COPCA program for infants at risk of neurodevelopmental disorders
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
This trial will try the COPCA coaching program with infants under 12 months who are at risk of neurodevelopmental disorders to see if it improves motor development and helps families feel more empowered.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | N/A to 12 Months |
| Sex | All |
| Sponsor | University of Seville Academic / other |
| Locations | 1 site (Seville, Seville) |
| Trial ID | NCT07387627 on ClinicalTrials.gov |
What this trial studies
This interventional study compares the COPCA® (Coping with and Caring for Infants with Special Needs) coaching program to conventional pediatric physiotherapy and a parental education program in infants at risk of neurodevelopmental disorders. Infants under 12 months corrected age who are already receiving early intervention or pediatric physiotherapy, together with their parents or primary caregivers, are enrolled and receive one of the intervention approaches. Primary outcomes include measures of motor development and functional abilities in the infants and family empowerment and parents' perception of care. The trial is conducted at a single site in Seville, Spain, and follows participants through the immediate post-intervention period to compare effects across groups.
Who should consider this trial
Good fit: Infants younger than 12 months corrected age who are at risk of neurodevelopmental disorders and are currently receiving early intervention or pediatric physiotherapy, along with their parents or primary caregivers, are ideal candidates.
Not a fit: Infants with a confirmed neurodevelopmental disorder at enrollment, those with complex medical or surgical conditions that limit participation, or families with severe socio-communicative barriers are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, COPCA could lead to better early motor outcomes for at-risk infants and greater parental confidence and involvement in care.
How similar studies have performed: Family-centered coaching and early physiotherapy approaches similar to COPCA have shown promise in prior studies, but direct head-to-head comparisons with conventional therapy remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Seville, Seville
- Escuela Infantil El Nido de los Perdigones — Seville, Seville, Spain (Recruiting)
Study contacts
- Study coordinator: Miryam Quintano-Villar, PT
- Email: mquintano@us.es
- Phone: +34 633665237
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.