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Personalised anxiety treatment for autism - the PAT-A trial

Exploring the effectiveness of personalised non-pharmacological anxiety treatment for autistic adults and older people

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN15881562
Enrollment
40
Registered
2019-08-09
Start date
2018-10-01
Completion date
Unknown
Last updated
2023-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Mental and Behavioural Disorders Autism

Interventions

Anxiety is common in people on the autism spectrum, and leads to everyday difficulties affecting quality of life. This study will investigate the feasibility of providing a personalised anxiety treatm
CCS). We will measure whether the treatment is acceptable to autistic adults (and where relevant, their relatives). We will investigate effectiveness by comparing the impact of anxiety on the individu

Sponsors

Northumberland, Tyne And Wear NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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. In addition, acceptability of trial procedures and treatment received will be measured using a bespoke semi-structured interview administered 3 months post-intervention.

Secondary

MeasureTime frame
1. Adaptive functioning is measured by the Waisman Activities of Daily Living Scale – Adaptive (W-ADL) at baseline 2. Ability to recognise and describe emotions is measured by the Toronto Alexithymia Scale (TAS-20) at baseline. 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. 4. Health-related quality of life is measured by the EQ-5D at baseline. 5. Anxiety disorders and other related diagnoses are measured by the Anxiety and Other Related Disorders Interview Schedule (ADIS-5) at baseline. 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.

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026