For example, changes were made to intervention delivery based on the organizational culture. The CWG expressed strong preferences against the use of the diagnosis-based clinical model of care, instead favoring a peer approach that promotes reciprocal, mutual, and nondirective delivery styles. In response, we shifted the intervention to a hybrid approach, which integrates some aspects of the peer approach into the traditional cognitive behavioral therapy delivery style. This included text revisions to the manual and alterations to trainings and consultation style for peer specialists. General principles that guided revisions included: (1) reducing language that implied power differentials between peer interventionists and recipients; (2) shifting terms from a clinical to a wellness frame; (3) delivering care through a conversational style, such as psychoeducation that starts with eliciting knowledge from trial participants prior to providing information; and (4) skillfully integrating peer interventionists’ own lived experiences into psychoeducation, skills training, and skills practice. Lastly, the CWG encouraged the use of the VHA developed STAIR Coach App (2017) as a helpful tool for increasing “mutuality” in our hybrid approach. The rationale for increased mutuality was that both peers and participants practiced the therapeutic exercises together in session in real-time. Overall, these changes aimed to decrease the interventionist’s power and increase trial participant engagement as we cultivated a balance between “peer” and traditional cognitive behavioral therapy approaches.

The CWG also weighed in on the process of recruiting peer interventionists and trial participants, and identifying the preferred setting for service delivery. Peer specilists were selected through a nomination process developed by the CWG and the research team. CWG members invited peer specialists who they believed had the highest likelihood of delivering the intervention skillfully (i.e., with fidelity and flexibility) to participate. As for the setting for service delivery, the CWG advocated against the peer organization space for this phase of the research study due to concerns about professionals entering the protected peer-only spaces (via training and consultation activities). As a result, a research setting was elected for care delivery. Similarly, CWG members understandably opposed internal screenings at their organization for study referral. Instead, we relied on word-of-mouth channels whereby peers and CWG members handed out study flyers in peer support groups and during community outreach activities. Those interested contacted study staff directly via phone and completed a brief phone screen and baseline visit that assessed for study eligibility (see Smith et al., 2020 for full details).

Lastly, the CWG recommended that the intervention be delivered in a group format that is aligned with typical peer-led services. This change was not implemented because it would dramatically shift the scope and aims of the funded project, and this flexibility was not possible (i.e., group delivery would lead to administration of the intervention only once by each peer specialist; as opposed to 3 or more times via individual format). We agreed to consider this as potential next step, post-trial.

Training and Evaluation Modifications.

The next set of modifications were in the area of training and evaluation of intervention outcomes. No changes were made to training at this phase based on the CWG’s feedback but several changes were made to the evaluation plan. Specifically, we altered language in study measures to be consistent with intervention materials (e.g., “peer specialist,” “trial participant”). At the CWG’ s request, we added a measure on psychological abuse exposure as the group hypothesized that psychological abuse would be common and may influence intervention response.

The research team reduced trial participant burden with the CWG’s help by noting which measures should be removed or shortened. At the CWG’s suggestion, we piloted the administration of measures with someone from the target population to ensure completion within 60 min. CWG agreed with computer administration as the best method to gather sensitive information, but encouraged us to develop a contingency plan for clients that may need modifications based on computer and reading literacy (i.e., interview style administration). Lastly, the CWG helped the research team by identifying areas where sensitivity was crucial to rapport between peer interventionists and researchers. The CWG was satisfied with how these concerns were addressed in the informed consent.

Intervention Developer Input

We presented CWG feedback to the intervention developers to gather their input on how to improve peer delivery for STAIR-PC and enhance its fit for recipients. STAIR-PC intervention developer, Dr. Marylene Cloitre, and director of the STAIR training institute, Dr. Christie Jackson, ensured that modifications retained the core components of the intervention.

Content Modifications.

As with the CWG, core components of STAIR-PC remained unchanged (i.e., coping skills for CBT that include cognitive, affective, and behavioral strategies). However, the number of skills and exercises within each session were reduced by specifying several of them as optional, including progressive muscle relaxation, opposite action skill, and self-compassion meditation. We also removed two exercises that were deemed nonessential and overly complex (i.e., Compassion Worksheet; and merged Old and New Habits worksheet into a new Accomplishments worksheet). In addition, several changes were made to “design quality and packaging” of STAIR-PC during this part of the first phase. Manual changes were made to Sessions 4 and 5, to ensure that content focused on relationships and on behavior skills could be adequately covered in a 50-min session. Specifically, two relationship-focused handouts were moved from Session 4 to Session 5. Optional tools remained in the manual, but would be briefly summarized as a “menu” from which participants could select—this allowed us to retain core content while allowing peers and participants to select the best tools for that individual. We added more scripted psychoeducation to teach concepts such as “I-messages,” review of intervention progress, and facilitate termination.

During this phase, intervention developers approved content changes proposed by the CWG which included: (a) additional scripted content and “Tips”; (b) revisions for parsimony, literacy, and target population fit; (c) flow and format; (d) replacement of clinical language with terms suggested by the CWG; (e) simplification of goal setting and homework tracking handouts; and (f) selection of skills deemed optional (non-essential).

Training Modifications.

Changes were also made to training materials and the consultation approach based on feedback from intervention developers. Overall, training was revised to fit peer interventionists training needs and a non-clinical care delivery model. For example, STAIR-PC training was tailored to emphasize the resilience framework of the intervention (e.g., fostering increased skills in managing emotions and relationships instead of symptom reduction). In addition, information was included on the burden of trauma and discrimination in the target population, including the effects of race- and ethnicity- and disability-based discrimination with explicit linkage to mental health disparities (including PTSD). As for training materials, empirical support and academic content was rephrased for a lay audience and content was revised to reflect manual modifications of skills. In addition, we introduced the STAIR Coach App (2017) for relevant skills during the training.

Phase 2 (Pilot Phase)

During the pilot trial, no proactive adaptations were made to the intervention. This phase consisted of peer specialists delivering STAIR-PC in an individual format. The research team monitored for ad hoc (reactive) alterations made by peer specialist and categorized them as consistent or inconsistent with fidelity during delivery of STAIR-PC. For the purposes of this paper, fidelity-consistent was defined as modifications that retain core elements of the intervention, adherence to the protocol, and do not introduce foreign elements from other treatments whereas fidelity-inconsistent modifications were defined as the opposite, meaning alterations that changed core elements of the intervention, and/or muddled differences between interventions (Marques et al. 2019; Wiltsey Stirman et al., 2015). Feedback was provided on alterations and cases on a weekly basis through audio review and consultation for the duration of the pilot phase. Thus, fidelity-inconsistent modifications to STAIR-PC were reviewed in consultation to improve fidelity. Such modifications usually did not include elements from other interventions (as may be the case with community clinicians) but focused mostly on leaving out content or exercises due to difficulties with time management or with taking on a more directive role. As such, fidelity-inconsistent modifications were associated to concerns about trial participants receiving an adequate dosage of core intervention components (see, Valentine et al., in press).

In addition, several reactive modifications were made during this phase that were fidelity-consistent. These reactive changes included the addition of domestic violence psychoeducation and resources based on apparent need for these materials when peers were delivering care. These reactive modifications fell under the umbrella of content modifications in the FRAME model. The research team and intervention developers considered these additions fidelity-consistent because STAIR-PC focuses on trauma’s impact on relationships and behaviors, which includes the higher likelihood of interpersonal violence in relationships for those with a history of trauma. Thus, introducing psychoeducation about relationships and behaviors related to interpersonal violence and encouraging more adaptive behaviors was aligned with the core principles of the intervention.

Phase 3 (Post-trial)

Following the feasibility pilot, a third round of adaptations were made or recommended for roll-out at the organization based on feedback from a post-trial CWG meeting, peer consultation meetings, interviews with peer specialist and interviews with trial participants who received the intervention, and a post-trial meeting with the intervention developers. Changes made in Phase 3 were planned and proactive (for a future roll-out) and fell in the following three FRAME model categories: “content,” “context,” and “training and evaluation”.

Content Modifications

In the third phase of modifications to the intervention content, we did not make changes to core components of STAIR-PC (i.e., cognitive, affective, and behavioral strategies). However, the number of skills in the intervention was pared down based on feedback from peer interventionists, trial participants, trial group consultation with the PI (SEV), and a post-trial meeting with the intervention developers. As a result, opposite action and slow down skills were removed and intervention developers agreed to this change. In addition, some exercises or worksheets removed in Phase 1 were added back or revised based on Phase 3 feedback. For example, we added simplified versions of the compassion worksheet and goal-setting worksheet, provided by the intervention developers. Next, we addressed “design quality and packaging” (as we had in prior phases). Overall, providers reported that the manual was highly usable and relevant to trial participants, but indicated specific places that needed more scripted language (e.g., feelings monitoring form, feelings wheel), which we developed and added after the trial. In addition, session content was reduced to fit into 45-min sessions, allowing a 15 min “buffer” to complete the session within 60 min. This decision was also made given peer specialists’ interviews and researcher field notes that pointed to challenges in fitting session content into a group format (see context modifications below), which may take longer to cover material.

Trial participants recommended expanding the program by adding sessions and a 5-min debriefing exercise after each session, and by creating an additional “more advanced” course based off of the program. We prioritized modifications that supported roll-out at the organization, and did not extend or add content per trial participant feedback given that the intervention was largely effective in its current form. We hypothesize that trial participants wanted more content because they were highly satisfied, but our preliminary clinical outcome data (Smith et al., 2020) indicate that longer intervention may not be warranted.

Next, decisions were made based on peer-specialist feedback (e.g., interviews, skills ratings) and researcher field notes for skills that were deemed nonessential in an effort to shorten sessions and increase STAIR-PC’s flexibility to address trial participants’ needs. For example, in-session review of the lengthy “Relationship Guidelines” handout was made optional (although participants were still provided the handout to review outside of session) and participants were given the option to choose one of three body tools (self-care health plan v. soothing the senses tool v. progressive muscle relaxation exercise).

The presentation of skills was also tailored in Phase 3. Skills were condensed or combined to shorten session length and integrate concepts. Changes included: (1) shortening focused breathing script; (2) merging of two emotion psychoeducation handouts; (3) combining handouts for cognitive distortions and thinking styles; (4) updating the pleasant activities exercise to include positive imagery exercises; and (5) condensing meditation scripts. We again reorganized skills within sessions based on most-to-least essential (from consensus across stakeholders, approved by intervention experts).

Next, researcher field notes informed minor changes to worksheet and skill names to increase clarity (e.g., changed “Three Channels Emotion Regulation Tools” title to “Emotion Regulation Tools”). These changes were made based on a combination of researcher field notes, developer revisions, and peer feedback. Lastly, peer interventionists suggested that language in the manual could be further tweaked to meet literacy and educational background of trial participants. This change has not been implemented yet, but is planned for the roll-out.

Contextual Modifications

We identified several recommended contextual modifications. A suggestion from peer and participant interviews was to add a week between intervention sessions and to embed extended skill practice in-session for participants rather than independent homework. Providers also suggested that assigning written homework (i.e., tracking tool, feelings monitoring form) may pose challenges for the population served. In addition, interviews with peers and feedback from the CWG (corroborated by researcher field notes) suggested that a guided skill practice rather than independent homework approach may be more feasible for roll-out of the intervention and more in line with the peer approach. We chose not to make changes to the 5-session intervention, but would recommend that the organization might host “study halls” or similar drop-in peer support focused on skills practice between sessions as needed. In addition, a group format was adopted for rollout because it fits well with the organization culture and was recommended in peer interventionist and trial participant interviews as well as in post-trial CWG feedback, although peer and participants noted that the one-on-one delivery mode was beneficial for rapport building and increasing engagement in trial participant. Interviews with peer interventionists and trial participants as well as feedback from the post-trial meeting with the CWG suggest that STAIR-PC could be implemented within peer spaces. Lastly, interviews with peers and trial participants (corroborated by researcher field notes) suggest that the program could be utilized as a first-step intervention, or an introduction to therapy, that may facilitate access to and engagement in more intensive interventions as needed.

Training and Evaluation Modifications

A set of changes were identified for training and evaluation of the intervention. In the post-trial CWG meeting, members confirmed that a train-the-trainer model of STAIR-PC (e.g., peer experts train other peers) might be needed for sustainability. The CWG also identified the need for a professional-led training booster to maintain provider skill level, competency, and adherence to the intervention program. Similarly, peer-run consultation, (e.g., peer-experts leading supervision) was seen positively by CWG but not peers who reported a preference for professional-facilitated consultation. Peers also noted concerns about the feasibility and acceptability of receiving consultation from professional clinicians in peer physical spaces. Lastly, trial participants reported in interviews that they found PCL-5 and PTSD symptom assessment helpful in reviewing progress each week, but peer providers indicated difficulty explaining and reviewing PTSD symptom assessment (per research field notes). We did not initially train peers in the PCL-5, because of the non-clinical approach to the program (per CWG input), but we now understand that these are important for peer- and self-management interventions to monitor progress. We course-corrected during the trial by providing training on the PCL in consultation, but think that symptom tracking should be integrated into the peer adapted intervention (even in cases where organizations are hesitant to gather symptom information from program participants).

Discussion

The current paper describes our adaptation process for the STAIR-PC intervention sequentially as it unfolded over time, with a focus on our data-driven and stakeholder engagement decision-making. We also present how modification types differed across phases, based on adaptation goals and in response to organization, interventionist, and program recipient needs, and rationales for key decisions. Our adaptation process was systematic and aimed to balance fidelity (i.e., to the original intervention, empirical literature for psychological interventions) and flexibility (i.e., to peer delivery, stakeholder engagement). We applied a rapid coding procedure across multiple data sources to specify adaptations based on the FRAME.

Results from this study outlined both the process and content of adaptations. In summary, prior to pilot testing, the research team formed a CWG group that provided recommendations based on the local organizational context for selecting and tailoring an intervention for peer delivery. Then, researchers coordinated with intervention developers to maintain fidelity while adapting the intervention. Pre-trial changes consisted of improving intervention “design and packaging” for peer delivery, removing clinical and stigmatizing language, amending existing examples to the targeted intervention population, enhancing mutual delivery for a hybrid peer-specialist style, and revising training materials to fit peer provider needs. During the pilot trial, limited reactive adaptations were undertaken that maintained fidelity to the intervention and provided needed additional information, such as resources and psychological education for intimate partner violence. Also, weekly feedback was given to peer specialists on fidelity-inconsistent adaptations that they made when delivering care. Lastly, a third round of adaptations were made for future implementation of integrating the intervention into the peer organization. These changes consisted of: reducing the number of skills, 45-min sessions, group format for STAIR-PC in line with setting practices, and continued peer-to-peer consultation. Ideally, a professional expert trainer would provide consultation to peer supervisors until supervision competency was attained.

This study extends the literature in implementation science by describing the application of the FRAME model to characterize iterative stakeholder-engaged adaptations of STAIR-PC, which may be useful for real-world applications of EBIs. Other implementation frameworks tend to focus on content adaptations through a series of linear steps and do not typically address the iterative nature of EBI adaptations and pilot testing (Glasgow & Chambers, 2012; Miller et al., 2020; Nilsen, 2015). We describe a systematic approach to the adaptation process and decision points for each phase as well as how various stages impacted one another, which only a handful of other studies have done, to our knowledge (Baumann et al., 2014; Glasgow et al., 2020; La Bash et al., 2019; Miller et al., 2020). For example, Glasgow et al. (2020) used an implementation framework (RE-AIM) in an iterative manner to support the implementation of health services related to coronary disease in the VHA. They found the iterative use of RE-AIM, use of mixed-methods and a rapid and collaborative adaptation process was feasible and acceptable. Baumann et al. (2014) found that an iterative process worked well but was long and cumbersome while conducting cultural adaptations for an intervention on parent management training in Mexico. Similar to our findings, these studies reported on the benefits of iterative adaptations across phases. However, more research is needed to determine essential aspects of and optimal timing for iterative adaptations, including methods for shortening the process.

In addition, we have provided data on decision points and detailed key aspects of the process for EBI adaptations through stakeholder engagement and community-based participatory research. By explicating the involvement of multiple stakeholders across multiple time points, and utilizing the research team to incorporate feedback from each group reciprocally, we have outlined how to thoroughly engage stakeholder groups with the process of adaptation at each stage while strengthening both community and professional partnerships. Prior research has established the utility of stakeholder engagement (Concannon et al., 2014; Wallerstein & Duran, 2010), but little is typically reported about the degree to which stakeholders are engaged in research activities (Bowen et al., 2017; Byrne, 2019). Also, research is sparse on stakeholder engagement for groups other than patients and clinicians, and prior studies have predominantly focused on engaging stakeholders once during the adaptation process instead of throughout it (Concannon et al., 2014).

We attempted to close the gap in this area by thoroughly detailing the intensity of stakeholder engagement throughout our process of adaptation, and hope the current study serves as a model for how research teams can promote research partnerships with community and professional stakeholders through the intense engagement of stakeholders we used to adapt the intervention. The degree to which we considered and thoughtfully integrated stakeholder feedback resulted in stronger partnerships with the peer-led organization, peer interventionists, community members, and intervention developers, which may facilitate sustainment of the intervention and future evaluation in community settings. Moreover, community stakeholder engagement in our study likely shaped our resulting intervention to be more culturally and community valid and, in the future, may facilitate implementation success upon roll-out. However, we did not directly test the impact of stakeholder engagement on implementation or trial participant outcomes. More research is needed to directly test the impact of stakeholder engaged adaptations on implementation and clinical outcomes (Bowen et al., 2017; Byrne, 2019).

Stakeholder engagement may be particularly aligned with adaptation for peer-delivered interventions, as it highlights the reciprocity and mutuality highly valued in the peer model. Moreover, professionals in clinical and research settings may find intensive stakeholder engagement conducive to the development and reparation of partnerships with peer communities that often initially mistrust the intentions of clinicians and researchers based on past negative experiences and history of mistreatment (Kaltman et al., 2014; Valentine et al., 2016). By relying on stakeholder-engagement and community partnerships, the current study extends the literature by providing some key modifications that may be particularly relevant to adapting manualized behavioral health interventions for peer delivery.

Given that EBIs may be just as effective when delivered by peers (Pitt et al., 2013), understanding how to adapt interventions for peer delivery is particularly important. Research in the U.S. for adapting EBIs for peer delivery is limited but much has been published in low- and middle-income countries for peers and lay counselors (Raviola et al., 2019; Sikander et al., 2015; Sorsdahl et al., 2015). In the U.S., a study similar to ours examined the early stages of adaptation for behavioral activation delivered by peers in a community setting for individuals with high rates of substance use (Satinsky et al., 2020), where they describe adaptations to support intervention fit with target population, such as the promotion of low or no-cost activities, inclusion of case management content, and supplemental resources for medication assisted treatment for opioid use disorder. Participants in this study expressed a strong preference for peer-delivery of the EBI (Satinsky et al., 2020). We, notably, made similar adaptations to the behavioral activation component of our EBI.

Limitations

The process we undertook was labor intensive and likely not feasible for most adaptation or implementation trials; however, we think that some of the core concepts that were identified may help reduce the burden in future adaptation research by streamlining processes for stakeholder-engaged work (e.g., tailoring language, literacy level, condensing materials, improving design and packaging). Findings from this study should be understood within their limitations. First, we did not quantify reactive adaptations that occurred during the trial due to the resource intense nature of such work. Future studies on adaptations should identify and list both planned and reactive adaptations thoroughly. Second, like many implementation trials, we lacked randomized comparison of adaptation strategies to determine which ones would be most effective. Therefore, we cannot determine with certainty that any one adaptation strategy or combination of strategies led to successful implementations outcomes or participant improvement. Also, we lacked data on how feasible and acceptable each adaptation was. Instead, the project generated a breadth of adaptations relevant for peer delivery that may provide context for future research that singles out individual adaptations. Similarly, research on the effectiveness of stakeholder engagement is very limited and we cannot determine its importance in the process of adaption or for implementation and participant outcomes. Even though we highlight our study as an example of high stakeholder engagement, we cannot draw strong conclusions about its impact on our outcomes at this stage of the research endeavor. Future research that compares high and low levels of stakeholder engagement through controlled trials is sorely needed.

Implications and Future Directions

Despite the intensive adaptation process, the strategies and strengths of our study may be useful to others undertaking the work of closing the science-to-practice gap. For example, we found our CWG meetings—which were highly structured and involved detailed presentations of information related to the intervention, the trial, and research protocol—to be highly productive. Such structure allowed for direct feedback in response to our prepared materials from members of the CWG and set clear priorities from the beginning. Other studies have used less structured meetings, which rely on the CWG to generate content, concerns, and concepts for the researchers to address (Concannon et al., 2014; Vayachuta et al., 2019). This strategy may be less productive when the CWG are not well-versed with intervention adaptation and trial management. Similarly, we note the benefit of clearly defined roles for each stakeholder group, as well as articulated goals and deliverables for each stage, which can facilitate the execution of the study and improve project management.

Conclusion

We have presented a systematic process of stakeholder-engaged adaptations to a brief cognitive behavioral intervention for PTSD. We strongly believe that stakeholder involvement is necessary for implementation and sustainability of program, yet there are limited articles to provide detailed guidance on exactly how and when to engaged stakeholders in the process. We think our approach of engaging stakeholders early and often was quite fruitful, and hope that future research may be able to examine the role of stakeholder engagement on implementation success and intervention effectiveness. Descriptions of the process and key findings regarding how the focus of adaptation efforts evolved over the course of a multi-phase study may serve as a helpful exemplar to others aiming to integrate peers as interventionists.