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

Official title

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

Overview

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.

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.

Primary outcome measures

• Infant Motor Profile (IMP) [Time frame: Baseline, during intervention (3 months), post-intervention (6 months) and follow up (3 and 6 months after intervention)]
• Pediatric Evaluation of Disability Inventory (PEDI) [Time frame: 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) [Time frame: Baseline, post-intervention (6 months) and follow-up (6 months after intervention)]
• Measurement of Processes of Care (MPOC-20) [Time frame: Post-intervention (6 months)]

Secondary outcome measures (2)

• Family Empowerment Scale (FES) [Time frame: Post-intervention (6 months)]
• Semi-structured interview [Time frame: Post-intervention (6 months)]

Eligibility 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Spain · 1 center

• Escuela Infantil El Nido de los Perdigones — Seville

Identifiers

NCT: NCT07387627 · SICEIA-2025-003712 · SICEIA-2025-003712

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗