Virtual reality intervention for anxiety in children with ASD

ISRCTN	ISRCTN78861851
DOI	https://doi.org/10.1186/ISRCTN78861851
Secondary identifying numbers	18461

Submission date: 22/04/2015
Registration date: 23/04/2015
Last edited: 15/02/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration.

Contact information

Dr Morag Maskey
Scientific

Newcastle University
Institute of Neuroscience
Sir James Spence
Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom

Study information

Study design	Randomised; Interventional; Design type: Treatment
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a participant information sheet
Scientific title	Reducing anxiety in children with autism spectrum disorders through virtual reality environments
Study objectives	The aim of this study is to investigate whether a virtual reality environment is effective at treating specific fears/phobias in young people with autism spectrum disorders.
Ethics approval(s)	North East - Tyne & Wear South Research Ethics Committee, 15/12/2014, ref: 14/NE/1177
Health condition(s) or problem(s) studied	Topic: Children, Mental Health; Subtopic: All Diagnoses, Anxiety, Autism spectrum disorders; Disease: Anxiety, Autism spectrum disorders, All Diseases
Intervention	Virtual reality: Computer generated images of the phobia/fear that a child with ASD has. Follow Up Length: 12 month(s); Study Entry : Single Randomisation only
Intervention type	Other
Primary outcome measure	Reduction in anxiety and improvement in functional behaviour; Timepoint(s): 2 weeks after intervention, 6 months after intervention and 12 months after intervention
Secondary outcome measures	N/A
Overall study start date	01/03/2015
Completion date	01/03/2016

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	8 Years
Upper age limit	14 Years
Sex	Both
Target number of participants	Planned Sample Size: 32; UK Sample Size: 32
Key inclusion criteria	1. Children aged 8-14 years old, boys and girls, with a diagnosis of autism, ASD or Asperger's syndrome 2. Learning ability/IQ estimated to be within the average range 3. Fluent verbal skills; having situation specific anxiety 4. Parent/carer and young person willing to attend sessions at the VRE Target Gender: Male & Female; Upper Age Limit 14 years ; Lower Age Limit 8 years
Key exclusion criteria	Children without fluent verbal skills due to the need to have sufficient feedback on the use of the VRE. Children unable/unwilling to travel to the VRE. Insufficient English or intellectual ability to understand the forms.
Date of first enrolment	01/03/2015
Date of final enrolment	01/03/2016

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Newcastle University

Institute of Neuroscience
Sir James Spence
Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom

Sponsor information

Northumberland, Tyne and Wear NHS Foundation Trust
Hospital/treatment centre

St Nicholas Hospital
Gosforth
Newcastle upon Tyne
NE3 3XT
England
United Kingdom

"ROR"	https://ror.org/01ajv0n48

Funders

Funder type

Government

National Institute for Health Research
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2019		Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

15/02/2019: Publication reference added.
14/05/2018: No publications found, verifying study status with principal investigator.