Clinical trial NCT06450665: Reducing Social Avoidance Among Adolescents With Special Educational Needs
Official title: Reducing Social Avoidance Among Adolescents With Special Educational Needs
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Social Avoidant Behavior
Social Anxiety
Keywords: Social Avoidant Behavior
Adolescents
Special Education Needs
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Chinese University of Hong Kong
First posted: 2024-06-10
Enrollment: 208
Sex: ALL
Minimum age (years): 16
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention group will go through three 30-minute VR sessions over a period of 3 weeks. The wait-list control group will complete the questionnaires in the same interval as the intervention group, with promise of receiving VR intervention after 1-month follow-up is over.
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to examine the effectiveness of a Virtual Reality (VR) social avoidance intervention in reducing social avoidance symptoms among adolescents with special educational needs. Participants will complete tasks in the VR scenario with increasing difficulty and learn that they can cope in situations that they previously avoid. We hypothesize that, comparing with usual care (i.e. waitlist control), the intervention group will experience a significant reduction on social avoidance symptoms after treatment and this benefit will persist till 1-month follow-up.

Detailed description: Over the past 25 years, VR has been used to complement therapist-delivered psychological interventions, primarily exposure therapy for anxiety related disorders. VR renders real-world social interactions simulation, which allows users to experience an anxiety provoking situation with a greater sense of control. In Hong Kong, with the lack of mental health professionals being a perennial problem, VR-based interventions offer the potential to substantially reduce the treatment time and cost, as well as to increase access to evidence-based psychological interventions.

The Virtual Reality (VR) social avoidance intervention used in the current study is designed based on cognitive-behavioral approach with a virtual coach acting as the therapist. It is designed in tandem with input from Hong Kong users to ensure the scenario can resonate with them.

Eligibility criteria: Inclusion Criteria:

* Age 16-19
* Can read traditional Chinese and understand Cantonese
* Self-report on experiencing social avoidance symptoms

Exclusion Criteria:

* History of photosensitive epilepsy
* Impairment of stereoscopic vision
* Balance problems

Primary outcomes:
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: 1st week, 4th week, 8th week
measure: Generalized Anxiety Disorder Assessment (GAD-7)
timeFrame: 1st week, 4th week, 8th week
measure: Work and Social Adjustment Scale (WSAS)
timeFrame: 1st week, 4th week, 8th week
measure: Brief Fear of Negative Evaluation Scale (bFNE)
timeFrame: 1st week, 4th week, 8th week
measure: Oxford Behavioural Avoidance Task - HK (OBAT-HK)
timeFrame: 1st week, 4th week, 8th week
measure: Social phobia (SPS-6)
timeFrame: 1st week, 4th week, 8th week
measure: Mental health related Quality of Life (REQoL-20)
timeFrame: 1st week, 4th week, 8th week
measure: Self-esteem (RSE)
timeFrame: 1st week, 4th week, 8th week
measure: Social Interaction Anxiety Scale-6 (SIAS-6)
timeFrame: 1st week, 4th week, 8th week, and after each session of VR intervention
measure: Social Anxiety Session Change Index (SASCI)
timeFrame: After each session of VR intervention
measure: Working Alliance Inventory applied to VR and AR (WAI-VAR)
timeFrame: 4th week
measure: Gatineau Presence Questionnaire (GPQ)
timeFrame: 4th week
measure: Social presence (SPSQ)
timeFrame: 4th week
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Applied Social Sciences, PolyU
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Xiaohua Sylvia Chen
role: PRINCIPAL_INVESTIGATOR
affiliation: Chinese University of Hong Kong
name: Winnie Wing Sze Mak
role: PRINCIPAL_INVESTIGATOR
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