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Background: Men’s depression, alcohol use, and family problems commonly co-occur to create of cluster of mental health problems. Yet, few treatments exist to address these problems, especially in low and middle-income countries (LMICs). This paper describes the development and initial feasibility and acceptability of a novel task-shifted intervention to address this cluster of men’s mental health problems with a focus on engaging and retaining men in treatment. Methods: The intervention, Learn, Engage, Act, Dedicate (LEAD), is based in behavioral activation blended with motivational interviewing and was pilot tested in Kenya. To develop LEAD, we engaged in a community-engaged multi-step, collaborative process with local Kenyan stakeholders. LEAD was piloted with nine fathers reporting problem drinking. To assess initial feasibility and acceptability, recruitment and participation were tracked and descriptive statistics were generated given engagement of men was key for proof of concept. Semi-structured interviews were conducted with participants and analyzed using thematic content analysis. Results: The development process resulted in a weekly 5-session intervention rooted in behavioral activation, motivational interviewing, and masculinity discussion strategies. These approaches were combined and adapted to fit contextually salient constructs, such as the importance of the man as provider, and streamlined for lay providers. Feasibility and acceptability results were promising with high attendance, acceptability of delivery and intervention content, and perceived intervention helpfulness. Conclusion: Results describe an acceptable task-shifted treatment that may engage men in care and addresses a cluster of common mental health problems among men in ways that consider social determinants like masculinity. Findings set the stage for a larger trial. Trial registration ISRCTN, ISRCTN130380278. Registered 7 October 2019—Retrospectively registered, http://www.isrctn.com/ISRCTN13038027.
Here we describe multi-step, iterative process of treatment development and identification of broad treatment approaches foundational to the resulting intervention [63]. The first goal of the process was to identify any existing EBTs that target the cluster of outcomes (family, alcohol, mood) that were most likely to be feasible and acceptable in the Kenyan context. To this end, we began by analyzing previously collected qualitative data examining family interaction patterns associated with family functioning and child mental health (see [49, 50]). Qualitative results were based on focus group discussions with caregivers, youth, and mental health service providers in the area for a larger study on family functioning and youth mental health in the community. For this study, we focused on the findings related to fathers’ impact on the family system and child mental health. Findings showed two central themes: (1) the importance of gender-specific role fulfillment with the father as provider and (2) the pervasive burden of economic strain on men and family interactions. For fathers, this often led to an expectation to provide for family but an inability to do so. This inability was tied to feelings of purposelessness, idle time, disrespect from family, and conflict with partners. Drinking was often cited as a means to cope with associated difficult emotions, gain relief, and enjoy time with friends. Men’s drinking also seemed drive family conflict, with these fathers more likely to fight with family, act violently, not come home, or spend money on alcohol. Consequences of these behaviors included a lack of basic needs and, in some cases, the partner and child leaving. Data showed cycles of conflict, family problems, and depressive symptoms perpetuating drinking. These results informed our aim to treat depressive symptoms and alcohol use and improve family engagement by targeting these patterns. Next, we aimed to identify evidence-based treatment (EBT) approaches that would form the foundation of the intervention. To do this, we conducted a systematic review of interventions targeting this cluster in LMICs, as well as a review of other evidence-based strategies targeting these outcomes globally [16]. The literature was then evaluated alongside qualitative results to assess the fit of treatment strategies with local needs, context, and amenability to lay provider use. Based on results from this process, we identified the therapeutic approaches that would be core to informing the intervention, described in the following section. Using these, we began developing the specific intervention. We first developed a theory of change to guide our process of combining, sequencing, and adapting the approaches for the context and for lay providers. The result was the first draft of the manual. Using the initial manual draft, we then engaged in the next step—a process of collaborative development with a local team. The local team consisted of our Kenyan co-investigator (Author 2), individuals with mental health backgrounds (university students and community providers), local clinical supervisors, and lay counselors delivering the intervention. The process allowed for adaptations to occur at any point in development to optimize therapeutic strategies and their cultural relevance. After a full review by the two senior clinical psychologists from Kenya and the US, four individuals with undergraduate degrees in medical psychology from Moi University reviewed the manual, taking structured notes on feasibility, acceptability, understandability, and cultural relevance. Following revisions, we continued development by presenting the core intervention concepts, session content, and tools (i.e., worksheets, metaphors) to a group of nine Kenyan individuals with previous counseling experience (eight with a bachelors degree or higher in psychology; all with counseling experience). All concepts and materials were reviewed for acceptability, understandability, and cultural relevance. This led to another round of minor changes to metaphors, visualizations, and explanations. Together, the above reviews led to iterative manual changes and a full revised second version with detailed session outlines. To pilot these, each session was role-played fully with two individuals with undergraduate degrees in medical psychology and previous counseling experiences to examine content flow and complexity, as well as language. During this process, key terms and concepts, such as “urges,” were identified, discussed, and translated for conceptual meaning and understandability. This step led to very specific adjustments and set the stage for full manual translation and the consistent translation of key terms. The full manual was then fully translated by one of the individuals involved in the role-play with experience translating mental health content. Each section was translated in order. After each section was translated, we evaluated comprehensibility and acceptability through discussion. To further revise the Kiswahili manual, the manual concepts were presented, discussed, and role played with lay counselor trainees to confirm conceptual understanding of translations and to ensure that the manual and materials were easy to use. Lastly, the intervention was tested with the first two participants in the pilot study, as described below; process data from session transcripts and selected supervision records were examined from these two cases for an initial assessment of understandability, feasibility, and acceptability prior to finalizing the manual. As described above, we combined our formative qualitative results, findings from our systematic review, and considerations related to lay provider and context delivery to identify evidence-based approaches to guide the development of the intervention. Three promising approaches emerged that matched needs, were parsimonious, had strong evidence, and were adaptable. These were: (1) Motivational Interviewing (MI); (2) Behavioral Activation (BA); and (3) Masculinity Discussion Strategies (MDS). MI and BA were identified as central mechanistic components from which to build a contextually feasible and culturally-congruent intervention. MI functions to increase intrinsic motivation to change and ambivalence about a behavior like drinking or treatment engagement [54]. BA aims to increase client engagement in value-aligned activities to increase positive reinforcement for behaviors inconsistent with drinking and/or depressive symptoms [22]. MDS are strategies used for expanding traditional conceptions of masculinity to include care and nurturance, as well as for exploring fathers’ models and beliefs about family [51]. MI has demonstrated efficacy reducing problem drinking and increasing mental health treatment engagement among men globally [67]. It is client-centered, increasing potential for adaptation with change in part predicated by the clients’ self-identification of values. We then chose to integrate BA given its efficacy reducing depression as well as multiple problems simultaneously, including substance use and depression in a low-resource United States settings [10]. It also uses a parsimonious approach [28], has shown widespread effectiveness across populations, contexts, and providers [7, 30]; and is anchored in personal values that are amenable to adaptation. Lastly, MDS was selected given its promise for improving family outcomes among men in LMICs, such as South Africa, as well as its focus on expanding ideas of ‘what it means to be a man’ given this emerged strongly in formative qualitative analysis [12]. Three existing treatment packages guided development. For MI, these were the mhGAP and the Screening, Brief intervention and Referral to Treatment (SBIRT) guidelines previously used in LMICs [1, 67]. For BA, this was Life Enhancement Treatment for Substance Use (LET’s ACT!); a flexible group treatment developed based on BA for depression to treat co-morbid depression and substance use disorder [11]. LET’s ACT targets the link between mood, use, and behavior by addressing goal-driven, non-drug forms of reinforcement [11]. For MDS, this was Program P: Manual for Engaging Men in Fatherhood, which compiles practices for engaging men in maternal and child health, caregiving, and violence prevention through a gender equity lens [51]. Study activities were conducted in the Rift Valley Province of Kenya—a lower middle income country—in a peri-urban community surrounding the town of Eldoret. Eldoret is the largest town in the Province (population = 400,000), located on a main transportation route, and home to multiple ethnic groups. Historically, Eldoret and surrounding areas have experienced multiple periods of ethnic violence [61]. As in most LMIC settings, Kenya has very few mental health resources with two psychiatrists per 1,000,000 people [68]. All activities were done in collaboration with Moi Teaching and Referral Hospital (MTRH), the academic model providing access to healthcare (AMPATH), which is a consortium that included Moi University, MTRH, the Ministry of Health, and North American Universities. MTRH provides some psychiatric services, including limited inpatient and outpatient care. All procedures were approved by the Institutional Research and Ethics Committee at Duke University and MTRH; these included de-identifying all clinical data and storage on encrypted, password-protected devices. Three lay counselors were selected to deliver the treatment through a multi-stage process described elsewhere (redacted). First, community leaders identified ten men who they perceived to be role models in their communities and to have good listening and leadership skills. Men also were required to be fathers themselves and to have no prior counseling experience. We interviewed the group, invited six to a 10-day training, and made final selections based on training performance, including general counseling skills assessed with the ENhancing Common Therapeutic Factors Scale (ENACT; [27]), understanding of intervention theory and content, effective use of the manual, and receptivity to supervision. We asked six community leaders and the six counselor trainees to refer fathers for treatment, with a target sample of ten participants. Participant eligibility was based on the following: (a) scoring between 8 and 20 on the alcohol use disorder identification test (AUDIT; [2]); responses were summed with higher scores indicating more problematic drinking patterns (α = 0.89) within the past 2 months and excluding those with possible dependence; (b) having a child between the ages of 8 and 17 years; and (c) having a partner willing to participate in assessment of men’s behavior to complement men’s self-report. At this proof-of-concept stage, we did not include depression symptom cut-off scores as part of eligibility as men often underreport or deny depression symptoms. Therefore, we choose to use drinking as the primary eligibility criteria given drinking is more observable and has been conceptualized as a diffuse indicator of mental health problems like depression. Throughout the trial, depression with the Patient Health Questionnaire, validated in Kenya [36, 59] was measured throughout. Supervision followed a tiered approach in which mental health professionals provide consultation to local supervisors who were trained to supervise lay counselors (redacted for review; [38]). For this study, three Kenyan supervisors were selected who had a bachelor’s degree in psychology. Local supervisors consulted with a US-based Masters-level clinical psychology doctoral candidate weekly to review cases and determine next steps. This consultant was in turn was overseen by a Kenyan clinical psychologist (Author 2) and a US clinical psychologist (Author 3) with weekly check-ins. Below are measures and indicators used to assess initial feasibility. Recruitment tracking All steps of the family recruitment process were documented throughout. From the beginning of the process, paper forms documenting recruiter and referee details for each participant were recorded in a database and used to track all referral sources; forms were completed by recruiters with the help of a project research assistant (RA). An RA in Kenya also recorded the number of men contacted, the number enrolled, the number eligible, and the number participating. This information was then entered into the database that was used to populate a data log with these numbers. Reasons for drop out or ineligibility were also recorded. Treatment attendance and exposure Attendance logs were used to track and record participant attendance and attrition. Local supervisors completed logs based on post-session data forms completed by counselors and conversations with counselors. Scheduled sessions that were not attended with no 24 h notice given were considered to be a missed. Treatment exposure was measured by amount of time in each session and overall throughout the course of the treatment. Time exposed was documented using the length of session recordings and was cross-checked against post-session counselor notes on which the session time was recorded in order to account for any difficulties with recorder use. This was done for all participants. Qualitative interviews Semi-structured interviews were conducted with each father. Participants were asked questions about the acceptability of the intervention, including content, materials and counselor, as well as about how helpful they perceived the intervention to be. All interviews lasted approximately one hour and were conducted individually in Kiswahili by trained research assistants not involved in intervention delivery. Interviews were audio-recorded, transcribed verbatim into English, and de-identified prior to analysis. Descriptive statistics were generated for attendance, attrition, and exposure. Qualitative interviews were analyzed using thematic analysis [62]. Two team members identified themes through close readings of transcripts, which were operationalized into a codebook. Two coders coded transcripts independently, double coding and reaching consensus on the first four. After reaching 80% agreement across codes on these transcripts, they were divided between coders, and thematic summaries were written for each to synthesize themes.
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