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

StatusActive, Not Recruiting
PhaseNot applicable
Started2024-01-27
View on ClinicalTrials.gov ↗

Amendment history

2025-08-20
Not Yet Recruiting→Active, Not Recruiting Study Status, Sponsor/Collaborators, Oversight, Study Description, Study Design, Arms and Interventions, Outcome Measures, Contacts/Locations v4
Trial statusNot Yet Recruiting→Active, Not Recruiting
Primary completion dateestimated 2024-10-31→confirmed 2025-06-30
Completion date2024-12-31→2025-12-31
Start dateestimated 2024-04-30→confirmed 2024-01-27
Study sites0→1
Secondary endpoints2 to 5 entries
Parenting satisfaction Marital satisfaction Fidelity
Primary endpoints3 entries, revised
WellbeingPsychological well-being
Study description-74 characters
[...] caregivers of children with NDDs in Bangladesh and promote their long-term caregiving abilities. Objectives: The project aims [...] app/software and the diary will support parents in improving their emotional intelligence skills, benefiting family well-being [...] ds. Outcomes: This study's aim to assess the intervention's feasibilityeffectiveness and acceptancefeasibility in Bangladesh's Child Development Centers and among the targeted parents from April 2024 to October 2024. From April to October 2024, we'll evaluate parentingParenting stress and psychological wellbeingwell-being will be evaluated. Secon [...] [...]
Collaborators+135 characters
Centre for Injury Prevention and Research Bangladesh University of Dhaka, Bangladesh Directorate General of Health Services, Bangladesh
2024-05-07
Study Status, Study Description, Study Design v3
Re-verified, no change to tracked fields
2024-03-31
Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Contacts/Locations, IPDSharing v2
Primary completion date2024-10-01→2024-10-31
Start date2024-02-04→2024-04-30
Enrollment target1200→480
Study arms3→2
InterventionsParent's Emotional Intelligence Network (Behavioral)→Diary (Device), Mobile App (Device), Parent's Emotional Intelligence Network (Behavioral)
Secondary endpointsdetails revised at 2 of 2 entries
Study description-18 characters
[...] Research underscores the importance of addressing caregiver's well-being, as it indirectly impacts the child's health and [...] rial (CRCT) methodology. Methods: Study settings: The study focusesis oncentered IPNAaround the Institute of Paediatric Neurology and Autism (IPNA) and Child Development Centers or Shishu Bikash Kendra (SBKs) in Bangladesh's eight administrative divisions. IPNA at BSM [...] ing, impacting national mental health policy. Additionally, tenfifteen nonprofitgovernment medical college hospitals operate SBKs inas theoutdoor US, with thirty-four state-run SBKsservices. These centers offer [...] [...]
2024-01-16
Study Status, Outcome Measures v1
Secondary endpointsdetails revised at 2 of 2 entries
2023-12-03
Original filing
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.
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