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

Summary

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

• Neurodevelopmental Disorders
• Neurodevelopmental Disorders and Developmental Abnormalities

Interventions

OTHER

Coping with and Caring for Infants with Special Needs

COPCA®-based intervention focused on caregiver coaching and promotion of infant motor initiative and variability. Delivered weekly for up to 45 minutes over 6 months, either in person or online after an initial in-person assessment, integrated into daily routines and emphasizing self-exploration.

OTHER

Parental Education Program

Online group-based parental education on motor development and home stimulation, delivered in 90-minute sessions every two weeks for 6 months, without individualized child intervention.

OTHER

Conventional Pediatric Physiotherapy

Standard pediatric physiotherapy delivered according to routine clinical practice in Early Intervention services. The intervention consists of therapist-led sessions using structured exercises and movement facilitation techniques, with frequency and duration determined by the reference center.

Sponsors & Collaborators

• University of Seville

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Max Age

12 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-02-10

Primary Completion

2027-02-01

Completion

2027-06-01

Countries

• Spain

Study Locations