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Enhancing Social Communication and Emotional Development in Under 5 Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04541069
Recruitment Status : Not yet recruiting
First Posted : September 9, 2020
Last Update Posted : September 9, 2020
Information provided by (Responsible Party):
Saidur Rahman Mashreky, Centre for Injury Prevention and Research Bangladesh

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.

Condition or disease Intervention/treatment Phase
Early Childhood Developmental Disability (Disorder) Behavioral: Social Communication and Emotional Skill Development (SCESD) module Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2004 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Pragmatic Cluster Randomized Trial
Masking: Single (Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Prevention
Official Title: Enhancing Social Communication and Emotional Development in Under 5 Children: Intervention Strategies for Inclusive Child Care Practices in Bangladesh.
Estimated Study Start Date : October 2020
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Arm Intervention/treatment
Experimental: Social Communication and Emotional Skill Development (SCESD)
This arm will get the intervention which is the Early Childhood Development (ECD) training.
Behavioral: Social Communication and Emotional Skill Development (SCESD) module
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.

No Intervention: Control
This arm will not get any intervention.

Primary Outcome Measures :
  1. ASQ score (Ages and stages questionnaire) score [ Time Frame: 6 months ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04541069

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Contact: Farah N Rahman, MBBS +8801784868088

Sponsors and Collaborators
Centre for Injury Prevention and Research Bangladesh
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Principal Investigator: Saidur R Mashreky, Phd Director
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Responsible Party: Saidur Rahman Mashreky, Professor, Director, Centre for Injury Prevention and Research Bangladesh Identifier: NCT04541069    
Other Study ID Numbers: 2005
First Posted: September 9, 2020    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Developmental Disabilities
Neurodevelopmental Disorders
Mental Disorders