Neurodevelopmental Disorders, Neurodevelopmental Disorders and Developmental Abnormalities
Conditions
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.
Interventions
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.
OTHERParental 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.
OTHERConventional 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
University of Seville
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 12 Months
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infant Motor Profile (IMP) | Baseline, during intervention (3 months), post-intervention (6 months) and follow up (3 and 6 months after intervention) | 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. |
| Pediatric Evaluation of Disability Inventory (PEDI) | Baseline, during intervention (3 months), post-intervention (6 months) and follow-up after intervention (3 and 6 months) | 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. |
| Merrill-Palmer-Revised Scales of Development (MP-R) | Baseline, post-intervention (6 months) and follow-up (6 months after intervention) | 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. |
| Measurement of Processes of Care (MPOC-20) | Post-intervention (6 months) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Family Empowerment Scale (FES) | Post-intervention (6 months) | 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. |
| Semi-structured interview | Post-intervention (6 months) | 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. |
Countries
Spain
Contacts
CONTACTMiryam Quintano-Villar, PT
Outcome results
None listed