Personalised anxiety treatment for autism - the PAT-A trial

Not Applicable

Completed

• Conditions: Autism; Mental and Behavioural Disorders

• Registration Number: ISRCTN15881562
• Lead Sponsor: orthumberland, Tyne And Wear NHS Foundation Trust

Brief Summary

2020 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/32171316 protocol (added 17/03/2020) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37728782/ (added 17/11/2023)

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-09
• Study Completion: 2022-03-31
• Last Update Posted: 28 November 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Current inclusion criteria as of 03/10/2019:
1. Adults aged 18+ who are able to provide informed consent
2. With a diagnosed autism spectrum disorder
3. Experiencing clinically significant anxiety
4. Living in the area serviced by the sponsoring NHS Foundation Trust

Previous inclusion criteria:
1. Adults aged 18+ with a diagnosed autism spectrum disorder
2. Relatives of adults with ASD; where both relatives and adults are over the ages of 18
3. Relatives of children with ASD; where the relative is over the age of 18 and the child is under the age of 18
4. Health professionals with experience of working clinically with adults with ASD

Exclusion Criteria

1. Co-morbid physical or mental health condition that would significantly inhibit their ability to engage in the interventions delivered as part of the trial
2. Do not have the capacity to provide informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
WP4 is a pilot and feasibility trial of the treatment package developed by the research team, where the main hypothesised outcome is a reduction of anxiety in the autistic adults who participate. We do not have a primary outcome as this is a pilot/feasibility trial. However, based upon our current research, the outcome we anticipate being most useful and acceptable is the Target Behaviours scale (a description of the participant’s behaviour in relation to a specific real-life anxiety-related goal). This research will evaluate whether that is correct or whether a questionnaire might be more appropriate.<br>In addition, acceptability of trial procedures and treatment received will be measured using a bespoke semi-structured interview administered 3 months post-intervention.

Secondary Outcome Measures

Name	Time	Method
1. Adaptive functioning is measured by the Waisman Activities of Daily Living Scale – Adaptive (W-ADL) at baseline<br>2. Ability to recognise and describe emotions is measured by the Toronto Alexithymia Scale (TAS-20) at baseline.<br>3. Quality of life is measured by the World Health Organisation Qualify of Life – BREF (WHOQOL-BREF) scale plus the disabilities module and ASD addendum at baseline.<br>4. Health-related quality of life is measured by the EQ-5D at baseline.<br>5. Anxiety disorders and other related diagnoses are measured by the Anxiety and Other Related Disorders Interview Schedule (ADIS-5) at baseline.<br>6. Anxiety is measured by the Anxiety Scale – Autism (ASA) and the Hospital Anxiety and Depression Scale (HADS) at baseline, immediately post-intervention and three months post-intervention.