Enhancing Social Communication and Emotional Development in Under 5 Children

NCT04541069 | Unknown

• 1 other identifier: 2005
• Study Type: interventional
• Target: 2,004
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Early Childhood Developmental Disability (Disorder)

Outcome Measures

Primary Outcomes (1)

• ASQ score (Ages and stages questionnaire) score

  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, this instrument will be used.

  6 months

Study Arms (2)

Social Communication and Emotional Skill Development (SCESD)

EXPERIMENTAL

This arm will get the intervention which is the Early Childhood Development (ECD) training.

Behavioral: Social Communication and Emotional Skill Development (SCESD) module

Control

NO INTERVENTION

This arm will not get any intervention.

Interventions

Social Communication and Emotional Skill Development (SCESD) module BEHAVIORAL

The intervention, Social Communication and Emotional Skill Development (SCESD) module, is based on the basics of the neuroscience of child development. 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.

Social Communication and Emotional Skill Development (SCESD)

Eligibility Criteria

• Age: 2 Months - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Mother of children under 2 months of age
• Eligible mother who will give consent to participate in the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre for Injury Prevention and Research Bangladesh: lead

Study Officials

• Saidur R Mashreky, Phd

  Director

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Farah N Rahman, MBBS

CONTACT

+8801784868088; farah.naz@ciprb.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: When the early childhood development assessment will be done by data collectors through ASQ insruments, they will not be aware of the respondent's status of whether they received the intervention or not.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Director

Model Details: Pragmatic Cluster Randomized Trial

Study Record Dates

• First Submitted: September 1, 2020
• First Posted: September 9, 2020
• Study Start: March 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: July 1, 2022
• Last Updated: January 27, 2021

Record last verified: 2021-01