Evaluation of the Videodrama Therapeutic Device for Children With Autism Spectrum Disorders
VIDEOTSA
1 other identifier
interventional
30
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 4, 2023
CompletedFirst Submitted
Initial submission to the registry
May 30, 2024
CompletedFirst Posted
Study publicly available on registry
June 5, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 4, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 4, 2027
February 6, 2025
February 1, 2025
3.2 years
May 30, 2024
February 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Cars-T questionnaire
9 months
Sceno Test
9 months
Study Arms (2)
Group of young ASD patients receiving videodrama sessions and interviews
EXPERIMENTALChildren participating in videodrama sessions, one per week for 9 sessions.
Cohort of ASD patients not receiving videodrama but receiving care in participating units
NO INTERVENTIONPatients included in the cohort will be managed as part of their routine care
Interventions
Patients included in the videodrama arm will participate in a total of 18 videodrama sessions, with one session per week. Each session will include a patient welcome period, the viewing of a video excerpt (in slow motion or not), a playtime, a drawing period, and a group closing session. For the play and drawing activities, the same materials will be provided in each department and for each group, including small figurines, animals, shapes (such as cubes, triangles, circles), small plush toys, markers, colored pencils, and A4 white sheets of paper.
Eligibility Criteria
You may qualify if:
- Children aged 3 to 15 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 18 video drama sessions.
- Not having benefited from disease care in the past.
- Affiliation to a social security system
You may not qualify if:
- No ASD diagnosis.
- Younger than 3 or older than 15 at the study start.
- No interest in screens or video content.
- Parental or legal guardian refusal for participation.
- Dropping out before completing 18 sessions.
- Patient having benefited a disease care in the past
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHI Robert Ballanger
Aulnay-sous-Bois, 93600, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2024
First Posted
June 5, 2024
Study Start
December 4, 2023
Primary Completion (Estimated)
March 4, 2027
Study Completion (Estimated)
March 4, 2027
Last Updated
February 6, 2025
Record last verified: 2025-02