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

Nanjing Normal University

Status: Enrolling

Conditions: Autism Spectrum Disorder

Treatments: Behavioral: Thought-bubble training; Behavioral: Visual perspective taking training; Behavioral: Treatment as usual; Behavioral: Block building training

Study type: Interventional

Funder types: Other

Identifiers

NCT06196060

NNU202202002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 3 to 8 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 4 patient groups, including a placebo group

Visual perspective taking training

Experimental group

Description:

Participants will receive visual perspective taking training in this arm.

Treatment:

Behavioral: Visual perspective taking training

Block building training

Experimental group

Description:

Participants will receive block building training in this arm.

Treatment:

Behavioral: Block building training

Thought-bubble training

Active Comparator group

Description:

Participants will receive thought-bubble training in this arm.

Treatment:

Behavioral: Thought-bubble training

Treatment as usual

Placebo Comparator group

Description:

Participants will continue to receive routine therapy in this arm.

Treatment:

Behavioral: Treatment as usual