Autism Mental and Behavioural Disorders
Conditions
Interventions
This is a feasibility study, due to the novel intervention, it is an initial development and feasibility investigation. Due to the feasibility stage, it will have a limited sample size (10-25 particip
Sponsors
Hertfordshire Partnership University NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
12 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. Community-based service users, aged 12-18 years 2. Significant autistic traits as assessed by a score of 32-50 on the Autism Quotient (AQ) questionnaire (indicates a strong likelihood of ASD) 3. Significant anxiety as assessed by a total score of 20 or above on the Anxiety Scale for Children with ASD (ASC-ASD) and a score of 30 or above on the Liebowitz Social Anxiety Scale (30-49 indicates mild social anxiety) 4. Ongoing medication (SSRI, tricyclic antidepressant, antipsychotic, benzodiazepine) is allowed as long as the dose is kept stable for a sustained period before (>=6 weeks)
Exclusion criteria
Exclusion criteria: 1. Score on the Visually Induced Motion Sickness Susceptibility Questionnaire (VIM SSQ), that is one standard deviation above the mean total score will be advised not to take part in the study (Mean Score Females, 29.23 Standard Deviation 19.05; Mean Score Males 11.36, Standard Deviation 7.76) 2. History of psychotic disorder (psychotic symptoms, bipolar disorder) 3. Alcohol/substance abuse disorders within the past 12 months 4. Any other DSM-5 disorder that is considered the primary focus of treatment 5. Actively planning suicide as judged by the clinician to be at significant risk of acts of suicide 6. Received Virtual Reality Treatment in the last 6 months 7. CBT is not allowed during or within 6 weeks of the start of the intervention 8. Regular psychotropic drugs use other than permitted medication 9. Currently involved in a treatment research study 10. Epilepsy or other clinically defined neurological disorder or insult 11. Currently receiving specialist care for any vision-related difficulties (e.g. double vision) 12. Experience of severe migraines 13. Inadequate understanding of English to give informed consent or such that the outcome measurement is not possible
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary aim of this study is to establish the feasibility of a future trial using the following outcome measures: 1. Recruitment rate recorded as the number of eligible participants who consent to participate in the study by 6 months 2. Recruitment rate considered by the number of referrals per professional group will also be collated over 6 months. 3. Attrition rate using the number of participants who consent to participate who remain in the study until the end of follow-up at 12 months 4. Ascertainment ratio using the flow of patients through the study from identification to completion over 12 months 5. Session completeness as recorded by session attendance (no. of missed sessions) and homework completion over 12 months 6. Tolerability as measured by the number and nature of adverse events, including ratings on the Simulator Sickness Questionnaire over 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Positive experience as measured by Likert scale ratings of sessions over 12 months 2. Appropriateness of outcomes measures as considered by consistency with ratings of goals over 12 months | — |
Countries
England, United Kingdom
Outcome results
None listed