Comparing two therapies for infants with Down syndrome
Coping and Caring for Families With Babies With Down Syndrome. A Family-centered Intervention
NA · University of Seville · NCT06197035
This study is testing whether a family-centered program for infants with Down syndrome works better than regular physical therapy to help them develop.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 1 Month to 18 Months |
| Sex | All |
| Sponsor | University of Seville (other) |
| Locations | 1 site (Sevilla) |
| Trial ID | NCT06197035 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a family-centered program called Coping with and Caring for Infants with Special Needs (COPCA) against standard infant physical therapy for infants diagnosed with Down syndrome. Conducted in the homes and outpatient settings in Spain, the trial will utilize a randomized controlled design and assess outcomes using an evaluation battery that includes both child and family metrics, as well as video analysis of therapy sessions. The primary outcome measure will be the Infant Motor profile, which will help determine the impact of each intervention on the infants' development.
Who should consider this trial
Good fit: Ideal candidates for this study are infants diagnosed with Down syndrome and their families who are engaged in pediatric physical therapy.
Not a fit: Patients with other associated developmental disorders or those who do not speak Spanish may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective therapeutic approach for infants with Down syndrome, enhancing their developmental outcomes.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in family-centered interventions for developmental disabilities.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Sevilla
- University of Seville — Sevilla, Spain (RECRUITING)
Study contacts
- Study coordinator: Elena Pinero-Pinto, PhD
- Email: epinero@us.es
- Phone: +34655108763
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Down Syndrome, Family, Physical Disability