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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06196060
Enrollment
100
Registered
2024-01-09
Start date
2023-11-15
Completion date
2024-09-01
Last updated
2024-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

Keywords

Autism Spectrum Disorder, Theory of Mind, Visual Perspective Taking, Facial Emotion Recognition

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.

Interventions

BEHAVIORALVisual 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.

BEHAVIORALBlock 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.

BEHAVIORALThought-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.

BEHAVIORALTreatment as usual

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

Sponsors

Zhuhai Fudan Innovation Institute
CollaboratorUNKNOWN
Second Affiliated Hospital of Guangxi Medical University
CollaboratorOTHER
Nanjing Normal University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
3 Years to 8 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Theory of Mind scaleThe 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)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 Chinese version of Theory of Mind Task Battery (ToMTB)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 takingThe 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.

Secondary

MeasureTime frameDescription
Spatial abilityThe 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)
Mental rotationThe 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.
Facial emotion recognitionThe 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026