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NCT07387627: COPCA

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

Not yet recruiting NA Last updated 9 February 2026
What this trial tests

NA trial testing Coping with and Caring for Infants with Special Needs in Neurodevelopmental Disorders in 40 participants. Not yet recruiting.

Timeline
10 February 2026
Primary endpoint
1 February 2027
1 June 2027

Quick facts

Lead sponsorUniversity of Seville
PhaseNA
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment40
Start date10 February 2026
Primary completion1 February 2027
Estimated completion1 June 2027

Drugs / interventions tested

Conditions studied

Sponsor

University of Seville

Who can join

Under 12 Months, any sex, with Neurodevelopmental Disorders or Neurodevelopmental Disorders and Developmental Abnormalities. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Neurodevelopmental Disorders

Currently open trials in the same condition.

Other University of Seville trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07387627.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing