AzTrials
AzTrials

Autism Spectrum DisorderNCT06196060

Improving ToM in Children With ASD Through VPT Training: Behavioral and fNIRS Study

A study testing Visual perspective taking training, Block building training and Thought-bubble training in people with Autism Spectrum Disorder, run by Nanjing Normal University at 3 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This study aims to employ a longitudinal tracking research to investigate the effects of a visual perspective taking intervention on the development of theory of mind in children with autism. Read more about this study

Who is it for?
Ages 3 to 8 yearsHealthy volunteers can take part
Conditions the study is for
Autism Spectrum Disorder
What is being tested?
Visual perspective taking training, Block building training and Thought-bubble training
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
3 sitesChina
Study dates
15 Nov 2023to 1 Sep 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 3 to 8 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • ASD group:
  • With a diagnosis of ASD.
  • Age between 3 and 8 years old.
  • Monolinguals, Chinese native speakers.
  • Providing written informed consent sighed by parents.
  • Control group:
Show all 10Show fewer
  • No diagnosis of ASD (including individuals who are typically developing, have attention deficit hyperactivity disorder, etc.)
  • Age between 3 and 8 years old.
  • Monolinguals, Chinese native speakers.
  • Providing written informed consent sighed by parents.

Who cannot join

  • Language or motor impairments hindering participation in the study.

Trial locations and contacts

3 sites in 1 country.

China3 sites, 3 recruiting
  • Nanjing Normal University

    Nanjing, Jiangsu, 210023

    Mi Tian, +86 15295526069, tianmi@njnu.edu.cn

    Not yet recruiting
  • The Second Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi

    Xin Li, +86 13877146945, 47400124@qq.com

    Recruiting
  • Zhuhai Fudan Innovation Institute

    Zhuhai, Guangdong, 519031

    Xuezhen Xiao, +86 13425122570, xiaoxuezhen@gmail.com

    Not yet recruiting

Other trials in China

About this study

Official title: Improving Theory of Mind in Children With Autism Spectrum Disorder Through Visual Perspective Taking Training: Behavioral and Functional Near-Infrared Spectroscopy Research

This study aims to employ a longitudinal tracking research to investigate the effects of a visual perspective taking intervention on the development of theory of mind in children with autism. Additionally, the investigators seek to examine modifications in the neural mechanisms linked to facial emotion recognition in children both before and after intervention by using the functional Near-Infrared Spectroscopy (fNIRS) to record the relative changes in blood oxygen levels in the cerebral cortex with the oddball Face-Periodic Visual Stimulation (FPVS) paradigm.

Read the detailed description

The deficiency or delayed development of Theory of Mind (ToM) stands as a significant contributing factor to social disorders observed in children with Autism Spectrum Disorder (ASD). Consequently, improving ToM ability is considered pivotal way to improve the development of social function of children with ASD. This study aims to improve ToM ability of children with ASD, and the purpose of this study are as follows:

  1. Reveal the development mechanism of theory of mind of children with ASD, based on embodied cognition theory. Explore whether visual perspective taking training can improve the development of Theory of Mind in children with ASD, and if such enhancement exhibits long-term stability.
  2. Undertake a longitudinal investigation to assess the stability of visual perspective taking training in improving the development of Theory of Mind in children with ASD. Additionally, the study aims to compare the differential effects and stability of various intervention programs in improving the Theory of Mind in children with ASD.
  3. Explore potential disparities in the brain mechanisms of facial emotion recognition between children with ASD and typically developing children before and after the intervention. Specifically, the study seeks to discern whether the intervention can enhance facial emotion recognition abilities in children with ASD and assess the longevity of such enhancements.

The study consists of two parts. In Study 1, participants will be randomly assigned to distinct training groups based on baseline task performance, undergoing three sessions per week for a duration of 4 weeks. In Study 2, the investigators will mainly use the fNIRS with the oddball FPVS paradigm to test children's ability to distinguish facial emotion pictures before and after the intervention, assessing whether the intervention enhances facial emotion recognition ability and if effects vary across different training methods.

Being tested
Visual perspective taking training, Block building training, Thought-bubble training, Treatment as usual
Keywords
Autism Spectrum Disorder, Theory of Mind, Visual Perspective Taking, Facial Emotion Recognition
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.

  • Visual perspective taking trainingBehavioural

    Participants will be instructed to utilize small building blocks for the construction of diverse three-dimensional models, with a particular emphasis on employing various perspectives. The visual perspective taking training sessions will be conducted three times weekly over a period of 4 weeks.

  • Block building trainingBehavioural

    Participants will be instructed to utilize unit building blocks to construct diverse three-dimensional models. The block building training sessions will be conducted three times weekly over a period of 4 weeks.

  • Thought-bubble trainingBehavioural

    Participants will be instructed in the comprehension of mental states through the utilization of cartoon thought-bubbles as a representational tool. The thought-bubble training sessions will be conducted three times weekly over a period of 4 weeks.

  • Treatment as usualBehavioural

    Participants will continue to receive treatment as usual during the trial.

Study groups in NCT06196060
Study groupRoleWhat they receive
Visual perspective taking trainingExperimentalParticipants will receive visual perspective taking training in this arm.
Receives: Behavioral: Visual perspective taking training
Block building trainingExperimentalParticipants will receive block building training in this arm.
Receives: Behavioral: Block building training
Thought-bubble trainingActive comparatorParticipants will receive thought-bubble training in this arm.
Receives: Behavioral: Thought-bubble training
Treatment as usualPlacebo comparatorParticipants will continue to receive routine therapy in this arm.
Receives: Behavioral: Treatment as usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Theory of Mind scale

    This scale comprises seven subtests reflecting the sequential development of these concepts throughout the preschool years, including diverse desires, diverse beliefs, knowledge-ignorance or access, contents false belief, explicit false belief, belief emotion and real-apparent emotion.

    Measured: The test will be measured before, after immediately and three months after the intervention.

  2. The Chinese version of Theory of Mind Inventory-2 (ToMI-2-C)

    The ToMI-2 is a questionnaire filled by parents or guardians. It encompasses 60 items, which are categorized into three empirically derived subscales-Early, Basic, and Advanced-to comprehensively measure ToM abilities.

    Measured: The test will be measured before, after immediately and three months after the intervention.

  3. The Chinese version of Theory of Mind Task Battery (ToMTB)

    The ToMTB encompasses nine tasks, including an emotion recognition task, a desire-based emotion task, a seeing-leads-to-knowing task and so forth.

    Measured: The test will be measured before, after immediately and three months after the intervention.

  4. Visual perspective taking

    A small toy will be placed on a square turntable, which has distinct colored sides. The child will be presented with a laminated card representing four images of the toy, each captured from the front, back, left, and right perspectives. The experimenter will randomly place a small doll in different positions (left, right, or the distant side). The child will be asked, 'This is a little seahorse. When the seahorse is here, which view will the seahorse have?' The child's response will be recorded and scored.

    Measured: The test will be measured before, after immediately and three months after the intervention.

Secondary outcomes (3)
  1. Facial emotion recognition

    fNIRS recordings of relative changes in blood oxygen levels in the cerebral cortex under the oddball FPVS paradigm were employed to assess the recognition of emotional facial images in children with ASD.

    Measured: The test will be measured before, after immediately and three months after the intervention.

  2. Spatial ability

    Spatial ability will be assessed using the Block Design subtest from the Wechsler Preschool and Primary Scale of Intelligence,4th ed. (WPPSI-IV)

    Measured: The test will be measured before, after immediately and three months after the intervention.

  3. Mental rotation

    A small toy will be placed on a square turntable, which has distinct colored sides. The child will be presented with a laminated card representing four images of the toy, each captured from the front, back, left, and right perspectives. After the child correctly identifies the starting direction of the toy, the toy will be covered with an opaque cup. Subsequently, the examiner will randomly rotate the turntable by 90 degrees. The child is then tasked with identifying what the toy will look like when the cup is unveiled. The child's response will be recorded and scored.

    Measured: The test will be measured before, after immediately and three months after the intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2024
  2. Study start15 Nov 2023
  3. Primary completion1 Jun 2024 (estimated)
  4. Study completion1 Sep 2024 (estimated)

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06196060
Sponsor's protocol ID
NNU202202002
Status last verified
Mar 2024
First submitted
5 Dec 2023
Last updated
29 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Caldwell MP, Cheung H, Cheung SK, Li JB, Carrey Siu TS. Visuospatial perspective-taking in social-emotional development: enhancing young children's mind and emotion understanding via block building training. BMC Psychol. 2022 Nov 12;10(1):264. doi: 10.1186/s40359-022-00976-5.

    PubMed 36371295
  • Coll MP, Murphy J, Catmur C, Bird G, Brewer R. The importance of stimulus variability when studying face processing using fast periodic visual stimulation: A novel 'mixed-emotions' paradigm. Cortex. 2019 Aug;117:182-195. doi: 10.1016/j.cortex.2019.03.006. Epub 2019 Mar 19.

    PubMed 30986633
  • Dwyer P, Xu B, Tanaka JW. Investigating the perception of face identity in adults on the autism spectrum using behavioural and electrophysiological measures. Vision Res. 2019 Apr;157:132-141. doi: 10.1016/j.visres.2018.02.013. Epub 2018 Jul 26.

    PubMed 30012353
  • Erle TM, Topolinski S. The grounded nature of psychological perspective-taking. J Pers Soc Psychol. 2017 May;112(5):683-695. doi: 10.1037/pspa0000081. Epub 2017 Mar 2.

    PubMed 28253002
  • Hamilton AF, Brindley R, Frith U. Visual perspective taking impairment in children with autistic spectrum disorder. Cognition. 2009 Oct;113(1):37-44. doi: 10.1016/j.cognition.2009.07.007. Epub 2009 Aug 13.

    PubMed 19682673
  • Hofmann SG, Doan SN, Sprung M, Wilson A, Ebesutani C, Andrews LA, Curtiss J, Harris PL. Training children's theory-of-mind: A meta-analysis of controlled studies. Cognition. 2016 May;150:200-12. doi: 10.1016/j.cognition.2016.01.006. Epub 2016 Feb 20.

    PubMed 26901235
  • Hutchins TL, Prelock PA, Bonazinga L. Psychometric evaluation of the Theory of Mind Inventory (ToMI): a study of typically developing children and children with autism spectrum disorder. J Autism Dev Disord. 2012 Mar;42(3):327-41. doi: 10.1007/s10803-011-1244-7.

    PubMed 21484516
  • Retter TL, Rossion B. Uncovering the neural magnitude and spatio-temporal dynamics of natural image categorization in a fast visual stream. Neuropsychologia. 2016 Oct;91:9-28. doi: 10.1016/j.neuropsychologia.2016.07.028. Epub 2016 Jul 25.

    PubMed 27461075
  • Rossion B. Understanding face perception by means of human electrophysiology. Trends Cogn Sci. 2014 Jun;18(6):310-8. doi: 10.1016/j.tics.2014.02.013. Epub 2014 Apr 1.

    PubMed 24703600
  • Surtees A, Apperly I, Samson D. Similarities and differences in visual and spatial perspective-taking processes. Cognition. 2013 Nov;129(2):426-38. doi: 10.1016/j.cognition.2013.06.008. Epub 2013 Sep 14.

    PubMed 23999408
  • Tian M, Luo T, Ding J, Wang X, Cheung H. Spatial Ability and Theory of Mind: A Mediating Role of Visual Perspective Taking. Child Dev. 2021 Jul;92(4):1590-1604. doi: 10.1111/cdev.13546. Epub 2021 Jan 28.

    PubMed 33507549
  • Tracy JL, Robins RW, Schriber RA, Solomon M. Is emotion recognition impaired in individuals with autism spectrum disorders? J Autism Dev Disord. 2011 Jan;41(1):102-9. doi: 10.1007/s10803-010-1030-y.

    PubMed 20464465
  • Van der Donck S, Dzhelyova M, Vettori S, Mahdi SS, Claes P, Steyaert J, Boets B. Rapid neural categorization of angry and fearful faces is specifically impaired in boys with autism spectrum disorder. J Child Psychol Psychiatry. 2020 Sep;61(9):1019-1029. doi: 10.1111/jcpp.13201. Epub 2020 Jan 31.

    PubMed 32003011
  • Vettori S, Dzhelyova M, Van der Donck S, Jacques C, Steyaert J, Rossion B, Boets B. Reduced neural sensitivity to rapid individual face discrimination in autism spectrum disorder. Neuroimage Clin. 2019;21:101613. doi: 10.1016/j.nicl.2018.101613. Epub 2018 Nov 28.

    PubMed 30522972
  • Wellman HM, Baron-Cohen S, Caswell R, Gomez JC, Swettenham J, Toye E, Lagattuta K. Thought-bubbles help children with autism acquire an alternative to a theory of mind. Autism. 2002 Dec;6(4):343-63. doi: 10.1177/1362361302006004003.

    PubMed 12540127

Questions about this trial

What is this clinical trial studying?

A study testing Visual perspective taking training, Block building training and Thought-bubble training in people with Autism Spectrum Disorder, run by Nanjing Normal University at 3 sites in China.

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 10 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 29 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. 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. Some participants in this study may receive a placebo. 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Theory of Mind scale (time frame: The test will be measured before, after immediately and three months after the intervention.). The study lists 4 primary outcomes in all. 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 NCT06196060, which also lists 20 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 29 Mar 2024; AzTrials last refreshed its copy on 31 Oct 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in