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Abstract Background Most children with developmental disabilities (DD) live in low- and middle-income countries, but access to services is limited, impacting their ability to thrive. Pilot study findings of the World Health Organization’s Caregiver Skills Training (WHO CST) intervention, which equips caregivers with strategies to facilitate learning and adaptive behaviours in children with DD, are promising but evidence from an appropriately powered trial delivered by non-specialist facilitators is lacking. This study will investigate the effectiveness and the resource impacts and costs and consequences of the WHO CST intervention in four sites in rural and urban Kenya and Ethiopia. Methods This is a 2-arm multi-site hybrid type-1 effectiveness implementation cluster randomised controlled superiority trial. After baseline assessments (T0) are completed by participants in clusters comprising 7 to 10 caregiver-child dyads, the clusters will be randomised to either the WHO CST intervention arm or a waitlist enhanced care as usual control arm. Further assessments will be completed at endpoint (T1, 18 ± 2 weeks after randomisation) and follow-up (T2, 44 ± 2 weeks after randomisation). The intervention comprises three individualised home visits and nine group sessions with trained non-specialist facilitators. Participants in the control arm will receive the intervention after completing follow-up assessments. We aim to recruit 544 child-caregiver dyads, evenly distributed across the two arms and countries. The co-primary outcomes are the child-focused Child Behavior Checklist (assessing emotional and behavioural problems) and the caregiver-focused Pediatric Quality of Life Inventory (assessing caregiver quality of life), both assessed at endpoint. Secondary outcome measures comprise the two co-primary outcomes at follow-up and ten additional outcome measures at endpoint, assessing stigma-based experiences, depressive symptoms, household food insecurity, child disciplinary strategies and beliefs, CST knowledge and skill competencies, caregiver and child quality of life, social support, and children’s communication modes and functions. After quantitative follow-up assessments are completed, a mixed-methods evaluation approach will be used to investigate implementation processes and acceptability, feasibility, and potential sustainability of the intervention. Discussion The study’s findings will provide evidence of the effectiveness and resource impacts and costs and consequences of a non-specialist-delivered intervention in under-resourced contexts in one low-income and one middle-income country in East Africa. Findings will inform future research, intervention, and policy efforts to support children with DD and their families in under-resourced majority world contexts. Trial registration Pan African Clinical Trial Registry PACTR202310908063134. Registered on October 16, 2023.

Summary: Background: Subthreshold depression is a risk factor for major depression and is associated with increased morbidity and mortality, especially in older adults. There is emerging evidence that digital interventions, including self-help interventions, may reduce depressive symptoms. We aimed to evaluate the effectiveness of a mobile messaging intervention at reducing subthreshold depressive symptoms among older adults in Brazil. Methods: PRODIGITAL was a single blind, two-arm, individually randomised controlled trial conducted in 46 primary care clinics in the city of Guarulhos, Brazil. Individuals aged 60+ years were contacted by phone following a randomly ordered list for a screening assessment. Those who presented with anhedonia and/or depressed mood (Patient Health Questionnaire (PHQ)-2≥1), and who subsequently scored between 5 and 9 on the PHQ-9 were invited to participate. The intervention arm received the ‘Viva Vida’ digital self-help intervention consisting of automated multi-media messages sent via WhatsApp. Forty-eight audio and visual messages based on psychoeducation and behavioural activation were automatically delivered over six weeks. The control arm received a single message containing information about depression. The primary outcome was the difference in mean PHQ-9 scores between treatment arms at the three-month follow-up. All primary analyses were performed according to allocated arm with imputed data. The trial is registered with ReBEC, RBR-6c7ghfd. Findings: Participants were recruited between 8 September 2021 and 19 August 2022. Of the 454 participants enrolled, 223 were randomised to the intervention arm, 231 to the control arm. Participants’ mean age was 65.3 years (SD 5.0) and 64.0% (n = 292) were female. A total of 385 (84.8%) completed the three-month follow-up assessment; no difference in mean PHQ-9 scores between the treatment arms was observed (adjusted difference: −0.61; 95% CI: −1.75, 0.53; p = 0.29). Interpretation: These results demonstrate that the Viva Vida digital self-help intervention did not help to improve subthreshold depressive symptoms amongst older adults. Further research is needed to understand why this self-help intervention was not effective in this population, and to explore how it might be adapted to achieve this goal. Funding: São Paulo Research Foundation and UK Joint Global Health Trials.

Abstract Background The Ethiopian Primary Healthcare Clinical Guidelines (EPHCG) seek to improve quality of primary health care, while also expanding access to care for people with Non-Communicable Diseases and Mental Health Conditions (NCDs/MHCs). The aim of this study was to identify barriers and enablers to implementation of the EPHCG with a particular focus on NCDs/MHCs. Methods A mixed-methods convergent-parallel design was employed after EPHCG implementation in 18 health facilities in southern Ethiopia. Semi-structured interviews were conducted with 10 primary healthcare clinicians and one healthcare administrator. Organisational Readiness for Implementing Change (ORIC) questionnaire was self-completed by 124 health workers and analysed using Kruskal Wallis ranked test to investigate median score differences. Qualitative data were mapped to the Consolidated Framework for Implementation Science (CFIR) and the Theoretical Domains Framework (TDF). Expert Recommendations for Implementing Change (ERIC) were employed to select implementation strategies to address barriers. Results Four domains were identified: EPHCG training and implementation, awareness and meeting patient needs (demand side), resource constraints/barriers (supply side) and care pathway bottlenecks. The innovative facility-based training to implement EPHCG had a mixed response, especially in busy facilities where teams reported struggling to find protected time to meet. Key barriers to implementation of EPHCG were non-availability of resources (CFIR inner setting), such as laboratory reagents and medications that undermined efforts to follow guideline-based care, the way care was structured and lack of familiarity with providing care for people with NCDs-MHCs. Substantial barriers arose because of socio-economic problems that were interlinked with health but not addressable within the health system (CFIR outer setting). Other factors influencing effective implementation of EPHCG (TDF) included low population awareness about NCDs/MHCs and unaffordable diagnostic and treatment services (TDF). Implementation strategies were identified. ORIC findings indicated high scores of organisational readiness to implement the desired change with likely social desirability bias. Conclusion Although perceived as necessary, practical implementation of EPHCG was constrained by challenges across domains of internal/external determinants. This was especially marked in relation to expansion of care responsibilities to include NCDs/MHCs. Attention to social determinants of health outcomes, community engagement and awareness-raising are needed to maximize population impact.

Objective: To ascertain whether sociodemographic and health-related characteristics known from previous research to have a substantive impact on recovery from depression modified the effect of a digital intervention designed to improve depressive symptoms (CONEMO). Methods: The CONEMO study consisted of two randomized controlled trials, one conducted in Lima, Peru, and one in São Paulo, Brazil. As a secondary trial plan analysis, mixed logistic regression was used to explore interactions between the treatment arm and subgroups of interest defined by characteristics measured before randomization – suicidal ideation, race/color, age, gender, income, type of mobile phone, alcohol misuse, tobacco use, and diabetes/hypertension – in both trials. We estimated interaction effects between the treatment group and these subgroup factors for the secondary outcomes using linear mixed regression models. Results: Increased effects of the CONEMO intervention on the primary outcome (reduction of at least 50% in depressive symptom scores at 3-month follow-up) were observed among older and wealthier participants in the Lima trial (p = 0.030 and p = 0.001, respectively). Conclusion: There was no evidence of such differential effects in São Paulo, and no evidence of impact of any other secondary outcomes in either trial. Clinical trial registration: NCT02846662 (São Paulo, Brazil – SP), NCT03026426 (Lima, Peru – LI). Funded by the U.S. National Institute of Mental Health (grant U19MH098780).

Psychological interventions have demonstrated effectiveness in treating perinatal depression (PND), but understanding for whom, how and under what conditions they improve symptoms in low- and middle-income countries (LMICs) is largely unknown. This review aims to synthesise current knowledge about predictors, moderators and mediators of psychological therapies to treat PND in LMICs. Five databases were searched for studies quantitatively examining the effects of at least one mediator, moderator or predictor of therapies for PND in LMICs. The review sampled seven publications evaluating findings from randomised trials conducted in Asia and sub-Saharan Africa. The small number of included studies limited generalisability of findings. Analyses of trials with acceptable quality suggest that patient activation in Pakistan and social support in both India and Pakistan may mediate psychotherapy effectiveness, higher baseline depression severity may moderate treatment response in South Africa, and shorter depression duration at baseline may moderate intervention response in India. This review highlights current gaps in evidence quality and the need for future trials exploring PND psychotherapy effectiveness in LMICs to follow reporting guidelines to facilitate appropriate predictor, moderator and mediator analyses.

Introduction: Mental health interventions have traditionally been developed by clinicians and researchers without the meaningful engagement and partnership with those who would receive, deliver, and fund them. Recent progress has highlighted the importance of the co-design of interventions, through stakeholder participation, as a means of increasing the integration of mental health interventions into existing health, education, and social care systems. This protocol describes the pre-implementation phase of the INSPIRE (Innovative approaches to adolescent perinatal wellbeing) project which aims to identify challenges, and design and test interventions to promote mental wellbeing and good mental health of adolescent girls during pregnancy and the year after birth with local stakeholders in Kenya and Mozambique. Methods: A participatory approach that blends human-centred design, systems thinking, and implementation science methods will be used to engage adolescents (aged 15–19 years), their families, and other stakeholders who can influence implementation efforts, in planning and preparing interventions. First, an understanding of context, barriers, and opportunities related to adolescent perinatal mental health will be elicited through individual interviews, focus group discussions, and observations. This will be complemented by a scoping review of relevant interventions. The research team will identify contextual insights relating to adolescent and system characteristics, strengths, and challenges. These will be shared with and refined by stakeholders. Thematic analysis will be conducted to describe the experiences of adolescent girls, and barriers and enablers to maintaining good mental health. The former will be triangulated with the Context and Implementation of Complex Intervention (CICI) framework. Causal loop diagrams will be developed to illustrate the individual and system-level variables which influence adolescent perinatal mental health.Stakeholder workshops will be used to identify priorities, brainstorm potential interventions, develop a program theory, and prototype an intervention and implementation strategies. Intervention acceptability, appropriateness, and feasibility will be assessed, and a theory of change map finalized. Results: To date the study has recruited 169 participants to complete individual interviews, focus group discussions and observation activities. Conclusions: It is anticipated that the use of a participatory and systematic approach to the development of an intervention to improve mental health, will improve its perceived appropriateness, acceptability, and feasibility among key stakeholders. This may, in turn, significantly improve its availability, uptake, and sustainability.

Abstract Background Depression in older adults is a challenge for health systems in most low- and middle-income countries (LMICs). Digital strategies for the management of this condition have been emerging worldwide, but the effectiveness of most of them is still unclear, especially among older adults. Thus, we aim to assess the effectiveness and cost-effectiveness of a digital psychosocial intervention to treat depression among older adults living in socioeconomically deprived areas in Guarulhos, Brazil. Methods We will conduct a two-arm individually randomised controlled trial with 1:1 allocation ratio. Five hundred older adults aged 60 years or over with depressive symptomatology (9-item Patient Health Questionnaire score, PHQ-9 ≥ 10) and registered with one of the primary care clinics will be recruited to participate in this study. A 6-week digital psychosocial programme, named Viva Vida, will be delivered via WhatsApp to participants allocated to the intervention arm. The Viva Vida will send psychoeducational and behavioural activation audio and visual messages 4 days a week for 6 weeks. The control arm will only receive a single message with general information about depression. The primary outcome will be the proportion of depression recovery (PHQ-9 < 10) assessed at 3 months. The cost-effectiveness of the intervention will be assessed at 5 months. A detailed process evaluation will be used to explore context and important implementation outcomes. Discussion This programme was based on the PROACTIVE intervention and designed to be delivered without face-to-face contact. If effective, it could be a simple treatment option, appropriate not only when social distancing is required, but it could also be included as a regular public health programme to initiate depression treatment, particularly in LMICs where resources allocated to mental health are scarce. Trial registration Registro Brasileiro de Ensaios Clínicos (ReBEC), RBR-4c94dtn. Registered on 22 October 2021 (submitted on 03 August 2021).

Abstract Background During the perinatal period, common mental disorders (CMDs) such as depression and anxiety are highly prevalent, especially in low-resource settings, and are associated with domestic violence, poverty, and food insecurity. Perinatal CMDs have been associated with several adverse maternal and child outcomes. While the Department of Health in South Africa provides healthcare workers with the tools to detect psychological distress and experiences of domestic violence, few healthcare workers routinely screen pregnant women at clinic visits, citing discomfort with mental health issues and the lack of standardised referral pathways as the key barriers. The aim of this study is to select and evaluate a set of health systems strengthening (HSS) interventions aimed at improving the care and outcomes for perinatal women with CMDs and experiences of domestic violence, attending public healthcare facilities in Cape Town. Methods This study consists of a pre-implementation, development, and implementation phase. Contextual barriers identified during the pre-implementation phase included poor patient knowledge and health-seeking behaviour, high levels of stigma, and poor detection, referral, and treatment rates. Implementation science determinant frameworks were applied to findings from the pre-implementation phase to identify determinants and gaps in delivering high-quality evidence-informed care. A participatory Theory of Change workshop was used to design a HSS programme, consisting of awareness raising, detection, referral, and treatment. HSS interventions selected to support the delivery of the HSS programme includes training, health promotion, change to the healthcare environment, task-sharing, audit and feedback, and performance monitoring. The implementation phase will be used to assess several implementation and clinical outcomes associated with the delivery of the HSS programme, which will be piloted at three healthcare facilities. Qualitative and quantitative methods will be used to evaluate the implementation and clinical outcomes. Discussion This pilot implementation study will inform us about a range of implementation and clinical outcome measures that are relevant for assessing HSS interventions for perinatal women with depression, anxiety, or experiences of domestic violence in low-resource settings. Lessons learnt from the pilot study will be incorporated into the design of a cluster randomised control trial for which further funding will be sought.

Abstract Background South Africa has a high burden of perinatal common mental disorders (CMD), such as depression and anxiety, as well as high levels of poverty, food insecurity and domestic violence, which increases the risk of CMD. Yet public healthcare does not include routine detection and treatment for these disorders. This pilot study aims to evaluate the implementation outcomes of a health systems strengthening (HSS) intervention for improving the quality of care of perinatal women with CMD and experiences of domestic violence, attending public healthcare facilities in Cape Town. Methods Three antenatal care facilities were purposively selected for delivery of a HSS programme consisting of four components: (1) health promotion and awareness raising talks delivered by lay healthcare workers; (2) detection of CMD and domestic violence by nurses as part of routine care; (3) referral of women with CMD and domestic violence; and (4) delivery of structured counselling by lay healthcare workers in patients’ homes. Participants included healthcare workers tasked with delivery of the HSS components, and perinatal women attending the healthcare facilities for routine antenatal care. This mixed methods study used qualitative interviews with healthcare workers and pregnant women, a patient survey, observation of health promotion and awareness raising talks, and a review of several documents, to evaluate the acceptability, appropriateness, feasibility, adoption, fidelity of delivery, and fidelity of receipt of the HSS components. Thematic analysis was used to analyse the qualitative interviews, while the quantitative findings for adoption and fidelity of receipt were reported using numbers and proportions. Results Healthcare workers found the delivery and content of the HSS components to be both acceptable and appropriate, while the feasibility, adoption and fidelity of delivery was poor. We demonstrated that the health promotion and awareness raising component improved women’s attitudes towards seeking help for mental health conditions. The detection, referral and treatment components were found to improve fidelity of receipt, evidenced by an increase in the proportion of women undergoing routine detection and referral, and decreased feelings of distress in women who received counselling. However, using a task-sharing approach did not prove to be feasible, as adding additional responsibilities to already overburdened healthcare workers roles resulted in poor fidelity of delivery and adoption of all the HSS components. Conclusions The acceptability, appropriateness and fidelity of receipt of the HSS programme components, and poor feasibility, fidelity of delivery and adoption suggest the need to appoint dedicated, lay healthcare workers to deliver key programme components, at healthcare facilities, on the same day.

Abstract Background In low-resource settings, e-mental health may substantially increase access to evidence-based interventions for common mental disorders. We conducted a systematic literature search to identify randomised trials examining the effects of digital interventions with or without therapeutic guidance compared to control conditions in individuals with anxiety and/or depression symptoms in low- and middle-income countries (LMICs). Methods The main outcome was the reduction in symptoms at the post-test. Secondary outcomes included improvements in quality of life and longer-term effects (≥20 weeks post-randomisation). The effect size Hedges’ g was calculated using the random effects model. Results A total of 21 studies (23 comparisons) with 5.296 participants were included. Digital interventions were more effective than controls in reducing symptoms of common mental disorders at the post-test (g = −0.89, 95% confidence interval [CI] −1.26 to −0.52, p

This study aimed to investigate the relationship between sociodemographic characteristics, depressive symptomatology, mobile phone ownership, and different uses of WhatsApp among older adults enrolled in primary care clinics in Guarulhos, São Paulo State, Brazil. This is a secondary data analysis, using data collected in the screening of participants to be included in the PROACTIVE cluster randomized trial. Individuals aged ≥ 60 years, registered in primary care clinics in Guarulhos, were assessed for sociodemographic characteristics, depressive symptoms according to the PHQ-9, mobile phone ownership, and use of WhatsApp. We performed multiple logistic regression models to investigate characteristics of the potential users of digital interventions. Of 3,356 older adults screened for depression, 45.7% said they use WhatsApp to receive/send messages. In the subsample that presented depressive symptomatology (n = 1,020), 41.9% stated using WhatsApp. Younger older adults and those with better socioeconomic status used more WhatsApp and were more likely to own a mobile phone. Participants with higher levels of symptoms of depression were less likely to use WhatsApp. Gender, age, schooling level, income, and depressive symptomatology are variables associated with the possession of a cell phone and with the use of WhatsApp by the older adults of the sample. These findings can help to implement digital health programs better suited to disadvantaged populations in Brazil and other low- and middle-income countries through mental telehealth interventions using WhatsApp and mobile health services to the older people.

To achieve universal health coverage, health system strengthening (HSS) is required to support the of delivery of high-quality care. The aim of the National Institute for Health Research Global Research Unit on HeAlth System StrEngThening in Sub-Saharan Africa (ASSET) is to address this need in a four-year programme, with three healthcare platforms involving eight work-packages. Key to effective health system strengthening (HSS) is the pre-implementation phase of research where efforts focus on applying participatory methods to embed the research programme within the existing health system. To conceptualise the approach, we provide an overview of the key methods applied across work-package to address this important phase of research conducted between 2017 and 2021. Work-packages are being undertaken in publicly funded health systems in rural and urban areas in Ethiopia, Sierra Leone, South Africa, and Zimbabwe. Stakeholders including patients and their caregivers, community representatives, clinicians, managers, administrators, and policymakers are the main research participants. In each work-package, initial activities engage stakeholders and build relationships to ensure co-production and ownership of HSSIs. A mixed-methods approach is then applied to understand and address determinants of high-quality care delivery. Methods such as situation analysis, cross-sectional surveys, interviews and focus group discussions are adopted to each work-package aim and context. At the end of the pre-implementation phase, findings are disseminated using focus group discussions and participatory Theory of Change workshops where stakeholders from each work package use findings to select HSSIs and develop a programme theory. ASSET places a strong emphasis of the pre-implementation phase in order to provide an in-depth and systematic diagnosis of the existing heath system functioning, needs for strengthening and stakeholder engagement. This common approach will inform the design and evaluation of the HSSIs to increase effectiveness across work packages and contexts, to better understand what works, for whom, and how.