Autism Spectrum Disorder (ASD)VIDEOTSANCT06443320
Evaluation of the Videodrama Therapeutic Device for Children With Autism Spectrum Disorders
A study testing patient included in experimental groupe will view the video excerpt, a playtime, a drawing activities in people with Autism Spectrum Disorder (ASD), run by Centre Hospitalier Intercommunal Robert Ballanger at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 3 to 15 years
- Conditions the study is for
- Autism Spectrum Disorder (ASD)
- What is being tested?
- patient included in experimental groupe will view the video excerpt, a playtime, a drawing activities
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 4 Dec 2023to 4 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHI Robert Ballanger
Aulnay-sous-Bois, 93600
Mathilde ZERR, 0182372332, mathilde.zerr@ght-gpne.fr
Constance LEMARCHAND, 01 49 36 72 50, constance.lemarchand@ght-gpne.fr
About this study
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).
Read the 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
- Conditions
- Autism Spectrum Disorder (ASD)
- Being tested
- patient included in experimental groupe will view the video excerpt, a playtime, a drawing activities
- Keywords
- autism, videodrama
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient included in experimental groupe will view the video excerpt, a playtime, a drawing activitiesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group of young ASD patients receiving videodrama sessions and interviews | Experimental | Children participating in videodrama sessions, one per week for 9 sessions. Receives: Other: patient included in experimental groupe will view the video excerpt, a playtime, a drawing activities |
| Cohort of ASD patients not receiving videodrama but receiving care in participating units | No intervention | Patients included in the cohort will be managed as part of their routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dunn Sensory Profile questionnaire
Sensory atypicality frequency will be assessed using the Dunn Sensory Profile questionnaire, describing child behavior in various sensory experiences
Measured: 9 months
Secondary outcomes (2)
Cars-T questionnaire
Observe improvements in social skills (interaction and communication) in children with ASD, assessed by the Cars-T questionnaire,
Measured: 9 months
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.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start4 Dec 2023
- Primary completion4 Mar 2027 (estimated)
- Study completion4 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum Disorder (ASD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Robert Ballanger
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06443320
- Sponsor's protocol ID
- GHT_CHIRB 20220420
- Acronym
- VIDEOTSA
- Status last verified
- Feb 2025
- First submitted
- 30 May 2024
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Videodrama Therapeutic Device for Children With Autism Spectrum Disorders
- ClinicalTrials.gov ID
- NCT06443320
- Acronym / sponsor ID
- VIDEOTSA / GHT_CHIRB 20220420
- Conditions
- Autism Spectrum Disorder (ASD)
- Keywords
- autism, videodrama
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Centre Hospitalier Intercommunal Robert BallangerUniversity, hospital or other
- Study start
- 4 Dec 2023 (actual)
- Primary completion
- 4 Mar 2027 (estimated)
- Study completion
- 4 Mar 2027 (estimated)
- First posted
- 5 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group of young ASD patients receiving videodrama sessions and interviews | Experimental | Other: patient included in experimental groupe will view the video excerpt, a playtime, a drawing activitiesChildren participating in videodrama sessions, one per week for 9 sessions. |
| Cohort of ASD patients not receiving videodrama but receiving care in participating units | No intervention | –Patients included in the cohort will be managed as part of their routine care |
Who may qualify
- Ages
- 3 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| patient included in experimental groupe will view the video excerpt, a playtime, a drawing activitiesPatients 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. | Other | Group of young ASD patients receiving videodrama sessions and interviews |
Primary outcome
Dunn Sensory Profile questionnaire
Time frame: 9 months
Sensory atypicality frequency will be assessed using the Dunn Sensory Profile questionnaire, describing child behavior in various sensory experiences
2 secondary outcomes
Cars-T questionnaire
Time frame: 9 months
Sceno Test
Time frame: 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing patient included in experimental groupe will view the video excerpt, a playtime, a drawing activities in people with Autism Spectrum Disorder (ASD), run by Centre Hospitalier Intercommunal Robert Ballanger at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Constance LEMARCHAND (0182372332, constance.lemarchand@ght-gpne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dunn Sensory Profile questionnaire (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.