NCT07387627 Effectiveness of the COPCA Program in Infants at Risk of Neurodevelopmental Disorders
| NCT ID | NCT07387627 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Seville |
| Condition | Neurodevelopmental Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-02-10 |
| Primary Completion | 2027-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2026-02-10 with a primary completion date of 2027-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07387627 clinical trial?
This trial is open to participants of all sexes, up to 12 Months, studying Neurodevelopmental Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07387627 currently recruiting?
Yes, NCT07387627 is actively recruiting participants. Contact the research team at mquintano@us.es for enrollment information.
Where is the NCT07387627 trial being conducted?
This trial is being conducted at Seville, Spain.
Who is sponsoring the NCT07387627 clinical trial?
NCT07387627 is sponsored by University of Seville. The trial plans to enroll 40 participants.