Exploring preference for delivery methods for a psychosocial intervention for prenatal anxiety: A qualitative study from a tertiary care hospital in Pakistan.

Objective: This qualitative study explores therapists' and participants' preferences for delivery methods (face-to-face and phone sessions) of a cognitive behavioral therapy-based psychosocial intervention for prenatal anxiety delivered in a tertiary care hospital. Setting: The research was conducted in a randomized controlled trial in Pakistan, where a shift from face-to-face to phone-based therapy occurred during the coronavirus disease-2019 (COVID-19) pandemic. Participants: Twenty in-depth interviews and a focus group discussion were conducted with participants and therapists, respectively. Transcripts were analyzed using thematic analysis. Results: Participants generally preferred face-to-face sessions for rapport building, communication, and comprehension. However, barriers like venue accessibility, childcare, and lack of family support hindered engagement. Telephone sessions were favored for easy scheduling and the comfort of receiving the session at home, but there were challenges associated with phone use, distractions at home, and family members' limited mental health awareness. A mix of face-to-face and telephone sessions was preferred, with rapport from in-person sessions carrying over to telephone interactions. Conclusion: This study underscores the need for adaptable intervention delivery strategies that consider cultural norms, logistical challenges, and individual family dynamics. By combining the benefits of both delivery methods, mental health interventions can be optimized to effectively address prenatal anxiety and promote well-being in resource-constrained settings like Pakistan.

Born in Bradford's Age of Wonder cohort: protocol for adolescent data collection.

Background: Adolescence and transition into adulthood are periods shaping life-long mental health, cardiometabolic risk, and inequalities. However, they are poorly studied and understood. By extending and expanding the Born in Bradford (BiB) cohort study through this period using innovative, co-produced approaches to collect and analyse data, we aim to understand better the interplay of factors that influence health and wellbeing, and inform/evaluate interventions to improve them and reduce inequalities. Protocol: BiB Age of Wonder (AoW) is a large, whole city cohort that will capture the contemporary lived experience amongst multi-ethnic adolescents progressing into young adulthood. We will collect repeated data from existing BiB participants and their peers (N~30,000 adolescents). The protocol for the first phase of the quantitative methods, involving survey measurements and health assessments in mainstream secondary schools is described here. We describe the co-production behind these methods, and lessons learned from the first year of data collection.

Born in Bradford have been following the health and wellbeing of over 13,000 Bradford children since they were born. This group of children are now in their teenage years ­ a time that is crucial for their future mental and physical health. Age of Wonder aims to capture this journey through adolescence and early adulthood with up to 30,000 young people in Bradford over 7 years. In the first phase of this project, data collection is taking part in secondary schools in Bradford. This protocol describes how this data collection is currently being carried out in the schools. Young people aged 12-15 are being asked to complete questionnaires, covering topics such as mental and physical health. These topics have been designed with groups of young people, schools and other partners, to make sure we are capturing data on the things most important to young people. Those in Year 9 (13-14 years old), are also asked to take part in physical health measurements such as height, weight, blood pressure and a blood sample, as well as computer-based assessments of cognition (memory), movement and language. There have been a number of lessons learned from the first full year of data collection, such as how to make the research as easy as possible for schools to take part in when they have so many competing demands on their time.

The immune phenotype of perinatal anxiety in an anxiety-focused behavioral intervention program in Pakistan.

BACKGROUND: Dysregulation of the immune system has been associated with psychiatric disorders and pregnancy-related complications, such as perinatal depression. However, the immune characteristics specific to perinatal anxiety remain poorly understood. In this study, our goal was to examine specific immune characteristics related to prenatal anxiety within the context of a randomized controlled trial designed to alleviate anxiety symptoms-the Happy Mother - Healthy Baby (HMHB) study in Rawalpindi, Pakistan. MATERIALS AND METHODS: Pregnant women (n = 117) were followed prospectively in the 1st, 2nd, and 3rd trimesters (T1, T2, T3) and at 6 weeks postpartum (PP6). Each visit included a blood draw and anxiety evaluation (as measured by the anxiety subscale of the Hospital Anxiety and Depression Scale - HADS -using a cutoff ≥ 8). We enrolled both healthy controls and participants with anxiety alone; those with concurrent depression were excluded. RESULTS: K-means cluster analysis revealed three anxiety clusters: Non-Anxiety, High and Consistent Anxiety, and Decreasing Anxiety. Principal components analysis revealed two distinct clusters of cytokine and chemokine activity. Women within the High and Consistent Anxiety group had significantly elevated chemokine activity across pregnancy (in trimester 1 (ß = 0.364, SE = 0.178, t = 2.040, p = 0.043), in trimester 2 (ß = 0.332, SE = 0.164, t = 2.020, p = 0.045), and trimester 3 (ß = 0.370, SE = 0.179, t = 2.070, p = 0.040) compared to Non-Anxiety group. Elevated chemokine activity was associated with low birthweight (LBW) and small for gestational age (SGA). CONCLUSION: Our findings reveal a unique pattern of immune dysregulation in pregnant women with anxiety in a Pakistani population and offer preliminary evidence that immune dysregulation associated with antenatal anxiety may be associated with birth outcomes. The dysregulation in this population is distinct from that in our other studies, indicating that population-level factors other than anxiety may play a substantial role in the differences found. (Clinicaltrials.gov # NCT04566861).

Multicomponent Behavioural Intervention during Pregnancy to Reduce Home Exposure to Second-Hand Smoke: A Pilot Randomised Controlled Trial in Bangladesh and India.

BACKGROUND: Pregnant women exposed to second-hand smoke (SHS) are at increased risk of poor birth outcomes. We piloted multicomponent behavioural intervention and trial methods in Bangalore, India, and Comilla, Bangladesh. METHODS: A pilot individual randomised controlled trial with economic and process evaluation components was conducted. Non-tobacco-using pregnant women exposed to SHS were recruited from clinics and randomly allocated to intervention or control (educational leaflet) arms. The process evaluation captured feedback on the trial methods and intervention components. The economic component piloted a service use questionnaire. The primary outcome was saliva cotinine 3 months post-intervention. RESULTS: Most pregnant women and many husbands engaged with the intervention and rated the components highly, although the cotinine report elicited some anxiety. Forty-eight (Comilla) and fifty-four (Bangalore) women were recruited. The retention at 3 months was 100% (Comilla) and 78% (Bangalore). Primary outcome data were available for 98% (Comilla) and 77% (Bangalore). CONCLUSIONS: The multicomponent behavioural intervention was feasible to deliver and was acceptable to the interventionists, pregnant women, and husbands. With the intervention, it was possible to recruit, randomise, and retain pregnant women in Bangladesh and India. The cotinine data will inform sample size calculations for a future definitive trial.

Family concerns and relationship problems in anxious pregnant women and their associations with postnatal functional disability in Pakistan.

OBJECTIVE: Expanding on existing research suggesting that strategies to reduce prenatal anxiety can decrease functional disability (e.g., difficulties in performing everyday activities and social participation), we examined if this effect varied by type of anxiety-producing problem (i.e., having family concerns and relationship problems versus other problems) reported during pregnancy. Further, we explored if perceived social support mediated this relationship. METHODS: We used longitudinal data on 310 anxious Pakistani women who received any psychosocial intervention sessions as part of a program that was based on Cognitive Behavioral Therapy. The Psychological Outcome Profiles (PSYCHLOPS) was used to assess whether women had 'family concerns and relationship problems' or 'other problems.' The WHO Disability Assessment Schedule 2.0 assessed functional disability at six-weeks after delivery. Lack of support was measured using a 12-item Multi-dimensional Scale of Perceived Social Support. We employed linear regression to examine associations between types of problems reported during pregnancy and postnatal functional disability. Causal mediation analysis was used to assess whether postnatal social support mediated this relationship. RESULTS: Of anxious pregnant women, 34% reported family concerns or relationship problems as primary problems in pregnancy. They were more likely to report higher functional disability at six-weeks after delivery than women who reported other problems (adjusted B = 2.40, 95% CI: 0.83-3.97). Lack of overall social support (Estimateindirect = 0.69, 95% CI: 0.04-1.38) and lack of support from friends (Estimateindirect = 0.62, 95% CI: 0.01-1.29) significantly mediated the relationship. CONCLUSIONS: Findings suggest that complementing pre- and post-natal care with support programs and services that address family concerns and relationship problems, as well as enhancing social support is important to functional disability.

Social Support and Spousal Relationship Quality Improves Responsiveness among Anxious Mothers.

Maternal responsiveness, a mother's ability to consistently identify infant cues and then act on them, is critical for healthy child development. A woman's social support and spousal relationship may affect responsiveness to an infant, especially among mothers with anxiety. We assessed how social support and spousal relationship quality is associated with responsiveness among anxious mothers, and if postpartum depression (PPD) moderated these associations. Cross-sectional data were collected from 2019 to 2022 in a public hospital in Pakistan from 701 women at six-weeks postpartum. Eligible women had at least mild anxiety in early- to mid- pregnancy. Linear regression analyses assessed if spousal relationship quality and social support from family and friends were associated with maternal responsiveness, measured using the Maternal Infant Responsiveness Instrument. Interaction terms were used to examine if PPD moderated these associations. Spousal relationship quality (B = 2.49, 95% CI: 1.48, 3.50) and social support (B = 1.07, 95% CI: 0.31, 1.83) were positively related to maternal responsiveness to the infant. Emotional support from a spouse was positively associated with responsiveness (B = 1.08, 95% CI: 0.12, 2.03 depressed; B = 2.96, 95% CI: 1.34, 4.58 non-depressed), and conflict with the spouse was negatively associated with responsiveness (B=-1.02, 95% CI: -1.94, -0.09 depressed; B=-2.87, 95% CI: -4.36, -1.37 non-depressed). However, social support was related to responsiveness only in non-depressed women (B = 2.61, 95% CI: 1.14, 4.07). While spousal relationships and social support enhance maternal responsiveness, for depressed women, spousal relationships were particularly critical. In considering maternal-infant interventions to improve child development outcomes, our study indicates the importance of supportive relationships that foster effective responsiveness.

Editorial: Equity/inequality, diversity and inclusion in child and adolescent mental health - a perspective from the South Asian region.

Over 1.8 billion people, about a quarter of the world's population live in the seven countries of South Asia: Afghanistan, Bangladesh, Bhutan, India, Nepal, Pakistan, and Sri Lanka. The population is characterized by a significant demographic youth bulge, with over 40% under the age of 18. This young population poses challenges related to ensuring their well-being and development. Issues such as poverty, undernutrition, lack of early stimulation, limited access to quality education and health care, and gender disparities persist in large parts of South Asia, affecting the lives of many children and adolescents. The promotion of child and adolescent mental health remains a challenge. Accumulating evidence suggests that early interventions can provide long-term health and socioeconomic benefits by prevention of the onset of mental health problems and their development into chronic disorders. This needs to be coupled with specialist services that can cater to the needs of children with greater needs, and support the community and schools-based non-specialist led services. Addressing child and adolescent mental health in South Asia presents a window of opportunity, because this regional youth bulge can contribute significantly to the global economy of the future.

Pregnancy stressors and postpartum symptoms of depression and anxiety: the moderating role of a cognitive-behavioural therapy (CBT) intervention.

Background: Little is known about the association between stressors (especially positive stressors) during pregnancy and postpartum depression and anxiety. Aims: We investigated the association between positive and negative stress events during different stages of pregnancy and postpartum mental health outcomes among low-income pregnant women with symptoms of anxiety in Pakistan and evaluated whether an intervention based on cognitive-behavioural therapy (CBT) had a regulatory effect. Methods: Participants were 621 pregnant Pakistani women with mild anxiety. Using the Pregnancy Experience Scale-Brief Version, six scores were created to assess positive and negative stressors. We performed a multivariate linear regression to examine whether these six scores, measured both at baseline and in the third trimester, were associated with postpartum anxiety and depressive symptoms. The effect of the intervention on this relationship was examined by adding an interaction term to the regression model. Results: Hassles frequency measured in the third trimester was positively associated with depression (B=0.22, 95% confidence interval (CI): 0.09 to 0.36) and anxiety (B=0.19, 95% CI: 0.08to 0.30). At the same timepoint, uplifts intensity was negatively associated with symptoms of depression (B=-0.82, 95% CI: -1.46 to -0.18) and anxiety (B=-0.70, 95% CI: -1.25 to -0.15), whereas hassles intensity was positively related to symptoms of depression (B=1.02, 95% CI: 0.36 to 1.67) and anxiety (B=0.90, 95% CI: 0.34 to 1.47). The intensity ratio of hassles to uplifts reported in the third trimester was positively related to both depression (B=1.40, 95% CI: 0.59 to 2.20) and anxiety (B=1.26, 95% CI: 0.57 to 1.96). The intervention strengthened the overall positive effects of uplifts and the negative effects of hassles. Pregnancy experiences at baseline during early pregnancy to mid-pregnancy were not associated with mental health outcomes. Conclusions: Stressors in the third trimester but not earlier in pregnancy were associated with postpartum symptoms of anxiety and depression. The CBT intervention modified the association between pregnancy stressors and postpartum mental health outcomes. Programmes that promote positive experiences and reduce negative experiences, especially in late pregnancy, may mitigate postpartum mental health consequences. Trial registration number: NCT03880032.

Anxiety-focused cognitive behavioral therapy delivered by non-specialists to prevent postnatal depression: a randomized, phase 3 trial.

Anxiety experienced by women during pregnancy is highly prevalent, especially in resource-poor settings and strongly predicts postnatal common mental disorders (CMDs), anxiety and depression. We evaluated the effectiveness of an anxiety-focused early prenatal intervention on preventing postnatal CMDs. This study was a phase 3, two-arm, single-blind, randomized controlled trial conducted in Pakistan with women who were ≤22 weeks pregnant and had at least mild anxiety without clinical depression. Participants were randomized to the Happy Mother-Healthy Baby program, based on cognitive behavioral therapy, consisting of six one-on-one intervention sessions in pregnancy delivered by non-specialist providers, or to enhanced care alone. The primary outcome was major depression, generalized anxiety disorder or both at 6 weeks after delivery. Overall, 755 women completed postnatal assessments (380 (50.3%), intervention arm; 375 (49.7%) enhanced-care arm). The primary outcomes were met. Examined jointly, we found 81% reduced odds of having either a major depressive episode (MDE) or moderate-to-severe anxiety for women randomized to the intervention (adjusted odds ratio (aOR) = 0.19, 95% CI 0.14-0.28). Overall, 12% of women in the intervention group developed MDE at 6 weeks postpartum, versus 41% in the control group. We found reductions of 81% and 74% in the odds of postnatal MDE (aOR = 0.19, 95% CI 0.13-0.28) and of moderate-to-severe anxiety (aOR = 0.26, 95% CI 0.17-0.40), respectively. The Happy Mother-Healthy Baby program early prenatal intervention focusing on anxiety symptoms reduced postpartum CMDs. ClinicalTrials.gov identifier NCT03880032 .

scGIST: gene panel design for spatial transcriptomics with prioritized gene sets.

A critical challenge of single-cell spatial transcriptomics (sc-ST) technologies is their panel size. Being based on fluorescence in situ hybridization, they are typically limited to panels of about a thousand genes. This constrains researchers to build panels from only the marker genes of different cell types and forgo other genes of interest, e.g., genes encoding ligand-receptor complexes or those in specific pathways. We propose scGIST, a constrained feature selection tool that designs sc-ST panels prioritizing user-specified genes without compromising cell type detection accuracy. We demonstrate scGIST's efficacy in diverse use cases, highlighting it as a valuable addition to sc-ST's algorithmic toolbox.

Research Review: Psychological and psychosocial interventions for children and adolescents with depression, anxiety, and post-traumatic stress disorder in low- and middle-income countries - a systematic review and meta-analysis.

BACKGROUND: The incidence of depression, anxiety, and post-traumatic stress disorder (PTSD) among children and adolescents residing in low- and middle-income countries (LMICs) poses a significant public health concern. However, there is variation in the evidence of effective psychological interventions. This meta-analysis aims to provide a complete overview of the current body of evidence in this rapidly evolving field. METHODS: We conducted searches on PubMed, Embase.com, and EBSCO/APA PsycInfo databases up to June 23, 2022, identify randomized controlled trials (RCTs) investigating the effectiveness of psychological interventions in LMICs that targeted children and adolescents with elevated symptoms above a cut-off score for depression, anxiety, and PTSD, comparing a psychological or psychosocial intervention with other control conditions. We conducted random effects meta-analyses for depression, anxiety, and PTSD symptoms. Sensitivity analysis for outliers and high-risk studies, and analyses for the publication bias were carried out. Subgroup analyses investigated how the intervention type, intervention format, the facilitator, study design, and age group of the participant predicted effect sizes. RESULTS: Thirty-one RCTs (6,123 participants) were included. We found a moderate effect of interventions on depression outcomes compared to the control conditions (g = 0.53; 95% CI: 0.06-0.99; NNT = 6.09) with a broad prediction interval (PI) (-1.8 to 2.86). We found a moderate to large effect for interventions on anxiety outcomes (g = 0.88; 95% CI: -0.03 to 1.79; NNT = 3.32) with a broad PI (-3.14 to 4.9). Additionally, a moderate effect was observed on PTSD outcomes (g = 0.54; 95% CI: 0.19-0.9; NNT = 5.86) with a broad PI (-0.64 to 1.72). CONCLUSIONS: Psychological and psychosocial interventions aimed at addressing depression, anxiety, and PTSD among children and adolescents in LMICs have demonstrated promising results. However, future studies should consider the variation in evidence and incorporate long-term outcomes to better understand the effectiveness of these interventions.

Predictors of spontaneous remission and recovery among women with untreated perinatal depression in India and Pakistan.

Background: Mothers with perinatal depression can show different symptom trajectories and may spontaneously remit from depression, however, the latter is poorly understood. This is the first study which sought to investigate predictors of spontaneous remission and longer-term recovery among untreated women with perinatal depression. Methods: We analysed data from two randomised controlled trials in women with perinatal depression in India and Pakistan. Analyses were restricted to women in the control groups who did not receive active treatment. Generalised estimating equations and logistic regressions were used to estimate odds ratios (ORs) and 95% confidence intervals (CIs), adjusting for within-person correlation. Results: In multivariable analyses, remission was associated with a husband who is not working (adjusted OR, aOR = 2.04, 95% CI 1.02-4.11), lower Patient Health Questionnaire-9 score at baseline (aOR = 0.43, 95% CI 0.20-0.90 for score of ≥20 vs. 10-14) and better social support at baseline (aOR = 2.37, 95% CI 1.32-4.27 for high vs. low social support). Conclusions: Women with low baseline severity may remit from perinatal depression with adequate social support from family and friends. These factors are important contributors to the management of perinatal depression and the prevention of clinical worsening, and should be considered when designing low-threshold psychological interventions.

Optimizing cognitive and behavioral approaches for perinatal depression: A systematic review and meta-regression analysis.

Cognitive behavioral therapies (CBT) have been demonstrated efficacious in treating perinatal depression (PND). This has been demonstrated in several meta-analyses of randomized controlled trials and quasi-experimental studies. However, there is a need for up-to-date meta-analytical evidence providing reliable estimates for CBT's effectiveness in treating and preventing PND. Furthermore, with the world moving toward precision medicine, approaches require a critical synthesis of psychotherapies, especially to unpack their mechanisms of action and to understand what approaches work best for whom. Therefore, the present systematic review and meta-regression analyses aim to answer these research questions. We searched six academic databases through February 2022 and identified 56 studies for an in-depth review. Using pretested data extraction sheets, we extracted patient-level and intervention-level characteristics and effect size data from each study. Random-effects meta-analyses and mixed-effect subgroup analyses were run to delineate the effectiveness and moderators of CBT interventions for PND, respectively. CBT-based interventions yielded a strong effect size (SMD = -0.74, 95% confidence interval [CI]: -0.91 to -0.56, n = 9,722) in alleviating depressive symptoms. These interventions were effective across different delivery formats (individual, group, and electronic) and could be delivered effectively by specialists and nonspecialists. Longer duration CBT interventions may not necessarily be more effective than shorter ones. Moreover, CBT-based interventions should consider including various behavioral ingredients to maximize intervention benefits.

Translation, adaptation, and initial evaluation of a guided self-help intervention to reduce psychological distress among nurses during COVID-19 in China.

Background: This study aimed to reduce the unprecedented and intense psychological distress that nurses were forced to experience during the COVID-19 pandemic. A Chinese version of the World Health Organization's Self-Help Plus (SH+) intervention guide was adapted and tested among nurses. The objective of this study was to translate and adapt the SH+ guideline into the Chinese version and to test its feasibility in reducing psychological distress among nurses during COVID-19. Methods: A staged approach comprising translation, adaptations, initial evaluation by pilot implementation, and a qualitative process evaluation was conducted in two hospitals in Xi'an, China. The translation of the Chinese version was authorized by the World Health Organization. We adapted SH+ for use among clinical nurses working during the pandemic in China through a qualitative process evaluation, which was guided by the descriptive phenomenological study design. The outcomes of the pilot included psychological distress, psychological flexibility, depressive and anxiety symptoms, post-traumatic stress disorder (PTSD) symptoms, and subjective psychological wellbeing, which were assessed using the Kessler 6 symptom checklist, the Comprehensive Assessment of ACT Process (CompACT), the Patient Health Questionnaire-9 (PHQ-9), the Generalized Anxiety Disorder scale (GAD-7), the PTSD Checklist-Civilian Version (PCL-C), and the Index of Wellbeing (IWB), respectively. Results: The SH+ materials, including audio-recorded sessions and an accompanying illustrated manual, were translated into Chinese and adapted in line with feedback from the nurses. An uncontrolled pilot study (n = 28) for 5 weeks showed a statistically significant reduction of psychological distress (mean difference in Kessler 6 score, -2.74; 95% CI [-3.71, -1.78]; p < 0.001). We also found improvements in psychological flexibility (mean difference in CompACT score, 6.89; 95% CI [-12.35, -4.47]; p < 0.001), subjective psychological wellbeing (mean difference in IWB score, 0.86; 95% CI [0.07, 1.65]; p < 0.05), and depressive symptoms (mean difference in PHQ-9 score, -1.52; 95% CI [-2.78, -0.26]; p < 0.05). The process evaluation showed that nurses found the SH+ program very useful but difficult to adhere to. Conclusion: We found that the translated Chinese version of SH+ was applicable and feasible in the Chinese cultural context. There was a potential effect of adapted SH + in reducing nurses' psychological distress during COVID-19 and suggested the value of exploring strategies to increase adherence to the program.

Exploring Heterogeneity in perinatal depression: a comprehensive review.

Perinatal depression (PND) is a significant contributor to maternal morbidity globally. Recognized as a major cause of poor infant development, epidemiological and interventional research on it has increased over the last decade. Recently, studies have pointed out that PND is a heterogeneous condition, with variability in its phenotypes, rather than a homogenous latent entity and a concrete diagnosis, as previously conceptualized in psychometric literature and diagnostic systems. Therefore, it is pertinent that researchers recognize this to progress in elucidating its aetiology and developing efficacious interventions.This systematic review is conducted in accordance with the Meta-analysis of observational studies in epidemiology (MOOSE). It aims to provide an updated and comprehensive account of research on heterogeneity in phenotypes of PND and its implications in research, public health, and clinical practice. It provides a synthesis and quality assessment of studies reporting heterogeneity in PND using cutting-edge statistical techniques and machine learning algorithms. After reporting the phenotypes of PND, based on heterogeneous trajectories and symptom profiles, it also elucidates the risk factors associated with severe forms of PND, followed by robust evidence for adverse child outcomes. Furthermore, recommendations are made to improve public health and clinical practice in screening, diagnosis, and treatment of PND.

Technology-assisted cognitive-behavior therapy delivered by peers versus standard cognitive behavior therapy delivered by community health workers for perinatal depression: study protocol of a cluster randomized controlled non-inferiority trial.

BACKGROUND: The lack of trained mental health professionals is a key barrier to scale-up of evidence-based psychological interventions in low and middle-income countries. We have developed an app that allows a peer with no prior experience of health-care delivery to deliver the cognitive therapy-based intervention for perinatal depression, the Thinking Healthy Programme (THP). This trial aims to assess the effectiveness and cost-effectiveness of this Technology-assisted peer-delivered THP versus standard face-to-face Thinking Healthy Programme delivered by trained health workers. METHODS: We will employ a non-inferiority stratified cluster randomized controlled trial design comparing the two formats of intervention delivery. A total of 980 women in the second or third trimester of pregnancy with a diagnosis of Major Depressive Episode, evaluated with the Structured Clinical Interview for DSM-V Disorders (SCID), will be recruited into the trial. The unit of randomization will be 70 village clusters randomly allocated in a 1:1 ratio to the intervention and control arms. The primary outcome is defined as remission from major depressive episode at 3 months postnatal measured with the SCID. Data will also be collected on symptoms of anxiety, disability, quality of life, service use and costs, and infant-related outcomes such as exclusive breastfeeding and immunization rates. Data will be collected on the primary outcome and selected secondary outcomes (depression and anxiety scores, exclusive breastfeeding) at 6 months postnatal to evaluate if the improvements are sustained in the longer-term. We are especially interested in sustained improvement (recovery) from major depressive episode. DISCUSSION: This trial will evaluate the effectiveness and cost-effectiveness of a technology-assisted peer-delivered cognitive behavioral therapy-based intervention in rural Pakistan. If shown to be effective, the novel delivery format could play a role in reducing the treatment gap for perinatal depression and other common mental disorders in LMIC. TRIAL REGISTRATION: The trial was registered at Clinicaltrials.gov (NCT05353491) on 29 April 2022.

Can home visits for early child development be implemented with sufficient coverage and quality at scale? Evidence from the SPRING program in India and Pakistan.

Introduction: There is limited evidence from low and middle-income settings on the effectiveness of early child development interventions at scale. To bridge this knowledge-gap we implemented the SPRING home visiting program where we tested integrating home visits into an existing government program (Pakistan) and employing a new cadre of intervention workers (India). We report the findings of the process evaluation which aimed to understand implementation. Methods and materials: We collected qualitative data on acceptability and barriers and facilitators for change through 24 in-depth interviews with mothers; eight focus group discussions with mothers, 12 with grandmothers, and 12 with fathers; and 12 focus group discussions and five in-depth interviews with the community-based agents and their supervisors. Results: Implementation was sub-optimal in both settings. In Pakistan issues were low field-supervision coverage and poor visit quality related to issues scheduling supervision, a lack of skill development, high workloads and competing priorities. In India, issues were low visit coverage - in part due to employing new workers and an empowerment approach to visit scheduling. Coaching caregivers to improve their skills was sub-optimal in both sites, and is likely to have contributed to caregiver perceptions that the intervention content was not new and was focused on play activities rather than interaction and responsivity - which was a focus of the coaching. In both sites caregiver time pressures was a key reason for low uptake among families who received visits. Discussion: Programs need feasible strategies to maximize quality, coverage and supervision including identifying and managing problems through monitoring and feedback loops. Where existing community-based agents are overstretched and system strengthening is unlikely, alternative implementation strategies should be considered such as group delivery. Core intervention ingredients such as coaching should be prioritized and supported during training and implementation. Given that time and resource constraints were a key barrier for families a greater focus on communication, responsivity and interaction during daily activities could have improved feasibility.

Effect of the SPRING home visits intervention on early child development and growth in rural India and Pakistan: parallel cluster randomised controlled trials.

Introduction: Almost 250 million children fail to achieve their full growth or developmental potential, trapping them in a cycle of continuing disadvantage. Strong evidence exists that parent-focussed face to face interventions can improve developmental outcomes; the challenge is delivering these on a wide scale. SPRING (Sustainable Programme Incorporating Nutrition and Games) aimed to address this by developing a feasible affordable programme of monthly home visits by community-based workers (CWs) and testing two different delivery models at scale in a programmatic setting. In Pakistan, SPRING was embedded into existing monthly home visits of Lady Health Workers (LHWs). In India, it was delivered by a civil society/non-governmental organisation (CSO/NGO) that trained a new cadre of CWs. Methods: The SPRING interventions were evaluated through parallel cluster randomised trials. In Pakistan, clusters were 20 Union Councils (UCs), and in India, the catchment areas of 24 health sub-centres. Trial participants were mother-baby dyads of live born babies recruited through surveillance systems of 2 monthly home visits. Primary outcomes were BSID-III composite scores for psychomotor, cognitive and language development plus height for age z-score (HAZ), assessed at 18 months of age. Analyses were by intention to treat. Results: 1,443 children in India were assessed at age 18 months and 1,016 in Pakistan. There was no impact in either setting on ECD outcomes or growth. The percentage of children in the SPRING intervention group who were receiving diets at 12 months of age that met the WHO minimum acceptable criteria was 35% higher in India (95% CI: 4-75%, p = 0.023) and 45% higher in Pakistan (95% CI: 15-83%, p = 0.002) compared to children in the control groups. Discussion: The lack of impact is explained by shortcomings in implementation factors. Important lessons were learnt. Integrating additional tasks into the already overloaded workload of CWs is unlikely to be successful without additional resources and re-organisation of their goals to include the new tasks. The NGO model is the most likely for scale-up as few countries have established infrastructures like the LHW programme. It will require careful attention to the establishment of strong administrative and management systems to support its implementation.

Maternal time investment in caregiving activities to promote early childhood development: evidence from rural India.

Introduction: Intervention strategies that seek to improve early childhood development outcomes are often targeted at the primary caregivers of children, usually mothers. The interventions require mothers to assimilate new information and then act upon it by allocating sufficient physical resources and time to adopt and perform development promoting behaviours. However, women face many competing demands on their resources and time, returning to familiar habits and behaviours. In this study, we explore mothers' allocation of time for caregiving activities for children under the age of 2, nested within a cluster randomised controlled trial of a nutrition and care for development intervention in rural Haryana, India. Methods: We collected quantitative maternal time use data at two time points in rural Haryana, India, using a bespoke survey instrument. Data were collected from 704 mothers when their child was 12 months old, and 603 mothers when their child was 18 months old. We tested for significant differences in time spent by mothers on different activities when children are 12 months of age vs. 18 months of age between arms as well as over time, using linear regression. As these data were collected within a randomised controlled trial, we adjusted for clusters using random effects when testing for significant differences between the two time points. Results: At both time points, no statistically significant difference in maternal time use was found between arms. On average, mothers spent most of their waking time on household chores (over 6 h and 30 min) at both time points. When children were aged 12 months, approximately three and a half hours were spent on childcare activities for children under the age of 2 years. When children were 18 months old, mothers spent more time on income generating activities (30 min) than when the children were 12 years old, and on leisure (approximately 4 h and 30 min). When children were 18 months old, less time was spent on feeding/breastfeeding children (30 min less) and playing with children (15 min). However, mothers spent more time talking or reading to children at 18 months than at 12 months. Conclusion: We find that within a relatively short period of time in early childhood, maternal (or caregiver) time use can change, with time allocation being diverted away from childcare activities to others. This suggests that changing maternal time allocation in resource poor households may be quite challenging, and not allow the uptake of new and/or optimal behaviours.

Mental health and psychosocial support in humanitarian settings: research priorities for 2021-30.

We describe an effort to develop a consensus-based research agenda for mental health and psychosocial support (MHPSS) interventions in humanitarian settings for 2021-30. By engaging a broad group of stakeholders, we generated research questions through a qualitative study (in Indonesia, Lebanon, and Uganda; n=101), consultations led by humanitarian agencies (n=259), and an expert panel (n=227; 51% female participants and 49% male participants; 84% of participants based in low-income and middle-income countries). The expert panel selected and rated a final list of 20 research questions. After rating, the MHPSS research agenda favoured applied research questions (eg, regarding workforce strengthening and monitoring and evaluation practices). Compared with research priorities for the previous decade, there is a shift towards systems-oriented implementation research (eg, multisectoral integration and ensuring sustainability) rather than efficacy research. Answering these research questions selected and rated by the expert panel will require improved partnerships between researchers, practitioners, policy makers, and communities affected by humanitarian crises, and improved equity in funding for MHPSS research in low-income and middle-income countries.