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Effectiveness of the Coping With and Caring for Infants With Special Needs Program in Infants at Risk of Neurodevelopmental Disorders. A Comparison With Conventional Pediatric Physiotherapy Models and Parent Training
The purpose of this clinical trial is to evaluate whether the COPCA® program (Coping with and Caring for Infants with Special Needs) is more effective than conventional pediatric physiotherapy and parent education in improving development in infants at risk of neurodevelopmental disorders, as well as empowering their families. This study will include infants younger than 12 months of corrected age who are at risk of neurodevelopmental disorders and are currently receiving early intervention or pediatric physiotherapy services, together with their parents or primary caregivers. The main questions this study aims to answer are: Does the COPCA® program improve motor development and functional abilities in infants at risk of neurodevelopmental disorders more than conventional pediatric physiotherapy or parent education? Does the COPCA® program increase family empowerment and improve parents' perception of the care they receive compared with traditional intervention models? The researchers will compare outcomes across four study groups: In-person COPCA® intervention Online COPCA® intervention Parent education group Conventional pediatric physiotherapy group Participants will be randomly assigned to one of the four groups. The intervention period will last 6 months, with assessments conducted at the start of the study, during the intervention, and during follow-up. Infants will take part in age-appropriate daily activities and play situations. Parents or caregivers will actively participate in the intervention sessions and will be supported in learning how to promote their child's development during everyday routines. The study will assess infant motor development, functional abilities, overall development, family empowerment, and parents' perception of family-centered care using validated assessment tools and interviews. The results of this study may help improve early intervention strategies for infants at risk of neurodevelopmental disorders and support more family-centered approaches to care.
Age
0 - 1 years
Sex
ALL
Healthy Volunteers
No
Start Date
February 10, 2026
Primary Completion Date
February 1, 2027
Completion Date
June 1, 2027
Last Updated
February 9, 2026
40
ESTIMATED participants
Coping with and Caring for Infants with Special Needs
OTHER
Parental Education Program
OTHER
Conventional Pediatric Physiotherapy
OTHER
Lead Sponsor
University of Seville
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06926166