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

Not Applicable

Recruiting

• Conditions: Family; Physical Disability; Down Syndrome

• Registration Number: NCT06197035
• Lead Sponsor: University of Seville

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-25
• Study First Submitted QC: 2023-12-25
• Study First Posted: 2024-01-09
• Status Verified: 2024-03
• Study Start: 2024-03-10
• Last Update Submitted: 2024-03-28
• Last Update Posted: 2024-04-01
• Primary Completion: 2024-10-20
• Study Completion: 2024-10-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Motor Development	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 Outcome Measures

Name	Time	Method
Family empowerment	3-6-18 months	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.

Trial Locations

Locations (1)

University of Seville; 🇪🇸 Sevilla, Spain