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

NCT ID: NCT06443320

Last Updated: 2025-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-04

Study Completion Date

2027-03-04

Brief Summary

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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

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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

Conditions

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Autism Spectrum Disorder (ASD)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Group of young ASD patients receiving videodrama sessions and interviews

Children participating in videodrama sessions, one per week for 9 sessions.

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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.

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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, markers, colored pencils, and A4 white sheets of paper.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Intercommunal Robert Ballanger

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHI Robert Ballanger

Aulnay-sous-Bois, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Constance LEMARCHAND

Role: CONTACT

0182372332

Facility Contacts

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Mathilde ZERR

Role: primary

0182372332

Constance LEMARCHAND

Role: backup

01 49 36 72 50

Other Identifiers

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GHT_CHIRB 20220420

Identifier Type: -

Identifier Source: org_study_id

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