Psychosis Recovery Orientation in Malawi by Improving Services and Engagement (PROMISE) protocol.

Malawi has a population of around 20 million people and is one of the world's most economically deprived nations. Severe mental illness (largely comprising psychoses and severe mood disorders) is managed by a very small number of staff in four tertiary facilities, aided by clinical officers and nurses in general hospitals and clinics. Given these constraints, psychosis is largely undetected and untreated, with a median duration of untreated psychosis (DUP) of around six years. Our aim is to work with people with lived experience (PWLE), caregivers, local communities and health leaders to develop acceptable and sustainable psychosis detection and management systems to increase psychosis awareness, reduce DUP, and to improve the health and lives of people with psychosis in Malawi. We will use the UK Medical Research Council guidance for developing and evaluating complex interventions, including qualitative work to explore diverse perspectives around psychosis detection, management, and outcomes, augmented by co-design with PWLE, and underpinned by a Theory of Change. Planned deliverables include a readily usable management blueprint encompassing education and community supports, with an integrated care pathway that includes Primary Health Centre clinics and District Mental Health Teams. PWLE and caregivers will be closely involved throughout to ensure that the interventions are shaped by the communities concerned. The effect of the interventions will be assessed with a quasi-experimental sequential implementation in three regions, in terms of DUP reduction, symptom remission, functional recovery and PWLE / caregiver impact, with quality of life as the primary outcome. As the study team is focused on long-term impact, we recognise the importance of having embedded, robust evaluation of the programme as a whole. We will therefore evaluate implementation processes and outcomes, and cost-effectiveness, to demonstrate the value of this approach to the Ministry of Health, and to encourage longer-term adoption across Malawi.

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.

Hypoallergenic and anti-inflammatory feeds in children with complicated severe acute malnutrition: an open randomised controlled 3-arm intervention trial in Malawi.

Intestinal pathology in children with complicated severe acute malnutrition (SAM) persists despite standard management. Given the similarity with intestinal pathology in non-IgE mediated gastrointestinal food allergy and Crohn's disease, we tested whether therapeutic feeds effective in treating these conditions may benefit children with complicated SAM. After initial clinical stabilisation, 95 children aged 6-23 months admitted at Queen Elizabeth Central Hospital, Blantyre, Malawi between January 1st and December 31st, 2016 were allocated randomly to either standard feeds, an elemental feed or a polymeric feed for 14 days. Change in faecal calprotectin as a marker of intestinal inflammation and the primary outcome was similar in each arm: elemental vs. standard 4.1 µg/mg stool/day (95% CI, -29.9, 38.15; P = 0.81) and polymeric vs. standard 10 (-23.96, 43.91; P = 0.56). Biomarkers of intestinal and systemic inflammation and mucosal integrity were highly abnormal in most children at baseline and abnormal values persisted in all three arms. The enteropathy in complicated SAM did not respond to either standard feeds or alternative therapeutic feeds administered for up to 14 days. A better understanding of the pathogenesis of the gut pathology in complicated SAM is an urgent priority to inform the development of improved therapeutic interventions.

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.

The care, stimulation and nutrition of children from 0-2 in Malawi-Perspectives from caregivers; "Who's holding the baby?"

INTRODUCTION: Universal access to quality early childhood development and care is a fundamental part of Sustainable Development Goal 4.2.1. Research from diverse settings, including that in low and middle income countries, now demonstrates the positive impact that interventions to promote play, stimulation, early communication and responsiveness can have, not just on child development, but on long term gains in education and economic growth. International agencies have recently produced the Nurturing Care Framework for Early Child Development in order to promote this and to encourage countries to move the focus from child survival to child thrival. Research on the best methods of integration of these programmes into present care practices, particularly in African settings is still very limited. METHODS: We used qualitative methods to gain an understanding of care practices (play, developmental stimulation, early communication and responsive feeding) for children 0-2 years. We conducted 18 focus groups (FGDs), six PFGDs (Participatory Research focus groups), 18 in depth interviews (IDIs) and 20 observations with caregivers in rural and urban settings of Malawi. We used a topic guide, audio-recorded the FGDs and IDIS and transcribed them in Chichewa or Yao and then into English. We coded data using an inductive approach to thematic analysis. We placed the data within a framework with the emerging major and minor themes. We conducted quality assurance for translations and coding frameworks through cross comparison of data and used respondent validation to check our results. RESULTS: Malawian caregivers see children's play as a consequence of good health and wellbeing, less an interaction that a parent undertakes to promote wellbeing and learning. Non-verbal communication and responsiveness with infants is clearly present and caregivers have many one-on-one interactions with young infants. Furthermore, many caregivers have good knowledge of feeding recommendations but cannot always follow these due to constraints on money. When children become mobile (toddlers), play is an activity done more often between children or with other caregivers such as siblings or grandparents. Community members consider that caring for children from 0-2 years is a woman's domain. Despite this, both men and women acknowledge the importance of maternal wellbeing in enabling good care of children. The present socioeconomic situation of most families in our study means that income generation and food security come first. Many mothers spend most of their time managing the responsibilities of daily living and have limited time to dedicate to children's play, responsiveness and communication with their children. DISCUSSION: Programmes promoted as part of the Nurturing Care Framework which provide advice on developmental stimulation, play, early communication and responsive feeding should ensure that topics within these programmes are culturally appropriate for the setting. Furthermore, programmes must not be an added burden to parents but be supportive to parents managing many responsibilities of daily living. Multi-sectorial approaches where both men and women are provided with knowledge but are also supported through programmes which address family finances, safe spaces for children whilst families are working, and family mental health and relationships may enable programmes to work more effectively.

Care for Child Development in rural Malawi: a model feasibility and pilot study.

Evidence demonstrates that encouraging stimulation, early communication, and nutrition improves child development. Detailed feasibility studies in real-world situations in Africa are limited. We piloted Care for Child Development through six health surveillance assistants (HSAs) in group and individual sessions with 60 caregivers and children <2 years and assessed recruitment, frequency, timings, and quality of intervention. We collected baseline/endline anthropometric, child development (MDAT), maternal stress (SRQ), and family care indicators (FCIs) data and determined acceptability through 20 interviews with caregivers and HSAs. HSAs could only provide coverage on 14.2% of eligible children in their areas; 86% of group sessions and a mean of 3.6/12 individual sessions offered to mothers were completed. Pre- and post-assessment of children demonstrated significant changes in MDAT language and social Z-scores and FCIs. Caregivers perceived sessions as beneficial and HSAs good leaders but that they could be provided through other mechanisms. Integrated Care for Child Development programs for 0-2 years old are readily accepted in Malawi, but they are not feasible to conduct universally through HSAs due to limited coverage; other models need to be considered.

Developmental and behavioural problems in children with severe acute malnutrition in Malawi: A cross-sectional study.

BACKGROUND: Early childhood development provides an important foundation for the development of human capital. Although there is a clear relation between stunting and child development outcomes, less information is available about the developmental and behavioural outcomes of children with severe acute malnutrition (SAM). Particularly an important research gap exists in Sub-Saharan Africa where there is a high prevalence of SAM and a high rate of co-occurring HIV (human immune deficiency virus) infection. Our first objective was to assess the prevalence and severity of developmental and behavioural disorders on a cohort of children admitted to an inpatient nutritional rehabilitation centre in Malawi. Our second objective was to compare the developmental and behavioural profiles of children with the two main phenotypes of SAM: kwashiorkor and marasmus. METHODS: This was a cross-sectional observational study including all children hospitalized with complicated SAM in Blantyre, Malawi over an 8-month period from February to October 2015. At discharge, children were assessed with the well-validated Malawi Developmental Assessment Tool (MDAT) for gross motor, fine motor, language and social development. In children ≥24 months, emotional and behavioural problems were measured using the Strengths and Difficulties Questionnaire (SDQ). RESULTS: 150 children (55% boys) with SAM were recruited; mean age of 27.2 months (standard deviation 17.9), 27 children (18%) had pre-existing neurodisabilities (ND) and 34 (23%) had a co-occurring human immune deficiency virus (HIV) infection. All children with SAM experienced profound delays in the gross and fine motor, language and social domains. Linear regression analysis demonstrated that children with kwashiorkor scored 0.75 standard deviations lower (95% confidence interval -1.43 to -0.07) on language MDAT domain than children with marasmus when adjusted for covariates. The prosocial behaviour score of the SDQ was low in children with SAM, indicating a lack of sensitive behaviour in social interactions. CONCLUSIONS: Children with SAM have severe developmental delays after a hospital admission. Our results indicate that there might be a significant difference in developmental attainment between children with kwashiorkor and with marasmus. Future studies exploring longer-term outcomes and testing possible intervention strategies are urgently needed.