Targeting the Sensory Disturbance in Autism Spectrum Disorder

Autistic Disorders Spectrum Clinical Trial

Official title:

Targeting the Sensory Disturbance in Autism Spectrum Disorder: The Effectiveness of Cognitive-behavior Therapy-based Virtual Reality Exposure Program

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05157477
• Other study ID #: 201712172RINC
• Status: Recruiting
• Phase: N/A
• Start date: June 17, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: National Taiwan University Hospital
• Contact: Yi-Ling Chien, Ph.D
• Phone: +886-2-23123456
• Email: chienyiling[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to establish a cognitive-behavior therapy (CBT) based virtual exposure (VR) exposure program to train ASD adults coping with everyday sensory scenarios. Through the practice and training, the ASD participants may learn the strategy to deal with the common sensory scenarios and master the anxiety around the exposure. The anticipatory anxiety and the maladaptive behaviors may be decreased along with the process of desensitization, while the functional impairment related to sensory sensitivity can partly be recovered.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• young adult aged between 18 and 45 years who had a diagnosis of ASD from a licensed mental health or medical professional based on DSM-5;
• has sensory and social problems as reported by the participant and the caregiver;
• is motivated to participate in the treatment;
• is fluent in Chinese;
• has a full-scale IQ > 70 on WAIS-IV;
• scored ? 26 on the caregiver-reported Autism Spectrum Quotient (AQ), indicating clinical impairment associated with ASD.

Exclusion Criteria:

• A history of major mental illness (e.g., bipolar affective disorder, schizophrenia, or psychosis) or neurological diseases;
• visual impairment and/or hearing impairment that would preclude participation in the CBT-based VR exposure program

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Autistic Disorders Spectrum

Intervention

Behavioral:
• CBT-based VR exporsure program
This project seeks to establish a 8-week CBT-based VR exposure program to tackle sensory problems in ASD according to the theory of exposure and desensitization (both social and non-social scenarios) as well as identifying dysfunctional thought and searching for alternative thinking. In brief, this program aims to build up the core competence of the ASD individuals in facing the sensory environment, including (1) Relaxation skills (2) Ranking the fearful sensory situations (3) Anxiety coping strategy (3) Graded exposure (4) Cognitive appraisal and restructuring: identifying the dysfunctional thought when facing the social situations and figuring out alternative thinking.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of heart rate	The change of heart rate is related to the activation level of sympathetic nervous system, which can describe the change on anxiety level.	Two months, first time in the first week and second time in the last week.