Viewing Study NCT06443320


Ignite Creation Date: 2025-12-25 @ 4:15 AM
Ignite Modification Date: 2025-12-26 @ 3:14 AM
Study NCT ID: NCT06443320
Status: RECRUITING
Last Update Posted: 2025-02-06
First Post: 2024-05-30
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Evaluation of the Videodrama Therapeutic Device for Children With Autism Spectrum Disorders
Sponsor: Centre Hospitalier Intercommunal Robert Ballanger
Organization:

Study Overview

Official Title: Evaluation of the Videodrama Therapeutic Device for Children With Autism Spectrum Disorders
Status: RECRUITING
Status Verified Date: 2025-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: VIDEOTSA
Brief Summary: Autism spectrum disorder (ASD) is a neurodevelopmental disorder (Valerie, Sperenza, 2009) that begins early in development, characterized by persistent deficits in communication and social interactions across various contexts and restricted, repetitive patterns of behavior, interests, or activities. These symptoms significantly impact social, school/professional functioning, or other important areas and are not better explained by intellectual disability or global developmental delay (American Psychiatric Association, 2013).
Detailed Description: Currently, managing children with ASD emphasizes compensating for communication and social interaction disabilities. Communication tools like PECS or Makaton and social skills groups have shown effectiveness but have limitations, particularly not addressing sensory atypicalities seen in children with ASD. These sensory atypicalities are evident when children watch videos on screens. The idea is to use video to understand the sensory experiences of children with ASD and help them move away from an isolated relationship with screens. New technologies can further isolate children with ASD in their autistic sphere. The hypothesis is that observing these children with screens will provide better understanding of their sensory experiences and improve therapeutic support towards play and interaction with others

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: