Effect of a Telerehabilitation-Supported, Family-Centered Early Intervention Program on Neurodevelopmental and Parental Outcomes in Infants at Mild-to-Moderate Risk

Background and rationale

Infants discharged from the neonatal intensive care unit (NICU) are at increased risk of developmental delays, even when their medical risk is classified as mild or moderate. Early intervention during the first year of life, when brain plasticity is high, may help reduce these risks. Family-centered approaches, in which parents are supported to integrate developmental activities into daily routines, are recommended, but access to regular in-person services is often limited by distance, cost, and the burden of frequent hospital visits. Parents of NICU graduates also commonly experience elevated stress and anxiety, which can affect parent-infant interaction and, in turn, infant development. Remote delivery (telehealth) offers a way to provide structured, family-centered support at home, but evidence on its feasibility and effects in this population is limited. This pilot trial is designed to generate preliminary data on the effects of such a program and to inform the design of a larger trial.

Intervention

The intervention is the ÇAPA family-centered early intervention program, developed by the study team. The program consists of \[number\] modules addressing \[e.g., motor development, sensory and cognitive development, communication and language\] and a psychosocial module (Module C) focused on parental well-being, coping with stress, and supporting parent-infant interaction. Module C is delivered by a psychologist and is supported by animated educational videos developed for the program.

Over 8 weeks, families in the intervention group take part in weekly online sessions in which the therapist reviews the infant's progress, demonstrates activities, and adapts the home program to the infant's needs. Between sessions, parents carry out the home program as part of daily routines and send short video recordings of practice; the therapist provides individualized feedback on these videos. Ongoing contact and reminders are maintained through a messaging application.

The control group receives standard information about infant development and continues routine follow-up care.

Study procedures

The study is conducted at \[Esnaf Hospital, Istanbul, Türkiye\]. After eligibility screening and informed consent, baseline assessments are performed, and infants are randomly allocated in a 1:1 ratio to the intervention or control group using \[randomization method, e.g., computer-generated block randomization with sealed opaque envelopes\]. Outcome assessments are performed at baseline and \[after the 10-week intervention period / follow-up time point\] by an assessor blinded to group allocation.

Pilot objectives

In addition to estimating the effects of the program, this pilot study will evaluate feasibility indicators, including \[recruitment rate, retention, session attendance, adherence to the home program, and parent satisfaction\], to inform sample size calculation and procedures for a future definitive trial.

• Remote Family-Centered Early Intervention Program (Behavioral): 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 (Behavioral): 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.

Primary outcomes

• Change in Bayley Motor Scales of Infant and Toddler Development, Third Edition (Bayley-III) Composite Scores [8 weeks]: Infant development will be assessed with the Bayley-III by a blinded assessor. Cognitive, Language, and Motor composite scores will be calculated (each with a mean of 100 and a standard deviation of 15; range 40-160). Higher scores indicate better developmental performance. Change from baseline to post-intervention will be compared between groups.

Sex: All, ages: 6 Months to 10 Months, accepts healthy volunteers

Inclusion Criteria:

* Corrected age of 6 to 10 months
* Mild or moderate risk group according to the Turkish Neonatology Society High-Risk Infant Follow-up Guideline
* History of neonatal intensive care unit admission
* Written informed consent from the family
* Caregiver able to carry out the home program
* Family access to telephone, internet, and a computer or tablet
* Family agrees to attend remote follow-up sessions

Exclusion Criteria:

* High risk group according to the Turkish Neonatology Society High-Risk Infant Follow-up Guideline
* Birth weight below 1000 g
* Gestational age below 29 weeks
* History of grade 3-4 intracranial hemorrhage
* History of cystic periventricular leukomalacia
* Hydrocephalus, cerebral infarction, or severe central nervous system pathology
* History of seizures or uncontrolled epilepsy
* Markedly abnormal neurological examination at discharge
* Need for advanced resuscitation at birth
* History of prolonged mechanical ventilation
* History of bronchopulmonary dysplasia, severe apnea, or pneumothorax
* Severe visual or hearing impairment
* Congenital anomaly or severe systemic disease
* Currently attending another rehabilitation program
* Communication or language barrier that prevents reliable intervention and assessment and cannot be resolved with accessible arrangements

• Ayşe Resa Aydın, professor, Principal investigator, Istanbul University