Autism Spectrum DisorderI-ROBINCT05991791
Intelligent Robotic Interactions for Children With Autism Spectrum Disorders
A study testing Early Start Denver Model (ESDM) in people with Autism Spectrum Disorder, run by University Hospital, Montpellier at 1 site in France.
Trial summary
For several years, studies have been developed on the contribution of social robots as a tool for interventions for children with autism spectrum disorders (ASD). One of the recommended intervention models is the ESDM (Early Start Denver Model). Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Early Start Denver Model (ESDM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- 19 Oct 2023to 19 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient living in the Hérault department (France),
- Patient with a diagnosis of ASD confirmed by a psychiatrist or a psychologist and receiving current care according to the ESDM model in the MPEA Peyre Plantade child psychiatry service.
Who cannot join
- Patients
- Failure to obtain written informed consent after a cooling-off period
- Participating in another type of program other than ESDM
- Not being affiliated to a French social security system or being a beneficiary of such a system
- Therapist
- History of epilepsy for health professionals (therapists)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital La Colombière - CHU de Montpellier
Montpellier
Amaria BAGHDADLI, Pr, a-baghdadli@chu-montpellier.fr
About this study
Official title: Adapted and Individualized Intelligent Robotic Interactions to the Ability Spectrum of Children With Autism Spectrum Disorder
For several years, studies have been developed on the contribution of social robots as a tool for interventions for children with autism spectrum disorders (ASD). One of the recommended intervention models is the ESDM (Early Start Denver Model). It consists of setting up an individualized, intensive program (at least 20 hours per week) through the pleasure of play. The teacher follows the motivation and interests of the child, and it is the child who chooses the activities. Studies published in recent years tend to show that robots bring benefits to ASD children, particularly in the treatment of social interactions and in clinical settings. However, there is no scientific consensus on the generalized contribution and effect over time of these interventions. Moreover, a robotic solution controlled by a practitioner through a telepresence system allows for a better adaptability to the responses and desires of the children during the interventions. The investigators believe that such a solution would allow for better assessment of progress in the core skills of expressive communication and imitation and greater engagement during interventions.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Early Start Denver Model (ESDM)
- Keywords
- Autism spectrum disorder, children, interventional care, robotics, telepresence
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Start Denver Model (ESDM)Other
Phase A
- 4 individual sessions (1 per week)
- Additional time of 15 minutes to evaluate 3 selected tasks of the ESDM
- Satisfaction Evaluation - Parent
- Satisfaction Evaluation - Therapist
Phase B :
- 11 sessions (1 per week)
- Additional time of 15 minutes to evaluate 3 selected tasks of the ESDM with the help of the robot Pepper
- Satisfaction Evaluation - Parent
- Satisfaction Evaluation - Therapist
Phase C :
- 4 sessions (1 per week)
- Additional time of 15 minutes to evaluate 3 selected tasks of the ESDM without the help of the robot Pepper
- Satisfaction Evaluation - Parent
- Satisfaction Evaluation - Therapist
- All sessions will also be filmed and recorded
| Study group | Role | What they receive |
|---|---|---|
| Children with autism spectrum disorders | Other | Not described Receives: Other: Early Start Denver Model (ESDM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of success on the selected task in the ESDM program
Measure the success score for the selected task using the ESDM scoring grid. As soon as the child successfully completes one of the different learning stages, a success score is given to the task. This score will be maximum if all the learning stages of the task considered have been reached (Task 1 = 6 learning stages (maximum score =6); Tasks 2 and 3 = 7 stages (maximum score =7)). The ESDM scoring grid will be completed by the research therapists at the end of each session.
Measured: From phase A (baseline) to phase C (post-intervention) = 19 weeks
Secondary outcomes (1)
Time of the child's viewing and movement of the head and body towards the robot (task 1: saying "hello")
Measurement of the viewing and movement times toward the robot, as well as the response time from the analysis of the videos made during the sessions using the Pepper robot.
Data from the robot: - Video recording by camera of the sessions of the whole room (camera independent of the robot) - Video return by the camera installed on the robot - Audio feedback from the therapist, the robot and the child.
Measured: During Phase B = 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start19 Oct 2023
- Primary completion19 Mar 2025 (estimated)
- Study completion19 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05991791
- Sponsor's protocol ID
- RECHMPL23_0056
- Acronym
- I-ROBI
- Status last verified
- Nov 2023
- First submitted
- 28 Jul 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fournier C, Michelon C, Granit V, Audoyer P, Bernardot A, Picot MC, Kheddar A, Baghdadli A. Pilot study protocol evaluating the impact of telerobotics interactions with autistic children during a Denver intervention on communication skills using single-case experimental design. BMJ Open. 2024 Nov 12;14(11):e084110. doi: 10.1136/bmjopen-2024-084110.
PubMed 39532363
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapted and Individualized Intelligent Robotic Interactions to the Ability Spectrum of Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT05991791
- Acronym / sponsor ID
- I-ROBI / RECHMPL23_0056
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism spectrum disorder, children, interventional care, robotics, telepresence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France
- Study start
- 19 Oct 2023 (actual)
- Primary completion
- 19 Mar 2025 (estimated)
- Study completion
- 19 Sep 2025 (estimated)
- First posted
- 15 Aug 2023 (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.
For several years, studies have been developed on the contribution of social robots as a tool for interventions for children with autism spectrum disorders (ASD). One of the recommended intervention models is the ESDM (Early Start Denver Model). It consists of setting up an individualized, intensive program (at least 20 hours per week) through the pleasure of play. The teacher follows the motivation and interests of the child, and it is the child who chooses the activities. Studies published in recent years tend to show that robots bring benefits to ASD children, particularly in the treatment of social interactions and in clinical settings. However, there is no scientific consensus on the generalized contribution and effect over time of these interventions. Moreover, a robotic solution controlled by a practitioner through a telepresence system allows for a better adaptability to the responses and desires of the children during the interventions. The investigators believe that such a solution would allow for better assessment of progress in the core skills of expressive communication and imitation and greater engagement during interventions.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with autism spectrum disorders | Other | Other: Early Start Denver Model (ESDM) |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patient living in the Hérault department (France),
- Patient with a diagnosis of ASD confirmed by a psychiatrist or a psychologist and receiving current care according to the ESDM model in the MPEA Peyre Plantade child psychiatry service.
Key exclusion criteria (6 listed)
- Patients
- Therapist
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 |
|---|---|---|
| Early Start Denver Model (ESDM)Phase A * 4 individual sessions (1 per week) * Additional time of 15 minutes to evaluate 3 selected tasks of the ESDM * Satisfaction Evaluation - Parent * Satisfaction Evaluation - Therapist Phase B : * 11 sessions (1 per week) * Additional time of 15 minutes to evaluate 3 selected tasks of the ESDM with the help of the robot Pepper * Satisfaction Evaluation - Parent * Satisfaction Evaluation - Therapist Phase C : * 4 sessions (1 per week) * Additional time of 15 minutes to evaluate 3 selected tasks of the ESDM without the help of the robot Pepper * Satisfaction Evaluation - Parent * Satisfaction Evaluation - Therapist * All sessions will also be filmed and recorded | Other | Children with autism spectrum disorders |
Primary outcome
Score of success on the selected task in the ESDM program
Time frame: From phase A (baseline) to phase C (post-intervention) = 19 weeks
Measure the success score for the selected task using the ESDM scoring grid. As soon as the child successfully completes one of the different learning stages, a success score is given to the task. This score will be maximum if all the learning stages of the task considered have been reached (Task 1 = 6 learning stages (maximum score =6); Tasks 2 and 3 = 7 stages (maximum score =7)). The ESDM scoring grid will be completed by the research therapists at the end of each session.
1 secondary outcome
Time of the child's viewing and movement of the head and body towards the robot (task 1: saying "hello")
Time frame: During Phase B = 11 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Derived from this study: PubMed 39532363Fournier C, Michelon C, Granit V, Audoyer P, Bernardot A, Picot MC, Kheddar A, Baghdadli A. Pilot study protocol evaluating the impact of telerobotics interactions with autistic children during a Denver intervention on communication skills using single-case experimental design. BMJ Open. 2024 Nov 12;14(11):e084110. doi: 10.1136/bmjopen-2024-084110.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Start Denver Model (ESDM) in people with Autism Spectrum Disorder, run by University Hospital, Montpellier 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 2 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: status not confirmed, as of the sponsor's last update on 13 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amaria BAGHDADLI, Pr (04 67 33 96 96, a-baghdadli@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of success on the selected task in the ESDM program (time frame: From phase A (baseline) to phase C (post-intervention) = 19 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05991791, which also lists 1 linked publication.
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 13 Nov 2023.