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

Autism Spectrum Disorder (ASD) Clinical Trial

— VIDEOTSA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06443320
• Other study ID #: GHT_CHIRB 20220420
• Status: Recruiting
• Phase: N/A
• Start date: December 4, 2023
• Est. completion date: March 4, 2027

Study information

• Verified date: May 2024
• Source: Centre Hospitalier Intercommunal Robert Ballanger
• Contact: Mathilde ZERR
• Phone: 0182372332
• Email: mathilde.zerr[@]ght-gpne.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 4, 2027
• Est. primary completion date: March 4, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autism Spectrum Disorder (ASD)
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

Device:
• videodrama sessions
Patients will benefit from videodrama sessions, one per week for 9 sessions

Locations

Country	Name	City	State
France	CHI Robert Ballanger	Aulnays-sous-bois

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal Robert Ballanger

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cars-T questionnaire	Observe improvements in social skills (interaction and communication) in children with ASD, assessed by the Cars-T questionnaire,	9 months
Secondary	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