High-risk InfantsBBL-ATOPNCT06608576
Telematic Support in Early Intervention on Infants At Risk of Neurodevelopmental Delays
A study testing Face-to-face standard treatment and Telematic Support in people with High-risk Infants, run by Universidad de Granada at 1 site in Spain.
Trial summary
The purpose of this study is to evaluate the effects of early intervention support sessions via video conferencing as an adjuvant option to motor development on infants at risk of neurodevelopmental delays or disorders. Read more about this study
- Who is it for?
- Ages 3 to 12 months
- Conditions the study is for
- High-risk Infants
- What is being tested?
- Face-to-face standard treatment and Telematic Support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 15 Feb 2024to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 3 to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Minor infants with a chronological or corrected age of 3 to 12 months and their parents attending physical therapy early intervention protocol at the Neuropediatrics and Neurodevelopment Unit of San Cecilio University Hospital in Granada.
- At risk of neurodevelopmental delays or disorders.
- Whose family has a cell phone with WhatsApp Application installed and internet to be able to carry out the telematic tests.
Who cannot join
- Independent walking children.
- Minor infants with diagnosis of neuromotor injury, visual and auditory sensory disorders or congenital anomalies.
- Infants with orthoses and/or prostheses.
- Children with health complications that enable the child's participation in the study.
- Not spanish-speaking parents.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario San Cecilio de Granada
Granada, Granada, 18007
About this study
Official title: Effects of Telematic Support in Physical Therapy Early Intervention on Infants At Risk of Neurodevelopmental Delays and Disorders
The purpose of this study is to evaluate the effects of early intervention support sessions via video conferencing as an adjuvant option to motor development on infants at risk of neurodevelopmental delays or disorders.
Read the detailed description
The parents will be informed about the procedure and will be given a written informed consent in order to participate in the study. Then, the families will be randomized into one of two groups: standard treatment or telematic support. Both treatments in a 2-month period.
- Conditions
- High-risk Infants
- Being tested
- Face-to-face standard treatment, Telematic Support
- Keywords
- early intervention, telerehabilitation, physical therapy, child development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face-to-face standard treatmentOther
Individualized early intervention treatment on physical therapy area as usual in the early intervention facilities once a month for two months. Instructions will be given to the parents for follow-up at home to stimulate the baby's motor development until next face-to-face session.
Telematic SupportOther
The physiotherapist in charge of the telematic sessions will review and guide in real time through WhatsApp platform, the performance and active participation of the parents in the therapeutic activities being asked to follow-up at home in the face-to-face appointment, correcting, as necessary.
| Study group | Role | What they receive |
|---|---|---|
| Standard Treatment | Active comparator | participants will receive face-to-face early intervention treatment on physical therapy area once a month for two months. Receives: Other: Face-to-face standard treatment |
| Telematic Support | Experimental | Participants will receive weekly telematic early intervention sessions at home via video conferencing for two months. Receives: Other: Telematic Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Motor Development on the Motor scale of the Infant Motor Development on the Bayley Scales of Infant and Toddler Development-III® (BSID-III) at month 2.
The BSID-III is an assessment tool for diagnosing developmental delays in early childhood from 1 to 42 months. It assesses 5 developmental domains: Cognitive Scale, Language Scale, Motor scale, Social-Emotional Scale and Adaptative Scale. The motor scale has 66 items in the fine motor and 72 items in the gross motor domain which are administrated according to the child development. Change= (2 months development score - baseline Score).
Measured: Baseline and Month 2.
Change from Baseline in maturation of motor skills on the Alberta Infant Motor Scale (AIMS) at month 2.
The AIMS is an observational assessment tool that requires minimal handling of an infant by the examiner. It assesses the maturation of infant's motor skills from term (40 weeks gestation) to 18 months. It has 58 observational items divided into four subscales which are prone, supine, sitting and standing. Change= (2 months development score - baseline Score).
Measured: Baseline and Month 2.
Change from Baseline in infant motor behaviour and motor development on the Infant Motor Profile (IMP) at month 2.
The IMP is a video-based assessment for infants aged 3 to 18 months. It assesses the spontaneous motor behaviour in supine, prone, sitting, standing, walking and during reaching and grasping - depending on the age of the infant. Includes 5 domains: the size of the infant's motor repertoire, the infant's ability to make an adaptive selection out of his/her repertoire, performance, symmetry and fluency. Change= (2 months IMP total and subscales scores - baseline scores).
Measured: Baseline and Month 2.
Secondary outcomes (4)
Change from Baseline in parents' quality of life on the Care-related quality of life (CarerQol) at month 2.
CarerQol measures the impact of providing informal care on caregivers. Consists of seven items questionnaire to evaluate the impact of informal care on satisfaction, support, problems with daily activities, and financial, relational, mental health and physical health problems of caregivers, and a Visual Analogue Scale which measures general well-being in terms of happiness from 0 (completely unhappy) to 10 (completely happy). Change= (2 months scores on each item - baseline Score).
Measured: Baseline and Month 2.
Change from Baseline in levels of stress experienced by parents on the Parental Stress Scale (PSS) at month 2.
The Paretal Stress Scale is an 18-item self-report measure design to assess the perceived levels of stress resulting from being a parent. Overall possible scores on the scale range from 18 to 90 with higher scores indicating a higher level of stress. There are no average scores or "cut-off's" for this tool. Change= (2 months stress score - baseline score).
Measured: Baseline and Month 2.
Parents satisfaction with the telematic support service measured with the Client Satisfaction Questionnaire (CSQ-8).
The Client Satisfaction Questionnaire is an 8-item measure of client or consumer satisfaction with health and human services including governmental and public benefit programs and services. Overall possible scores on the scale range from 8 to 32 with higher scores indicating a higher level of satisfaction with the given service. There are no average scores or "cut-off's" for this tool.
Measured: Month 2
Change from Baseline in parental self-efficacy and satisfaction of being a parent on the Parenting Sense of Competence (PSOC) at month 2.
PSOC is a self-report measure that uses 17 questions to measure how capable a caregiver feels as a parent and how satisfied they are with being a parent. Possible scores range from 17 to 102 with higher scores indicating a higher parenting sense of competency. There are no average scores or "cut-off's" for this tool. Change= (2 months sense of competence score - baseline score).
Measured: Baseline and Month 2.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start15 Feb 2024
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-risk InfantsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario San Cecilio de Granada
- Responsible party
- Principal investigator, Marie Carmen Valenza, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06608576
- Sponsor's protocol ID
- BBL-ATPO-2023
- Acronym
- BBL-ATOP
- Status last verified
- Sep 2024
- First submitted
- 19 Sep 2024
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Telematic Support in Physical Therapy Early Intervention on Infants At Risk of Neurodevelopmental Delays and Disorders
- ClinicalTrials.gov ID
- NCT06608576
- Acronym / sponsor ID
- BBL-ATOP / BBL-ATPO-2023
- Conditions
- High-risk Infants
- Keywords
- early intervention, telerehabilitation, physical therapy, child development
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Collaborators
- Hospital Universitario San Cecilio de Granada
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 23 Sep 2024 (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 purpose of this study is to evaluate the effects of early intervention support sessions via video conferencing as an adjuvant option to motor development on infants at risk of neurodevelopmental delays or disorders.
Detailed description
The parents will be informed about the procedure and will be given a written informed consent in order to participate in the study. Then, the families will be randomized into one of two groups: standard treatment or telematic support. Both treatments in a 2-month period.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Treatment | Active comparator | Other: Face-to-face standard treatmentparticipants will receive face-to-face early intervention treatment on physical therapy area once a month for two months. |
| Telematic Support | Experimental | Other: Telematic SupportParticipants will receive weekly telematic early intervention sessions at home via video conferencing for two months. |
Who may qualify
- Ages
- 3 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Minor infants with a chronological or corrected age of 3 to 12 months and their parents attending physical therapy early intervention protocol at the Neuropediatrics and Neurodevelopment Unit of San Cecilio University Hospital in Granada.
- At risk of neurodevelopmental delays or disorders.
- Whose family has a cell phone with WhatsApp Application installed and internet to be able to carry out the telematic tests.
Key exclusion criteria (5 listed)
- Independent walking children.
- Minor infants with diagnosis of neuromotor injury, visual and auditory sensory disorders or congenital anomalies.
- Infants with orthoses and/or prostheses.
- Children with health complications that enable the child's participation in the study.
- Not spanish-speaking parents.
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 |
|---|---|---|
| Face-to-face standard treatmentIndividualized early intervention treatment on physical therapy area as usual in the early intervention facilities once a month for two months. Instructions will be given to the parents for follow-up at home to stimulate the baby's motor development until next face-to-face session. | Other | Standard Treatment |
| Telematic SupportThe physiotherapist in charge of the telematic sessions will review and guide in real time through WhatsApp platform, the performance and active participation of the parents in the therapeutic activities being asked to follow-up at home in the face-to-face appointment, correcting, as necessary. | Other | Telematic Support |
Primary outcome
Change from Baseline in Motor Development on the Motor scale of the Infant Motor Development on the Bayley Scales of Infant and Toddler Development-III® (BSID-III) at month 2.
Time frame: Baseline and Month 2.
The BSID-III is an assessment tool for diagnosing developmental delays in early childhood from 1 to 42 months. It assesses 5 developmental domains: Cognitive Scale, Language Scale, Motor scale, Social-Emotional Scale and Adaptative Scale. The motor scale has 66 items in the fine motor and 72 items in the gross motor domain which are administrated according to the child development. Change= (2 months development score - baseline Score).
Change from Baseline in maturation of motor skills on the Alberta Infant Motor Scale (AIMS) at month 2.
Time frame: Baseline and Month 2.
The AIMS is an observational assessment tool that requires minimal handling of an infant by the examiner. It assesses the maturation of infant's motor skills from term (40 weeks gestation) to 18 months. It has 58 observational items divided into four subscales which are prone, supine, sitting and standing. Change= (2 months development score - baseline Score).
Change from Baseline in infant motor behaviour and motor development on the Infant Motor Profile (IMP) at month 2.
Time frame: Baseline and Month 2.
The IMP is a video-based assessment for infants aged 3 to 18 months. It assesses the spontaneous motor behaviour in supine, prone, sitting, standing, walking and during reaching and grasping - depending on the age of the infant. Includes 5 domains: the size of the infant's motor repertoire, the infant's ability to make an adaptive selection out of his/her repertoire, performance, symmetry and fluency. Change= (2 months IMP total and subscales scores - baseline scores).
4 secondary outcomes
Change from Baseline in parents' quality of life on the Care-related quality of life (CarerQol) at month 2.
Time frame: Baseline and Month 2.
Change from Baseline in levels of stress experienced by parents on the Parental Stress Scale (PSS) at month 2.
Time frame: Baseline and Month 2.
Parents satisfaction with the telematic support service measured with the Client Satisfaction Questionnaire (CSQ-8).
Time frame: Month 2
Change from Baseline in parental self-efficacy and satisfaction of being a parent on the Parenting Sense of Competence (PSOC) at month 2.
Time frame: Baseline and Month 2.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Face-to-face standard treatment and Telematic Support in people with High-risk Infants, run by Universidad de Granada at 1 site in Spain.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 23 Sep 2024. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Motor Development on the Motor scale of the Infant Motor Development on the Bayley Scales of Infant and Toddler Development-III® (BSID-III) at month 2. (time frame: Baseline and Month 2.). 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 23 Sep 2024.