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Effect of a Telerehabilitation-Supported, Family-Centered Early Intervention Program on Neurodevelopmental and Parental Outcomes in Infants at Mild-to-Moderate Risk
Sponsor: Bengisu Boz Gürboğa
Summary
The goal of this pilot randomized controlled trial is to learn whether a family-centered early intervention program, delivered remotely to parents and carried out at home, can support the development of infants who were treated in a neonatal intensive care unit (NICU) and are at mild-to-moderate developmental risk (for example, due to preterm birth or low birth weight). The study will also look at whether the program helps parents' stress and well-being. The main questions it aims to answer are: Does the remote family-centered early intervention program improve infants' motor, cognitive, language, and neurological development compared with standard care? Does the program reduce parental stress and anxiety and improve parents' perception of family-centered care? Researchers will compare an intervention group with a control group receiving standard information and routine follow-up, to see whether the program leads to better infant and parent outcomes. The study will include 36 infants (18 per group) with a corrected age of 6 to 10 months. Participants in the intervention group will: Attend weekly online sessions with the research team for 10 weeks Carry out a home-based developmental activity program with their infant Share short videos of home practice and receive feedback, with follow-up via messaging Participants in the control group will receive standard information and routine follow-up. Infant development will be assessed with the Bayley-III and SINDA, and parents will complete questionnaires on stress, anxiety, and family-centered care. Assessors will be blinded to group assignment.
Official title: Effect of a Telerehabilitation-Supported, Family-Centered Early Intervention Program on Neurological, Developmental, and Parental Outcomes in Infants at Mild and Moderate Neurodevelopmental Risk: A Pilot Randomized Controlled Trial
Key Details
Gender
All
Age Range
6 Months - 10 Months
Study Type
INTERVENTIONAL
Enrollment
36
Start Date
2026-11-16
Completion Date
2027-05-15
Last Updated
2026-10-16
Healthy Volunteers
Yes
Interventions
Remote Family-Centered Early Intervention Program
The CAPA program is a 8-week, family-centered early intervention delivered remotely to parents of infants discharged from the NICU at mild-to-moderate developmental risk. Unlike clinic-based therapist-delivered interventions, parents are coached to carry out developmental activities within the infant's daily routines at home. Components: 1. 3 individual online video sessions with a therapist, in which the infant's progress is reviewed, activities are demonstrated, and the home program is individually adapted to the infant's developmental needs; 2. A structured home program targeting motor, cognitive, sensory, and communication/language development, which parents are asked to practice 3. Video-based feedback: parents record short videos of home practice \[weekly\] and receive individualized written/verbal feedback from the therapist; 4. A psychosocial education module (Module C), delivered by a psychologist and support
Standard Information and Routine Follow-up
Families receive standard information about typical infant development and general recommendations for supporting development at home, provided \[verbally and/or as a written brochure\] at enrollment. Infants continue routine follow-up care at the hospital's high-risk infant follow-up clinic as usual. No structured home program, online sessions, video-based feedback, psychosocial education module, or messaging-based follow-up is provided during the study period.
Locations (1)
Istanbul University
Istanbul, Fatih, Turkey (Türkiye)