NCT06196060

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2023

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

December 5, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 9, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

March 29, 2024

Status Verified

March 1, 2024

Enrollment Period

7 months

First QC Date

December 5, 2023

Last Update Submit

March 28, 2024

Conditions

Keywords

Autism Spectrum DisorderTheory of MindVisual Perspective TakingFacial Emotion Recognition

Outcome Measures

Primary Outcomes (4)

  • 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.

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

  • 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.

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

  • 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.

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

  • 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.

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

Secondary Outcomes (3)

  • Facial emotion recognition

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

  • Spatial ability

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

  • Mental rotation

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

Study Arms (4)

Visual perspective taking training

EXPERIMENTAL

Participants will receive visual perspective taking training in this arm.

Behavioral: Visual perspective taking training

Block building training

EXPERIMENTAL

Participants will receive block building training in this arm.

Behavioral: Block building training

Thought-bubble training

ACTIVE COMPARATOR

Participants will receive thought-bubble training in this arm.

Behavioral: Thought-bubble training

Treatment as usual

PLACEBO COMPARATOR

Participants will continue to receive routine therapy in this arm.

Behavioral: Treatment as usual

Interventions

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.

Visual perspective taking training

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.

Block building training

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.

Thought-bubble training

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

Treatment as usual

Eligibility Criteria

Age3 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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:
  • 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.

You may not qualify if:

  • Language or motor impairments hindering participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Zhuhai Fudan Innovation Institute

Zhuhai, Guangdong, 519031, China

NOT YET RECRUITING

The Second Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

RECRUITING

Nanjing Normal University

Nanjing, Jiangsu, 210023, China

NOT YET RECRUITING

Related Publications (20)

  • 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.

    PMID: 36371295BACKGROUND
  • 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.

    PMID: 30986633BACKGROUND
  • 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.

    PMID: 30012353BACKGROUND
  • 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.

    PMID: 28253002BACKGROUND
  • 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.

    PMID: 19682673BACKGROUND
  • 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.

    PMID: 26901235BACKGROUND
  • 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.

    PMID: 21484516BACKGROUND
  • 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.

    PMID: 27461075BACKGROUND
  • 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.

    PMID: 24703600BACKGROUND
  • 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.

    PMID: 23999408BACKGROUND
  • 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.

    PMID: 33507549BACKGROUND
  • 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.

    PMID: 20464465BACKGROUND
  • 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.

    PMID: 32003011BACKGROUND
  • 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.

    PMID: 30522972BACKGROUND
  • 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.

    PMID: 12540127BACKGROUND
  • Wellman HM, Liu D. Scaling of theory-of-mind tasks. Child Dev. 2004 Mar-Apr;75(2):523-41. doi: 10.1111/j.1467-8624.2004.00691.x.

    PMID: 15056204BACKGROUND
  • Chen KL, Jiang DR, Yu YT, Lee YC. Development and psychometric evidence of the Chinese Version of the Theory of Mind Inventory-2 (ToMI-2) in children with autism spectrum disorder. Research in Autism Spectrum Disorders. 2023; 103: 102132.

    BACKGROUND
  • Kessler K, Wang H. Spatial perspective taking is an embodied process, but not for everyone in the same way: Differences predicted by sex and social skills score. Spatial Cognition & Computation. 2012; 12(2-3): 133-158.

    BACKGROUND
  • Knoll M, Charman T. Teaching false belief and visual perspective taking skills in young children: Can a theory of mind be trained? Child Study Journal. 2000; 30(4): 273-273.

    BACKGROUND
  • Liao Y, Dillenburger K, He W, Xu Y, Cai H. A Systematic Review of Applied Behavior Analytic Interventions for Children with Autism in Mainland China. Review Journal of Autism and Developmental Disorders. 2020; 7(4): 333-351.

    BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 5, 2023

First Posted

January 9, 2024

Study Start

November 15, 2023

Primary Completion

June 1, 2024

Study Completion

September 1, 2024

Last Updated

March 29, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations