Effectiveness of the COPCA Program in Infants at Risk of Neurodevelopmental Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 12
SponsorUniversity of Seville
About this trial
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.
Eligibility criteria
Qualifiers
Infants at risk of neurodevelopmental disorders.
Participation in pediatric physiotherapy and/or Early Intervention programs at the time of study inclusion, regardless of the reference center.
Corrected age under 12 months at the time of recruitment.
Disqualifiers
Infants with confirmed neurodevelopmental disorders at the time of inclusion.
Presence of additional medical conditions requiring complex medical or surgical interventions that could interfere with participation in the study (e.g., recent or planned surgery).
Severe family socio-communicative difficulties that limit participation in coaching sessions (e.g., significant language barriers).
Trial design
Treatments tested in this trial
- Coping with and Caring for Infants with Special Needs
- Parental Education Program
- Conventional Pediatric Physiotherapy
Treatment groups
40 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov