Autism Spectrum DisorderNCT06179927
Group Intervention on Theory of Mind in Children With Autism Spectrum Disorder.
A study testing QT voice and Image stimuli in people with Autism Spectrum Disorder, run by Istituto per la Ricerca e l'Innovazione Biomedica at 1 site in Italy.
Trial summary
The project involves the participation of 40 children with Autism Spectrum Disorder of both sexes, aged between 6 and 10 years. The subjects will undergo a pre-intervention evaluation phase, which will consist of administering the Theory of Mind (ToM) test present in the NEuroPSYcology second edition (NEPSY) battery… Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- QT voice and Image stimuli
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 16 Oct 2023to 22 Jan 2024
- 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 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Proven diagnosis of autism
- QS ≥ 75 assessed by administration of the GRIFFITHS scales
- Passing the emotional recognition test of the NEPSY II battery
Who cannot join
- presence of other medical disorders
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
Messina, 98164
Flavia Marino, +393395798263, flavia.marino@irib.cnr.it
Giovanni Pioggia, +393203390892, giovanni.pioggia@irib.cnr.it
About this study
Official title: Enhancing Theory of Mind Skills in Children With Autism Spectrum Disorder.
The project involves the participation of 40 children with Autism Spectrum Disorder of both sexes, aged between 6 and 10 years. The subjects will undergo a pre-intervention evaluation phase, which will consist of administering the Theory of Mind (ToM) test present in the NEuroPSYcology second edition (NEPSY) battery, part A. The same test will be administered again at the end of the intervention. Once the inclusion criteria have been met and following the randomization of the sample, divided into Experimental Group (EG n=20) and Control Group (CG n=20), the administration of the search task will proceed. The study involves 12 sessions, one per week, lasting 45 minutes. The EG will view twelve social scenes created through a tablet. In the scenario, the depictions will be presented in color. Guided by the narrating voice of QT Robot, they will have to choose between two or three alternatives the one that represents the appropriate mental state by selecting it on the tablet. Consequently, an audio-visual feedback will be provided, through the robot, to give the subject information about the accuracy of their response. In both groups, a simple instruction will be given to the child, telling them to pay attention to the story that will be narrated and then answer simple questions. In the EG, QT robot will speak, while in the CG it will be the operator. The prompts will be related to the accuracy of the response or they will rather be aimed at encouraging the child to give the correct answer.
- Conditions
- Autism Spectrum Disorder
- Being tested
- QT voice, Image stimuli
- Keywords
- Autism, children, theory of mind
- 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.
QT voiceOther
The subjects will undergo a pre-intervention assessment phase that will consist of administering the Theory Of Mind (TOM) test found in the NEuroPSYcology second edition (NEPSY) battery, part A; the same test will be re-submitted at the end of the intervention. Having ascertained the presence of the inclusion criteria and following randomization of the sample, the Experimental Group constituted of 20 children, will be administered the research task, which involves 12 sessions, one per week lasting 45 minutes. the experimental group will view 12 social scenes made via tablet. In the scenario, the depictions will be presented in color. They, guided by QT Robot's narrator voice, will have to choose from two or three alternatives the one that represents the appropriate mental state by selecting it on the tablet. Consequently, audio visual feedback will be provided, via the robot, to return information to the subject about the accuracy of the response.
Image stimuliOther
The subjects will undergo a pre-intervention assessment phase that will consist of administering the Theory Of Mind (TOM) test found in the NEuroPSYcology second edition (NEPSY) battery, part A; the same test will be re-submitted at the end of the intervention. Having ascertained the presence of the inclusion criteria and following randomization of the sample, the control group constituted of 20 children, will be administered the research task, which involves 12 sessions, one per week lasting 45 minutes. the experimental group will view 12 social scenes on paper. They, guided by the narrator's voice of the operator will have to choose from two or three alternatives the one that represents the appropriate mental state by indicating it on the paper. Consequently, feedback will be provided by the operator to return information to the subject on the accuracy of the response.
| Study group | Role | What they receive |
|---|---|---|
| QT robot treatment | Experimental | Twenty children from the experimental group will undergo the treatment using QT Robot and the tablet. Receives: Other: QT voice |
| Traditional treatment | Experimental | Twenty children belonging to the control group will be subjected to the same training but in a traditional way, that is, by presenting image stimuli in a paper format. Receives: Other: Image stimuli |
What is being measured
The primary outcome is the main question the study is designed to answer.
NEuroPSYcology second edition (NEPSY-II) evaluations
NEuroPSYcology second edition (NEPSY-II) is the most internationally known battery for assessing neuropsychological development in developmental age. Each NEPSY-II test provides raw scores that must be converted into scalar scores (min 1 - max 19) or percentile scores (min <2% - max >75%) according to the conversion tables in the manual. For each sub-scale higher scores correspond to better performance. NESPY's Theory of Mind (ToM) sub test, section A is used in this protocol. Assesses the ability to decode and interpret others' intentions and life points and understand how they influence behavior. the test will be given to children pre- and post-intervention.
The ToM test is divided into verbal: the child is read scenarios or shown figures and asked questions that require understanding of the other's point of view; nonverbal: the child is asked to choose the emotional expression appropriate to the mood of a character depicted in certain contexts.
Measured: The tests will be scheduled pre intervention (T0), at 6 months (T1) and at the study conclusion, about 1 year (T2).The test needs about 120-180 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2023
- Study start16 Oct 2023
- Primary completion4 Dec 2023
- Study completion22 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione Biomedica
- Sponsor type
- University, hospital or other
- Collaborators
- Messina, Italy
- Responsible party
- Principal investigator, Flavia Marino, Istituto per la Ricerca e l'Innovazione Biomedica
- Investigators
- Flavia Marino, Principal investigator, Istituto per la Ricerca e l'Innovazione Biomedica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06179927
- Sponsor's protocol ID
- CNR-IRIB-PRO-2023-008
- Status last verified
- Dec 2023
- First submitted
- 12 Dec 2023
- Last updated
- 22 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lecce S & Bianco F. Mettiti nei miei panni, Erickson 2018
Begeer S, Howlin P, Hoddenbach E, Clauser C, Lindauer R, Clifford P, Gevers C, Boer F, Koot HM. Effects and Moderators of a Short Theory of Mind Intervention for Children with Autism Spectrum Disorder: A Randomized Controlled Trial. Autism Res. 2015 Dec;8(6):738-48. doi: 10.1002/aur.1489. Epub 2015 Apr 6.
PubMed 25847054Helen Tager-Flusberg, Evaluating the Theory-of-Mind Hypothesis of Autism, 2007
Uta Frith, Autism and Theory of mind in everyday life, 2018
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Theory of Mind Skills in Children With Autism Spectrum Disorder.
- ClinicalTrials.gov ID
- NCT06179927
- Acronym / sponsor ID
- CNR-IRIB-PRO-2023-008
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism, children, theory of mind
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione BiomedicaUniversity, hospital or other
- Collaborators
- Messina, Italy
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 4 Dec 2023 (actual)
- Study completion
- 22 Jan 2024 (estimated)
- First posted
- 22 Dec 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.
The project involves the participation of 40 children with Autism Spectrum Disorder of both sexes, aged between 6 and 10 years. The subjects will undergo a pre-intervention evaluation phase, which will consist of administering the Theory of Mind (ToM) test present in the NEuroPSYcology second edition (NEPSY) battery, part A. The same test will be administered again at the end of the intervention. Once the inclusion criteria have been met and following the randomization of the sample, divided into Experimental Group (EG n=20) and Control Group (CG n=20), the administration of the search task will proceed. The study involves 12 sessions, one per week, lasting 45 minutes. The EG will view twelve social scenes created through a tablet. In the scenario, the depictions will be presented in color. Guided by the narrating voice of QT Robot, they will have to choose between two or three alternatives the one that represents the appropriate mental state by selecting it on the tablet. Consequently, an audio-visual feedback will be provided, through the robot, to give the subject information about the accuracy of their response. In both groups, a simple instruction will be given to the child, telling them to pay attention to the story that will be narrated and then answer simple questions. In the EG, QT robot will speak, while in the CG it will be the operator. The prompts will be related to the accuracy of the response or they will rather be aimed at encouraging the child to give the correct answer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QT robot treatment | Experimental | Other: QT voiceTwenty children from the experimental group will undergo the treatment using QT Robot and the tablet. |
| Traditional treatment | Experimental | Other: Image stimuliTwenty children belonging to the control group will be subjected to the same training but in a traditional way, that is, by presenting image stimuli in a paper format. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Proven diagnosis of autism
- QS ≥ 75 assessed by administration of the GRIFFITHS scales
- Passing the emotional recognition test of the NEPSY II battery
Key exclusion criteria (1 listed)
- presence of other medical disorders
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 |
|---|---|---|
| QT voiceThe subjects will undergo a pre-intervention assessment phase that will consist of administering the Theory Of Mind (TOM) test found in the NEuroPSYcology second edition (NEPSY) battery, part A; the same test will be re-submitted at the end of the intervention. Having ascertained the presence of the inclusion criteria and following randomization of the sample, the Experimental Group constituted of 20 children, will be administered the research task, which involves 12 sessions, one per week lasting 45 minutes. the experimental group will view 12 social scenes made via tablet. In the scenario, the depictions will be presented in color. They, guided by QT Robot's narrator voice, will have to choose from two or three alternatives the one that represents the appropriate mental state by selecting it on the tablet. Consequently, audio visual feedback will be provided, via the robot, to return information to the subject about the accuracy of the response. | Other | QT robot treatment |
| Image stimuliThe subjects will undergo a pre-intervention assessment phase that will consist of administering the Theory Of Mind (TOM) test found in the NEuroPSYcology second edition (NEPSY) battery, part A; the same test will be re-submitted at the end of the intervention. Having ascertained the presence of the inclusion criteria and following randomization of the sample, the control group constituted of 20 children, will be administered the research task, which involves 12 sessions, one per week lasting 45 minutes. the experimental group will view 12 social scenes on paper. They, guided by the narrator's voice of the operator will have to choose from two or three alternatives the one that represents the appropriate mental state by indicating it on the paper. Consequently, feedback will be provided by the operator to return information to the subject on the accuracy of the response. | Other | Traditional treatment |
Primary outcome
NEuroPSYcology second edition (NEPSY-II) evaluations
Time frame: The tests will be scheduled pre intervention (T0), at 6 months (T1) and at the study conclusion, about 1 year (T2).The test needs about 120-180 minutes.
NEuroPSYcology second edition (NEPSY-II) is the most internationally known battery for assessing neuropsychological development in developmental age. Each NEPSY-II test provides raw scores that must be converted into scalar scores (min 1 - max 19) or percentile scores (min <2% - max >75%) according to the conversion tables in the manual. For each sub-scale higher scores correspond to better performance. NESPY's Theory of Mind (ToM) sub test, section A is used in this protocol. Assesses the ability to decode and interpret others' intentions and life points and understand how they influence behavior. the test will be given to children pre- and post-intervention. The ToM test is divided into verbal: the child is read scenarios or shown figures and asked questions that require understanding of the other's point of view; nonverbal: the child is asked to choose the emotional expression appropriate to the mood of a character depicted in certain contexts.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
- BackgroundLecce S & Bianco F. Mettiti nei miei panni, Erickson 2018
- Background: PubMed 25847054Begeer S, Howlin P, Hoddenbach E, Clauser C, Lindauer R, Clifford P, Gevers C, Boer F, Koot HM. Effects and Moderators of a Short Theory of Mind Intervention for Children with Autism Spectrum Disorder: A Randomized Controlled Trial. Autism Res. 2015 Dec;8(6):738-48. doi: 10.1002/aur.1489. Epub 2015 Apr 6.
- BackgroundHelen Tager-Flusberg, Evaluating the Theory-of-Mind Hypothesis of Autism, 2007
- BackgroundUta Frith, Autism and Theory of mind in everyday life, 2018
- Individual participant dataSharing planned: No
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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.
Flavia Marino principal investigator
Istituto per la Ricerca e l'Innovazione Biomedica
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QT voice and Image stimuli in people with Autism Spectrum Disorder, run by Istituto per la Ricerca e l'Innovazione Biomedica at 1 site in Italy.
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 3 inclusion and 1 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 22 Dec 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 Italy. 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 Germana Doria (+393465142289, germana.doria@irib.cnr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NEuroPSYcology second edition (NEPSY-II) evaluations (time frame: The tests will be scheduled pre intervention (T0), at 6 months (T1) and at the study conclusion, about 1 year (T2).The test needs about 120-180 minutes.). 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 NCT06179927, which also lists 4 linked publications.
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 22 Dec 2023.