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

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.

Study Overview

• Status: Recruiting
• Conditions: Down Syndrome; Physical Disability; Family
• Intervention / Treatment: Procedure: Coping With and Caring for Infants With Special Needs; Procedure: Standard Physiotherapy

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elena Pinero-Pinto, PhD; Phone Number: +34655108763; Email: epinero@us.es

Study Locations

• Spain
  • Sevilla, Spain
    • Recruiting
    • University of Seville
    • Contact: Piñero Pinto, PhD; Phone Number: +34655108763; Email: epinero@us.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	Procedure: Standard Physiotherapy; Pediatric physiotherapy techniques aimed at improving the development of the baby and young child from manual therapy tools, or baby management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Seville
• Investigators: Study Director: Elena Pinero-Pinto, PhD, University of Seville

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2024
• Primary Completion (Estimated): October 20, 2024
• Study Completion (Estimated): October 20, 2024

Study Registration Dates

• First Submitted: December 25, 2023
• First Submitted That Met QC Criteria: December 25, 2023
• First Posted (Actual): January 9, 2024

Study Record Updates

• Last Update Posted (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Disease; Congenital Abnormalities; Genetic Diseases, Inborn; Intellectual Disability; Abnormalities, Multiple; Chromosome Disorders; Syndrome; Down Syndrome
• Other Study ID Numbers: USeville-EPINTO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The publication of the results of this research is planned.
• IPD Sharing Time Frame: In 6 months
• IPD Sharing Access Criteria: Asking t the investigator
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No