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

University of Seville

Status: Enrolling

Conditions: Physical Disability; Down Syndrome; Family

Treatments: Procedure: Coping With and Caring for Infants With Special Needs; Procedure: Standard Physiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06197035

USeville-EPINTO

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 1 to 18 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

COPCA (Coping With and Caring for Infants With Special Needs) Intervention

Experimental group

Description:

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.

Treatment:

Procedure: Coping With and Caring for Infants With Special Needs

Standard physiotherapy

Active Comparator group

Description:

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.

Treatment:

Procedure: Standard Physiotherapy