Developing a Psychoeducation Tool for Anxiety in Autism
Research type
Research Study
Full title
The development of a psychoeducation tool to manage anxiety in people with Autism Spectrum Disorders: the Managing Anxiety iN Autism GuidE (MANAGE)
IRAS ID
200774
Contact name
Emily Simonoff
Contact email
Sponsor organisation
King's College London
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
Ethical approval is sought to recruit 30 participants with autism spectrum disorder (ASD) and high levels of anxiety (aged 8-25 years) and their parent/caregiver into a pilot trial of a psychoeducation intervention. Participants will be recruited through clinical services in South London and the Maudsley (SLaM) and Guy’s and St Thomas’ (GSTT) NHS trusts through the patient consent to contact register (C4C) in SLaM and via referral from clinical care co-ordinators in the clinics in each trust. Additional participants may be recruited from non-clinical sources such as research recruitment lists held by autism charities or advertisements, including local newsletters, social media sites, emails or letters.
TThe aim is to improve participants’ and their parent/caregivers’ knowledge of the presentation of anxiety in ASD and simple strategies for its management. The primary outcome is improvement of participant and parent/caregiver understanding of the presentation of and simple management strategies for anxiety in ASD. Secondary outcomes include improvement in anxiety symptoms, quality of life and confidence in managing anxiety as well as feedback on acceptability, usefulness and appropriateness of the guide. This is a pilot efficacy trial of newly developed psychoeducation guides employing a randomized, parallel-arm, intention to treat design with a 4 week intervention. Participant families will be randomly allocated (1:1) to either an immediate or a delayed start group to allow measurement of anxiety symptoms over a one month period with and without the psychoeducation guide. This design helps to control for the effects of attention (anxiety may show a large placebo response) while allowing all participants access to the intervention.
Four psychoeducation guides are available: one for parent/caregivers and three for different age/ability levels of people with ASD. More detail about the guides can be found in the MANAGE protocol (Version 1).
REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
16/LO/1299
Date of REC Opinion
28 Jul 2016
REC opinion
Favourable Opinion