Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04541069 |
| Other study ID # |
2005 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 2021 |
| Est. completion date |
July 2022 |
Study information
| Verified date |
January 2021 |
| Source |
Centre for Injury Prevention and Research Bangladesh |
| Contact |
Farah N Rahman, MBBS |
| Phone |
+8801784868088 |
| Email |
farah.naz[@]ciprb.org |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
