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Effectiveness of the COPCA Program in Infants at Risk of Neurodevelopmental Disorders

RecruitingNAAges any - 12 MonthsAllUniversity of Seville
NCT07387627 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 pare

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * 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).
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What it tests

  • Coping with and Caring for Infants with Special Needs
  • Parental Education Program
  • Conventional Pediatric Physiotherapy
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Where

1 site
Escuela Infantil El Nido de los Perdigones
Seville, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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