Clinical trial NCT06682858: Developing a Novel Therapy for Aversive Sensory Experiences in Autism
Official title: Developing a Mechanistically Informed Therapy for Aversive Sensory Experiences with Autistic Youth
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism
Autism in Children
Keywords: sensory processing
anxiety
cognitive behavioural therapy
perception
autism
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: South London and Maudsley NHS Foundation Trust
First posted: 2024-11-12
Enrollment: 34
Sex: ALL
Minimum age (years): 11
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this study is to assess whether a new psychological treatment can lead to changes in sensory experiences in autistic young people. Participants will complete a group intervention designed to help manage sensory difficulties and associated anxiety. Participants will also complete tasks before and after the intervention to assess whether the treatment can lead to changes in brain and behavioural responses to sensory experiences.

The main questions the study aims to answer are:

1. Does the intervention improve sensory difficulties and associated anxiety in autistic young people?
2. Does the intervention change brain and biological responses to sensory experiences in autistic young people?

Researchers will also collect feedback from participants to help improve the design and delivery of the treatment in future studies.

Detailed description: The purpose of this study is to pilot a group-based cognitive behavioural therapy (CBT) intervention focused on managing sensory differences associated with autism. Another aim of this study is to test whether the intervention can modulate perceptual and neurophysiological markers (e.g. via electrocephalogram \[EEG\], heart rate and skin conductance) of sensory processing in autistic children and adolescents. A final aim will be to collect qualitative feedback from autistic young people with the aim of refining and improving the intervention for larger studies in the future.

The main aims of the study are:

1. To assess the feasibility of a novel CBT intervention for the management of sensory difficulties and associated anxiety in autistic youth.
2. To gather proof-of-concept data that the intervention can be used to modulate sensory neurophysiological and perceptual markers.
3. To gather qualitative feedback and PPIE to inform refinements on the design and delivery of the intervention for further studies.

Eligibility criteria: Inclusion Criteria:

* Confirmed clinical diagnosis of autism
* Verbal/intellectual ability in average range
* Sufficient spoken English to be able to access the intervention
* Under the care of a local mental health service
* Not currently taking part in another psychological intervention

Exclusion Criteria:

* Verbal/intellectual ability below the average range
* Insufficient spoken English to be able to access the intervention
* Currently receiving a psychological intervention
* Individuals at high risk of harm to themselves or others

Primary outcomes:
measure: Acceptability
timeFrame: Acceptability of the intervention will be assessed through study completion, an average of 1 year
Secondary outcomes:
measure: Adolescent/Adult Sensory Profile (AASP)
timeFrame: Data collected on 2 visit days for each participant, before and after the intervention, about 12 weeks apart
measure: Revised Child Anxiety and Depression Scale (RCADS)
timeFrame: Data collected on 2 visit days for each participant, before and after the intervention, about 12 weeks apart
measure: Interoception Sensory Questionnaire (ISQ-8)
timeFrame: Data collected on 2 visit days for each participant, before and after the intervention, about 12 weeks apart
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College London
Study officials:
References:
citation: Edgington L, Hill V, Pellicano E. The design and implementation of a CBT-based intervention for sensory processing difficulties in adolescents on the autism spectrum. Res Dev Disabil. 2016 Dec;59:221-233. doi: 10.1016/j.ridd.2016.09.004. Epub 2016 Sep 14.