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

NCT06197035 | Recruiting DMC

• 1 other identifier: USeville-EPINTO
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Down Syndrome; Family; Physical Disability

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Family empowerment

  3-6-18 months

Study Arms (2)

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

EXPERIMENTAL

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

Standard physiotherapy

ACTIVE COMPARATOR

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

Interventions

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.

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

Standard Physiotherapy PROCEDURE

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

Standard physiotherapy

Eligibility Criteria

• Age: 1 Month - 18 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Babies with Down syndrome
• Families involved in Pediatric Physical Therapy

You may not qualify if:

• Other associated developmental disorders
• To not speak Spanish
• Do not sign informed consent

Sponsors & Collaborators

• University of Seville: lead

Study Sites (1)

University of Seville

Seville, Spain

RECRUITING

MeSH Terms

Conditions

Down Syndrome

Interventions

Coping Skills

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Elena Pinero-Pinto, PhD

  University of Seville

  STUDY DIRECTOR

Central Study Contacts

Elena Pinero-Pinto, PhD

CONTACT

+34655108763; epinero@us.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Two intervention groups, a group with COPCA intervention and a group with standard physiotherapy

Study Record Dates

• First Submitted: December 25, 2023
• First Posted: January 9, 2024
• Study Start: March 10, 2024
• Primary Completion: October 20, 2024
• Study Completion: October 20, 2024
• Last Updated: April 1, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: In 6 months
• Access Criteria: Asking t the investigator

Locations

ES (1)