Coping and Caring for Families With Babies With Down Syndrome. A Family-centered Intervention
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 month
Maximum Age: 1
Healthy Volunteers: f
View:
• Babies with Down syndrome
• Families involved in Pediatric Physical Therapy
Locations
Other Locations
Spain
University of Seville
RECRUITING
Seville
Contact Information
Primary
Elena Pinero-Pinto, PhD
epinero@us.es
+34655108763
Time Frame
Start Date: 2024-03-10
Estimated Completion Date: 2024-10-20
Participants
Target number of participants: 40
Treatments
Experimental: COPCA (Coping With and Caring for Infants With Special Needs) Intervention
The intervention will be delivered by COPCA coaches who follow the programme's theoretical and practical principles. Caregivers learnt how to stimulate their infant's development by challenging their motor behaviour with trial and error experiences.~This aim to empower the caregivers' competencies to stimulate the infant's daily development, by increasing their motor repertoire.~and enhancing their capacity to adapt movements to situations.
Active_comparator: Standard physiotherapy
Standard care will be based on what paediatric physiotherapists generally assume to be useful to promote the development of infants with special needs. Standard care is heterogeneous and eclectic, uses parent training and often includes components of neurodevelopmental treatment with hands-on techniques.
Related Therapeutic Areas
Sponsors
Leads: University of Seville