Condition category
Mental and Behavioural Disorders
Date applied
22/04/2015
Date assigned
23/04/2015
Last edited
23/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration.

Trial website

Contact information

Type

Scientific

Primary contact

Dr Morag Maskey

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

18461

Study information

Scientific title

Reducing anxiety in children with autism spectrum disorders through  virtual reality environments

Acronym

Study hypothesis

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

14/NE/1177

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a participant information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/03/2015

Overall trial end date

01/03/2016

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 32; UK Sample Size: 32

Participant 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.

Recruitment start date

01/03/2015

Recruitment end date

01/03/2016

Locations

Countries of recruitment

United Kingdom

Trial 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

Organisation

Northumberland, Tyne and Wear NHS Foundation Trust

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes