COPCA program for infants at risk of neurodevelopmental disorders

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.