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

March 28, 2024 updated by: Mi Tian, Nanjing Normal University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Zhuhai, Guangdong, China, 519031
        • Not yet recruiting
        • Zhuhai Fudan Innovation Institute
        • Contact:
    • Guangxi
      • Nanning, Guangxi, China
        • Recruiting
        • The Second Affiliated Hospital of Guangxi Medical University
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210023
        • Not yet recruiting
        • Nanjing Normal University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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.

Exclusion Criteria:

  • Language or motor impairments hindering participation in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Visual perspective taking training
Participants will receive visual perspective taking training in this arm.
Behavioral: Visual perspective taking training
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.
Experimental: Block building training
Participants will receive block building training in this arm.
Behavioral: Block building 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.
Active Comparator: Thought-bubble training
Participants will receive thought-bubble training in this arm.
Behavioral: Thought-bubble 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.
Placebo Comparator: Treatment as usual
Participants will continue to receive routine therapy in this arm.
Behavioral: Treatment as usual
Participants will continue to receive treatment as usual during the trial.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 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)
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.
The test will be measured before, after immediately and three months after the intervention.
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.
The test will be measured before, after immediately and three months after the intervention.
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.
The test will be measured before, after immediately and three months after the intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Facial emotion recognition
Time Frame: The test will be measured before, after immediately and three months after the intervention.
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.
The test will be measured before, after immediately and three months after the intervention.
Spatial ability
Time Frame: The test will be measured before, after immediately and three months after the intervention.
Spatial ability will be assessed using the Block Design subtest from the Wechsler Preschool and Primary Scale of Intelligence,4th ed. (WPPSI-IV)
The test will be measured before, after immediately and three months after the intervention.
Mental rotation
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. 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.
The test will be measured before, after immediately and three months after the intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing Normal University

Collaborators

Second Affiliated Hospital of Guangxi Medical University
Zhuhai Fudan Innovation Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

December 5, 2023

First Submitted That Met QC Criteria

December 23, 2023

First Posted (Actual)

January 9, 2024

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 28, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NNU202202002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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