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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06443320
Other study ID # GHT_CHIRB 20220420
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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