Risky BabyNCT07499843
Synchronous vs. Asynchronous Telerehabilitation for High-Risk Infants
A study testing Synchronous Telerehabilitation Group and Asynchronous Telerehabilitation Group in people with Risky Baby and Premature Birth of Newborn, run by Biruni University at 1 site in Turkey (Türkiye).
Trial summary
Premature birth, low birth weight, and a history of neonatal intensive care history are significant risk factors associated with long-term neurodevelopmental adverse outcomes in infants. Read more about this study
- Who is it for?
- Ages 6 to 9 months
- Conditions the study is for
- Risky Baby, Premature Birth of Newborn, Motor Delay
- What is being tested?
- Synchronous Telerehabilitation Group and Asynchronous Telerehabilitation Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 May 2026to 4 Jul 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 9 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age ≤32 weeks and/or birth weight ≤1500 grams.
- Corrected age between 6 and 9 months at the time of enrollment.
- Referral to a pediatric neurology clinic and/or current follow-up by a pediatric neurologist due to developmental risk.
- A total score of ≤73 on the Hammersmith Infant Neurological Examination (HINE) (Romeo et al., 2021; Novak et al., 2017).
- A score ≤5th percentile on the Alberta Infant Motor Scale (AIMS) (Fuentefria et al., 2017).
- Parental willingness to participate and signing of the "Informed Consent Form."
- Access to the minimum technological infrastructure required for telerehabilitation (smartphone, tablet, or computer with video calling capability and active internet access).
Who cannot join
- Presence of diagnosed genetic syndromes or metabolic diseases known to directly affect neuro-motor development.
- Major congenital malformations causing significant movement restriction or exercise intolerance.
- History of symptomatic hypoglycemia associated with severe brain injury during the neonatal period.
- Sensory impairments (bilateral blindness or severe bilateral hearing loss not correctable with hearing aids) that prevent participation in assessments and exercises based on visual and auditory stimuli.
- Acute or unstable clinical conditions that preclude the safe conduct of the intervention (e.g., continuous mechanical ventilation, hemodynamic instability, uncontrolled seizures, or active acute infections).
- Non-adherence to the study protocol, defined as missing more than 6 intervention sessions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Biruni University Department of Physiotherapy and Rehabilitation
Istanbul, Zeyti̇nburnu, 34010
GÜLSENA UTKU UMUT, PhD, +905370664646, gulsenautkuumut@gmail.com
GÜLSENA UTKU UMUT, PhD
About this study
Official title: Family-Centered Early Intervention Program Under Physiotherapist Coaching for High-Risk Infants: A Comparison of Synchronous and Asynchronous Telerehabilitation Models
Premature birth, low birth weight, and a history of neonatal intensive care history are significant risk factors associated with long-term neurodevelopmental adverse outcomes in infants. Family-centered early intervention programs play a critical role in minimizing the impact of these risks and optimizing developmental potential. Currently, telerehabilitation (TR) has emerged as a cost-effective solution that facilitates access to early intervention services. However, there is limited literature directly comparing the efficacy and feasibility of synchronous (real-time) and asynchronous (store-and-forward) parent coaching-based TR models specifically within the at-risk infant population.
The primary objective of this project is to comparatively examine the effects of synchronous and asynchronous TR programs on motor development levels, individualized goal attainment, and parental self-efficacy in infants aged 6-9 months (corrected age) at risk of developmental delay, against a standard home program (control group). Designed as a randomized controlled trial, the study will include 45 high-risk infants meeting the inclusion criteria, who will be randomly allocated into three groups: Synchronous TR, Asynchronous TR, and Control. In the Synchronous group, parents will receive real-time coaching via video conferencing for 12 weeks, whereas the Asynchronous group process will be managed through video analysis and delayed feedback mechanisms. The Control group will be provided with standard digital educational materials.
The primary outcome measures of the study include Goal Attainment Scaling (GAS) scores, the Parental Self-Efficacy Instrument, and the Parenting Stress Index. Secondary measures will include the Bayley Scales of Infant and Toddler Development (Bayley-IV), the Alberta Infant Motor Scale (AIMS), and the Hammersmith Infant Neurological Examination (HINE). Data will be collected at baseline (T0) and post-intervention (T1) by an assessor blinded to group allocation. The findings obtained from this study aim to demonstrate the clinical efficacy of different TR models, thereby providing guidance for the planning and dissemination of remote healthcare services for high-risk infants.
- Conditions
- Risky Baby, Premature Birth of Newborn, Motor Delay
- Being tested
- Synchronous Telerehabilitation Group, Asynchronous Telerehabilitation Group
- Keywords
- At-risk infant, Early intervention, Telerehabilitation, Parent coaching, Motor development
- Medical subject headings
- Premature Birth, Psychomotor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synchronous Telerehabilitation GroupOther
A 12-week remote physiotherapy program based on a 'parent coaching' model delivered via real-time video conferencing (Zoom). The intervention consists of weekly 45-minute sessions where the physiotherapist acts as a coach, providing live verbal and visual guidance to parents as the primary implementers of the intervention. Activities are integrated into the infant's natural daily routines (play, feeding, care). Pre-session standardized guidance (camera positioning, infant readiness) is provided via WhatsApp. Clinical progress is monitored through weekly evaluation and updating of Goal Attainment Scaling (GAS) objectives tailored to the infant's developmental needs.
Asynchronous Telerehabilitation GroupOther
A 12-week remote physiotherapy program based on a parent coaching model using a delayed feedback principle. To ensure therapeutic intensity equivalent to synchronous sessions, parents record and submit 10-15 minutes of video clips weekly through secure, end-to-end encrypted messaging. These clips demonstrate intervention activities integrated into daily routines (play, feeding, care). The physiotherapist performs a detailed analysis of handling techniques and movement quality, providing feedback via recorded demonstration videos (using a model doll or the therapist) to correct or reinforce motor patterns. Each weekly cycle includes evaluating Goal Attainment Scaling (GAS) objectives and updating motor strategies based on the infant's current developmental needs.
| Study group | Role | What they receive |
|---|---|---|
| Synchronous Telerehabilitation Group | Other | Participants in the synchronous group will receive a 12-week telerehabilitation program based on a 'parent coaching' model. The intervention consists of weekly 45-minute real-time video consultations via Zoom. To optimize session efficiency, parents receive standardized pre-session guidance (camera setup, infant readiness) via WhatsApp. The physiotherapist acts as a remote coach, providing live verbal and visual feedback to guide parents as the primary implementers during natural daily routines (play, feeding, care). Each session involves evaluating Goal Attainment Scaling (GAS) objectives from the previous week and collaborative development of new motor strategies and environmental modifications tailored to the infant's current developmental needs. Receives: Other: Synchronous Telerehabilitation Group |
| Asynchronous Telerehabilitation Group | Other | Participants in the asynchronous group will follow a 12-week telerehabilitation program based on a parent coaching model with a delayed feedback principle. To ensure therapeutic intensity equivalent to the synchronous sessions, parents will record and submit 10-15 minutes of video clips weekly, showing intervention activities integrated into daily routines (play, feeding, care). These videos are shared via secure, end-to-end encrypted messaging. The physiotherapist performs a detailed analysis of the parents' handling techniques and the infant's movement quality. Feedback is provided through recorded demonstration videos (using a model doll or the therapist) to correct or reinforce motor patterns. Each weekly cycle includes evaluating Goal Attainment Scaling (GAS) objectives and updating motor strategies based on the infant's current developmental needs. Receives: Other: Asynchronous Telerehabilitation Group |
| Control Group | No intervention | Participants in the control group will follow a standard home-based program without active physiotherapist supervision or individualized coaching. At baseline (T0), infant-specific Goal Attainment Scaling (GAS) parameters are established. Families receive comprehensive standardized educational materials, including a 'Parent Education Booklet' (PDF) and instructional videos demonstrating motor activities and positioning. Throughout the 12-week period, families implement these strategies independently. Unlike the experimental groups, no live feedback, video analysis, or weekly goal revisions are provided; GAS goals remain fixed and are evaluated only at the 12th week (T1). For ethical monitoring, brief phone calls are conducted at weeks 4 and 8 to assess study adherence and general health, strictly excluding any therapeutic guidance or intervention updates. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Goal Attainment Scaling
Goal Attainment Scaling (GAS) is a standardized method used to evaluate the achievement of individualized treatment goals in pediatric rehabilitation. For each infant, 3 to 5 SMART (specific, measurable, attainable, relevant, and time-bound) goals are collaboratively established by the physiotherapist and the family. Each goal is scored on a 5-point scale: -2 (baseline level), -1 (less than expected), 0 (expected outcome), +1 (more than expected), and +2 (much more than expected). The raw scores are converted into a standardized T-score using the formula with a mean of 50 and a standard deviation of 10. A T-score of 50 or higher indicates that the intervention has successfully met or exceeded the expected goals.
Measured: Baseline and after 12 weeks
Parental Self-Efficacy Instrument for Children with Disabilities
The Parental Self-Efficacy Scale, developed by Guimond et al. (2005) and adapted into Turkish by Cavkaytar et al. (2014), assesses the self-efficacy perceptions of parents of children with disabilities regarding their caregiving and child-rearing capacities. The scale consists of 17 items rated on a 5-point Likert-type scale. It is primarily administered as a self-report tool, with researchers providing assistance (reading items) for illiterate participants if necessary. The Turkish version demonstrated high internal consistency (Cronbach's Alpha = 0.95) and test-retest reliability (r = 0.79). Total scores range from 17 to 85, where higher scores indicate a greater sense of parenting competence and self-efficacy in their roles.
Measured: Baseline and after 12 weeks
Parenting Stress Index - Short Form (PSI-SF)
The Parenting Stress Index - Short Form (PSI-SF), originally developed by Abidin (1983) and validated in Turkish by Mert et al. (2008), is a 36-item self-report instrument designed to assess stress within the parent-child system. It consists of three subscales (12 items each): Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child. The Total Stress score is calculated by summing these three subscale scores. Total scores range from 36 to 180, where higher scores represent higher levels of perceived parenting stress. The Turkish version demonstrated internal consistency (Cronbach's Alpha = 0.71 for Total Stress; 0.76-0.81 for subscales) and high test-retest reliability (r = 0.88).
Measured: Baseline and after 12 weeks
Secondary outcomes (5)
Hammersmith Infant Neurological Examination
The Hammersmith Infant Neurological Examination (HINE) is a standardized, quantitative tool for the neurological assessment of infants aged 2 to 24 months. It comprises three sections: (1) a 26-item neurological examination assessing cranial nerve function, posture, movement quality, muscle tone, and reflexes; (2) an 8-item assessment of developmental motor milestones; and (3) a 3-item behavioral assessment. The total neurological score is derived from the 26 items in the first section, with a maximum possible score of 78. Higher scores indicate better neurological development and maturity.
Measured: Baseline and after 12 weeks
Bayley Scales of Infant and Toddler Development, Fourth Edition
The Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-IV) is a comprehensive assessment used to evaluate developmental functioning in infants and toddlers aged 16 days to 42 months. It covers five primary domains: Cognitive, Language (Receptive and Expressive), Motor (Fine and Gross), Social-Emotional, and Adaptive Behavior. The assessment involves interactive tasks with the child and caregiver questionnaires. Standardized composite scores are calculated for each domain, with scores below the 10th percentile indicating a risk of developmental delay. For this study, all assessments will be conducted by certified researchers to ensure standardized administration and scoring.
Measured: Baseline and after 12 weeks
Alberta Infant Motor Scale
The Alberta Infant Motor Scale (AIMS), developed by Piper and Darrah (1992), is a norm-referenced standardized instrument used to assess the gross motor development of infants from birth through independent walking (approx. 18 months). It consists of 58 items distributed across four postural positions: prone (21), supine (9), sitting (12), and standing (16). Scoring is based on clinical observation of weight-bearing, postural alignment, and anti-gravity movements. The total score ranges from 0 to 58, where higher scores indicate more advanced gross motor maturation (Piper \& Darrah, 1992; Eliks et al., 2022).
Measured: Baseline and after 12 weeks
Telehealth Usability Questionnaire
The Telehealth Usability Questionnaire (TUQ), developed by Parmanto et al. (2016) and validated in Turkish (Ozden et al., 2021), is a 21-item instrument designed to evaluate the quality of telerehabilitation services, software, and systems. It assesses six domains: usefulness, ease of use and learnability, interface quality, interaction quality, reliability, and satisfaction. Items are rated on a 7-point Likert scale (1=Strongly Disagree, 7=Strongly Agree). Total scores range from 21 to 147, where higher scores indicate greater usability and satisfaction with the telehealth system. This scale will be used to compare the technical infrastructure performance and family-system interaction levels for both synchronous and asynchronous models.
Measured: Baseline and after 12 weeks
Telemedicine Satisfaction Questionnaire
The Telehealth Satisfaction Questionnaire (TSQ), developed by Yip et al. (2003) and validated in Turkish (Ozden et al., 2021), is a 14-item instrument designed to assess the level of satisfaction among participants receiving telehealth services. The questionnaire uses a 5-point Likert-type scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree). Total scores range from 14 to 70, where higher scores indicate a higher level of satisfaction with the telerehabilitation service provided.
Measured: Baseline and after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start4 May 2026 (estimated)
- Primary completion4 May 2027 (estimated)
- Study completion4 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risky BabyStudies of the same condition, open and under way.
- More trials run by Biruni UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülsena Utku Umut, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07499843
- Sponsor's protocol ID
- 1002-EI-ASYN-VS-SYN
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect the privacy of the infants and their families, as the study involves sensitive developmental data and video recordings. Ethical approval from the Institutional Review Board does not include permission for public data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family-Centered Early Intervention Program Under Physiotherapist Coaching for High-Risk Infants: A Comparison of Synchronous and Asynchronous Telerehabilitation Models
- ClinicalTrials.gov ID
- NCT07499843
- Acronym / sponsor ID
- 1002-EI-ASYN-VS-SYN
- Conditions
- Risky Baby, Premature Birth of Newborn, Motor Delay
- Keywords
- At-risk infant, Early intervention, Telerehabilitation, Parent coaching, Motor development
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 4 May 2026 (estimated)
- Primary completion
- 4 May 2027 (estimated)
- Study completion
- 4 Jul 2027 (estimated)
- First posted
- 30 Mar 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.
Premature birth, low birth weight, and a history of neonatal intensive care history are significant risk factors associated with long-term neurodevelopmental adverse outcomes in infants. Family-centered early intervention programs play a critical role in minimizing the impact of these risks and optimizing developmental potential. Currently, telerehabilitation (TR) has emerged as a cost-effective solution that facilitates access to early intervention services. However, there is limited literature directly comparing the efficacy and feasibility of synchronous (real-time) and asynchronous (store-and-forward) parent coaching-based TR models specifically within the at-risk infant population.
The primary objective of this project is to comparatively examine the effects of synchronous and asynchronous TR programs on motor development levels, individualized goal attainment, and parental self-efficacy in infants aged 6-9 months (corrected age) at risk of developmental delay, against a standard home program (control group). Designed as a randomized controlled trial, the study will include 45 high-risk infants meeting the inclusion criteria, who will be randomly allocated into three groups: Synchronous TR, Asynchronous TR, and Control. In the Synchronous group, parents will receive real-time coaching via video conferencing for 12 weeks, whereas the Asynchronous group process will be managed through video analysis and delayed feedback mechanisms. The Control group will be provided with standard digital educational materials.
The primary outcome measures of the study include Goal Attainment Scaling (GAS) scores, the Parental Self-Efficacy Instrument, and the Parenting Stress Index. Secondary measures will include the Bayley Scales of Infant and Toddler Development (Bayley-IV), the Alberta Infant Motor Scale (AIMS), and the Hammersmith Infant Neurological Examination (HINE). Data will be collected at baseline (T0) and post-intervention (T1) by an assessor blinded to group allocation. The findings obtained from this study aim to demonstrate the clinical efficacy of different TR models, thereby providing guidance for the planning and dissemination of remote healthcare services for high-risk infants.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Synchronous Telerehabilitation Group | Other | Other: Synchronous Telerehabilitation GroupParticipants in the synchronous group will receive a 12-week telerehabilitation program based on a 'parent coaching' model. The intervention consists of weekly 45-minute real-time video consultations via Zoom. To optimize session efficiency, parents receive standardized pre-session guidance (camera setup, infant readiness) via WhatsApp. The physiotherapist acts as a remote coach, providing live verbal and visual feedback to guide parents as the primary implementers during natural daily routines (play, feeding, care). Each session involves evaluating Goal Attainment Scaling (GAS) objectives from the previous week and collaborative development of new motor strategies and environmental modifications tailored to the infant's current developmental needs. |
| Asynchronous Telerehabilitation Group | Other | Other: Asynchronous Telerehabilitation GroupParticipants in the asynchronous group will follow a 12-week telerehabilitation program based on a parent coaching model with a delayed feedback principle. To ensure therapeutic intensity equivalent to the synchronous sessions, parents will record and submit 10-15 minutes of video clips weekly, showing intervention activities integrated into daily routines (play, feeding, care). These videos are shared via secure, end-to-end encrypted messaging. The physiotherapist performs a detailed analysis of the parents' handling techniques and the infant's movement quality. Feedback is provided through recorded demonstration videos (using a model doll or the therapist) to correct or reinforce motor patterns. Each weekly cycle includes evaluating Goal Attainment Scaling (GAS) objectives and updating motor strategies based on the infant's current developmental needs. |
| Control Group | No intervention | –Participants in the control group will follow a standard home-based program without active physiotherapist supervision or individualized coaching. At baseline (T0), infant-specific Goal Attainment Scaling (GAS) parameters are established. Families receive comprehensive standardized educational materials, including a 'Parent Education Booklet' (PDF) and instructional videos demonstrating motor activities and positioning. Throughout the 12-week period, families implement these strategies independently. Unlike the experimental groups, no live feedback, video analysis, or weekly goal revisions are provided; GAS goals remain fixed and are evaluated only at the 12th week (T1). For ethical monitoring, brief phone calls are conducted at weeks 4 and 8 to assess study adherence and general health, strictly excluding any therapeutic guidance or intervention updates. |
Who may qualify
- Ages
- 6 to 9 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Gestational age ≤32 weeks and/or birth weight ≤1500 grams.
- Corrected age between 6 and 9 months at the time of enrollment.
- Referral to a pediatric neurology clinic and/or current follow-up by a pediatric neurologist due to developmental risk.
- A total score of ≤73 on the Hammersmith Infant Neurological Examination (HINE) (Romeo et al., 2021; Novak et al., 2017).
- A score ≤5th percentile on the Alberta Infant Motor Scale (AIMS) (Fuentefria et al., 2017).
Key exclusion criteria (6 listed)
- Presence of diagnosed genetic syndromes or metabolic diseases known to directly affect neuro-motor development.
- Major congenital malformations causing significant movement restriction or exercise intolerance.
- History of symptomatic hypoglycemia associated with severe brain injury during the neonatal period.
- Sensory impairments (bilateral blindness or severe bilateral hearing loss not correctable with hearing aids) that prevent participation in assessments and exercises based on visual and auditory stimuli.
- Acute or unstable clinical conditions that preclude the safe conduct of the intervention (e.g., continuous mechanical ventilation, hemodynamic instability, uncontrolled seizures, or active acute infections).
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 |
|---|---|---|
| Synchronous Telerehabilitation GroupA 12-week remote physiotherapy program based on a 'parent coaching' model delivered via real-time video conferencing (Zoom). The intervention consists of weekly 45-minute sessions where the physiotherapist acts as a coach, providing live verbal and visual guidance to parents as the primary implementers of the intervention. Activities are integrated into the infant's natural daily routines (play, feeding, care). Pre-session standardized guidance (camera positioning, infant readiness) is provided via WhatsApp. Clinical progress is monitored through weekly evaluation and updating of Goal Attainment Scaling (GAS) objectives tailored to the infant's developmental needs. | Other | Synchronous Telerehabilitation Group |
| Asynchronous Telerehabilitation GroupA 12-week remote physiotherapy program based on a parent coaching model using a delayed feedback principle. To ensure therapeutic intensity equivalent to synchronous sessions, parents record and submit 10-15 minutes of video clips weekly through secure, end-to-end encrypted messaging. These clips demonstrate intervention activities integrated into daily routines (play, feeding, care). The physiotherapist performs a detailed analysis of handling techniques and movement quality, providing feedback via recorded demonstration videos (using a model doll or the therapist) to correct or reinforce motor patterns. Each weekly cycle includes evaluating Goal Attainment Scaling (GAS) objectives and updating motor strategies based on the infant's current developmental needs. | Other | Asynchronous Telerehabilitation Group |
Primary outcome
Goal Attainment Scaling
Time frame: Baseline and after 12 weeks
Goal Attainment Scaling (GAS) is a standardized method used to evaluate the achievement of individualized treatment goals in pediatric rehabilitation. For each infant, 3 to 5 SMART (specific, measurable, attainable, relevant, and time-bound) goals are collaboratively established by the physiotherapist and the family. Each goal is scored on a 5-point scale: -2 (baseline level), -1 (less than expected), 0 (expected outcome), +1 (more than expected), and +2 (much more than expected). The raw scores are converted into a standardized T-score using the formula with a mean of 50 and a standard deviation of 10. A T-score of 50 or higher indicates that the intervention has successfully met or exceeded the expected goals.
Parental Self-Efficacy Instrument for Children with Disabilities
Time frame: Baseline and after 12 weeks
The Parental Self-Efficacy Scale, developed by Guimond et al. (2005) and adapted into Turkish by Cavkaytar et al. (2014), assesses the self-efficacy perceptions of parents of children with disabilities regarding their caregiving and child-rearing capacities. The scale consists of 17 items rated on a 5-point Likert-type scale. It is primarily administered as a self-report tool, with researchers providing assistance (reading items) for illiterate participants if necessary. The Turkish version demonstrated high internal consistency (Cronbach's Alpha = 0.95) and test-retest reliability (r = 0.79). Total scores range from 17 to 85, where higher scores indicate a greater sense of parenting competence and self-efficacy in their roles.
Parenting Stress Index - Short Form (PSI-SF)
Time frame: Baseline and after 12 weeks
The Parenting Stress Index - Short Form (PSI-SF), originally developed by Abidin (1983) and validated in Turkish by Mert et al. (2008), is a 36-item self-report instrument designed to assess stress within the parent-child system. It consists of three subscales (12 items each): Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child. The Total Stress score is calculated by summing these three subscale scores. Total scores range from 36 to 180, where higher scores represent higher levels of perceived parenting stress. The Turkish version demonstrated internal consistency (Cronbach's Alpha = 0.71 for Total Stress; 0.76-0.81 for subscales) and high test-retest reliability (r = 0.88).
5 secondary outcomes
Hammersmith Infant Neurological Examination
Time frame: Baseline and after 12 weeks
Bayley Scales of Infant and Toddler Development, Fourth Edition
Time frame: Baseline and after 12 weeks
Alberta Infant Motor Scale
Time frame: Baseline and after 12 weeks
Telehealth Usability Questionnaire
Time frame: Baseline and after 12 weeks
Telemedicine Satisfaction Questionnaire
Time frame: Baseline and after 12 weeks
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 30 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect the privacy of the infants and their families, as the study involves sensitive developmental data and video recordings. Ethical approval from the Institutional Review Board does not include permission for public data sharing.
Related trials for Risky Baby
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synchronous Telerehabilitation Group and Asynchronous Telerehabilitation Group in people with Risky Baby and Premature Birth of Newborn, run by Biruni University 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 6 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 30 Mar 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 GÜLSENA UTKU UMUT, PhD (+905370664646, gulsenautkuumut@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Goal Attainment Scaling (time frame: Baseline and after 12 weeks). The study lists 3 primary outcomes in all. 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 30 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.