Targeting the Sensory Disturbance in Autism Spectrum Disorder

NCT ID: NCT05157477

Last Updated: 2023-04-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-17
• Study Completion Date: 2023-12-31

Brief 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.

Conditions

Autistic Disorders Spectrum

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

VR-Group

The participants who are randomized into 'CBT-based VR exposure program' (CBT+VR group) will receive the individual intervention weekly with a total of 8 sessions. The therapists, PI (Chien YL) and a clinical psychologist who is familiar with ASD psychopathology and CBT approach, will provide the CBT-based VR exposure intervention for each individual every week based on the above protocol. The participants complete the homework (i.e., relaxation and real-life exposure) between the sessions, and record 'anxiety level' before, during, and after the real-life exposure. The outcome measures will be scheduled at the end of intervention (8th week) within one week of program closure.

Group Type: EXPERIMENTAL

CBT-based VR exporsure program

Intervention Type: BEHAVIORAL

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.

CBT-GROUP

The 'CBT alone' intervention applies the same protocol excluding VR exposure, which is replaced by traditional role play with the therapist.

Group Type: EXPERIMENTAL

CBT-based VR exporsure program

Intervention Type: BEHAVIORAL

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.

Control group

The participants who are randomized into control group will be regularly followed in a naturalistic outpatient clinic setting (every 2-4 week). During the clinic, sensory and socioemotional problems will be discussed face-to-face for 10 to 20 minutes, some self-help books will be recommended.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Yi-Ling Chien, Ph.D

Role: CONTACT

chienyiling@gmail.com

+886-2-23123456 ext. 66013

Other Identifiers

201712172RINC

Identifier Type: -

Identifier Source: org_study_id