Clinical trial NCT03321591: Maternal Cognitive Function and Neurobehavioral Development of Underprivileged Children
Official title: Maternal Cognitive Function and Neurobehavioral Development of Underprivileged Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Child Development
Lead sponsor: University of Dhaka
Sponsor class: OTHER
First posted: 2017-10-25
Enrollment: 200
Sex: ALL
Minimum age (years): 12
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The sample (mothers \& children) is collecting from the underprivileged population

Brief summary: It is estimated that over 200 million children under 5 years of age in developing countries are not attaining their developmental potential (e.g., neurobehavioral development) primarily because of poverty and associated health, nutritional deficiencies, and unstimulating home environment. Child's Neurobehavioral development consists of several interdependent domains of sensory-motor, cognitive-language, and social-emotional function. Experiences in the first few years of life are of particular importance because vital development occurs during this period. Early under nutrition, iron-deficiency, environmental toxins, stress, and poor stimulation and social interaction can affect brain structure and function. Stunting, inadequate cognitive stimulation, iodine deficiency, and iron deficiency anemia are identified as key risk factors, where the need for cognitive intervention is urgent, that prevent millions of young children from fulfilling their developmental potential and neurobehavioral development. It is clear that underprivileged children require not only good health, nutrition, and wealth but also supportive and caring environments and cognitive stimulation for their optimum neurobehavioral development as in the case of Bangladesh. Cognitive function and self-esteem of mothers is crucial for having the optimum outcome from intervention. However, little is known regarding the importance of mother's cognitive ability influencing different domains of her children's neurobehavioral development. This is how, the investigators plan to measure the maternal cognitive function and to assess the neurobehavioral development of underprivileged children. The investigators will enroll 200 mothers and children as a sample of the present study. Bayley Scales of Infant and Toddler Development will be used along with other interview scales.

Detailed description: Child development consists of several interdependent domains of sensory-motor, cognitive-language, and social-emotional function. Children's development is affected by psychosocial and biological factors through changes in brain structure and function, and behavioral changes. Experiences in the first few years of life are of particular importance because vital development occurs in all the domains during this period, and the interaction between early environments and genetics influences this development and human behavior. The brain growth occurs rapidly through neurogenesis, axonal and dendritic proliferation, synaptogenesis, cell death, synaptic pruning, myelination, and gliogenesis. Brain development can be modified by the quality of the environment. Independent animal research suggests that early under nutrition, iron-deficiency, environmental toxins, stress, and poor stimulation and social interaction can affect brain structure and function. In both humans and animals, variations in the quality of maternal care, a part of home environment, can yield changes in stress reactivity, anxiety, and memory function in the offspring. In later childhood the affected children will subsequently have lower levels of cognition and education. It is mentionable that remarkable recovery is often possible with early intervention through more nurturing environment with adequate stimulation, despite the vulnerability of the brain to early insult.

Stunting, inadequate cognitive stimulation, iodine deficiency, and iron deficiency anemia are identified as key risk factors, where the need for intervention is urgent, that prevent millions of young children from fulfilling their developmental potential. In low-income and middle-income countries, 34% of children younger than 5 years have linear growth retardation or stunting resulted from poor nutrition often accelerated by infectious diseases. It is reported that patterns of growth retardation are identical across countries. Although the vacillation in growth starts in utero or in the first 12-18 months, continue to around 40 months, but most children having stunting remain stunted through to adulthood. On the other hand, poverty and stunting are identified for indicators of poor development because the researchers represent different types of biological and psychosocial risks. Poverty is related to inadequate food, and poor sanitation and hygiene that increase infections and stunting in children. Poverty is also connected to poor maternal education, increased maternal stress and depression, and deficient stimulation in the home. All these factors deleteriously affect child development which, in turn, produces poor school achievement, which is further worsened by poor family support. Risk factors associated with poverty frequently happen together, and degree of development becomes lower with the number of risks factors. Deficits in child development are often occurred in infancy and increase further with age. Several longitudinal studies have found substantial association between socioeconomic status and parental wealth at birth, and cognitive attainment. Poverty and sociocultural background increase children's exposure to psychosocial risks that influence development through behavioral changes.

Parenting factors like cognitive stimulation or learning opportunities facilitates early cognitive development. Several studies examined the effect of stimulation or intervention on children from developing countries, including children living in poverty, which strongly supports the importance of early cognitive intervention for facilitating better cognitive and non-cognitive outcomes. Research revealed three aspects of parenting associated to young children's cognitive and social-emotional competence: cognitive stimulation, caregiver sensitivity and responsiveness to the child, and caregiver affect (National Research Council and Institute of Medicine. Regarding maternal sensitivity and responsivity several researches reported that these factors are associated with more secure infant attachment and higher cognitive ability respectively. Appropriate caregiver-child interactions facilitate early social-emotional development and learning materials promote age-appropriate language and problem-solving skills. These factors discussed above are the part of maternal cognitive function which implies that there might be a link between factors evolved from maternal cognitive state and child development. Showed that maternal cognitive ability works as an important factor in progressing children's height, even after controlling for child's age and gender, parental age, mother's and father's years of schooling and mother's height.

It is worth mentioning that substantial improvement in development is unlikely to be made without also increasing early learning opportunities, though there has been recent attention to the effect of nutrition on development. Non-US intervention studies showed that cognitive benefits were better in case of interventions having stimulation and education components compared with those involving nutrition or economic assistance only. In Bangladesh, research revealed that almost 60% children are exposed to risk of insufficient development caused by high prevalence of LBW (22%), stunting (41%), and poverty (43%), and lack of early stimulation due to low parental knowledge. Most of the data from developing countries including Bangladesh mainly focused on cognitive and motor outcome with less emphasis on maternal cognitive ability. This is why, in addition to the existing information, the investigators need to assess maternal cognitive ability and neurobehavioral development in order to prepare appropriate intervention particularly for disadvantaged children living in poverty in Bangladesh.

It is clear from the previous studies on poor populations that disadvantaged children require not only good health, nutrition, and wealth but also supportive and caring environments at home and cognitive stimulation in order to achieve their developmental potential as in the case of Bangladesh. According to Lancet review, most disadvantaged children get the maximum benefit of intervention. Cognitive function of parents, especially mothers, is crucial for having the optimum outcome from intervention. However, little is known regarding the importance of mother's cognitive functioning influencing different domains of her young children's neurobehavioral developmental outcome mediated by parenting, particularly who are from disadvantageous community in Bangladesh, residing in poverty. The investigators know of no other study, however, that directly emphasizes maternal cognitive function on different domains of development of disadvantaged children in Bangladesh.

The investigators, therefore, plan to examine the association of disadvantaged children's neurobehavioral development i.e., communication, motor skills, problem-solving, and personal-social skills and mother's cognitive function.

Hypothesis: Mothers with better cognitive function will have children with better neurobehavioral development.

Objectives: The specific objectives of the study are (a) to measure the maternal cognitive function, (b) to assess the neurobehavioral development of children.

A total of 200 mother-child will participate in the study. Data will be collected by the researchers or his representatives. Age range of children will range from 12-42 months residing in the slum area located in the city of Dhaka.

Eligibility criteria: Inclusion Criteria:

* Age: 12-42 months on enrolment
* Sex: both male and female
* Living within 30 minutes distance from the center where the test takes
* place
* Nutritional status: weight-for-age z score (WAZ)\>-3SD
* Consent: written consent provided by parents

Exclusion Criteria:

* Developmental anomalies,
* Known chronic illnesses like epilepsy, tuberculosis, mental retardation
* Twins and multiple births,
* Parents not consenting

Primary outcomes:
measure: Cognitive, Language and Motor Composite Score
timeFrame: 6 months
measure: Maternal Cognitive Function Score
timeFrame: 6 months
measure: Behavior ratings
timeFrame: 6 months
Secondary outcomes:
measure: Child's Home environment observation
timeFrame: 6 months
measure: Parent child interactions
timeFrame: 6 months
measure: Self-Esteem of mothers
timeFrame: 6 months
measure: Weight & height for Anthropometry measures
timeFrame: 6 months
measure: Mid Upper Arm Circumference (MUAC)
timeFrame: 6 months
measure: Head Circumference
timeFrame: 6 months
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: ICDDRB
Study officials:
affiliation: University of Dhaka
name: MD. KAMAL UDDIN, PhD
role: STUDY_DIRECTOR
References: