Effectiveness of the COPCA Program in Infants at Risk of Neurodevelopmental Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 12
SponsorUniversity of Seville
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Coping with and Caring for Infants with Special Needs
Other interventionCOPCA®-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.
Parental Education Program
Other interventionOnline 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.
Conventional Pediatric Physiotherapy
Other interventionStandard 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.
Treatment groups
40 Participants
are divided into 4 treatment groupsGroup A: In-person COPCA® InterventionExperimental treatment 1 intervention
Group B: Online COPCA® InterventionActive comparator 1 intervention
Group C: Parental Education GroupActive comparator 1 intervention
Group D: Conventional Pediatric PhysiotherapyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, during intervention (3 months), post-intervention (6 months) and follow up (3 and 6 months after intervention)2
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.
Time frame
Baseline, during intervention (3 months), post-intervention (6 months) and follow-up after intervention (3 and 6 months)3
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.
Time frame
Baseline, post-intervention (6 months) and follow-up (6 months after intervention)4
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.
Time frame
Post-intervention (6 months)Secondary outcomes
1
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.
Time frame
Post-intervention (6 months)2
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.
Time frame
Post-intervention (6 months)Sponsors and contacts
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Source ClinicalTrials.gov