Plain English Summary
Background and study aims
Many children with autism spectrum disorders (ASD) show anxiety in response to particular settings. Anxiety is problematic for children with ASD, their peers, parents and teachers, as it causes distress and limits opportunities to participate in activities and learning. Furthermore, the rigid ways of thinking characteristic of ASD mean that therapy for such problems requires some adaptions. This study will investigate one such adaption, the use of a virtual reality environment, combined with traditional therapy, to reduce anxiety in children with ASD.
Who can participate?
We will recruit children aged 8-14 years with fluent verbal skills and a diagnosis of ASD, autism or Asperger's syndrome.
What does the study involve?
Assessments will be carried out before the start of the study and an individualised programme of therapy is designed for each child. Their specific anxiety-provoking situation can be reproduced in a virtual reality facility known as the Blue Room. With support from a psychologist and training in coping strategies, children will be gradually introduced to their 'trigger' situation in the blue room environment. After 2-4 sessions in the virtual environment, they will be reintroduced to the real life environment that causes anxiety. Anxiety will be assessed before and after treatment using questionnaires and interviews. In addition, we will be testing the use of a physiological measure of anxiety. This will be via a wristband device and will measure galvanic skin response, which gives a measure of the level of anxiety experienced.
What are the possible benefits and risks of participating?
The benefits to taking part are that your childs anxiety to a specific situation may be reduced. There are no risks associated.
Where is the study run from?
Newcastle University, UK.
When is the study starting and how long is it expected to run for?
The study started in March 2012 and ran until March 2013.
Who is funding the study?
Newcastle University, Daphne Jackson Fellowship
Who is the main contact?
Dr Morag Maskey
morag.maskey@ncl.ac.uk
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Reducing anxiety in children with autism spectrum disorders through virtual reality environments
Acronym
Study hypothesis
1. This is an initial investigation into whether we can use a virtual reality room to recreate specific situations that children with autism spectrum disorder become anxious about.
2. To trial the use of a virtual reality (VR) environment as part of an anxiety treatment programme in young people with autism spectrum disorder (ASD).
3. Does using a VR environment as part of a treatment programme, reduce anxiety in children with ASD?
Ethics approval
National Health Service NRES Committee North East-Sunderland, 16/03/2012, ref. 12/NE/0018
Study design
Pre and post study design
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Autism spectrum disorders (ASDs)
Intervention
At baseline, there will be two meetings with families. First, a member of the research team will meet with the family at home to ensure that they have a clear understanding of what is involved and to answer questions. If the family want to join the study, consent will be obtained at this meeting or seven days thereafter, if they require further time to discuss it. Anxiety questionnaires will also be completed at this point. The meeting will last approximately 1 hour.
There will be a second meeting in the child's home with a clinical psychologist and research associate. This meeting will be a clinical assessment of the child's anxiety in order to select a target that might be addressed therapeutically. This meeting will last approximately 45 minutes.
The child will then receive four sessions in the VRE. Each session lasts approximately 30 minutes and we will undertake 2 sessions in one visit to the VRE location (with a rest gap in between) - with several days in between visits. The sessions will be carefully planned so that the child experiences a feeling of coping and mastery. They will be taught coping self statements and relaxation techniques by a psychologist, both before the session starts and in between sessions.
Before and after each session children will be asked to rate their confidence at tackling their target situation. Parents will watch the session via video link and be asked to rate their child's confidence using the same scale. Each child will also wear a wristband device while in the Blue Room, which measures galvanic skin response and can be used to monitor their levels of anxiety.
The final session will be real life exposure to the situation we have been working with, supported by the psychologist. The outcome measures will be the same (GSR, confidence ratings).
Six weeks after treatment we will visit the families and repeat the anxiety questionnaires and get an update on real life progress (session of approximately 30 minutes). We will also repeat the questionnaires and updates by telephone at six months and one year after treatment.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
1. Real life improvement measured at 6 weeks, 6 months and 1 year after intervention
2. Change in the Spence child anxiety scale measured at 6 weeks, 6 months and 1 year after intervention
3. Reduction in GSR readings from beginning to end of sessions
4. Change in participants rating of their confidence levels at tackling their target situation on a scale from 6 (very confident) to 0 (not confident)
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/03/2012
Overall trial end date
01/03/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Boys and girls aged 8-14 years old
2. Diagnosis of autism, ASD or Asperger's syndrome
3. Learning ability/IQ estimated to be within the average range
4. Fluent verbal skills
5. Having situation specific anxiety
6. Parent/carer and young person willing to attend sessions in the VRE in Durham
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
20
Participant exclusion criteria
1. Children without fluent verbal skills due to the need to have sufficient feedback on the use of the VRE
2. Children unable/unwilling to travel to the VRE in Durham
3. Insufficient English to understand the forms
4. Children with a co-morbid disorder e.g. depression, severe conduct disorder, severe generalised anxiety disorder
Recruitment start date
01/03/2012
Recruitment end date
01/03/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Victoria Infirmary
Newcastle upon Tyne
NE1 4LP
United Kingdom
Funders
Funder type
University/education
Funder name
Newcastle University
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24987957