Telematic Support in Early Intervention on Infants At Risk of Neurodevelopmental Delays (BBL-ATOP)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: High-risk Infants
• Intervention / Treatment: Other: Face-to-face standard treatment; Other: Telematic Support

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Granada, Spain, 18007
    • Hospital Universitario San Cecilio de Granada

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Treatment; participants will receive face-to-face early intervention treatment on physical therapy area once a month for two months.	Other: Face-to-face standard treatment; 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.
Experimental: Telematic Support; Participants will receive weekly telematic early intervention sessions at home via video conferencing for two months.	Other: Telematic Support; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	Baseline and Month 2.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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.	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).	Baseline and Month 2.

Collaborators and Investigators

• Sponsor: Universidad de Granada
• Collaborators: Hospital Universitario San Cecilio de Granada

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2024
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: September 19, 2024
• First Submitted That Met QC Criteria: September 19, 2024
• First Posted (Actual): September 23, 2024

Study Record Updates

• Last Update Posted (Actual): September 23, 2024
• Last Update Submitted That Met QC Criteria: September 19, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: early intervention; physical therapy; telerehabilitation; child development
• Other Study ID Numbers: BBL-ATPO-2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No