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Recruiting NCT06443320

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

No phase Interventional Autism Spectrum Disorder (ASD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: patient included in experimental groupe will view the video excerpt, a playtime, a drawing activities.
Who it may be relevant to
Registry conditions: Autism Spectrum Disorder (ASD). Basic parameters: 3 years — 15 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

Interventions

  • Other patient included in experimental groupe will view the video excerpt, a playtime, a drawing activities
    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, m

Primary outcome measures

  • Dunn Sensory Profile questionnaire [Time frame: 9 months]
Secondary outcome measures (2)
  • Cars-T questionnaire [Time frame: 9 months]
  • Sceno Test [Time frame: 9 months]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

France · 1 center
  • CHI Robert Ballanger — Aulnay-sous-Bois

Identifiers

NCT: NCT06443320 · GHT_CHIRB 20220420

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗