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Clinical Trials/NCT06196060
NCT06196060
Recruiting
Not Applicable

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

Nanjing Normal University3 sites in 1 country100 target enrollmentNovember 15, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Autism Spectrum Disorder
Sponsor
Nanjing Normal University
Enrollment
100
Locations
3
Primary Endpoint
The Chinese version of Theory of Mind Task Battery (ToMTB)
Status
Recruiting
Last Updated
2 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
November 15, 2023
End Date
September 1, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mi Tian

Associate Professor

Nanjing Normal University

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • Language or motor impairments hindering participation in the study.

Outcomes

Primary Outcomes

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

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

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

Visual perspective taking

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

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.

Theory of Mind scale

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

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

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

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.

Secondary Outcomes

  • Mental rotation(The test will be measured before, after immediately and three months after the intervention.)
  • 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.)

Study Sites (3)

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