Coping and Caring for Families With Babies With Down Syndrome. A Family-centered Intervention
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Down Syndrome
- Sponsor
- University of Seville
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Motor Development
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Elena Piñero Pinto
Professor
University of Seville
Eligibility Criteria
Inclusion Criteria
- •Babies with Down syndrome
- •Families involved in Pediatric Physical Therapy
Exclusion Criteria
- •Other associated developmental disorders
- •To not speak Spanish
- •Do not sign informed consent
Outcomes
Primary Outcomes
Motor Development
Time Frame: 3-6-18 months.
INFANT MOTOR PROFILE Results achieved between the 10% and 90% percentiles indicate adequate motor development. Results between the 5% and 10% percentiles indicate a risk for delays or problems in gross motor development.
Secondary Outcomes
- Family empowerment(3-6-18 months)