Maternal Cognitive Function and Neurobehavioral Development of Underprivileged Children

NCT03321591 | Unknown

• 1 other identifier: 89/2015-16
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Child Development

Outcome Measures

Primary Outcomes (3)

• Cognitive, Language and Motor Composite Score

  The outcomes are measured on Bayley Scales of Infant and Toddler Development, (3rd Edition). It measures three domains of child's development viz cognitive, language (receptive communication \& expressive communication), and motor (fine motor \& gross motor). The score of these three domains (or subscales) is calculated separately by adding up item score. Each item will get either 1 or 0. How many items is approached is dependent on child's age. Children having 16 days to 42.5 months are divided into 17 age groups having different starting point for item administration. Cognitive subscale has 91 items. Minimum and maximum scores will be 0 to 91. Language scale is comprised of receptive and expressive communication subtest. Total items of receptive and expressive subtests are 49 and 48 respectively \& ranges will be 0-49 and 0-48. Gross and fine motor have 66 \& 72 items and ranges 0-66 \& 0-72. The higher the score the better the developmental outcome will be.

  6 months

• Maternal Cognitive Function Score

  This outcome is measured on the mothers of children using The Bangla adaptation of Mini-Mental State Examination (BAMSE)

  6 months

• Behavior ratings

  The outcome is observed using Wolke's behavior ratings during the administration of the Bayley Scales of Infant and Toddler Development .

  6 months

Secondary Outcomes (6)

• Child's Home environment observation

  6 months

• Parent child interactions

  6 months

• Self-Esteem of mothers

  6 months

• Weight & height for Anthropometry measures

  6 months

• Mid Upper Arm Circumference (MUAC)

  6 months

Eligibility Criteria

• Age: 12 Months - 42 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The sample (mothers \& children) is collecting from the underprivileged population

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Dhaka: lead

Study Sites (1)

ICDDRB

Dhaka, Bangladesh

RECRUITING

Study Officials

• MD. KAMAL UDDIN, PhD

  University of Dhaka

  STUDY DIRECTOR

Central Study Contacts

ABU YUSUF MAHMUD, MSc

CONTACT

+88-01919412343; aymahmud@gmail.com

FAHMIDA TOFAIL, MBBS,PhD

CONTACT

+880 1715 700370; tofailf@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 13, 2017
• First Posted: October 25, 2017
• Study Start: September 12, 2017
• Primary Completion: December 31, 2017
• Study Completion: February 28, 2018
• Last Updated: December 29, 2017

Record last verified: 2017-12

Locations

BA (1)