Clinical Trial

Improving Psychological Wellbeing by Stress Reduction Among Parents Having Children With Neurodevelopmental Disorders

Active, Not Recruiting
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Summary
This project addresses the mental health challenges faced by parents caring for children with Neurodevelopmental Disorders (NDDs) in Bangladesh. These parents often experience high levels of stress, anxiety, and depression, impacting family dynamics and the child's development. The project aims to design, implement, and assess an intervention to reduce parenting stress and enhance parental well-being. This intervention focuses on emotional intelligence and will be delivered through in-person training and a mobile app. The study will use a cluster randomized controlled trial methodology, targeting parents of children diagnosed with NDDs. The study will be conducted in Child Development Centers in public medical college hospitals across Bangladesh. It will assess changes in parental stress, mental well-being, and emotional intelligence. Data collection will occur from January 2024 to June 2025. The project aims to recruit 480 parents from eight Child Development Centers, ensuring ethical considerations, data integrity, and participant privacy. The findings will be shared through national dissemination seminars, policy briefs, reports, and journal publications.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2023-12-03; most recent amendment 2025-08-20.
Status change: Not Yet Recruiting → Active, Not Recruiting 2025-08-20
Trial Details
NCT Number NCT06166550
Lead Sponsor Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Collaborators: Centre for Injury Prevention and Research Bangladesh, University of Dhaka, Bangladesh, Directorate General of Health Services, Bangladesh
Conditions Mental Health Issue
Enrollment 480 participants
Start Date 2024-01-27
Primary Completion 2025-06-30 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-08-22