The Role of Social Support in Perinatal Mental Health and Psychosocial Stimulation.

Social support refers to the help someone receives emotionally or instrumentally from their social network. Poor social support in the perinatal period has been associated with increased risk for symptoms of common mental disorders, including depression and posttraumatic stress symptoms (PTS), which may impact parenting behavior. Whether social support impacts parenting behaviors, independent of mental health symptomatology, remains unclear. Among N=309 participants of the Scaling Up Maternal Mental healthcare by Increasing access to Treatment (SUMMIT Trial), a large perinatal depression and anxiety treatment trial, we explored the relations between perceived social support, perinatal depressive and PTS symptoms, and psychosocial stimulation provided by the parent in their home environment. Social support was measured at baseline using the Multidimensional Scale of Perceived Social Support (MSPSS). Perinatal depressive symptoms were measured by the Edinburgh Postnatal Depression Scale (EPDS) and PTS symptoms were measured by the Abbreviated PTSD Checklist (PCL-6) at baseline, 3-, and 6-months post-randomization. Psychosocial stimulation was assessed by the Home Observation Measurement of the Environment (HOME) when the infant was between 6 to 24 months. Using stepwise hierarchical regressions, we found: (1) perceived social support at baseline significantly predicted both depressive and PTS symptoms at 3-months post-randomization, even when controlling for baseline depressive and PTS symptoms; and (2) while neither depressive nor PTS symptoms were significantly associated with psychosocial stimulation, perceived social support at baseline was a significant predictor. Clinical implications regarding treatment of perinatal patients are discussed.

Developmental and Nutritional Changes in Children with Severe Acute Malnutrition Provided with n-3 Fatty Acids Improved Ready-to-Use Therapeutic Food and Psychosocial Support: A Pilot Study in Tanzania.

Children with severe acute malnutrition (SAM) are at high risk of impaired development. Contributing causes include the inadequate intake of specific nutrients such as polyunsaturated fatty acids (PUFAs) and a lack of adequate stimulation. We conducted a pilot study assessing developmental and nutritional changes in children with SAM provided with a modified ready-to-use therapeutic food and context-specific psychosocial intervention in Mwanza, Tanzania. We recruited 82 children with SAM (6-36 months) and 88 sex- and age-matched non-malnourished children. We measured child development, using the Malawi Development Assessment Tool (MDAT), measures of family and maternal care for children, and whole-blood PUFA levels. At baseline, the mean total MDAT z-score of children with SAM was lower than non-malnourished children; -2.37 (95% confidence interval: -2.92; -1.82), as were their total n-3 fatty acids, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) levels. After 8 weeks of intervention, MDAT z-scores improved in all domains, especially fine motor, among children with SAM. Total n-3 and EPA levels increased, total n-6 fatty acids decreased, and DHA remained unchanged. Family and maternal care also improved. The suggested benefits of the combined interventions on the developmental and nutritional status of children with SAM will be tested in a future trial.

Child development beyond the nutrition-specific models: bridging the pathways via psychosocial stimulation.

Background: Undernutrition has severe and lasting consequences on child development. Evidently, the interventions based on the biomedical model with food and direct supplementation have failed to produce the desired outcomes for decades. In light of the established positive effects of psychosocial stimulation on developmental outcomes, we propose that the observed failures relate to not including psychosocial stimulation within the interventions. Here we test whether psychosocial stimulation mediates the association between nutritional status and motor and mental development in a large cohort from Madhya Pradesh, India. Method: Using a correlational design in children below 3 years of age (N = 275; Males = 148, Females = 127) nutritional status was measured through mid-upper arm circumference (MUAC), psychosocial stimulation was assessed with the HOME-inventory, and motor and mental development were assessed with the Developmental Assessment Scales for Indian Infants (DASII). We assessed the effectiveness of 25-week intervention model incorporating psychosocial stimulation on 95 undernourished children in experimental group and 77 in control group. Results: The study found that psychosocial stimulation fully mediated the relationship between nutritional status and the motor development [Effect = 1.03, 95% C.I. (0.19, 2.04), p = 0.05] and mental development [Effect = 0.49, 95% C.I. (0.09, 1.03), p = 0.05] in children under 3 years of age. Nutritional status significantly predicted the psychosocial stimulation to the child (R2 = 0.77). Analyzing the effectiveness of the intervention program revealed significant reduction in the developmental delays in both the motor [t(81) = 2.568, p = 0.012] and mental development [t(81) = 4.506, p = 0.001] of the undernourished children. Conclusion: Findings indicate that nutrition translates into positive developmental outcomes in a child only with the scaffolding effects of psychosocial stimulation primarily received from home. Integrating psychosocial stimulation activities like storytelling, play, art and crafts, puppets, travel etc. in the intervention programs designed to address undernutrition may yield rich dividends in bridging the developmental delays among undernourished children.

Scaling-up an early childhood parenting intervention by integrating into government health care services in rural Bangladesh: A cluster-randomised controlled trial.

AIMS: We evaluated the feasibility and effectiveness of utilising government health supervisors to train and supervise primary health care workers (HWs) in community clinics to deliver parenting sessions as part of their usual duties. METHODS: We randomly allocated 16 unions in the Mymensing district of Bangladesh 1:1 to an intervention or control group. HWs in clinics in the eight intervention unions (n = 59 health workers, n = 24 clinics) were trained to deliver a group-based parenting intervention, with training and supervision provided by government supervisors. In each of the 24 intervention clinics, we recruited 24 mothers of children aged 6-24 months to participate in the parenting sessions (n = 576 mother/child dyads). Mother/child dyads attended fortnightly parenting sessions at the clinic in groups of four to five participants for 6 months (13 sessions). We collected data on supervisor and HW compliance in implementing the intervention, mothers' attendance and the observed quality of parenting sessions in all intervention clinics and HW burnout at endline in all clinics. We randomly selected 32 clinics (16 intervention, 16 control) and 384 mothers (192 intervention, 192 control) to participate in the evaluation on mother-reported home stimulation, measured at baseline and endline. RESULTS: Supervisors and HWs attended all training, 46/59 health workers (78%) conducted the majority of parenting sessions, (only two HWs [3.4%] refused) and mothers' attendance rate was 86%. However, supervision levels were low: only 32/57 (56.1%) of HWs received at least one supervisory visit. Intervention HWs delivered the parenting sessions with acceptable levels of quality on most items. The intervention significantly benefitted home stimulation (effect size = 0.53SD, 95% confidence interval: 0.50, 0.56, p < 0.001). HW burnout was low in both groups. CONCLUSION: Integration into the primary health care service is a promising approach for scaling early childhood development programmes in Bangladesh, although further research is required to identify feasible methods for facilitator supervision.

Perceptions of Older People with Cognitive Impairment, Caregivers, and Professionals about ehcoBUTLER (Tablet Health Care Platform): A Qualitative Focus Group Study.

EhcoBUTLER is a tablet platform mainly aimed at the elderly with mild cognitive impairment (MCI) to promote their well-being and health. The main objective of this study was to explore the perceptions and feedback level of the ehcoBUTLER potential users and stakeholders to improve its development. Through this exploration, the secondary objective was to contribute to the development of software/apps that promote their integral health. Focus groups were conducted (13 elderly with MCI, 13 with dementia, 12 caregivers, 11 professionals). The content and feedback level were analyzed. Participants liked the appearance of ehcoBUTLER, would like to use it, and were mainly interested in the emotional, healthy lifestyle, cognitive, and ergonomic tools. It is necessary to have prior training, more intuitive/customizable apps, low-price/free, offline/USB content, and add other activities/features. EhcoBUTLER is well-oriented to meet the needs and preferences of potential users. However, improvements in its usability, accessibility, and sustainability are needed. The participants' perspectives provided a comprehensive view to improve ehcoBUTLER, so that in the future, it can benefit the elderly to be active agents in their health; support caregivers in their role and to have a respite; and professionals to have a multi-intervention platform. The present findings can contribute to the development of tablet software/apps that promote the integral well-being of this population.

A Mixed-Methods Cluster-Randomized Controlled Trial of a Hospital-Based Psychosocial Stimulation and Counseling Program for Caregivers and Children with Severe Acute Malnutrition.

BACKGROUND: Children with severe acute malnutrition (SAM) who require nutritional rehabilitation unit (NRU) treatment often have poor developmental and nutritional outcomes following discharge. The Kusamala Program is a 4-d hospital-based counseling program for caregivers of children with SAM that integrates nutrition, water, sanitation, and hygiene and psychosocial stimulation, aimed at improving these outcomes. OBJECTIVES: The aim was to evaluate the effects of the Kusamala Program on child development and nutritional status in children with SAM 6 mo after NRU discharge. The other aim was to qualitatively understand perceptions and experiences of caregivers who participated in the intervention. METHODS: A cluster-randomized controlled trial was conducted with caregivers and their children 6-59 mo of age with SAM admitted to the Moyo NRU in Blantyre, Malawi. The primary outcome of the trial was child development according to Malawi Developmental Assessment Tool (MDAT) composite z-scores of gross motor, fine motor, language, and social domains. A qualitative component with focus group discussions and in-depth interviews was also completed with a subset of caregivers who participated in the trial. RESULTS: Sixty-eight caregivers and children were enrolled to clusters by week and randomly assigned to the comparison arm and 104 to the intervention arm. There were no differences in child development, with mean MDAT composite z-scores in the comparison arm of -1.2 (95% CI: -2.1, -0.22) and in the intervention arm of -1.1 (95% CI: -1.9, -0.40) (P = 0.93). The qualitative evaluation with 20 caregivers indicated that the 3 modules of the Kusamala Program were appropriate and that they applied many of the lessons learned at home as much as possible. CONCLUSIONS: The Kusamala Program did not result in improved developmental or nutritional outcomes, yet it was viewed positively by caregivers according to qualitative results. Future research should evaluate more intensive interventions for caregivers and children with SAM. This trial was registered at www.clinicaltrials.gov as NCT03072433.

Influence of enhanced nutrition and psychosocial stimulation in early childhood on cognitive functioning and psychological well-being in Guatemalan adults.

RATIONALE: Early-life nutrition interventions in low and middle-income countries have demonstrated long-term benefits on cognitive skills, however, their influence on socioemotional outcomes has not been fully explored. Moreover, the mediating processes through which nutrition intervention effects operate and are maintained over time are understudied. METHODS: We followed-up a cohort of Guatemalan adults who participated as children in a community randomized food-supplementation trial. We examined associations of exposure to nutritional supplementation from conception to age 2 years with executive function (measured using three sub-tests of the NIH Toolbox Cognition Battery) and psychological well-being (measured using two sub-scales of the NIH Toolbox Emotion Battery) at ages 40-57 years (n = 1268). We used structural equation modeling to investigate the mediating role of psychosocial stimulation (measured in childhood using parent reports and ratings of home environments), cognitive ability (measured at ages 26-42 years using standardized tests), and executive function on the association of early-life exposure to nutritional supplementation with adult psychological well-being (n = 1640). RESULTS: We found positive but inconsistent associations of nutritional supplementation in childhood with executive function and psychological well-being in adulthood. Psychosocial stimulation, cognitive ability, and executive function did not mediate the association of early-life nutritional supplementation with adult psychological well-being. We found strong and positive associations of psychosocial stimulation in childhood with cognitive ability, executive function, and psychological well-being in adulthood. Moreover, we observed no interaction of exposure to nutritional supplementation and psychosocial stimulation in childhood with cognitive and psychological well-being outcomes in adulthood. CONCLUSION: Our findings suggest that childhood nutrition interventions have long-lasting effects on cognitive ability and psychological well-being outcomes.

Adaptation and Integration of Psychosocial Stimulation, Maternal Mental Health and Nutritional Interventions for Pregnant and Lactating Women in Rural Bangladesh.

Supporting caregivers' mental wellbeing and ability to provide psychosocial stimulation may promote early childhood development. This paper describes the systematic approach of developing an integrated stimulation intervention, identifying the feasibility and challenges faced throughout the period. We developed an integrated curriculum by culturally adapting three interventions (Reach Up, Thinking Healthy, and general nutrition advice) and piloted this curriculum (Mar-April 2017) in courtyard groups sessions and individual home visits with pregnant women (n = 11) and lactating mothers (of children <24 months) (n = 29). We conducted qualitative interviews with the participants (n = 8) and the community health workers who delivered the intervention (n = 2). Most participants reported willingness to attend the sessions if extended for 1 year, and recommended additional visual cues and interactive role-play activities to make the sessions more engaging. Participants and community health workers found it difficult to understand the concept of "unhealthy thoughts" in the curriculum. This component was then revised to include a simplified behavior-focused story. Community health workers reported difficulty balancing the required content of the integrated curriculum but were able to manage after the contents were reduced. The revised intervention is likely feasible to deliver to a group of pregnant and lactating mothers in a low-resource setting.

Study on the Acceptability of an ICT Platform for Older Adults with Mild Cognitive Impairment.

EhcoBUTLER is an Information and Communication Technology (ICT) solution funded by the European Union (H2020; ID: 643566) and intended especially for elderly people with mild cognitive impairment (MCI) to improve their health, independence and quality of life, particularly at the social level. The purpose of this study is to assess the acceptability of ehcoBUTLER based on a survey delivered to potential users and actors involved in their care, exploring their expectations and preferences, while anticipating the system's functional requirements. The survey was delivered online to 313 participants (11% end users, 25% informal caregivers, 48% formal caregivers and 16% administration/management staff) from eight countries. Participants rated the different functionalities of ehcoBUTLER positively, 86.1% perceiving it as an interesting and useful system. Likewise, they assessed it as a commercially attractive product (75.1%). End users expressed a stronger preference for the social module. Nevertheless, they would be ready to pay a low monthly price for ehcoBUTLER. Professionals would be willing to pay choosing its functionalities modularly, but they would also expect it to be funded by the National Health System, centres or businesses. The conclusion is that all participants found ehcoBUTLER interesting, useful and ergonomic. However, to effectively implement it, it is necessary to bridge the digital gap and address the issue of insufficient investment in products aimed at older adults with cognitive impairment. To supplement cognitive training systems with social, emotional or entertainment functionalities could improve adherence to their use.

Adapting an Evidence-Based, Early Childhood Parenting Programme for Integration into Government Primary Health Care Services in Rural Bangladesh.

This paper describes the process of adapting an early childhood development programme, with proven effectiveness in Bangladesh, for integration into government health services in rural Bangladesh. Through a three-stage process, we adapted an evidence-based, home-visiting, programme (Reach-Up and Learn) for delivery in government health clinics by government health staff as part of their regular duties. Stage one involved preparing an initial draft of two parenting interventions for use with: (1) pairs of mother/child dyads, and (2) small groups of mother/child dyads. In stage two, we piloted the adapted interventions in nine clinics with a total of twenty-seven health staff and 357 mother/child dyads. We used data from mothers' attendance, feedback from participating mothers and health staff and observations of parenting sessions by the research team to revise the interventions. Stage three involved piloting the revised interventions in six clinics with eighteen health staff and 162 mother/child dyads. We gathered additional data on mothers' attendance and used observations by the research team to finalize the interventions. Through this three-stage process, adaptations were made to the intervention content, process of delivery, materials, and engagement strategies used. The largest challenges were related to incorporating the parenting programme into health staff's existing workload and promoting mothers' engagement in the programme. We also simplified the content and structure of the curriculum to make it easier for health staff to deliver and to ensure mothers understood the activities introduced. This iterative piloting was used prior to implementing and evaluating the interventions through an effectiveness trial.

The effects of psychosocial stimulation on the development, growth, and treatment outcome of children with severe acute malnutrition age 6-59 months in southern Ethiopia: a parallel group cluster randomized control trial (EPSoSAMC study).

BACKGROUND: Severe Acute Malnutrition (SAM) remains a major cause of child mortality. To improve the management and survival of children the World Health Organization (WHO) endorsed the protocol for the management of SAM. The protocol suggested the integration of psychosocial stimulation as part of the medico-nutritional care process to prevent the long-term adverse developmental impact of the SAM. However, there is little scientific evidence behind the recommended stimulation intervention. METHOD: A parallel-group cluster-randomized controlled trial will be conducted among 144 children with SAM age 6-59 months in Southern Ethiopia. The study will have two groups where: children with SAM admitted in the intervention health facilities will receive psychosocial stimulation in addition to the routine inpatient care and for 6 months after discharge. Children with SAM admitted in the SC of the control health facilities will receive the routine inpatient care without psychosocial stimulation and home-based follow up for 6 months after discharge. All mothers/ caregivers will also receive uniform health education on child health-related issues. The primary outcome of the study will be child development while the secondary outcomes will include child growth and treatment outcome. All outcomes will be assessed four times: at enrollment, upon discharge from the SC, at 3 and 6 months of follow up. The data will be analyzed using STATA Version 15 Statistical Software. The anthropometric Z-scores and percentile of the median will be calculated child using WHO Anthro Version 3.2.2 Statistical Software. To assess the overall effect of the intervention by controlling other potential contributing factors, a generalized linear mixed model will be used. DISCUSSION: The present study will have an important contribution in generating supplementary evidence regarding the effect of psychosocial stimulation interventions on the development and growth outcomes of children with SAM. The study will further address the impact of the intervention on treatment outcome indicators that are still under-researched areas requiring new scientific evidence. TRIAL REGISTRATION: Pan African Clinical Trials Registry -PACTR201901730324304. Registered 25 November 2018, https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=5739.

Using community health workers to deliver a scalable integrated parenting program in rural China: A cluster-randomized controlled trial.

Inadequate care during early childhood can lead to long-term deficits in skill development. Parenting programs are promising tools for improving parenting practices and opportunities for healthy development. We implemented a non-masked cluster-randomized controlled trial in rural China in order to assess the effectiveness of an integrated home-visitation program that includes both psychosocial stimulation and health promotion at fostering development and health outcomes of infants and toddlers in rural China. All 6-18 month-old children of two rural townships and their main caregiver were enrolled. Villages were stratified by township and randomly assigned to intervention or control. Specifically, in September 2015 we assigned 43 clusters to treatment (21 villages, 222 caregiver-child dyads) or control (22 villages, 227 caregiver-child dyads). In the intervention group, community health workers delivered education and training on how to provide young children with psychosocial stimulation and health care (henceforth psychosocial stimulation and health promotion) during bi-weekly home visits over the period of one year. The control group received no home visits. Primary outcomes include measures of child development (i.e. the Bayley Scales of Infant and Toddler Development, third edition-or Bayley-III) and health (i.e. measures of morbidity, nutrition, and growth). Secondary outcomes are measures of parenting practices. Intention-to-treat (ITT) effects show that the intervention led to an improvement of 0·24 standard deviations (SD) [95% CI 0·04 SD-0·44 SD] in cognitive development and to a reduction of 8·1 [95% CI 3·8-12·4] percentage points in the risk of diarrheal illness. In addition, we find positive effects on parenting practices mirroring these results. We conclude that an integrated psychosocial stimulation and health promotion program improves development and health outcomes of infants and toddlers (6-30 month-old children) in rural China. Because of low incremental costs of adding program components (that is, adding health promotion to psychosocial stimulation programs), integrated programs may be cost-effective.

Peer Counseling Promotes Appropriate Infant Feeding Practices and Improves Infant Growth and Development in an Urban Slum in Bangladesh: A Community-Based Cluster Randomized Controlled Trial.

BACKGROUND: Undernutrition and poor cognitive development affect many children in developing countries. Good nutrition and health care are essential for optimal child development and growth. OBJECTIVES: We assessed the impact of peer counseling combined with psychosocial stimulation on feeding practices and child growth and development in slums in Bangladesh. METHODS: We performed a community-based cluster randomized controlled trial in selected slums; 350 mother-infant pairs were allocated to receive peer counseling on feeding practices plus psychosocial stimulation (PC + PCS; n = 175) or usual health messages (control; n = 175) using restricted randomization. Data were collected at enrollment and 1, 3, 5, 7, 9, and 12 mo after delivery. We collected data on infant and young child feeding practices and anthropometric measurements from birth until 12 mo to assess the main outcomes, including feeding practices and growth. We used the Bayley Scale III at 12 mo to assess child development. The effects of the PC + PCS intervention were assessed by using regression models. RESULTS: More mothers in the PC + PCS group than in the control group reported early initiation of breastfeeding (in the first hour: 89% compared with 78%, respectively; P < 0.05) and exclusive breastfeeding at 5 mo (73% compared with 27%, respectively; P < 0.001). Peer counseling had positively impacted infant length gain at 12 mo (P < 0.005). Children in the PC + PCS group were found to be more socially and emotionally active compared with controls at 12 mo (standardized score: 0.165 compared with -0.219, respectively; P < 0.05). CONCLUSION: Combining peer counseling with psychosocial stimulation had positive effects on infant feeding practices and growth at 12 mo and on the social-emotional development of young children. This trial was registered at clinicaltrial.gov as NCT03040375.

Effects of adding psychosocial stimulation for children of lactating mothers using an unconditional cash transfer platform on neurocognitive behavior of children in rural Bangladesh: protocol for a cluster randomized controlled trial.

BACKGROUND: There is sufficient evidence that psychosocial stimulation (PS) benefits children's neurocognitive behavior, however, there is no information on how it works when delivered through an Unconditional Cash Transfer (UCT) platform for poor rural population in developing countries. The objective of this study is to measure effects of adding PS for children of lactating mothers enrolled to receive UCT with health education (HE) on neurocognitive behavior of children in rural Bangladesh. METHODS: The study will be conducted at 11 unions of Ullapara sub-district in Bangladesh. The study is a cluster randomized controlled trial with three-arms; (i) PS and UCT with HE (ii) UCT with HE and iii) Comparison arm. The cluster will be considered as an old Ward of a Union, the lowest tier of local government system in rural Bangladesh. There are three old Wards in a union. These three clusters will be randomized to one of the three arms. Similarly, randomization will be done for each 11 Unions and then 11 clusters will be assigned to an arm. Eighteen participants will be recruited from each cluster randomly (n = 196 in each arm). The intervention designed for one year includes UCT with HE for the poor as a safety net program in rural Bangladesh with or without PS. An age-based curriculum of PS is already available for Bangladeshi children and this will be administered by trained local women; play leaders (PL) in intervention clusters. The government of Bangladesh is providing UCT of taka 500 ($6.25) as maternity allowance per month with HE. The primary outcomes will be cognitive, motor and language composite scores measured by Bayley-III and behavior using Wolke's behavior rating scale. The secondary outcomes will be children and mothers' growth, family food security status, health seeking behavior, mothers' depressive symptoms and self-esteem and violence against mothers. DISCUSSION: The study will provide a unique opportunity to assess an integrated early childhood development intervention using UCT platform to mitigate developmental delays in poor vulnerable children of rural Bangladesh. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT03281980, registered on September 13, 2017.

A quantitative cross-sectional survey of psychosocial stimulation and counselling interventions at nutritional rehabilitation units in Southern Malawi.

Background: Inpatient treatment at nutritional rehabilitation units (NRUs) is needed for children who have severe acute malnutrition (SAM) and acute illness, loss of appetite, or severe oedema. World Health Organization guidelines state that nutritional counselling should be done with primary caregivers at NRUs. These recommendations also include psychosocial stimulation interventions to improve developmental outcomes in children with SAM. However, there is limited information about the delivery of these types of interventions for caregivers and children in NRU settings. The primary objective of this research was therefore to obtain data about NRU resources, activities, and protocols relevant to psychosocial stimulation and counselling interventions during inpatient treatment of children with SAM. Methods: A cross-sectional survey was administered by interview at all 16 NRUs in seven districts in Southern Malawi. Participants were health workers, nurses, and nutritionists employed at the respective NRUs. Results: The response rate was 100% across NRUs. Half of participants said that psychosocial stimulation interventions are conducted at their respective NRUs, yet none of the NRUs have protocols for delivery of these interventions. Furthermore, 7/16 (44%) NRUs have no resources for psychosocial stimulation including play materials. Thirteen of 16 (81%) participants said that they feel this type of intervention is very important and 3/16 (19%) participants said that this somewhat important for children with SAM. All NRUs provide counselling to caregivers about breastfeeding and nutrition; 15/16 (94%) also give counselling about water, sanitation and hygiene. Conclusions: Ultimately, results from this survey highlighted that there is a need to invest in comprehensive interventions to improve developmental and nutritional outcomes in these vulnerable children requiring admission to NRUs.

A mixed methods feasibility study of the Kusamala Program at a nutritional rehabilitation unit in Malawi.

BACKGROUND: Children admitted to nutritional rehabilitation units (NRUs) for inpatient treatment of severe acute malnutrition (SAM) are at high risk of poor developmental and nutritional outcomes. The Kusamala Program is an interactive hospital-based counseling program for primary caregivers of children with SAM that integrates three modules: nutrition and feeding; water, sanitation, and hygiene (WASH); and psychosocial stimulation. This mixed methods feasibility study aimed to evaluate the implementation of the Kusamala Program in an NRU setting and developmental outcomes in children with SAM 6 months after inpatient treatment. METHODS: An internal pilot trial including the first 30 children and their primary caregivers enrolled to a cluster-randomized controlled trial of the Kusamala Program was performed. Barriers and enablers were identified in a qualitative study with a focus group discussion (FGD) and in-depth interviews (IDIs) with 12 hospital staff members, including five NRU nurses who deliver the Kusamala Program. RESULTS: Results demonstrated high participant engagement (100%) and adherence (87%) of primary caregivers to the Kusamala Program. Potential barriers to implementation identified through the qualitative study were caregivers' perceived value of the program, prioritization of other ward activities, and shortages of staff. On the other hand, enablers to implementation were engaging other staff members, motivation and work ethic, and refresher training. CONCLUSIONS: This mixed methods study demonstrates the feasibility of implementing the Kusamala Program in a real NRU setting. The full cluster-randomized controlled trial will be completed to evaluate the effectiveness of the Kusamala Program. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03072433. Registered on 7 March 2017-retrospectively registered.

The Kusamala Program for primary caregivers of children 6-59 months of age hospitalized with severe acute malnutrition in Malawi: study protocol for a cluster-randomized controlled trial.

BACKGROUND: Severe acute malnutrition (SAM) is associated with high mortality rates and impairments in growth and development in children that do survive. There are complex nutritional, health, and behavioural risk factors involving severely malnourished children and their primary caregivers, requiring integrated intervention approaches. METHODS: A cluster-randomized controlled trial at the Queen Elizabeth Central Hospital in Blantyre, Malawi will be conducted to evaluate the effectiveness of a 4-day hospital-based intervention programme directed at primary caregivers. This programme, titled the Kusamala Program, aims to improve developmental and nutritional outcomes in children with SAM. Up to six primary caregivers and their children will be enrolled to groups each week, which will be randomly allocated to intervention or comparison arms. The intervention package consists of interactive counselling on three modules: 1) nutrition and feeding; 2) water, sanitation, and hygiene (WASH); and 3) psychosocial stimulation. Data collection will be performed at enrolment, at discharge from hospital, and at 6 months following discharge. The primary outcome is child development assessed with the Malawi Developmental Assessment Tool (MDAT), a validated measure of gross and fine motor, language, and social development. DISCUSSION: This intervention programme is unique because it utilizes primary caregivers' time spent in-hospital while children receive treatment for SAM. The programme has the potential to be effective in addressing multiple aspects of child, nutrition and development. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03072433 . Registered on 7 March 2017.

Global health and development in early childhood.

Health and nutritional risks co-occur in the lives of children under the age of 2 years who live in developing countries. We review evidence showing how these risks, in addition to inadequate psychosocial stimulation, prevent children from developing expected cognitive and language abilities. A systematic review and meta-analysis of 21 interventions aimed at enhancing stimulation and 18 interventions that provided better nutrition--all conducted since 2000--revealed that stimulation had a medium effect size of 0.42 and 0.47 on cognitive and language development, respectively, whereas nutrition by itself had a small effect size of 0.09. The implementation processes of these interventions are described and compared. A number of unresolved issues are outlined and discussed, including ways to maximize parental health behavior change, assess mediators that account for intervention effects, and expand the assessment of young children's brain functions that underlie language and cognition and are affected by nutrition and stimulation.

Effect of a food supplementation and psychosocial stimulation trial for severely malnourished children on the level of maternal depressive symptoms in Bangladesh.

BACKGROUND: Maternal depression is associated with poor child development and growth in low-income countries. This paper evaluates the effect of a community-based trial providing psychosocial stimulation and food supplements to severely malnourished children on maternal depressive symptoms in Bangladesh. METHODS: Severely underweight (weight-for-age Z-score < -3) hospitalized children aged 6-24 months (n = 507), were randomly assigned to: psychosocial stimulation (PS), food supplementation (FS), PS+FS, clinic control (CC) and hospital control (CH) at discharge. PS included play sessions with children and parental counselling to mothers during fortnightly follow-up visit at community clinics, conducted by trained play leaders for 6 months. FS involved cereal-based supplements (150-300 kcal/day) for 3 months. All groups received medical care, micronutrient supplements and growth monitoring. We used Bayley scales, Home Observation for Measurement of Environment (HOME) inventory and a parenting questionnaire to assess child development, home stimulation and mothers' child-rearing practices, respectively. We assessed mothers' depressive symptoms using a modified version of Centre for Epidemiologic Studies Depression Scale at baseline and at 6 months post intervention. RESULTS: Maternal depressive symptoms were significantly lower in the CH group at baseline (P = 0.014). After 6 months of intervention there was no significant effect of intervention after adjusting for baseline scores and all possible confounders. Maternal depressive symptoms were higher among poorer (P = 0.06), older (P = 0.057) and less educated (P = 0.019) mothers, who were housewives (P = 0.053), and whose husbands had more unstable jobs (P = 0.058). At 6 months post intervention, children's cognitive (P = 0.045) and motor (P = 0.075) development, HOME (P = 0.012) and mother's parenting score (P = 0.057) were higher among mothers with lower depressive symptoms. CONCLUSION: The study did not show a significant effect of the intervention on the level of maternal depressive symptoms. Interventions with higher intensity and/or of longer duration focusing directly on maternal psychosocial functioning are probably needed to reduce maternal depressive symptoms.

Integrating early child development programs into health and nutrition services in Bangladesh: benefits and challenges.

Bangladesh is one of the poorest countries of the world with the highest population density. The Bangladesh government recognizes the educational and financial benefits of early childhood development (ECD) and has incorporated ECD into the national plan of action. However, ECD activities are not fully established in the country and there have been few evaluations. In this paper, we present ECD programs that are integrated into health and nutrition services in Bangladesh. We present four evaluation reports of such programs and we also include seven published research projects showing evidence that such integrations are feasible. We provide short reviews on coverage, methodology, and effects of the published reports and share our experience of challenges faced and steps taken to solve them. Overall, very few programs are based on scientific evidence and fewer are even evaluated. The research projects so far conducted are promising and there is sufficient evidence on feasibility of integrating ECD activities into nutrition and health programs. Suggestions are made on measures to overcome the implementation problems and on suitable methods to establish high-quality ECD programs in Bangladesh and in other low- and middle-income countries.