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

Down Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06197035
• Other study ID #: USeville-EPINTO
• Status: Recruiting
• Phase: N/A
• Start date: March 10, 2024
• Est. completion date: October 20, 2024

Study information

• Verified date: March 2024
• Source: University of Seville
• Contact: Elena Pinero-Pinto, PhD
• Phone: +34655108763
• Email: epinero[@]us.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 20, 2024
• Est. primary completion date: October 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Months

Eligibility

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

Related Conditions & MeSH terms

• Down Syndrome
• Family
• Physical Disability
• Syndrome

Intervention

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.
• Standard Physiotherapy
Pediatric physiotherapy techniques aimed at improving the development of the baby and young child from manual therapy tools, or baby management.

Locations

Country	Name	City	State
Spain	University of Seville	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
University of Seville

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Motor Development	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.	3-6-18 months.
Secondary	Family empowerment	Family Empowerment Scale; There are 28 items to be answered by the family with these options: 1= Strongly Agree' 2= Agree' 3= Disagree' 4= Strongly Disagree. The higher the score, the greater the empowerment.	3-6-18 months