Evaluation of the Videodrama Therapeutic Device for Children With Autism Spectrum Disorders (VIDEOTSA)

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).

Study Overview

• Status: Recruiting
• Conditions: Autism Spectrum Disorder (ASD)
• Intervention / Treatment: Device: videodrama sessions

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mathilde ZERR; Phone Number: 0182372332; Email: mathilde.zerr@ght-gpne.fr
• Study Contact Backup: Name: Constance LEMARCHAND; Phone Number: 0149367250; Email: constance.lemarchand@ght-gpne.fr

Study Locations

• France
  • Aulnays-sous-bois, France, 93600
    • Recruiting
    • CHI Robert Ballanger
    • Contact: Mathilde ZERR; Phone Number: 0182372332; Email: mathilde.zerr@ght-gpne.fr
    • Contact: Constance LEMARCHAND; Phone Number: 01 49 36 72 50; Email: constance.lemarchand@ght-gpne.fr
    • Sub-Investigator: Virginie CRUVEILLER

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Children aged 3 to 12 years.
• Clinically confirmed ASD by a psychiatrist.
• Parental or legal guardian consent for participation.
• Child showing a strong interest in screens and/or video content.
• Ability to tolerate the presence of other children.
• Minimum of 9 video drama sessions.
• Not having benefited from disease care in the past.
• Affiliation to a social security system

Exclusion Criteria:

• No ASD diagnosis.
• Younger than 3 or older than 12 at the study start.
• No interest in screens or video content.
• Parental or legal guardian refusal for participation.
• Dropping out before completing 9 sessions.
• Patient having benefited a disease care in the past

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group of young ASD patients receiving videodrama sessions and interviews; Children participating in videodrama sessions, one per week for 9 sessions.	Device: videodrama sessions; Patients will benefit from videodrama sessions, one per week for 9 sessions
No Intervention: Cohort of ASD patients not receiving videodrama but receiving care in participating units; Patients included in the cohort will be managed as part of their routine care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dunn Sensory Profile questionnaire	Sensory atypicality frequency will be assessed using the Dunn Sensory Profile questionnaire, describing child behavior in various sensory experiences	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cars-T questionnaire	Observe improvements in social skills (interaction and communication) in children with ASD, assessed by the Cars-T questionnaire,	9 months
Sceno Test	Observation of the emergence of a symbolic game. This emergence will be evaluated by the passation of the scenotest, a test which reveals the different modalities of integration of the game.	9 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal Robert Ballanger

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2023
• Primary Completion (Estimated): March 4, 2027
• Study Completion (Estimated): March 4, 2027

Study Registration Dates

• First Submitted: May 30, 2024
• First Submitted That Met QC Criteria: May 30, 2024
• First Posted (Actual): June 5, 2024

Study Record Updates

• Last Update Posted (Actual): June 5, 2024
• Last Update Submitted That Met QC Criteria: May 30, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: autism; videodrama
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
• Other Study ID Numbers: GHT_CHIRB 20220420

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No