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| ID | Type | Description | Link |
|---|---|---|---|
| SICEIA-2025-003712 | Registry Identifier | COPCA.01 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Miryam Quintano-Villar, PT | Contact | +34 633665237 | mquintano@us.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Escuela Infantil El Nido de los Perdigones | Recruiting | Seville | Seville | 41009 | Spain |
Sharing data
For a year since the study ends
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| 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. |
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| 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. |
|
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) |
| ID | Term |
|---|---|
| D065886 | Neurodevelopmental Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000097813 | Coping Skills |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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