Enhancing Social Communication and Emotional Development in Under 5 Children
Enhancing Social Communication and Emotional Development in Under 5 Children
In the United Nation's Sustainable Development Goals (SDGs), the conversation has shifted
 from the complexity of ensuring decrease in infant mortality to that of holistic wellbeing of
 children from conception onwards by ensuring early learning opportunities along with
 nutrition, security and safety. About 13 - 23 percent children in Bangladesh present symptoms
 of diagnosable and preventable mental health conditions in early childhood. The aim of this
 effectiveness-implementation hybrid type 2 cluster randomized trial is to implement training
 program to enhance parental understanding of child's social communication and emotional
 development, ways to support positive behavior management skills, and to enhance parents'
 cognizance about when professional help may be sought. Shuchona Foundation's module-based
 training manual on Social Communication and Emotional Skill Development (SCESD) is designed
 to sensitize and educate parents/ caregivers on child development. This module will be
 implemented in Sonargaon, Gojaria and Raiganj Upazilas. The administrative wards in the
 unions will serve as clusters for the study's first phase. The first phase of six months
 duration will explore qualitatively the adaptability of existing health system, train field
 level health workers, training of the data collectors on administering Ages and Stages
 Questionnaire (ASQ), enrol mothers for equipping them with knowledge and skill to stimulate
 Early Childhood Development (ECD) and identify delayed childhood development, followed by
 assessment of ability of mothers to note secondary outcomes or delay at the earliest. The
 sessions for mother will be conducted using the existing health system of Bangladesh.

 A mixed-methods approach comprising of process mapping, qualitative and quantitative data
 analyses will be used to assess implementation of the intervention with focus on identifying
 failures in implementation, why they exist and how to reduce them for future implementation
 and scale-up.
2. Introduction The last five years have witnessed a plethora of literature on early
 childhood development, the first 1000 days in infancy, and holistic wellbeing of children
 from conception onwards. In large part due to the United Nation's Sustainable Development
 Goals (SDGs), the conversation has shifted from the complexity of ensuring decrease in infant
 mortality to that of ensuring nutrition, prenatal health care, security and safety, early
 learning opportunities all of which work together to lead to better outcomes for children.
 This is a significant shift for most low and middle income countries (LMIC's), like
 Bangladesh, where a well-prepared plan to implement effective programs that are also low-cost
 and applicable to the existing infrastructure does not exist. According to the Early
 Childhood Nurturing Care Framework, nutrition, health, early learning, responsive caregiving,
 security and safety are important components that ensure that countries can achieve their
 SDG's and thereby enable better outcomes in later childhood and adulthood. 1 In addition,
 planning for an approach that ensures children at risk for conditions like autism and other
 developmental disorders are identified sufficiently early in infancy is an added challenge.
 According to Munir et al (2018), parents in LMIC's rarely reach out to health professionals
 for behavioral and developmental concerns due to social stigma and lack of evidence-based
 services, unless their child is experiencing acute medical distress. This in large part
 explains why, in a country like Bangladesh, which has a comprehensive policy for children,
 disabilities, health care and nutrition, there still continues to be delay in providing early
 intervention services and medical services to children with neurodevelopmental disorders.

 Figure 1 The nurturing care framework (Wertlieb, 2019) Nurturing care refers to giving
 children the opportunity to learn in their early childhood years through interactions with
 peers and adults in a responsive and emotionally supportive environment, which is the result
 of public policies, programs, and services that include health, nutrition and security.
 Global research indicates that nearly 385 million children are living in extreme poverty, 155
 million children under five have stunted growth, and more than 240 million affected by
 conflict.2-4 About 300 million children between ages two and four are regularly subjected to
 violent discipline, including physical punishment and psychological aggression.4 Moreover,
 around 250 million children (43%) less than 5 years of age in low- and middle-income
 countries are at risk of not reaching their developmental potential.5 Researches with
 0-5-years old indicate that health risks before 24 months impacts mental development of the
 child. More than 200 million children under 5 years of age are not reaching their
 developmental potential because of poor health, lack of nutrition and poverty. Medical issues
 such as delivery by unskilled attendant; infections like malaria and cholera, inadequate
 nutrition, and inadequate stimulation significantly increase risk for disabilities and reduce
 the potentiality for greater success in life.6-8 Bangladesh has implemented several programs
 in order to mitigate the effects of poverty, prenatal and early childhood malnutrition and
 adverse living conditions. Programs to educate pregnant women, provide health education in
 communities, adequate vaccinations, stipends and various forms of nutritional programs are
 currently being provided in many parts of the country through a variety of programs.
 Nevertheless, according to the recommendations of research in the area of early childhood
 intervention (EDI) and inclusive early childhood education (IEDE), the most effective
 programs should encompass both health, learning and stimulation9,10. According to results
 from the INTERGROWTH-21ST Project, when adequate nutrition and education are given to primary
 caregivers (mostly mothers) of under two years old children, it accounts for 10% variance in
 the acquisition of all developmental milestones across all domains, nullifying the supposed
 effects of cultural child-rearing practices11.

 The influence of risk and protective factors cannot be evaluated separately from each other;
 the balance between the burden experienced by parents, and the capacity and resources of the
 parents should always be evaluated together.12 A population based study in Bangladesh
 indicated that 14.6% of children have a diagnosable behavioral impairment13 with a higher
 prevalence (40.4%) among orphan children.14 Male children were found to be present with
 increased risk factors.15 A systematic review published in 2014 in Bangladesh indicated that
 13.4 to 22.9% children in Bangladesh present symptoms of diagnosable mental health
 condition.16 Bronfenbrenner17 evidenced that environmental factors play a critical role in
 coordinating the timing and pattern of gene expression, which in turn determine initial brain
 architecture. He stated that the development of children is rooted within a bigger context,
 which includes the characteristics of both the parents and the child, and are a result of
 constant interaction, as one influences the other: the bioecological model of specific
 experiences facilitates or inhibit neuronal connectivity at key developmental stages. Our
 perceptual, cognitive, and emotional capabilities are built upon the platform provided by
 early life experiences18 It has been evidenced that knowledgeable and skilled parenting can
 facilitate a supportive relationship and enhance the future positive psychosocial development
 of the child.12

 In the absence of clinically validated biomarkers and the significant variation in the
 presentation of milder autism cases (typically referred by clinicians as 'high functioning'
 autism), it is extremely necessary to find a methodology for early detection of risk factors
 that are easily noticeable by caregivers, coupled with intervention techniques that can be
 used effectively in the natural environment of the child. The median age of autism diagnosis
 and intervention in the United States, where tremendous awareness activities are being done,
 is still at 4.5 years of age. A recent review of the research on when and how parents should
 be informed about their child's autism diagnosis (See Figure 2) shows that although core
 areas of deficit in social communication and repetitive stereotypical behaviors do not become
 apparent till nearly 24 months of age, many early indicators do exist that have been
 substantiated as prodromal features in the first 6 months 20. And given our understanding of
 brain plasticity and developmental peaks, there is a strong likelihood that well-trained
 caregivers can effectively prevent core symptoms of autism from manifesting. At the very
 least, methods, as prescribed by the Social Communication and Emotional Skill Development
 (SCESD) manual, could enable a reduced intensity of the delays.

 Early identification of developmental disorders is critical to the well-being of children and
 their families.21 The earlier identification of delay increases the opportunity to provide
 early intervention, maximizing the benefit of that intervention.22 Thus promoting the
 development of the child in later years.12 Although evidence shows that early intervention
 can reduce the impact on the functioning of the child and the family, identification of
 inadequate social communication and emotional skills in young children has always been a
 challenging process.22 Family members can play a vital role in the identification and
 application of the intervention process especially in children under 5 years of age.23 In
 developing countries with increased child survival, the number of children with
 social-communication delay is also increasing24. Convention on the Rights of the Child (CRC)
 and the Convention on the Rights of People with Disabilities (CRPD), both state that children
 with disabilities have the right to develop to their maximum potential. Investment in Early
 Childhood Development (ECD), should also focus on children at risk of developmental delays or
 disabilities24. In a report of the project "Developing an Inclusive Education and ECD
 Strategy" (2013-2014), Plan Sri Lanka in collaboration with the faculty of medicine
 university of Kelaniya recommended each early learning activity to be broken down into small
 steps to support children with delays/ disabilities. It also recommended that the staff/
 teachers involved in pre-school cares should be well equipped with the knowledge of screening
 of early delays/ disabilities.

 Due to lack of proper tools and resources, many children with developmental delays are not
 being identified early in LMICs. Moreover, after the first concern, it requires a long time
 to get professional help. As a result, these children often must wait until they start going
 to school before they receive help25. Therefore, ECD programs beside providing child
 development strategies also need to make parents/ caregivers aware of the stages of regular
 child development which will potentially enable the families to pick up any difference from
 the typical developmental trajectory. This will in turn help early detection of developmental
 delays. With proper support, these delays can be prevented from growing into a disability or
 reducing the severity of the disability and thereby potentially leading to lesser poverty and
 marginalization.

 It should be noted that for LMIC's like Bangladesh, an early intervention model is needed
 that can be implemented by non-experts with minimal training, and at a low cost. It is also
 important that the model can be easily scaled up and implemented within the existing
 childcare service settings 26. In order to achieve these goals, Shuchona Foundation developed
 a training program that can be learned/adopted by parents, caregivers, daycare workers and
 others. The primary philosophy of the training is based on principals of the Early Start
 Denver Model and is focused on teaching social communication skills and behavior management
 techniques, which could be used within day-to-day typical childcare practices such as
 feeding, bathing, etc. Additionally, the current project would explore the possibility of
 parental skills training; in addition to a home-based early intervention model could be
 effectively incorporated into a variety of existing government programs.

 Shuchona Foundation's module-based training manual on Social Communication and Emotional
 Skill Development (SCESD) is designed to sensitize and educate parents and other caregivers
 on the development of the child under their care. Developed in Bangladesh and field-tested,
 the manual is based on the premises of social interaction challenges often experienced by
 children with autism spectrum disorders (ASD). It is based on the premise that enabling
 parents to recognize early indicators of social-communication delay and teaching them simple
 adaptations to everyday childcare practices, may serve as an effective prevention practice
 that possibly could mitigate the need for further screening and/or seeking specialist care
 for the milder delays 27. In addition, by teaching functional strategies applicable in the
 natural home environment, parents with children who later receive a diagnosis and require
 professional intervention would find it relatively easier to implement the professional's
 recommendations in the home. Thus, enabling the intervention to be more effective and
 increasing the likelihood that the parents would be partners in the treatment process of
 their child over the years. Recent studies on early autism interventions indicate programs
 that include parent skill-building programs are a key component to ensuring that the effects
 of the intervention remain in later childhood and those children do better in social
 interactions with peers28, although existing community-based programs appear not to be as
 effective as those implemented in clinical settings 29. The aim of this training is to
 enhance parental understanding of typical child development with significant focus on social
 communication and emotional development; to teach parents positive behavior management
 skills; teach parents and other caregivers simplified evidence-based strategies that can be
 implemented in the typical care of their child; to enable parents to be more cognizant for
 when professional help needs to be sought, and be effective partners with the professionals
 involved in the therapeutic treatment of their child.

 3. Objectives

 3.1 General objective To design of a social communication and emotional skill development
 intervention and determine its' efficacy in promoting Early Childhood Development (ECD) and
 controlling developmental delay among under 5 children using existing health system in
 Bangladesh.

 3.2 Specific objectives

 1. To design and strategize a social communication and emotional skill development
 intervention for infants and young children in community health care settings

 2. To assess the effectiveness of the community centered module-based approach in
 monitoring social communication and emotional development and those factors which may
 influence social-emotional development, in infants and young children.

 3. To conduct qualitative and quantitative assessment of fidelity of the trainer pool and
 carers who completed the training and competency test

 4. To compare the capacity/skill/competency to identify socioemotional problems among study
 population of trained carers to carers as usual.

 5. To evaluate the predictive values of community-based approach, in accurately identifying
 specific social-emotional problems among sample population

 6. To evaluate the quality of care and carers' compliance regarding responsive parenting,
 disclose concerns, as compared to carers as usual.

 7. To measure sociodemographic, reproductive and anthropometric characteristics and other
 potential confounders of the study population

 8. To use, adopt and or validate culturally sensitive, socially acceptable and
 scientifically rigorous research instrument for measuring the key variables of the study

 9. To assess the compatibility/system/adaptability/readiness of the existing primary health
 care settings to integrate and deliver the proposed intervention

 10. To determine the cost effectiveness of the intervention

 5. Brief description of the module for intervention The intervention, Social Communication
 and Emotional Skill Development (SCESD) module, is based on the basics of the neuroscience of
 child development. Some basic behaviors in early childhood, starting from infancy can predict
 future cognition, socialization and language acquisition. The module has focused on these
 basic behaviors of infants, and has incorporated strategies to enhance the five basic
 behaviors i.e. eye contact, attention to others, joint attention, imitation and non-verbal
 communication. The development of typical brain functioning requires input via all of the
 major sensory systems. Therefore, different fun activities have been shown to encourage
 children's tactile, auditory and visual sensation.

 The techniques used in this training can be used throughout the day during caregiving and
 other daily activities, based on the principles of the Early Start Denver Model (ESDM). ESDM,
 which is mainly used for children with ASD, is based on normal child development model,
 therefore the basic developmental stages and strategies to enhance child development in
 different domains can be applicable for all children. This has made the ECD module inclusive
 for all children and has reduced the gap between research and practice.

 The module has been developed after analysing the financial and other resource support system
 operating in the community, and as such has incorporated evidence based measures in ESDM for
 encouraging parent-child dyadic interaction.

 There are some chapters in the module that focus on children's 'Receptive' and 'Expressive'
 language development. Using non-verbal communication has also been encouraged through 'Least
 to Most technique'. After each chapter different stages of development on the specific topic
 have been described in an easy to understand way (including pictorial) to help the caregivers
 understand the level of functioning of the child and what steps need to be taken to advance
 the development. The basics of Applied Behavior Analysis (ABA) and Positive behavior Support
 (PSP) techniques have been explained in a way that can be translated into the real-life
 situation by parents and other caregivers. Two separate sections have been incorporated to
 encourage to support children's behaviors in a positive way. The need for setting up rules
 and how to do that has been explained in one. Strategies to tackle children's difficult
 behaviors has been discussed in another section. Besides teaching the behavioral strategies,
 the main focus of these chapters is to make sure that the children know about their emotions,
 and how to support them to express it properly; this is mainly based on the principles of
 children version of 'Cognitive Behavior Therapy' model. The chapter on children's attention
 skills and motor development has also been incorporated in the module.

 There is also a small booklet for the mothers with the key messages and relevant pictorial
 contents. The complete module takes a total of 19 hours to be delivered. The total content is
 split into 4 sessions. However, for the first phase of the project, only the first 3 sessions
 will be provided to the mothers. These 3 sessions will be distributed between 2 classes. The
 first class will be 30 minutes long, the second class which will also include some activity
 will be an hour long. The sessions will be taken in spaced intervals, and will be delivered
 personally to mothers and families at households by multi-purpose volunteers.

 The module was reviewed by international experts in the field of child development. Further
 revisions were done based on the experience and feedback from trainings conducted with
 different audience, including audience with limited or no literacy. The module was finalized
 by Shuchona Foundation Expert Team.

 6. Study Overview 6.1 Study setting The study setting for this effectiveness-implementation
 hybrid type 2 cluster randomized trial will be in three Upazilas of Bangladesh, namely
 Sonargaon, Gojaria and Raiganj. Each Upazilla usually comprises of 10 unions and each union
 has 9 wards in it. The wards in the unions will serve as clusters for the study. Usually,
 there is one Upazila Health complex (UHC) in each Upazila, while each ward consists of one
 community clinic, and five multipurpose volunteers. The community clinics are under the
 supervision of respective UHC. The community clinics and Upazila Health Complexes are the
 primary level of health care services.

 6.2 Study duration

 For effective intervention, the study has been divided into four phases as shown in figure 4.
 The first, second, third and fourth phase will be the focus of this study which will last for
 about 6 months. It would be pertinent to explain the phases to highlight the content of the
 four phases. The first phase will include an exploration to assess whether the health system
 is adaptive and ready for the implementation of this project. In the second phase, training
 of the primary health care providers who will give antenatal services and enrolment of
 mothers in the study, training of the Health Assistants (HA), Family Welfare Assistant (FWA)
 and Community Health Care Providers (CHCP) who will work in the community at household level
 to deliver the training to mothers and families, and also training of the data collectors who
 will measure the study outcomes at household level. Second phase will start enrolling mothers
 of children under 2 months of age, which will continue in subsequent phases of the study. In
 the third phase, mothers will be trained and data will be collected on the information of
 child development. The later phase of the study will assess children and mothers at different
 stages of the children's lives.

 The initial two months of the first phase will be used for qualitative data collection and,
 analysis, followed by designing the intervention incorporating the findings. Accordingly,
 antenatal care (ANC) providers, Health Assistants (HA), Family Welfare Assistant (FWA),
 Community Health Care Providers (CHCP), and data collectors will be trained, and enrolment of
 study participants will commence. During the next four months the designed intervention will
 be implemented, along with continuation of the enrolment of study participants. When mothers
 enrolled for the study have finished undergoing the training sessions, the respective
 children will be primarily assessed with the Ages and Stages Questionnaire (ASQ), followed by
 assessment of ability of mothers to note secondary outcomes or delay at the earliest.

 7. Study participants 7.1 Sample and sample size calculation All available clusters (wards)
 will be listed in the study area and thus a sampling frame will be generated. Required number
 of clusters calculated during sample size estimation will be selected from this frame
 randomly for entering the study using a random sequence generator in Microsoft Excel.
 Randomization of the available clusters into intervention and control groups will be done in
 the same manner using random numbers. Control and intervention groups will be selected in 1:1
 ratio.

 All mothers (primary caregivers) of children under 2 months of age in the study area will be
 approached for enrolment. The calculation of sample size is as follows. Prevalence of
 behavior problem of young children in Bangladesh was considered as the indicator for
 calculating the sample size of this study. The sample size has been calculated considering
 the prevalence to be 14.6%.16 To measure a 35% effect size, an equal and minimum number of
 624 mothers for each of the interventions and control arm will be recruited to gain a power
 of 80% at a 5% level of significance (two sided) with the formula for Randomized control
 trials. To address the cluster effect of the design, the sample size is multiplied by 1 + (m
 - 1)ρ, where m is the average cluster size and ρ is the is the inter cluster correlation
 coefficient (ICC).21,22 Considering inter cluster correlation of 0.05,22 and an average
 number of 10 eligible mother in each cluster the design effect is 1.45 [1+(10-1)*0.05]. Thus,
 we determined that we need a minimum of 905 eligible participants per arm. Considering 10%
 drop out the size will be 1002. Which in turn makes 101 clusters per arm. Total 2004 mother
 will be recruited for intervention and control arm.

 7.2 Participants Recruitment The study will focus on the rural population as majority of the
 country's population reside in rural areas, and are less likely to be exposed to ECD
 interventions. Primarily, the mothers of children under 2 months of age will be continuously
 enrolled as study participants. These mothers will be equipped with the knowledge and skill
 for stimulating ECD and identifying indicators of delayed development of children (training
 sessions), which will take place during the Inter personal communication (IPC), and Expanded
 Programme on Immunization (EPI) sessions where the mothers visit to get their children
 vaccinated. For the first phase, data of mothers who will undergo at least 2 training
 sessions will only be included for analysis. The mothers will then be followed up for the
 next two years covering both phases. In this second phase the mother child unit who were
 trained will be followed every two months, as well as the enrolment and training of new
 mothers will continue. The family of the mother will also receive the intervention which is
 thought to enable a supportive environment for the mother and also due to the fact that,
 children are exposed to and influenced by other family members as well. Mothers, however, are
 the main recipient of the intervention.

 The mothers will be identified at the primary health care center where they receive their
 antenatal check-ups. Assistance of field health workers will also be taken to identify and
 enroll the mothers. The health care provider at the center or field health workers will be
 responsible for taking consent, recording the enrolment of the eligible participant in the
 intervention and control clusters, and taking anthropometric measurements of all enrolled
 mothers. After randomization, the mothers enrolled in the control clusters of this study will
 receive conventional antenatal care. The contact information of these mothers will be
 collected and maintained by the manager of the primary health care center where mother
 receives antenatal service. This information will then be passed on to the Coordinators who
 will then coordinate with the data collectors.

 Inclusion Criteria:

 -  Mother of children under 2 months of age

 -  Eligible mother who will give consent to participate in the study

 Exclusion Criteria:

 -  Mothers with a critical illness that prevents them to take part in the training sessions
 or to take care of the child

 -  Families that intend to move out of the area within the study period

 7.3 Intervention distribution

 Distribution of Upazillas, Unions, and wards:

 1. There are 3 Upazillas (Nandail, Savar and Raiganj)

 2. Total 33 Unions (13 Unions in Nandail, 12 Unions in Savar, and 9 Unions in Raiganj).

 3. We will take about 9 to 10 Unions from each Upazilla

 4. So total 27 to 30 Unions

 5. Total about 297 wards. We will take 243 to 270 wards

 6. According to sample size calculation we need 202 wards (clusters) randomly selected from
 these 243 to 270.

 7. 101 of the wards will be randomly assigned to intervention arm and another 101 wards
 will be randomly assigned to control arm

 8. Total of 7 wards per Union will be selected.

 9. 3-4 intervention ward per Union and 3-4 control ward per Union

 Who will be assigned work at each level

 1. Each Union will have a Union supervisor

 2. So 27 to 30 Union Supervisors

 3. Each ward has a health assistant (HA) under it

 4. There will be one multipurpose volunteer per Union Role of individuals at each level

 1. Union supervisors:

 -  Make sure that the mothers are informed about the trainings

 -  Make sure that trainings are carried out at EPI session nearest to the
 enrolled/identified mothers

 -  Make sure that the mothers go to that EPI session and gets the SCESD training session

 -  Will know the exact age of the child

 -  Will schedule the points of data collection for each of the child accordingly (at 2
 months, 6 months, 12 months, and 18 months)

 -  Will keep track of the number of training sessions received by each of the mother

 -  This tracking has to be done for about 36 mother-child pair for each Union supervisor at
 each Union 2. Health assistants (HA):

 -  Deliver the training sessions every month according to schedule

 -  Training sessions concurrently with the EPI sessions as per necessity

 -  Total of 9-12 mother-child pair at each ward will receive the training sessions.

 -  Help in identifying and enrolling mothers for intervention (See "Enrollment of mothers)
 3. Multipurpose Volunteers (MPV):

 -  Deliver training sessions every month when a mother who is enrolled misses a session at
 the EPI

 -  Follow schedule for the training to individual mother

 -  Make sure total of 9 to 12 mothers receive the SCESD training per ward

 -  Help in identifying and enrolling mothers for intervention (See "Enrollment of mothers)

 7.4 Guidelines for field work during COVID-19 Purpose of the Guideline This guideline will
 provide direction and outline social interaction during the COVID-19 pandemic situation. The
 focus of this document is maintaining proper social distancing and protective measurements
 that will ensure to reduce the negative impact on health and social impacts.
Inclusion Criteria:

 -  Mother of children under 2 months of age

 -  Eligible mother who will give consent to participate in the study

 Exclusion Criteria:

 -  • Mothers with a critical illness that prevents them to take part in the training
 sessions or to take care of the child

 -  Families that intend to move out of the area within the study period