Actively Recruiting
Effectiveness of the COPCA Program in Infants at Risk of Neurodevelopmental Disorders
Led by University of Seville · Updated on 2026-04-29
40
Participants Needed
1
Research Sites
68 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effectiveness of the COPCA Program in Infants at Risk of Neurodevelopmental Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infants at risk of neurodevelopmental disorders.
- Currently participating in pediatric physiotherapy or Early Intervention programs.
- Corrected age under 12 months at the time of recruitment.
You will not qualify if you...
- Infants with confirmed neurodevelopmental disorders at the time of inclusion.
- Presence of medical conditions requiring complex medical or surgical interventions that could interfere with study participation.
- Severe family socio-communicative difficulties limiting participation in coaching sessions, such as significant language barriers.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Escuela Infantil El Nido de los Perdigones
Seville, Seville, Spain, 41009
Actively Recruiting
Research Team
M
Miryam Quintano-Villar, PT
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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