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Search / Trial NCT06197035

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

Launched by UNIVERSITY OF SEVILLE · Dec 25, 2023

Trial Information

Current as of July 23, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the effects of two different approaches to help infants with Down syndrome develop their physical skills. Researchers want to see how standard physical therapy compares to a family-centered program called "Coping with and Caring for Infants with Special Needs" (COPCA). The trial will take place in the homes of families and outpatient centers in Spain from January to March 2024. The main focus is to understand how these therapies affect the infants and their families, using detailed assessments and video recordings of therapy sessions.

To participate in the trial, infants must have Down syndrome, and their families should be involved in pediatric physical therapy. Unfortunately, babies with other developmental disorders or families who do not speak Spanish are not eligible. Families who join will receive either standard physical therapy or the COPCA program and will help researchers evaluate the outcomes for their child’s growth and development. This study aims to find the best ways to support infants with special needs and their families.

Gender

ALL

Eligibility criteria

  • 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

About University Of Seville

The University of Seville is a prestigious academic institution dedicated to advancing knowledge through innovative research and exceptional education. With a strong emphasis on interdisciplinary collaboration, the university actively engages in clinical trials aimed at enhancing patient care and medical outcomes. Its commitment to rigorous scientific inquiry and ethical standards positions it as a leading sponsor in the field of clinical research, fostering partnerships with healthcare professionals and institutions to drive advancements in medical science and improve public health.

Locations

Sevilla, , Spain

Patients applied

0 patients applied

Trial Officials

Elena Pinero-Pinto, PhD

Study Director

University of Seville

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported