Development DelayNCT07878819
Effect of a Telerehabilitation-Supported, Family-Centered Early Intervention Program on Neurodevelopmental and Parental Outcomes in Infants at Mild-to-Moderate Risk
A study testing Remote Family-Centered Early Intervention Program and Standard Information and Routine Follow-up in people with Development Delay and Motor Skills Disorders, run by Bengisu Boz Gürboğa at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 10 monthsHealthy volunteers can take part
- Conditions the study is for
- Development Delay, Motor Skills Disorders, Neurodevelomental Disorders
- What is being tested?
- Remote Family-Centered Early Intervention Program and Standard Information and Routine Follow-up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Nov 2026to 15 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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:
Read more
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.
Read the detailed description
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.
- Conditions
- Development Delay, Motor Skills Disorders, Neurodevelomental Disorders, High Risk Infant, Premature Birth
- Being tested
- Remote Family-Centered Early Intervention Program, Standard Information and Routine Follow-up
- Medical subject headings
- Learning Disabilities, Motor Skills Disorders, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Family-Centered Early Intervention ProgramBehavioural
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:
- 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;
- A structured home program targeting motor, cognitive, sensory, and communication/language development, which parents are asked to practice
- Video-based feedback: parents record short videos of home practice [weekly] and receive individualized written/verbal feedback from the therapist;
- A psychosocial education module (Module C), delivered by a psychologist and support
Standard Information and Routine Follow-upBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Remote Family-Centered Early Intervention | Experimental | 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. Receives: Behavioral: Remote Family-Centered Early Intervention Program |
| Standard Care | Active comparator | 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. Receives: Behavioral: Standard Information and Routine Follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start16 Nov 2026 (estimated)
- Primary completion27 Apr 2027 (estimated)
- Study completion15 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Development DelayStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bengisu Boz Gürboğa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bengisu Boz Gürboğa, Istanbul University
- Investigators
- Ayşe Resa Aydın, professor, Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07878819
- Sponsor's protocol ID
- E-90771246-302.14.03-4124744
- Status last verified
- Oct 2026
- First submitted
- 11 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07878819
- Acronym / sponsor ID
- E-90771246-302.14.03-4124744
- Conditions
- Development Delay, Motor Skills Disorders, Neurodevelomental Disorders, High Risk Infant, Premature Birth
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Bengisu Boz GürboğaUniversity, hospital or other
- Study start
- 16 Nov 2026 (estimated)
- Primary completion
- 27 Apr 2027 (estimated)
- Study completion
- 15 May 2027 (estimated)
- First posted
- 16 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote Family-Centered Early Intervention | Experimental | Behavioral: Remote Family-Centered Early Intervention ProgramInfants 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. |
| Standard Care | Active comparator | Behavioral: Standard Information and Routine Follow-upInfants 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. |
Who may qualify
- Ages
- 6 to 10 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote Family-Centered Early Intervention ProgramThe 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 | Behavioural | Remote Family-Centered Early Intervention |
| Standard Information and Routine Follow-upFamilies 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. | Behavioural | Standard Care |
Primary outcome
Change in Bayley Motor Scales of Infant and Toddler Development, Third Edition (Bayley-III) Composite Scores
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ayşe Resa Aydın, professor principal investigator
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Family-Centered Early Intervention Program and Standard Information and Routine Follow-up in people with Development Delay and Motor Skills Disorders, run by Bengisu Boz Gürboğa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bengisu Boz Gürboğa, bachelor (+905309300499, bengisuboz99@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Bayley Motor Scales of Infant and Toddler Development, Third Edition (Bayley-III) Composite Scores (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.