NCT06197035

The Coping With and Caring for Infants With Special Needs Intervention in Down Syndrome Infants

Coping and Caring for Families With Babies With Down Syndrome. A Family-centered Intervention

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Seville · Academic / Other
• Sex: All
• Age: 1 Month – 18 Months
• Healthy volunteers: Not accepted

Summary

The objective is to compare the impact of standard infant physical therapy and the family-centered program, Coping with and Caring for Infants with Special Needs (COPCA), on infants born with Down syndrome. This is a randomized controlled trial that will be carried out in the patients' homes and outpatient settings in Spain between January 2024 and March 2024. An evaluation battery will be used that includes child and family outcomes and video analysis of therapy sessions. The Infant Motor profile will be the primary outcome instrument.

Conditions

• Down Syndrome
• Family
• Physical Disability

Interventions

Type	Name	Description
PROCEDURE	Coping With and Caring for Infants With Special Needs	The early intervention programme for infants and young children focuses on the active inclusion of the whole family. The coaching of parents is a central component. Parents learn how they can independently and optimally support their child's development as part of the child's everyday life. The programme was developed at the beginning of the 2000s in the Netherlands by child physiotherapist Tineke Dirks and professor of developmental neurology Mijna Hadders-Algra.
PROCEDURE	Standard Physiotherapy	Pediatric physiotherapy techniques aimed at improving the development of the baby and young child from manual therapy tools, or baby management.

Timeline

• Start date: 2024-03-10
• Primary completion: 2024-10-20
• Completion: 2024-10-20
• First posted: 2024-01-09
• Last updated: 2024-04-01

Locations

1 site across 1 country: Spain