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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Neurodevelopmental Disorders; Neurodevelopmental Disorders and Developmental Abnormalities
• Intervention / Treatment: Other: Coping with and Caring for Infants with Special Needs; Other: Parental Education Program; Other: Conventional Pediatric Physiotherapy

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Miryam Quintano-Villar, PT; Phone Number: +34 633665237; Email: mquintano@us.es

Study Locations

• Spain
  • Seville
    • Seville, Seville, Spain, 41009
      • Recruiting
      • Escuela Infantil El Nido de los Perdigones
      • Contact: Elena Pinero-Pinto; Phone Number: +34 655108763; Email: epinero@us.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: In-person COPCA® Intervention; COPCA®-based intervention focused on caregiver coaching and promotion of infant motor initiative and variability. One weekly in-person session at the family home, up to 45 minutes, for 6 months.	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.
Active Comparator: Online COPCA® Intervention; COPCA®-based intervention delivered via videoconferencing, focused on caregiver coaching and infant motor initiative and variability. One weekly session of up to 45 minutes for 6 months, following an initial in-person assessment.	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.
Active Comparator: Parental Education Group; Online group-based parental education on motor development and home stimulation, without individualized child intervention. Sessions of 90 minutes every two weeks for 6 months.	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.
Active Comparator: Conventional Pediatric Physiotherapy; Standard pediatric physiotherapy delivered according to usual clinical practice in Early Intervention services, with therapist-led sessions using structured exercises and movement facilitation techniques.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infant Motor Profile (IMP)	Assessment of motor development and quality of motor behavior in infants. The IMP total score ranges from 0 to 100, where higher scores indicate better motor performance and motor behavior quality.	Baseline, during intervention (3 months), post-intervention (6 months) and follow up (3 and 6 months after intervention)
Pediatric Evaluation of Disability Inventory (PEDI)	Assessment of functional abilities and performance in daily activities. Scaled scores range from 0 to 100, where higher scores indicate better functional performance and greater independence.	Baseline, during intervention (3 months), post-intervention (6 months) and follow-up after intervention (3 and 6 months)
Merrill-Palmer-Revised Scales of Development (MP-R)	Assessment of overall development across cognitive, motor, and socio-emotional domains. Higher scores indicate higher developmental functioning. The score varies according to age so it does not have a general fixed minimum or maximum value.	Baseline, post-intervention (6 months) and follow-up (6 months after intervention)
Measurement of Processes of Care (MPOC-20)	Assessment of caregivers' perception of family-centered care. Items are rated on a 7-point Likert scale (1 to 7), where higher scores indicate a higher perception of family-centered care.	Post-intervention (6 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Family Empowerment Scale (FES)	Assessment of family empowerment and perceived impact of the intervention. Items are rated on a 5-point Likert scale (1 to 5), where higher scores indicate greater family empowerment.	Post-intervention (6 months)
Semi-structured interview	Qualitative exploration of family experiences, perceived usefulness of the intervention, and challenges in home implementation. This outcome does not use a numerical scale. Data will be analyzed using qualitative content analysis.	Post-intervention (6 months)

Collaborators and Investigators

• Sponsor: University of Seville

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: January 27, 2026
• First Submitted That Met QC Criteria: January 27, 2026
• First Posted (Actual): February 4, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Coping Skills
• Other Study ID Numbers: SICEIA-2025-003712 (Registry Identifier: COPCA.01)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Sharing data
• IPD Sharing Time Frame: For a year since the study ends
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No