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

NCT07387627 | Recruiting

• 1 other identifier: SICEIA-2025-003712
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Family Empowerment Scale (FES)

  Post-intervention (6 months)

• Semi-structured interview

  Post-intervention (6 months)

Study Arms (4)

In-person COPCA® Intervention

EXPERIMENTAL

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

Online COPCA® Intervention

ACTIVE COMPARATOR

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

Parental Education Group

ACTIVE COMPARATOR

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

Conventional Pediatric Physiotherapy

ACTIVE COMPARATOR

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

Interventions

Coping with and Caring for Infants with Special Needs OTHER

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.

Conventional Pediatric Physiotherapy; In-person COPCA® Intervention

Parental Education Program OTHER

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.

Online COPCA® Intervention

Conventional Pediatric Physiotherapy OTHER

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.

Parental Education Group

Eligibility Criteria

• Age: Up to 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants at risk of neurodevelopmental disorders.
• Corrected age under 12 months at the time of recruitment.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Seville: lead

Study Sites (1)

Escuela Infantil El Nido de los Perdigones

Seville, Seville, 41009, Spain

RECRUITING

MeSH Terms

Conditions

Neurodevelopmental Disorders

Interventions

Coping Skills

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Miryam Quintano-Villar, PT

CONTACT

+34 633665237; mquintano@us.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, PhD

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 4, 2026
• Study Start: February 10, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: For a year since the study ends

Locations

ES (1)