Future Directions for Community-Engaged Research in Clinical Psychological Science with Youth.

Despite advances in clinical science, the burden of mental health problems among youth is not improving. To tackle this burden, clinical science with youth needs methods that include youth and family perspectives on context and public health. In this paper, we illustrate how community-engaged research (CEnR) methods center these perspectives. Although CEnR methods are well-established in other disciplines (e.g. social work, community psychology), they are underutilized in clinical science with youth. This is due in part to misperceptions of CEnR as resource-intensive, overly contextualized, incompatible with experimentally controlled modes of inquiry, or irrelevant to understanding youth mental health. By contrast, CEnR methods can provide real-world impact, contextualized clinical solutions, and sustainable outcomes. A key advantage of CEnR strategies is their flexibility-they fall across a continuum that centers community engagement as a core principle, and thus can be infused in a variety of research efforts, even those that center experimental control (e.g. randomized controlled trials). This paper provides a brief overview of this continuum of strategies and its application to youth-focused clinical science. We then discuss future directions of CEnR in clinical science with youth, as well as structural changes needed to advance this work. The goals of this paper are to help demystify CEnR and encourage clinical scientists to consider adopting methods that better consider context and intentionally engage the communities that our work seeks to serve.

Should We Trust You? Strategies to Improve Access to Mental Healthcare to BIPOC Communities During the COVID-19 Pandemic.

Black, Indigenous, and People of Color (BIPOC) communities have weathered centuries of racism, causing transgenerational mental health consequences and hindering access to quality treatment. In this commentary, we describe the systemic challenges of engaging BIPOC to promote mental health equity during the COVID-19 pandemic. We then describe an initiative that illustrates these strategies, provide recommendations and further readings for academic institutions seeking to partner with community organizations to provide equitable mental health services to populations that have been traditionally overlooked.

Psychosocial and pharmacologic interventions to reduce harmful alcohol use in low- and middle-income countries.

BACKGROUND: Harmful alcohol use is defined as unhealthy alcohol use that results in adverse physical, psychological, social, or societal consequences and is among the leading risk factors for disease, disability and premature mortality globally. The burden of harmful alcohol use is increasing in low- and middle-income countries (LMICs) and there remains a large unmet need for indicated prevention and treatment interventions to reduce harmful alcohol use in these settings. Evidence regarding which interventions are effective and feasible for addressing harmful and other patterns of unhealthy alcohol use in LMICs is limited, which contributes to this gap in services. OBJECTIVES: To assess the efficacy and safety of psychosocial and pharmacologic treatment and indicated prevention interventions compared with control conditions (wait list, placebo, no treatment, standard care, or active control condition) aimed at reducing harmful alcohol use in LMICs. SEARCH METHODS: We searched for randomized controlled trials (RCTs) indexed in the Cochrane Drugs and Alcohol Group (CDAG) Specialized Register, the Cochrane Clinical Register of Controlled Trials (CENTRAL) in the Cochrane Library, PubMed, Embase, PsycINFO, CINAHL, and the Latin American and Caribbean Health Sciences Literature (LILACS) through 12 December 2021. We searched clinicaltrials.gov, the World Health Organization International Clinical Trials Registry Platform, Web of Science, and Opengrey database to identify unpublished or ongoing studies. We searched the reference lists of included studies and relevant review articles for eligible studies. SELECTION CRITERIA: All RCTs comparing an indicated prevention or treatment intervention (pharmacologic or psychosocial) versus a control condition for people with harmful alcohol use in LMICs were included. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. MAIN RESULTS: We included 66 RCTs with 17,626 participants. Sixty-two of these trials contributed to the meta-analysis. Sixty-three studies were conducted in middle-income countries (MICs), and the remaining three studies were conducted in low-income countries (LICs). Twenty-five trials exclusively enrolled participants with alcohol use disorder. The remaining 51 trials enrolled participants with harmful alcohol use, some of which included both cases of alcohol use disorder and people reporting hazardous alcohol use patterns that did not meet criteria for disorder. Fifty-two RCTs assessed the efficacy of psychosocial interventions; 27 were brief interventions primarily based on motivational interviewing and were compared to brief advice, information, or assessment only. We are uncertain whether a reduction in harmful alcohol use is attributable to brief interventions given the high levels of heterogeneity among included studies (Studies reporting continuous outcomes: Tau² = 0.15, Q =139.64, df =16, P<.001, I² = 89%, 3913 participants, 17 trials, very low certainty; Studies reporting dichotomous outcomes: Tau²=0.18, Q=58.26, df=3, P<.001, I² =95%, 1349 participants, 4 trials, very low certainty). The other types of psychosocial interventions included a range of therapeutic approaches such as behavioral risk reduction, cognitive-behavioral therapy, contingency management, rational emotive therapy, and relapse prevention. These interventions were most commonly compared to usual care involving varying combinations of psychoeducation, counseling, and pharmacotherapy. We are uncertain whether a reduction in harmful alcohol use is attributable to psychosocial treatments due to high levels of heterogeneity among included studies (Heterogeneity: Tau² = 1.15; Q = 444.32, df = 11, P<.001; I²=98%, 2106 participants, 12 trials, very low certainty). Eight trials compared combined pharmacologic and psychosocial interventions with placebo, psychosocial intervention alone, or another pharmacologic treatment. The active pharmacologic study conditions included disulfiram, naltrexone, ondansetron, or topiramate. The psychosocial components of these interventions included counseling, encouragement to attend Alcoholics Anonymous, motivational interviewing, brief cognitive-behavioral therapy, or other psychotherapy (not specified). Analysis of studies comparing a combined pharmacologic and psychosocial intervention to psychosocial intervention alone found that the combined approach may be associated with a greater reduction in harmful alcohol use (standardized mean difference (standardized mean difference (SMD))=-0.43, 95% confidence interval (CI): -0.61 to -0.24; 475 participants; 4 trials; low certainty). Four trials compared pharmacologic intervention alone with placebo and three with another pharmacotherapy. Drugs assessed were: acamprosate, amitriptyline, baclofen disulfiram, gabapentin, mirtazapine, and naltrexone. None of these trials evaluated the primary clinical outcome of interest, harmful alcohol use.   Thirty-one trials reported rates of retention in the intervention. Meta-analyses revealed that rates of retention between study conditions did not differ in any of the comparisons (pharmacologic risk ratio (RR) = 1.13, 95% CI: 0.89 to 1.44, 247 participants, 3 trials, low certainty; pharmacologic in addition to psychosocial intervention: RR = 1.15, 95% CI: 0.95 to 1.40, 363 participants, 3 trials, moderate certainty). Due to high levels of heterogeneity, we did not calculate pooled estimates comparing retention in brief (Heterogeneity: Tau² = 0.00; Q = 172.59, df = 11, P<.001; I2 = 94%; 5380 participants; 12 trials, very low certainty) or other psychosocial interventions (Heterogeneity: Tau² = 0.01; Q = 34.07, df = 8, P<.001; I2 = 77%; 1664 participants; 9 trials, very low certainty). Two pharmacologic trials and three combined pharmacologic and psychosocial trials reported on side effects. These studies found more side effects attributable to amitriptyline relative to mirtazapine, naltrexone and topiramate relative to placebo, yet no differences in side effects between placebo and either acamprosate or ondansetron. Across all intervention types there was substantial risk of bias. Primary threats to validity included lack of blinding and differential/high rates of attrition. AUTHORS' CONCLUSIONS: In LMICs there is low-certainty evidence supporting the efficacy of combined psychosocial and pharmacologic interventions on reducing harmful alcohol use relative to psychosocial interventions alone. There is insufficient evidence to determine the efficacy of pharmacologic or psychosocial interventions on reducing harmful alcohol use largely due to the substantial heterogeneity in outcomes, comparisons, and interventions that precluded pooling of these data in meta-analyses. The majority of studies are brief interventions, primarily among men, and using measures that have not been validated in the target population. Confidence in these results is reduced by the risk of bias and significant heterogeneity among studies as well as the heterogeneity of results on different outcome measures within studies. More evidence on the efficacy of pharmacologic interventions, specific types of psychosocial interventions are needed to increase the certainty of these results.

Feasibility and acceptability of a peer provider delivered substance use screening and brief intervention program for youth in Kenya.

BACKGROUND: Youth in sub-Saharan Africa are at high risk of substance use yet lack access to substance use interventions. The goal of this project was to evaluate the feasibility and acceptability of a peer-delivered, single-session substance use screening and brief intervention program for youth in Kenya. METHODS: This was a convergent parallel mixed methods study utilizing both quantitative and qualitative approaches. Two trained peer providers administered the screening and brief intervention program to 100 youth aged 15-24 years. To evaluate the implementation of the intervention, we collected quantitative and qualitative data. Feasibility and acceptability were quantitatively assessed using the Dissemination and Implementation Measures. Fidelity was assessed by rating all 100 audio-recorded sessions using a checklist. To obtain qualitative feedback on the intervention, we conducted five focus group discussions with 25 youths and six semi-structured interviews with two peer providers and four clinic leaders. The semi-structured interviews were guided by the Consolidated Framework for Implementation Research. Quantitative data was analyzed via descriptive statistics using STATA. Qualitative data was analyzed using thematic analysis with NVIVO. RESULTS: The lifetime prevalence of any substance use was 50%. The mean level of acceptability of the intervention from the perspective of the youth was 3.53 (SD 0.15), meaning that the youth found the intervention to be acceptable "a lot" of the time. Mean levels of implementation outcomes (acceptability, adoption, Acceptability, Appropriateness, Feasibility, Reach/access, Organizational climate, General leadership skills, and Sustainability) as rated by peer providers and clinic staff ranged between 2.61 ("a moderate amount") and 4.0 ("a lot"). In qualitative data, youth reported that the intervention was helpful and useful in enabling them to stop or reduce substance use. The peer providers felt that the intervention was easy to implement, while the clinic leaders felt that available resources were adequate, and that the intervention aligned well with the goals of the clinic. CONCLUSION: Our findings suggest that the peer-delivered screening and brief intervention program was perceived as acceptable to the youth and feasible to implement. TRIAL REGISTRATION: NCT04998045 Registration date: 10/08/2021.

Validating mental health assessment in Kenya using an innovative gold standard.

With the growing burden of mental health disorders worldwide, alongside efforts to expand availability of evidence-based interventions, strategies are needed to ensure accurate identification of individuals suffering from mental disorders. Efforts to locally validate mental health assessments are of particular value, yet gold-standard clinical validation is costly, time-intensive, and reliant on available professionals. This study aimed to validate assessment items for mental distress in Kenya, using an innovative gold standard and a combination of culturally adapted and locally developed items. The mixed-method study drew on surveys and semi-structured interviews, conducted by lay interviewers, with 48 caregivers. Interviews were used to designate mental health "cases" or "non-cases" based on emotional health problems, identified through a collaborative clinical rating process with local input. Individual mental health survey items were evaluated for their ability to discriminate between cases and non-cases. Discriminant survey items included 23 items adapted from existing mental health assessment tools, as well as 6 new items developed for the specific cultural context. When items were combined into a scale, results showed good psychometric properties. The use of clinically rated semi-structured interviews provides a promising alternative gold standard that can help address the challenges of conducting diagnostic clinical validation in low-resource settings.

Navigating grey areas in HIV and mental health implementation science.

INTRODUCTION: Implementation science (IS) offers methods to systematically achieve the Ending the HIV Epidemic goals in the United States, as well as the global UNAIDS targets. Federal funders such as the National Institutes of Mental Health (NIMH) have invested in implementation research to achieve these goals, including supporting the AIDS Research Centres (ARCs), which focus on high-impact science in HIV and mental health (MH). To facilitate capacity building for the HIV/MH research workforce in IS, "grey areas," or areas of IS that are confusing, particularly for new investigators, should be addressed in the context of HIV/MH research. DISCUSSION: A group of IS experts affiliated with NIMH-funded ARCs convened to identify common and challenging grey areas. The group generated a preliminary list of 19 grey areas in HIV/MH-related IS. From the list, the authors developed a survey which was distributed to all ARCs to prioritize grey areas to address in this paper. ARC members across the United States (N = 60) identified priority grey areas requiring clarification. This commentary discusses topics with 40% or more endorsement. The top grey areas that ARC members identified were: (1) Differentiating implementation strategies from interventions; (2) Determining when an intervention has sufficient evidence for adaptation; (3) Integrating recipient perspectives into HIV/MH implementation research; (4) Evaluating whether an implementation strategy is evidence-based; (5) Identifying rigorous approaches for evaluating the impact of implementation strategies in the absence of a control group or randomization; and (6) Addressing innovation in HIV/MH IS grants. The commentary addresses each grey area by drawing from the existing literature (when available), providing expert guidance on addressing each in the context of HIV/MH research, and providing domestic and global HIV and HIV/MH case examples that address these grey areas. CONCLUSIONS: HIV/MH IS is key to achieving domestic and international goals for ending HIV transmission and mitigating its impact. Guidance offered in this paper can help to overcome challenges to rigorous and high-impact HIV/MH implementation research.

Mutual capacity building model for adaptation (MCB-MA): a seven-step procedure bidirectional learning and support during intervention adaptation.

Global health reciprocal innovation emphasizes the movement of technologies or interventions between high- and low-income countries to address a shared public health problem, in contrast to unidirectional models of "development aid" or "reverse innovation". Evidence-based interventions are frequently adapted from the setting in which they were developed and applied in a new setting, presenting an opportunity for learning and partnership across high- and low-income contexts. However, few clear procedures exist to guide researchers and implementers on how to incorporate equitable and learning-oriented approaches into intervention adaptation across settings. We integrated theories from pedagogy, implementation science, and public health with examples from experience adapting behavioral health interventions across diverse settings to develop a procedure for a bidirectional, equitable process of intervention adaptation across high- and low-income contexts. The Mutual capacity building model for adaptation (MCB-MA) is made up of seven steps: 1) Exploring: A dialogue about the scope of the proposed adaptation and situational appraisal in the new setting; 2) Developing a shared vision: Agreeing on common goals for the adaptation; 3) Formalizing: Developing agreements around resource and data sharing; 4) Sharing complementary expertise: Group originating the intervention supporting the adapting group to learn about the intervention and develop adaptations, while gleaning new strategies for intervention implementation from the adapting group; 5) Reciprocal training: Originating and adapting groups collaborate to train the individuals who will be implementing the adapted intervention; 6) Mutual feedback: Originating and adapting groups share data and feedback on the outcomes of the adapted intervention and lessons learned; and 7) Consideration of next steps: Discuss future collaborations. This evidence-informed procedure may provide researchers with specific actions to approach the often ambiguous and challenging task of equitable partnership building. These steps can be used alongside existing intervention adaptation models, which guide the adaptation of the intervention itself.

Global Is Local: Leveraging Global Mental-Health Methods to Promote Equity and Address Disparities in the United States.

Structural barriers perpetuate mental health disparities for minoritized US populations; global mental health (GMH) takes an interdisciplinary approach to increasing mental health care access and relevance. Mutual capacity building partnerships between low and middle-income countries and high-income countries are beginning to use GMH strategies to address disparities across contexts. We highlight these partnerships and shared GMH strategies through a case series of said partnerships between Kenya-North Carolina, South Africa-Maryland, and Mozambique-New York. We analyzed case materials and narrative descriptions using document review. Shared strategies across cases included: qualitative formative work and partnership-building; selecting and adapting evidence-based interventions; prioritizing accessible, feasible delivery; task-sharing; tailoring training and supervision; and mixed-method, hybrid designs. Bidirectional learning between partners improved the use of strategies in both settings. Integrating GMH strategies into clinical science-and facilitating learning across settings-can improve efforts to expand care in ways that consider culture, context, and systems in low-resource settings.

Interventions addressing family violence and mental illness or substance use in low- and middle-income countries: A systematic review.

Most family violence research has been conducted in high-income countries, although family violence rates are higher in low- and middle-income countries (LMICs), and outcomes more severe. Given the strong associations of family violence with substance use and mental illness, the aim of this systematic review was to examine interventions that targeted familial violence and at least one other condition of substance use or mental illness to determine effective treatments in LMICs. We conducted a systematic review of interventions that addressed family violence and mental illness or substance use. A committee of three researchers independently screened titles and abstracts and conducted full-text eligibility assessments. Two researchers conducted a risk of bias assessment. Data were extracted using a structured spreadsheet and narratively synthesized. Our search identified 29 articles produced from 19 studies conducted in 13 LMICs. Most (n = 15) studies randomized to study condition. Lack of blinding was the most common threat. The external validity of studies was generally poor. Fourteen studies had a primary intervention target of family violence, mental health, substance use, economic improvement, or HIV. None of the studies showed improvements in all intervention areas. Child maltreatment was less likely to be addressed than intimate partner violence (IPV). Targeted interventions for substance and mental health mostly improved primary outcomes, although they were less effective in reducing IPV. Evidence-based treatments must be rigorously evaluated before innovations in implementation can occur. Interventions overwhelmingly addressed IPV victimization and should consider how to work with couples and include men and children.

Adapting a substance use screening and brief intervention for peer-delivery and for youth in Kenya.

Background: Substance use is a major problem among youth in sub-Saharan Africa, yet interventions that address this problem are scarce within the region. Screening and brief intervention is a cost-effective, efficacious, and easy to scale public health approach to addressing substance use problems. We conducted a pilot study to evaluate the feasibility of implementing a peer delivered screening and brief intervention program for youth in Kenya. The goal of this paper is to report on the process of adapting the Alcohol Smoking and Substance Involvement Screening Test for Youth- linked Brief Intervention (ASSIST-Y-linked BI) program for peer delivery and for the Kenyan context prior to the pilot. Methods: The adaptation process was led by a multi-disciplinary team comprised of psychiatrists, pediatricians, and psychologists. We utilized the ADAPT-ITT framework to adapt the ASSIST-Y-linked BI. The ADAPT-ITT framework consists of 8 phases including Assessment, Decision making, Adaptation, Production, Topical Experts, Integration, Training, and Testing the evidence-based intervention. Here, we report on phases 1-7 of the framework. The results of the pilot testing have been published elsewhere. Results: Overall, we made surface level adaptations to the ASSIST-Y-linked BI program such as simplifying the language to enhance understandability. We maintained the core components of the program i.e., Feedback, Responsibility, Advice, Menu of Options, Empathy, Self-efficacy (FRAMES). Conclusions: Our paper provides information which other stakeholders planning to implement the ASSIST-Y-linked BI for youth in sub-Saharan Africa, could use to adapt the intervention.

Application of the Expert Recommendations for Implementing Change (ERIC) compilation of strategies to health intervention implementation in low- and middle-income countries: a systematic review.

BACKGROUND: The Expert Recommendations for Implementing Change (ERIC) project developed a compilation of implementation strategies that are intended to standardize reporting and evaluation. Little is known about the application of ERIC in low- and middle-income countries (LMICs). We systematically reviewed the literature on the use and specification of ERIC strategies for health intervention implementation in LMICs to identify gaps and inform future research. METHODS: We searched peer-reviewed articles published through March 2023 in any language that (1) were conducted in an LMIC and (2) cited seminal ERIC articles or (3) mentioned ERIC in the title or abstract. Two co-authors independently screened all titles, abstracts, and full-text articles, then abstracted study, intervention, and implementation strategy characteristics of included studies. RESULTS: The final sample included 60 studies describing research from all world regions, with over 30% published in the final year of our review period. Most studies took place in healthcare settings (n = 52, 86.7%), while 11 (18.2%) took place in community settings and four (6.7%) at the policy level. Across studies, 548 distinct implementation strategies were identified with a median of six strategies (range 1-46 strategies) included in each study. Most studies (n = 32, 53.3%) explicitly matched implementation strategies used for the ERIC compilation. Among those that did, 64 (87.3%) of the 73 ERIC strategies were represented. Many of the strategies not cited included those that target systems- or policy-level barriers. Nearly 85% of strategies included some component of strategy specification, though most only included specification of their action (75.2%), actor (57.3%), and action target (60.8%). A minority of studies employed randomized trials or high-quality quasi-experimental designs; only one study evaluated implementation strategy effectiveness. CONCLUSIONS: While ERIC use in LMICs is rapidly growing, its application has not been consistent nor commonly used to test strategy effectiveness. Research in LMICs must better specify strategies and evaluate their impact on outcomes. Moreover, strategies that are tested need to be better specified, so they may be compared across contexts. Finally, strategies targeting policy-, systems-, and community-level determinants should be further explored. TRIAL REGISTRATION: PROSPERO, CRD42021268374.

Barriers and Facilitators to Father's Engagement in a Depression and Alcohol Use Intervention in Kenya: Father, Family, and Community Factors.

In Kenya, there is a treatment gap for depression and alcohol use that is especially large for fathers, which has consequences for families. While treatments exist, there are challenges to implementation. This study aimed to understand barriers and facilitators to implementing a treatment for fathers' depression and alcohol use in Eldoret, Kenya. Guided by the Consolidated Framework for Implementation Research and the Integrated Sustainability Framework, we conducted 18 key informant interviews and 7 focus group discussions (31 total participants) with stakeholders in Eldoret (hospital leaders, policy makers, mental health providers, community leaders, fathers, lay providers, and patients previously engaged in treatment). Interviews were analyzed using the framework method; themes were matrixed by framework domains. Participants identified barriers and facilitators, and opportunities for implementation, in the following domains: innovation, outer setting, inner setting, individual, sustainability, and characteristics of systems. Barriers included a lack of resources, stigma, masculine norms, cost of services, and alcohol dependence. Facilitators included community buy-in, family support, providers with lived experience, government support, and relevant treatment content. Findings will inform implementation strategy development for an intervention for fathers with depression and alcohol use, and family problems with local relevance and scalable potential.

Examination of the Factor Structure of Psychopathology in a Mozambican Sample.

Factor-analytic studies are needed in global samples to advance understanding of psychopathology. We aimed to examine the structure of psychopathology and a general psychopathology ('p') factor using data from a cross-sectional study of 971 adults (63% women) from Maputo City, Mozambique. We used confirmatory factor analyses of symptoms from 15 psychiatric disorders to test common models of the structure of psychopathology. Models including internalizing, substance use, and thought disorder factors as well as a general p-factor fit the data well. Measurement invariance testing revealed that factor loadings on p differed by gender. Higher levels of p, internalizing, and thought disorder factors were associated with greater suicide risk, psychiatric comorbidity, chronic medical illnesses, and poorer functioning. A general psychopathology ('p') factor and internalizing, substance use, and thought disorder factors are identifiable in this Mozambican sample. Understanding psychopathology dimensions is a step toward building more scalable mental health service approaches globally.

Peer-delivered Problem-solving Therapy for Adolescent Mental Health in Kenya: Adaptation for Context and Training of Peer-counselors.

Peer-delivered interventions for adolescent mental health can help address poor access to mental health interventions. Questions remain about how interventions can be adapted for peer delivery and whether peers can be trained. In this study, we adapted problem solving therapy (PST) for peer-delivery with adolescents in Kenya and explored whether peer counselors can be trained in PST. We adapted treatment prior to and during training using the Cultural Adaptation and Contextualization for Implementation framework. Nine peer counselors (Ages 20-24) were selected and trained over 10 days. Peer competencies and knowledge were measured pre-post using a written exam, a written case study, and role plays rated using a standardized competency measure. We chose a version of PST used in India with secondary school adolescents originally delivered by teachers. All materials were translated into Kiswahili. Language and format were adapted to Kenyan adolescents as well as for delivery by peers with a focus on understandability and relevance (e.g., noting shared experience). Metaphors, examples, and visual materials were adapted for the context to reflect the culture and vernacular of Kenyan youth. Peer counselors were able to be trained in PST. Pre-post competencies and understanding of content showed improvements with peers minimally meeting patient needs (pre) on average to moderate/fully meeting patient needs (post). Post-training written exam score showed an average 90% correct. There is an adapted version of PST for Kenyan adolescents and peer delivery. Peer counselors can be trained to deliver a 5-session PST in a community context.

Learn, Engage, Act, Dedicate (LEAD): development and feasibility testing of a task-shifted intervention to improve alcohol use, depression and family engagement for fathers.

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.

Mechanisms of change for a family intervention in Kenya: An Integrated Clinical and Implementation Mapping approach.

To increase cultural relevance and maximize access for historically underserved populations, there is a need to explore mechanisms underlying treatment outcomes during piloting. We developed a mixed-method approach, Integrated Clinical and Implementation Mapping (ICIM), to explore clinical and implementation mechanisms to inform improvements in content and delivery. We applied ICIM in a pilot of Tuko Pamoja, a lay counselor-delivered family intervention in Kenya (10 families with adolescents ages 12-17). ICIM is a 3-phase process to triangulate data sources to analyze how and why change occurs within individual cases and across cases. We synthesized data from session and supervision transcripts, fidelity and clinical skills ratings, surveys, and interviews. Outputs included a comprehensive narrative and visual map depicting how content and implementation factors influenced change. For Tuko Pamoja, ICIM results showed common presenting problems, including financial strain and caregivers' distress, triggering negative interactions and adolescent distress. ICIM demonstrated that active treatment ingredients included communication skills and facilitated, prescribed time together. Families improved communication, empathy, and hope, facilitated improved family functioning and mental health. Key implementation mechanisms included provider clinical competencies, alliance-building, treatment-aligned adaptations, and consistent attendance. Results guided manual and training refinements and generated hypotheses about mechanisms to test in larger trials.

"When my children see their father is sober, they are happy": A qualitative exploration of family system impacts following men's engagement in an alcohol misuse intervention in peri-urban Kenya.

Background: Men's alcohol misuse does not occur in a vacuum but has a cascade of consequences for families and children, with ties to violence, poor parenting, and poor partner and child mental health. Despite the intersection of individual and interpersonal problems associated with men's alcohol use, studies exploring the impact of men's completion of alcohol misuse treatment on family and family member outcomes are scarce. Here we begin to explore this question. Methods: We conducted qualitative interviews (N = 13) with female partners and children (8-17 years) of men with problem drinking who completed individual treatment targeting alcohol misuse, depressed mood, and family-focused efforts in Eldoret, Kenya. Interviews and thematic content analysis were guided by ecological-transactional systems theory. Results: Findings highlighted positive perceived changes for men, families, women and children that interacted together in a bi-directional pathway. Partners and children described men's reduced drinking, reduced spending, increased family-focused effort (e.g., coming home early), as well as increased emotion regulation, and openness to and communication with family. These changes were tied to perceived improvements in the couple and father-child relationship, including improved trust and time together, which were tied to improvements in women and children's emotional well-being (e.g., hope). Concurrently, reports noted men's increased effort to share money earned with the family which alleviated financial stress and helped ensure basic needs were met. Results aligned with the ecological transactional systems frame, with individuals in the family, family relationships, and economic climate each dynamically shaping each other. Conclusions: Although larger studies are needed, results provide promising signals regarding the potential downstream effects of individual treatment on family systems and members, which may in turn help maintain men's changes in drinking.

Development of the Family Togetherness Scale: A Mixed-Methods Validation Study in Kenya.

Family functioning is an important target of clinical intervention and research given its close ties with mental health outcomes of both children and adults. However, we lack family functioning measures validated for use in many low- and middle-income country (LMIC) settings. In this mixed-methods prospective diagnostic accuracy study, we first used formative qualitative data to develop an extensive battery of screening items to measure family functioning in Kenya. We then recruited 30 Kenyan families (N = 44 adults; 30 youth aged 8-17 years) to complete the questionnaires and participate in clinical interviews conducted by local interviewers. Quantitative and qualitative analyses were then conducted to select a subset of screening items that balanced conceptual understanding of family distress with diagnostic efficiency and accuracy to yield a brief but valid scale. The final index test consisting of 30 items correctly identified distressed families in 89% of cases according to adult-report and 76% of cases according to child-report. The optimal cutoffs are associated with estimates of sensitivity/specificity of 0.88/0.90 and 0.75/0.77 for adult-report and child-report measures, respectively. The final measure-the Family Togetherness Scale (FTS)-assesses global family functioning, including items related to family organization, emotional closeness, and communication/problem-solving. In addition to general items, the scale also includes items explicitly assessing family responses to stressors common in LMIC settings. Results establish a strong rationale for larger-scale validation studies.

Building community-based helping practices by training peer-father counselors: A novel intervention to reduce drinking and depressive symptoms among fathers through an expanded masculinity lens.

BACKGROUND: Problem drinking and co-occurring depression symptoms affect men at high rates and are associated with increased risk of family violence. In low- and middle-income countries, there is a large treatment gap for services due to a lack of human resources. Moreover, masculine norms are a barrier to men seeking treatment for drinking and depression in healthcare settings. We examined an approach for engaging peer-fathers to deliver an intervention to reduce alcohol use, improve depressive symptoms, and increase family involvement among fathers in Kenya with problem drinking. The intervention-LEAD (Learn, Engage, Act, Dedicate)-combines motivational interviewing, behavioral activation, and masculinity discussion strategies. METHODS: Community and religious leaders nominated fathers with no mental health training to serve as counselors (N=12); clients were recruited through community referrals. Nominated fathers completed a 10-day training beginning with treatment principles followed by manualized content. Three counselors were selected after training based on quantitative and qualitative assessments of communication skills, intervention knowledge, willingness to learn, ability to use feedback, and empathy. Supervision was tiered with local supervisors and clinical psychologist consultation. During LEAD delivery, counselor fidelity, delivery quality, and general and intervention-specific competencies were assessed. To evaluate acceptability, qualitative interviews were conducted with lay-counselors and clients (N=11). Descriptive statistics were calculated for quantitative outcomes; interviews were analyzed using thematic analysis. RESULTS: Peer-father lay counselors treated nine clients, with eight completing treatment. Counselors reached high rates of fidelity (93.8%) and high to optimal ratings on quality of delivery, clinical competency, and intervention-specific competencies. Qualitative results suggested high acceptability, with counselors expressing satisfaction and empowerment in their roles. Clients likewise described positive experiences with counselors. CONCLUSIONS: Findings provide initial support for the acceptability and feasibility of recruitment, selection, and training processes for peer-father lay counselors to deliver LEAD through a lens of masculinity that aligned with clients help-acceptance practices.