Prevalence of depression and associated symptoms among patients attending primary healthcare facilities: a cross-sectional study in Nepal.

BACKGROUND: Depression is a prevalent mental health condition worldwide but there is limited data on its presentation and associated symptoms in primary care settings in low- and middle-income countries like Nepal. This study aims to assess the prevalence of depression, its hallmark and other associated symptoms that meet the Diagnostic and Statistical Manual (DSM-5) criteria in primary healthcare facilities in Nepal. The collected information will be used to determine the content of a mobile app-based clinical guidelines for better detection and management of depression in primary care. METHODS: A total of 1,897 adult patients aged 18-91 (63.1% women) attending ten primary healthcare facilities in Jhapa, a district in eastern Nepal, were recruited for the study between August 2, 2021, and March 25, 2022. Trained research assistants conducted face-to-face interviews in private spaces before the consultation with healthcare providers. Depression symptoms, including hallmark symptoms, was assessed using the validated Nepali version of the Patient Health Questionnaire (PHQ-9). RESULTS: One in seven (14.5%) individuals attending primary health care facilities in Jhapa met the threshold for depression based on a validated cut-off score ( > = 10) on the PHQ-9. The most commonly reported depressive symptoms were loss of energy and sleep difficulties. Approximately 25.4% of women and 18.9% of men endorsed at least one of the two hallmark symptoms on the PHQ-9. Using a DSM-5 algorithm (at least one hallmark symptom and five or more total symptoms) to score the PHQ-9, 6.3% of women and 4.3% of men met the criteria for depression. The intra-class correlation coefficient for PHQ-9 total scores by health facility as the unit of clustering was 0.01 (95% confidence interval, 0.00-0.04). CONCLUSION: Depression symptoms are common among people attending primary healthcare facilities in Nepal. However, the most common symptoms are not the two hallmark criteria. Use of total scores on a screening tool such as the PHQ-9 risks overestimating the prevalence and generating false positive diagnoses. Compared to using cut off scores on screening tools, training health workers to first screen for hallmark criteria may increase the accuracy of identification and lead to better allocation of treatment resources.

Effectiveness of combining prevention psychological interventions with interventions that address the social determinants of mental health in low and middle-income countries: protocol of a systematic review and meta-analysis.

INTRODUCTION: Common mental health conditions (CMHCs), including depression, anxiety and post-traumatic stress disorder (PTSD), are highly prevalent in low and middle-income countries (LMICs). Preventive strategies combining psychological interventions with interventions addressing the social determinants of mental health may represent a key strategy for effectively preventing CMHCs. However, no systematic reviews have evaluated the effectiveness of these combined intervention strategies for preventing CMHCs. METHODS AND ANALYSIS: This systematic review will include randomised controlled trials (RCTs) focused on the effectiveness of interventions that combine preventive psychological interventions with interventions that address the social determinants of mental health in LMICs. Primary outcome is the frequency of depression, anxiety or PTSD at postintervention as determined by a formal diagnostic tool or any other standardised criteria. We will search Epistemonikos, Cochrane Controlled Trials Register (CENTRAL), MEDLINE, Embase, PsycINFO, CINAHL, Global Index Medicus, ClinicalTrials.gov (Ctgov), International Clinical Trials Registry Platform (ICTRP). Two reviewers will independently extract the data and evaluate the risk of bias of included studies using the Cochrane risk of bias tool 2. Random-effects meta-analyses will be performed, and certainty of evidence will be rated using the Grading of Recommendations Assessment, Development and Evaluation approach. ETHICS AND DISSEMINATION: This study uses data from published studies; therefore, ethical review is not required. Findings will be presented in a published manuscript. TRIAL REGISTRATION NUMBER: CRD42023451072.

Nurturing families: A feasibility randomised controlled trial of a whole-family intervention with vulnerable families in Jordan.

Armed conflict and forced displacement can significantly strain nurturing family environments, which are essential for child well-being. Yet, limited evidence exists on the effectiveness of family-systemic interventions in these contexts. We conducted a two-arm, single-masked, feasibility Randomised Controlled Trial (fRCT) of a whole-family intervention with Syrian, Iraqi and Jordanian families in Jordan. We aimed to determine the feasibility of intervention and study procedures to inform a fully-powered RCT. Eligible families were randomised to receive the Nurturing Families intervention or enhanced usual care (1:1). Masked assessors measured outcomes at baseline and endline; primary outcome measures were caregiver psychological distress, family functioning, and parenting practices. Families and implementing staff participated in qualitative interviews at endline. Of the 62 families screened, 60 (98%) were eligible, 97% completed the baseline and 90% completed the endline. Qualitative feedback indicated specific improvements in adolescent well-being, caregiver distress and parenting, and family relationships. Data highlighted high participant engagement and adequate facilitator fidelity and competence. Outcome measures had good psychometric properties (most α > 0.80) and sensitivity to change, with significant changes seen on most measures in the intervention but not control group. Findings indicate the acceptability and feasibility of intervention and study procedures. Subsequent full-scale evaluation is needed to determine effectiveness.

A qualitative study on the adaptation of community programmes for the promotion of early detection and health-seeking of perinatal depression in Nepal.

BACKGROUND: Despite the high burden of perinatal depression in Nepal, the detection rate is low. Community-based strategies such as sensitization programmes and the Community Informant Detection Tool (CIDT) have been found to be effective in raising awareness and thus promoting the identification of mental health problems. This study aims to adapt these community strategies for perinatal depression in the Nepalese context. METHODS: We followed a four-step process to adapt the existing community sensitization program manual and CIDT. Step 1 included in-depth interviews with women identified with perinatal depression (n=36), and focus group discussions were conducted with health workers trained in community mental health (n=13), female community health volunteers (FCHVs), cadre of Nepal government for the prevention and promotion of community maternal and child health (n=16), and psychosocial counsellors (n=5). We explored idioms and understanding of depression, perceived causes, and possible intervention. Step 2 included draft preparation based on the qualitative study. Step 3 included a one-day workshop with the psychosocial counsellors (n=2) and health workers (n=12) to assess the understandability and comprehensiveness of the draft and to refine the content. A review of the CIDT and community sensitization program manual by a psychiatrist was performed in Step 4. RESULTS: The first step led to the content development for the CIDT and community sensitization manual. Multiple stakeholders and experts reviewed and refined the content from the second to fourth steps. Idioms of depression and commonly cited risk factors were incorporated in the CIDT. Additionally, myths of perinatal depression and the importance of the role of family were added to the community sensitization manual. CONCLUSION: Both the CIDT and community sensitization manual are grounded in the local context and are simple, clear, and easy to understand.

Parenting and family interventions in lower and middle-income countries for child and adolescent mental health: A systematic review.

BACKGROUND: Given the protective effect of nurturing caregivers and families for child and adolescent mental health, there is a need to review and synthesize research evidence regarding the effectiveness of parenting and family interventions in low and middle-income countries, including humanitarian settings. To advance practice, further understanding of the active ingredients of such interventions and implementation factors that lead to effectiveness are essential. METHOD: This systematic review, an update from a previous review, included studies on any parenting or family intervention for children and adolescents aged 0-24, living in a low- or middle-income country, that quantitatively measured child or adolescent mental health outcomes. We searched Global Health, PubMed, PsychINFO, PILOTS and the Cochrane Library databases on the 9th July 2020, and updated on the 12th August 2022. Risk of bias was assessed using an adapted version of the NIH Quality Assessment Tool. We extracted data on: effectiveness outcomes, practice elements included in effective interventions, and implementation challenges and successes. MAIN FINDINGS: We found a total of 80 studies (n = 18,193 participants) representing 64 different family or parenting interventions, 43 of which had evidence of effect for a child or adolescent mental health outcome. Only 3 studies found no effect on child, adolescent or caregiver outcomes. The most common practice elements delivered in effective interventions included caregiver psychoeducation, communication skills, and differential reinforcement. Key implementation strategies and lessons learned included non-specialist delivery, the engagement of fathers, and integrated or multi-sector care to holistically address family needs. PRELIMINARY CONCLUSIONS: Despite a high level of heterogeneity, preliminary findings from the review are promising and support the use of parenting and family interventions to address the wider social ecology of children in low resource and humanitarian contexts. There are remaining gaps in understanding mechanisms of change and the empirical testing of different implementation models. Our findings have implications for better informing task sharing from specialist to non-specialist delivery, and from individual-focused to wider systemic interventions.

Follow-up and Mediation Outcomes of a Movement-Based Mental Health Promotion Intervention for Refugee Children in Uganda.

OBJECTIVE: There is limited evidence for the effectiveness of mental health promotion interventions in low- and middle-income settings, especially for longer-term benefits. This study evaluates the 5-month follow-up outcomes of a movement-based mental health promotion intervention (TeamUp) for refugee children in Northern Uganda (West Nile) and further investigates what explains longer-term benefits. METHODS: This quasi-experimental study was conducted in four primary schools, randomly allocated to an experimental or a control condition. Enrolled in the study were 549 children ages 10-15 years (n = 265 TeamUp; n = 284 control group). Primary outcomes were psychosocial well-being (Stirling Children's Wellbeing Scale), attitude toward school, and satisfaction with friendships (Multidimensional Students Life Satisfaction Scale [Friends and School subscales]). Mediators included social connectedness and sense of agency. RESULTS: At 5 months postintervention, 467 (85.1%) children were retained. Intent-to-treat analyses demonstrated sustained benefits for TeamUp for well-being (estimated mean difference -1.88, 95% CI -3.14 to -0.66, p = .003, effect size Cohen's d = 0.25) and friendships (-1.52, 95% CI -2.55 to -0.48, p = .005, d = 0.25). There were no significant between-group differences for attitude toward school. Secondary benefits were shown for traumatic stress (2.18, 95% CI 0.45 to 3.91, p = .014, d = 0.21), quality of life (-1.29, 95% CI -2.31 to -0.30, p = .014, d = 0.21), bullying (0.53, 95% CI 0.08 to 0.97, p = .020, d = 0.20), and depression symptoms (1.31, 95% CI 0.09 to 2.52, p = .035, d = 0.18). Increased sense of connectedness mediates the effect of TeamUp on improving well-being (indirect effect = 0.30, SE = 0.13, p = .001), explaining 15% of variance. CONCLUSION: This study shows sustained benefits of a mental health promotion intervention 5 months postintervention. Prolonged benefits are explained by an increase in social connectedness.

Evaluating a Movement-Based Mental Health Promotion Intervention for Refugee Children in Uganda: A Quasi-Experimental Study.

OBJECTIVE: Mental health promotion interventions are widely implemented in humanitarian settings and low- and middle-income contexts (LMICs), yet evidence on effectiveness is scarce and mixed. This study evaluated the movement-based mental health promotion intervention "TeamUp" in Bidibidi refugee settlement, in Northern Uganda. METHOD: A quasi-experimental study including four schools (two per arm) assessed the outcomes of 10- to 15-year-old South Sudanese and Ugandan children (n = 549). Randomly allocated, they either participated in up to 11 TeamUp sessions (n = 265) provided by trained facilitators; or belonged to a control group, which continued care as usual (n = 284). Primary outcomes measured psychosocial wellbeing, friendships and attitude to school; secondary outcomes included traumatic distress, depressive symptoms, quality of life, physical health, bullying, interoceptive awareness, and irritability. Data were collected at baseline and endline. RESULTS: Children joining TeamUp, showed significantly more improvements on primary outcomes: emotional and psychosocial wellbeing (Mdiff = -1.49, SE = 0.6, p = .01), satisfaction with and attitude toward school (-0.57, SE = 0.2, p = .004); and secondary outcomes: traumatic stress (2.64, SE = 0.8, p < .001), health-related quality of life (-1.56, SE = 0.4, p = .001), physical health (-0.78, SE = 0.3, p = .014) and the TeamUp mechanisms of action scale (-3.34, SE = 0.9, p < .001), specifically the subscales social connectedness (-0.74, SE = 0.3, p = .007) and sense of agency (-0.91, SE = 0.3, p = .005), compared to the control group. No significant differences were found on bullying, interoceptive awareness, irritability and depressive symptoms. CONCLUSION: The results are promising for TeamUp as a mental health promotion intervention for children affected by armed-conflict, displacement and on-going adversity. Further research will need to assess the intervention's effectiveness.

Umbrella Systematic Review and Meta-Analysis: Physical Activity as an Effective Therapeutic Strategy for Improving Psychosocial Outcomes in Children and Adolescents.

OBJECTIVE: Physical activity (PA) interventions are part of many interdisciplinary programs for the management of children and adolescents with or without physical or psychological conditions or disabilities. Aiming to summarize the available evidence, we conducted an umbrella review of meta-analyses of PA interventions that included psychosocial outcomes in populations of children and adolescents. METHOD: Literature searches were conducted in PubMed, Cochrane Central, Web of Science, Medline, SPORTDiscus, and PsychInfo from January 1, 2010, to May 6, 2022. Meta-analyses of randomized and quasi-randomized studies investigating the efficacy of PA interventions for psychosocial outcomes in children and adolescents were included. Summary effects were recalculated using common metric and random-effects models. We assessed between-study heterogeneity, predictive intervals, publication bias, small study effects, and whether the results of the observed positive studies were greater than expected due to chance. On the basis of these calculations, strength of associations was assessed using quantitative umbrella review criteria, and credibility of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Quality was assessed using the AMSTAR 2 tool. This study is registered with the Open Science Framework, https://osf.io/ap8qu. RESULTS: A total of 112 studies from 18 meta-analyses generating 12 new meta-analyses comprising 21,232 children and adolescents in population groups including attention-deficit/hyperactivity disorder, cancer, cerebral palsy, chronic respiratory diseases, depression, neuromotor impairment, and obesity and in general populations were included. PA interventions were efficacious in reducing psychological symptoms in all meta-analyses across the different population groups using random-effects models. However, umbrella review criteria suggested a weak strength of association for this outcome, and GRADE credibility of evidence ranged from moderate to very low. For psychological well-being, 3 out of 5 meta-analyses identified significant effects, but the strength of these associations was weak, and GRADE credibility of evidence ranged from moderate to very low. Similarly, for social outcomes, meta-analyses reported a significant summary effect, but the strength of association was weak, and GRADE credibility of evidence ranged from moderate to very low. For self-esteem, one meta-analysis in children with obesity failed to show any effect. CONCLUSION: Even though existing meta-analyses suggested a beneficial effect of PA interventions on psychosocial outcomes across different population groups, the strength of associations was weak, and the credibility of evidence was variable depending on the target population, outcome, and condition or disability. Randomized studies of PA interventions in children and adolescents with and without different physical and psychological conditions or disabilities should always include psychosocial outcomes as an important dimension of social and mental health. STUDY PREREGISTRATION INFORMATION: Prenatal Maternal Infection and Adverse Neurodevelopment: A Structural Equation Modelling Approach to Downstream Environmental Hits; https://osf.io/; ap8qu.

Implementation outcomes in psychosocial intervention studies for children and adolescents living in low- and middle-income countries: A systematic review.

Psychosocial interventions play a key role in addressing mental health and substance use needs for children and adolescents living in low- and middle-income countries (LMICs). While research efforts have primarily focused on their effectiveness, implementation outcomes also require examining. We conducted a systematic review of qualitative, quantitative, and mixed-methods studies (PROSPERO: CRD42022335997) to synthesize the literature on implementation outcomes for psychosocial interventions for children and adolescents in LMICs. We searched Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, Web of Science, PsychINFO, and Global Health through April 2023. Data were extracted and quality appraised through the Mixed Methods Appraisal Tool (MMAT) independently by two reviewers. A total of 13,380 records were screened, and 87 studies met inclusion criteria. Feasibility was the most reported implementation outcome (69, 79%), followed by acceptability (60, 69%), and fidelity (32, 37%). Appropriateness was assessed in 11 studies (13%), implementation costs in 10 (11%), and sustainability in one (1%). None of the included studies reported on penetration or adoption. Despite a growing body of evidence for implementation research in child and adolescent global mental health, most research focused on earlier-stage implementation outcomes, assessing them in research-controlled settings. To overcome this, future efforts should focus on assessing interventions in routine care, assessing later-stage implementation outcomes through standardized tools.

Strengthening self-regulation and reducing poverty to prevent adolescent depression and anxiety: Rationale, approach and methods of the ALIVE interdisciplinary research collaboration in Colombia, Nepal and South Africa.

AIMS: Depression and anxiety are the leading contributors to the global burden of disease among young people, accounting for over a third (34.8%) of years lived with disability. Yet there is limited evidence for interventions that prevent adolescent depression and anxiety in low- and middle-income countries (LMICs), where 90% of adolescents live. This article introduces the 'Improving Adolescent mentaL health by reducing the Impact of poVErty (ALIVE)' study, its conceptual framework, objectives, methods and expected outcomes. The aim of the ALIVE study is to develop and pilot-test an intervention that combines poverty reduction with strengthening self-regulation to prevent depression and anxiety among adolescents living in urban poverty in Colombia, Nepal and South Africa. METHODS: This aim will be achieved by addressing four objectives: (1) develop a conceptual framework that identifies the causal mechanisms linking poverty, self-regulation and depression and anxiety; (2) develop a multi-component selective prevention intervention targeting self-regulation and poverty among adolescents at high risk of developing depression or anxiety; (3) adapt and validate instruments to measure incidence of depression and anxiety, mediators and implementation parameters of the prevention intervention; and (4) undertake a four-arm pilot cluster randomised controlled trial to assess the feasibility, acceptability and cost of the selective prevention intervention in the three study sites. RESULTS: The contributions of this study include the active engagement and participation of adolescents in the research process; a focus on the causal mechanisms of the intervention; building an evidence base for prevention interventions in LMICs; and the use of an interdisciplinary approach. CONCLUSIONS: By developing and evaluating an intervention that addresses multidimensional poverty and self-regulation, ALIVE can make contributions to evidence on the integration of mental health into broader development policy and practice.

Implementing a Non-Specialist Delivered Psychological Intervention for Young Adolescents in a Protracted Refugee Setting: a Qualitative Process Evaluation in Lebanon.

There has been an increase in the evaluation and implementation of non-specialist delivered psychological interventions to address unmet mental health needs in humanitarian emergencies. While randomized controlled trials (RCTs) provide important evidence about intervention impact, complementary qualitative process evaluations are essential to understand key implementation processes and inform future scaling up of the intervention. This study was conducted as part of an RCT of the Early Adolescents Skills for Emotions (EASE) psychological intervention for young adolescents with elevated psychological distress (predominantly with a Syrian refugee background) in Lebanon. Our aims were firstly to conduct a qualitative process evaluation to understand stakeholder experiences and perceived impact of the intervention and identify barriers and facilitators for implementation, and secondly to explore considerations for scaling up. Eleven key informant interviews and seven focus groups were conducted with 39 respondents including adolescent and caregiver participants, trainers, providers, outreach workers, and local stakeholders. Data were analyzed using inductive and deductive thematic analysis. Respondents perceived the intervention to be highly needed and reported improvements in adolescent mental health and wellbeing. Key implementation factors that have potential to influence engagement, adherence, and perceived impact included the socio-economic situation of families, mental health stigma, coordination within and between sectors (particularly for scaling up), embedding the intervention within existing service pathways, having clear quality and accountability processes including training and supervision for non-specialists, and sustainable funding. Our findings provide important context for understanding effectiveness outcomes of the RCT and highlights factors that need to be considered when implementing a mental health intervention on a larger scale in a complex crisis.

Experience of primary healthcare workers in using the mobile app-based WHO mhGAP intervention guide in detection and treatment of people with mental disorders: A qualitative study in Nepal.

This study assessed perception and experience of trained primary health care workers in using a mobile app-based version of the WHO mental health gap action programme (mhGAP) Intervention Guide in the assessment and management of people with mental health conditions in primary care in Nepal. A qualitative study was conducted with primary healthcare workers who were trained in using the WHO mhGAP mobile application in Jhapa, a district in eastern Nepal. Semi-structured interviews were carried out with 15 healthcare workers (3 females and 12 males) nine months after the training. Interviews were audio recorded, transcribed and translated into English for the thematic qualitative data analysis. Health care workers (HCWs) found the mobile app helpful to verify and confirm their assessment and diagnosis. The other benefits reported by the participants were: bringing uniformity in diagnosis and management of mental health conditions across primary healthcare facilities; reminding the HCWs specific assessment questions; creating awareness on the importance of psychosocial intervention; improving the interaction between patients and service providers; and the importance of follow-up care. Despite these advantages, lack of clarity about report submission modality; lack of electricity or internet connectivity; and low technology literacy among older HCWs were some of the barriers in using the app. The major recommendation made by the HCWs for the guide included revision of the assessment process and system; inclusion of a chat function with supervisors; minimizing the amount of patients' data to be collected in the app; and addition of conversion and anxiety disorders to the app. This study concludes that the mobile decision support application could be acceptable and feasible in primary care settings if the suggested modifications are incorporated, in addition to addressing other systemic issues facing the primary care-based delivery of mental health services.

Reducing stigma impacting children and adolescents in low- and middle-income countries: The development of a common multi-component stigma reduction intervention.

INTRODUCTION: Stigmatisation impedes health and quality of life. Evidence regarding stigma reduction interventions is, albeit growing, limited. There is a gap in the availability and evidence of interventions for reducing stigma among children and adolescents, especially in low- and middle-income countries. This paper describes the process that led to a stigma reduction intervention impacting children and adolescents in low- and middle-income countries, following previously conducted formative research. METHODS: In this study, we conducted (i) online stakeholder consultations (FGD) (n = 43), including a survey assessing intervention acceptability, appropriateness, feasibility and scalability (n = 16); and (ii) preliminary field-testing of intervention content online and in a refugee settlement in Uganda. FINDINGS: Stakeholder consultation showed the initial version of STRETCH (Stigma Reduction to Trigger Change for Children), albeit positively received, required adaptations. We made adjustments to i) take into account implementation duration, intervention flexibility and intersectionality; (ii) strengthen the involvement of individuals, including adolescents/youth, with lived stigma experience; (iii) target people close to individuals with lived stigma experience; and (iv) address feasibility and sustainability concerns. Preliminary field-testing simplified STRETCH while adding a community outreach component and revisiting the intervention setup, to ensure STRETCH can also be applied from a modular perspective. CONCLUSION: We conducted a process to develop a child-focused multi-component stigma reduction intervention, with intended applicability across stigmas and settings. This paper provides an overview of the intervention development process, generating intervention-specific learnings with generic value. STRETCH aims to reduce stigmatisation at the implementing organisation, create community-wide reflection and stigma reduction demand, and reduce stigmatisation among various target groups.

Expanding mental health services in low- and middle-income countries: A task-shifting framework for delivery of comprehensive, collaborative, and community-based care.

This paper proposes a framework for comprehensive, collaborative, and community-based care (C4) for accessible mental health services in low-resource settings. Because mental health conditions have many causes, this framework includes social, public health, wellness and clinical services. It accommodates integration of stand-alone mental health programs with health and non-health community-based services. It addresses gaps in previous models including lack of community-based psychotherapeutic and social services, difficulty in addressing comorbidity of mental and physical conditions, and how workers interact with respect to referral and coordination of care. The framework is based on task-shifting of services to non-specialized workers. While the framework draws on the World Health Organization's Mental Health Gap Action Program and other global mental health models, there are important differences. The C4 Framework delineates types of workers based on their skills. Separate workers focus on: basic psychoeducation and information sharing; community-level, evidence-based psychotherapeutic counseling; and primary medical care and more advanced, specialized mental health services for more severe or complex cases. This paper is intended for individuals, organizations and governments interested in implementing mental health services. The primary aim is to provide a framework for the provision of widely accessible mental health care and services.

Primary-level and community worker interventions for the prevention of mental disorders and the promotion of well-being in low- and middle-income countries.

BACKGROUND: There is a significant research gap in the field of universal, selective, and indicated prevention interventions for mental health promotion and the prevention of mental disorders. Barriers to closing the research gap include scarcity of skilled human resources, large inequities in resource distribution and utilization, and stigma. OBJECTIVES: To assess the effectiveness of delivery by primary workers of interventions for the promotion of mental health and universal prevention, and for the selective and indicated prevention of mental disorders or symptoms of mental illness in low- and middle-income countries (LMICs). To examine the impact of intervention delivery by primary workers on resource use and costs. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, CINAHL, Global Index Medicus, PsycInfo, WHO ICTRP, and ClinicalTrials.gov from inception to 29 November 2021. SELECTION CRITERIA: Randomized controlled trials (RCTs) of primary-level and/or community health worker interventions for promoting mental health and/or preventing mental disorders versus any control conditions in adults and children in LMICs. DATA COLLECTION AND ANALYSIS: Standardized mean differences (SMD) or mean differences (MD) were used for continuous outcomes, and risk ratios (RR) for dichotomous data, using a random-effects model. We analyzed data at 0 to 1, 1 to 6, and 7 to 24 months post-intervention. For SMDs, 0.20 to 0.49 represented small, 0.50 to 0.79 moderate, and ≥ 0.80 large clinical effects. We evaluated the risk of bias (RoB) using Cochrane RoB2. MAIN RESULTS: Description of studies We identified 113 studies with 32,992 participants (97 RCTs, 19,570 participants in meta-analyses) for inclusion. Nineteen RCTs were conducted in low-income countries, 27 in low-middle-income countries, 2 in middle-income countries, 58 in upper-middle-income countries and 7 in mixed settings. Eighty-three RCTs included adults and 30 RCTs included children. Cadres of primary-level workers employed primary care health workers (38 studies), community workers (71 studies), both (2 studies), and not reported (2 studies). Interventions were universal prevention/promotion in 22 studies, selective in 36, and indicated prevention in 55 RCTs. Risk of bias The most common concerns over risk of bias were performance bias, attrition bias, and reporting bias. Intervention effects 'Probably', 'may', or 'uncertain' indicates 'moderate-', 'low-', or 'very low-'certainty evidence. *Certainty of the evidence (using GRADE) was assessed at 0 to 1 month post-intervention as specified in the review protocol. In the abstract, we did not report results for outcomes for which evidence was missing or very uncertain. Adults Promotion/universal prevention, compared to usual care: - probably slightly reduced anxiety symptoms (MD -0.14, 95% confidence interval (CI) -0.27 to -0.01; 1 trial, 158 participants) - may slightly reduce distress/PTSD symptoms (SMD -0.24, 95% CI -0.41 to -0.08; 4 trials, 722 participants) Selective prevention, compared to usual care: - probably slightly reduced depressive symptoms (SMD -0.69, 95% CI -1.08 to -0.30; 4 trials, 223 participants) Indicated prevention, compared to usual care: - may reduce adverse events (1 trial, 547 participants) - probably slightly reduced functional impairment (SMD -0.12, 95% CI -0.39 to -0.15; 4 trials, 663 participants) Children Promotion/universal prevention, compared to usual care: - may improve the quality of life (SMD -0.25, 95% CI -0.39 to -0.11; 2 trials, 803 participants) - may reduce adverse events (1 trial, 694 participants) - may slightly reduce depressive symptoms (MD -3.04, 95% CI -6 to -0.08; 1 trial, 160 participants) - may slightly reduce anxiety symptoms (MD -2.27, 95% CI -3.13 to -1.41; 1 trial, 183 participants) Selective prevention, compared to usual care: - probably slightly reduced depressive symptoms (SMD 0, 95% CI -0.16 to -0.15; 2 trials, 638 participants) - may slightly reduce anxiety symptoms (MD 4.50, 95% CI -12.05 to 21.05; 1 trial, 28 participants) - probably slightly reduced distress/PTSD symptoms (MD -2.14, 95% CI -3.77 to -0.51; 1 trial, 159 participants) Indicated prevention, compared to usual care: - decreased slightly functional impairment (SMD -0.29, 95% CI -0.47 to -0.10; 2 trials, 448 participants) - decreased slightly depressive symptoms (SMD -0.18, 95% CI -0.32 to -0.04; 4 trials, 771 participants) - may slightly reduce distress/PTSD symptoms (SMD 0.24, 95% CI -1.28 to 1.76; 2 trials, 448 participants). AUTHORS' CONCLUSIONS: The evidence indicated that prevention interventions delivered through primary workers - a form of task-shifting - may improve mental health outcomes. Certainty in the evidence was influenced by the risk of bias and by substantial levels of heterogeneity. A supportive network of infrastructure and research would enhance and reinforce this delivery modality across LMICs.

Strategies to improve the quality and usefulness of mental health trials in humanitarian settings.

A striking rise in the number of people affected by humanitarian crises has led to an increase in mental health and psychosocial support interventions to reduce the psychological effects of such crises. In a parallel trend, researchers have brought increased methodological rigour to their evaluation of these interventions. However, several methodological issues still constrain the quality and real-world relevance of the existing evidence base. We examine five core challenges in randomised controlled trials of mental health and psychosocial support interventions with conflict-affected and disaster-affected populations. These challenges are: translating intervention effects into metrics of real-world significance; giving adequate consideration to the selection and monitoring of control conditions; following rigorous processes to ensure outcome measures are culturally appropriate and psychometrically sound; ensuring and monitoring implementation variables, including fidelity, exposure, participant engagement, and the competence of implementation staff; and assessing mechanisms of change.

Evaluation of the Early Adolescent Skills for Emotions (EASE) intervention in Lebanon: A randomized controlled trial.

BACKGROUND: There is a need for scalable evidence-based psychological interventions for young adolescents experiencing high levels of psychological distress in humanitarian settings and low- and middle-income countries. Poor mental health during adolescence presents a serious public health concern as it is a known predictor of persistent mental disorders in adulthood. This study evaluates the effectiveness of a new group-based intervention developed by the World Health Organization (Early Adolescent Skills for Emotions; EASE), implemented by non-specialists, to reduce young adolescents' psychological distress among mostly Syrian refugees in Lebanon. METHODS: We conducted a two-arm, single-blind, individually randomized group treatment trial. Adolescents aged 10 to 14 years who screened positive for psychological distress using the Pediatric Symptom Checklist (PSC) were randomly allocated to EASE or enhanced treatment as usual (ETAU) (1:1.6). ETAU consisted of a single scripted psycho-education home-visit session with the adolescent and their caregivers. EASE consists of seven group sessions with adolescents and three sessions with caregivers. The primary outcome was adolescent-reported psychological distress as measured with the PSC (internalizing, externalizing, and attentional symptoms). Secondary outcomes included depression, posttraumatic stress, well-being, functioning, and caregivers' parenting and distress. All outcomes were assessed at baseline, endline, and 3 months (primary time point) and 12 months follow-up. RESULTS: Due to the COVID-19 pandemic and other adversities in Lebanon at the time of this research, the study was prematurely terminated, resulting in an under-powered trial sample (n = 198 enrolled compared to n = 445 targeted). We screened 604 children for eligibility. The 198 enrolled adolescents were assigned to EASE (n = 80) and ETAU (n = 118), with retention rates between 76.1 and 88.4% across all timepoints. Intent-to-treat analyses demonstrated no between-group differences on any of the outcome measures between the EASE and ETAU. We did observe a significant improvement on the primary outcome equally in the EASE and ETAU groups (-0.90, 95% CI: -3.6, 1.8; p = .52), - a trend that was sustained at three months follow-up. Sub-group analyses, for those with higher depression symptoms at baseline, showed ETAU outperformed EASE on reducing depression symptoms (difference in mean change = 2.7, 95% CI: 0.1, 5.3; p = .04; d = 0.59) and internalizing problems (difference in mean change 1.0, 95% CI: 0.08, 1.9; p = .03; d = 0.56) . CONCLUSION: No conclusions can be drawn about the comparative effectiveness of the intervention given that the sample was underpowered as a result of early termination. Both EASE and single session psycho-education home visits resulted in meaningful improvements in reducing psychological distress. We did not identify any indications in the data suggesting that EASE was more effective than a single session family intervention in the context of the COVID-19 pandemic and other crises in Lebanon. Fully powered research is needed to evaluate the effectiveness of EASE.

Interventions to increase help-seeking for mental health care in low- and middle-income countries: A systematic review.

Mental health problems are a significant and growing cause of morbidity worldwide. Despite the availability of evidence-based interventions, most people experiencing mental health problems remain untreated. This treatment gap is particularly large in low- and middle-income countries (LMIC) and is due to both supply-side and demand-side barriers. The aim of this systematic review is to identify and synthesise the evidence on interventions to improve help-seeking for mental health problems in LMICs. The protocol was registered a priori (Registration number: CRD42021255635). We searched eight databases using terms based on three concepts: 'mental health/illness' AND 'help-seeking' AND 'LMICs'; and included all age groups and mental health problems. Forty-two papers were eligible and included in this review. Intervention components were grouped into three categories following the steps in the help-seeking process: (1) raising mental health awareness among the general population (e.g., distribution of printed or audio-visual materials), (2) identification of individuals experiencing mental health problems (e.g., community-level screening or detection), and (3) promoting help-seeking among people in need of mental health care (e.g., sending reminders). The majority of interventions (80%) included components in a combination of the aforementioned categories. Most studies report positive outcomes, yet results on the effectiveness is mixed, with a clear trend in favour of interventions with components from more than one category. Ten out of 42 studies (24%) yielded a statistically significant effect of the intervention on help-seeking; and all targeted a combination of the aforementioned categories (i.e., raising awareness, identification and help-seeking promotion). Only six studies (14%) focused on children and adolescents. Due to the limited number of robust studies done in LMICs and the heterogeneity of study designs, outcomes and components used, no definite conclusions can be drawn with regards to the effects of individual strategies or content of the interventions.

Development and testing the feasibility of a sports-based mental health promotion intervention in Nepal: a protocol for a pilot cluster-randomised controlled trial.

BACKGROUND: Mental wellbeing encompasses life satisfaction, social connectedness, agency and resilience. In adolescence, mental wellbeing reduces sexual health risk behaviours, substance use and violence; improves educational outcomes; and protects mental health in adulthood. Mental health promotion seeks to improve mental wellbeing and can include activities to engage participants in sport. However, few high-quality trials of mental health promotion interventions have been conducted with adolescents, especially in low- and middle-income countries. We sought to address this gap by testing SMART (Sports-based Mental heAlth pRomotion for adolescenTs) in a pilot cluster-randomised controlled trial (cRCT) in Bardiya, Nepal. METHODS: The objectives of the trial are to assess the acceptability and feasibility of SMART, test trial procedures, explore outcome distributions in intervention and control clusters and calculate the total annual cost of the intervention and unit cost per adolescent. The trial design is a parallel-group, two-arm superiority pilot cRCT with a 1:1 allocation ratio and two cross-sectional census surveys with adolescents aged 12-19, one pre-intervention (baseline) and one post-intervention (endline). The study area is four communities of approximately 1000 population (166 adolescents per community). Each community represents one cluster. SMART comprises twice weekly football, martial arts and dance coaching, open to all adolescents in the community, led by local sports coaches who have received psychosocial training. Sports melas (festivals) and theatre performances will raise community awareness about SMART, mental health and the benefits of sport. Adolescents in control clusters will participate in sport as usual. In baseline and endline surveys, we will measure mental wellbeing, self-esteem, self-efficacy, emotion regulation, social support, depression, anxiety and functional impairment. Using observation checklists, unstructured observation and attendance registers from coaching sessions, and minutes of meetings between coaches and supervisors, we will assess intervention fidelity, exposure and reach. In focus group discussions and interviews with coaches, teachers, caregivers and adolescents, we will explore intervention acceptability and mechanisms of change. Intervention costs will be captured from monthly project accounts, timesheets and discussions with staff members. DISCUSSION: Findings will identify elements of the intervention and trial procedures requiring revision prior to a full cRCT to evaluate the effectiveness of SMART. TRIAL REGISTRATION: ISRCTN, ISRCTN15973986 , registered on 6 September 2022; ClinicalTrials.gov, NCT05394311 , registered 27 May 2022.