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

NCT06197035 — Not applicable, Unknown, 40 participants, University of Seville

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

Registry	NCT06197035
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	40 (Estimated)
Sponsor	University of Seville (Other)
Conditions	Down Syndrome, Family, Physical Disability
Interventions	Coping With and Caring for Infants With Special Needs, Standard Physiotherapy (Procedure)
Dates	start 2024-03-10, primary completion 2024-10-20 (estimated), completion 2024-10-20 (estimated), first posted 2024-01-09, last updated 2024-04-01
Locations	1 site in Spain

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
COPCA (Coping With and Caring for Infants With Special Needs) Intervention	Experimental	Procedure: Coping With and Caring for Infants With Special Needs	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.
Standard physiotherapy	Active comparator	Procedure: 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.

Coping With and Caring for Infants With Special Needs (Procedure): 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 (Procedure): Pediatric physiotherapy techniques aimed at improving the development of the baby and young child from manual therapy tools, or baby management.

+Outcome measures

Primary outcomes

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 outcomes

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.

+Eligibility

Sex: All, ages: 1 Month to 18 Months

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

+Locations (1)

Facility	City	Country	Status
University of Seville	Seville	Spain	Recruiting

+Investigators

Elena Pinero-Pinto, PhD, Study director, University of Seville

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