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Enrolling by Invitation

NCT Number: NCT06608576

Telematic Support in Early Intervention on Infants At Risk of Neurodevelopmental Delays

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.

Enrolling by Invitation

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Key information

Conditions

Age range

3 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario San Cecilio de Granada

Granada, 18007, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Face-to-face standard treatment

Other

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 Support

Other

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.

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

Secondary outcomes

  1. 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.

    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).

  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.

    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).

  3. Parents satisfaction with the telematic support service measured with the Client Satisfaction Questionnaire (CSQ-8).

    Time frame: Month 2

    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.

  4. 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.

    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).

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Collaborators

  • Hospital Universitario San Cecilio de Granada

Registry information

Official study title

Effects of Telematic Support in Physical Therapy Early Intervention on Infants At Risk of Neurodevelopmental Delays and Disorders

Acronym: BBL-ATOP

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 23, 2024
Registry last updated
Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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