An interventional study of Coping with and Caring for Infants with Special Needs and Parental Education Program in Neurodevelopmental Disorders and Neurodevelopmental Disorders and Developmental Abnormalities, sponsored by University of Seville. Recruiting at 1 site in Spain. Open to participants aged Up to 12 Months. Per ClinicalTrials.gov, last updated 2026-04-29.
Sponsored by University of Seville · Not applicable, Interventional, and Treatment
Among 20 studies in Neurodevelopmental Disorders with a site in Spain — 7 open to participants now, 12 under way, 5 of them phase 3. Neurodevelopmental Disorders · Spain.
Among the 20 studies in Neurodevelopmental Disorders with a site in Spain, this one is the 11th largest by planned enrollment of the 16 interventional ones, is one of 5 that started in 2026, is one of 9 with no phase, reaches primary completion later than 5 of the 11 other live ones, and was the 17th registered.
352 studies on the registry are indexed under Neurodevelopmental Disorders; 141 are open to participants now.
This study's planned enrollment of 40 is below the median of 88 across 217 interventional studies indexed under Neurodevelopmental Disorders.
Browse Neurodevelopmental Disorders studies →7 of the 20 studies in Neurodevelopmental Disorders with a site in Spain are open now, in 12 countries. Each count lists the studies.
Of the 100 Neurodevelopmental Disorders studies recruiting now, 20 (20%) set no upper age limit and 76 (76%) stop at 75 or younger; 86 take children under 18; 31 take healthy volunteers.
This study: Up to 12 Months · all sexes · no healthy volunteers.
The full table on the hub →20 studies; the count open now beside each. This study's row is marked.
First in 2016; this study’s year is marked. 5 started in 2026.
Median enrollment 60 across the 16 interventional studies, 75 across the 4 observational. Of the 7 that completed or were terminated, 0 (0%) have results posted.
12 of 20 have an industry lead sponsor. The 10 most frequent:
University of Seville is the lead sponsor of 130 studies on the registry; 39 are open to participants now.
University of Seville has 1 study filed under Neurodevelopmental Disorders — fewer than ten, so there is no comparison to draw.
5 of the studies in Neurodevelopmental Disorders with a site in Spain that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06660394Phase 3Longboard PharmaceuticalsA Phase 3, Placebo-Controlled Study to Investigate LP352 in Children and Adults With Dravet Syndrome (DS) | 2026-12-31 |
| NCT07224581Phase 3GRIN Therapeutics, Inc.Beeline: A Phase 3 Study in GRIN-related Neurodevelopmental Disorder | 2027-05 |
| NCT06908226Phase 3Longboard PharmaceuticalsA Study to Investigate LP352 in Children and Adults With Developmental and Epileptic Encephalopathy (DEE) | 2027-11-11 |
| NCT07387627University of SevilleEffectiveness of the COPCA Program in Infants at Risk of Neurodevelopmental Disorders | 2027-02-01 |
| NCT07654114Connecta Therapeutics, S.L.Safety, Tolerability, and Preliminary Effectiveness of CTH120 in Fragile X Syndrome | 2027-05 |
Among the 20 studies in Neurodevelopmental Disorders with a site in Spain, from their registry updates:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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
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
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
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.
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.
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.
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)
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)
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)
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)
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)
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)
Plan to share: Yes — Sharing data
Supporting information: Study protocol
Time frame: For a year since the study ends
No publications or documents are linked to this record.
Started Feb 2026 (actual). Primary completion is estimated for Feb 2027, 11 months after the start.
Of 142 non-industry interventional studies with no phase under Neurodevelopmental Disorders, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 52. This study's planned 11 months is below that.
Counting every sponsor, half of 148 studies reached it within 30 months; a quarter within 15 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
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Neurodevelopmental Disorders →