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Efficacy of a Video-based, Parent-centered Home Developmental Intervention for Infants at High Risk for Developmental Delay: a Multicenter Randomized Controlled Trial
Sponsor: Seoul National University Hospital
Summary
The purpose of this study is to determine whether the Motor Composite Score on the Bayley-III (administered at 6 months of corrected age) shows significant improvement in an intervention group-receiving usual care combined with a video-based home developmental intervention-compared to a control group receiving only usual care, among infants at high risk for developmental delay. The study subjects are infants discharged from the Neonatal Intensive Care Unit (NICU) who were born prematurely at a gestational age of less than 32 weeks or who sustained brain injury. The control group receives usual care only, while the intervention group receives usual care plus a parent-centered developmental training intervention. Parent education for this intervention involves 1:1 monitoring via video conferencing platforms to facilitate parent-centered early intervention at home; sessions last 30 minutes and are conducted once weekly from 0 to 3 months of corrected age and twice weekly from 4 to 6 months of corrected age.
Key Details
Gender
All
Age Range
0 Weeks - 1 Month
Study Type
INTERVENTIONAL
Enrollment
170
Start Date
2026-12-01
Completion Date
2027-12-30
Last Updated
2026-10-20
Healthy Volunteers
No
Conditions
Interventions
Family-centered developmental training intervention
In parent-centered developmental training interventions, parents administer developmental training to their infants at home, focusing on specific tasks selected by a therapist from a range of activities-such as motor play, look and see play, tactile play, and verbal play. Up to four tasks may be selected per day, with specific parameters regarding sessions, sets, and repetitions determined by medical staff or therapists based on the infant's performance. The program is implemented seven days a week.