An interventional study of Remote Family-Centered Early Intervention Program and Standard Information and Routine Follow-up in Development Delay, Motor Skills Disorders and Neurodevelomental Disorders, sponsored by Bengisu Boz Gürboğa. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 6 Months to 10 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Bengisu Boz Gürboğa · Not applicable, Interventional, and Prevention
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.
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.
150 studies on the registry are indexed under Learning Disabilities; 51 are open to participants now.
This study's planned enrollment of 36 is below the median of 60 across 101 interventional studies indexed under Learning Disabilities.
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Exclusion Criteria:
Infants and their parents receive the 8-week CAPA remote family-centered early intervention program in addition to routine follow-up. The program includes weekly online sessions with a therapist, a home-based developmental activity program integrated into daily routines, and individualized feedback on short videos of home practice recorded by parents. Parents also receive a psychosocial education module, delivered by a psychologist and supported by animated educational videos, focusing on parental well-being, coping with stress, and parent-infant interaction. Ongoing contact and reminders are provided via a messaging application.
Behavioral: Remote Family-Centered Early Intervention Program
Infants and their parents receive standard written/verbal information about infant development and continue routine follow-up care at the hospital. No additional intervention is provided during the study period.
Behavioral: Standard Information and Routine Follow-up
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
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.
Change in Bayley Motor Scales of Infant and Toddler Development, Third Edition (Bayley-III) Composite Scores
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.
Time frame: 8 weeks
Start is estimated for Nov 2026; primary completion for Apr 2027, 5 months later.
Of 55 non-industry interventional studies with no phase under Learning Disabilities, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 49. This study's planned 5 months is below that.
Counting every sponsor, half of 58 studies reached it within 30 months; a quarter within 7 and three quarters within 49.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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