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NCT Number: NCT06682858

Developing a Novel Therapy for Aversive Sensory Experiences in Autism

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.

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Key information

Conditions

Autism Anxiety Disorders Autism Spectrum Disorder Autism in Children Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

11 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King's College London

London, United Kingdom

About this study

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:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group Cognitive Behavioural Therapy

Behavioral

Participants will complete 8 group sessions of a CBT-based intervention designed to help self-regulate sensory difficulties in autistic young people

Primary outcomes

  1. Acceptability

    Time frame: Acceptability of the intervention will be assessed through study completion, an average of 1 year

    As this is a feasibility study, the primary outcome of interest is the acceptability of the intervention which will be assessed via drop-out rate and qualitative feedback

Secondary outcomes

  1. Adolescent/Adult Sensory Profile (AASP)

    Time frame: Data collected on 2 visit days for each participant, before and after the intervention, about 12 weeks apart

    The Adolescent/Adult Sensory Profile (AASP) is a 60-item self-report questionnaire on sensory preferences and responses to sensory experiences. The AASP yields 4 subscale scores for sensory avoiding, sensitivity, seeking, and low registration. Raw total scores can range 60-300, with higher scores indicating greater sensory difficulties.

  2. Revised Child Anxiety and Depression Scale (RCADS)

    Time frame: Data collected on 2 visit days for each participant, before and after the intervention, about 12 weeks apart

    The Revised Child Anxiety and Depression Scale (RCADS) is a 47-item youth self-report measure for anxiety and depression. Raw total scores can range 0-141, with higher scores indicating greater anxiety and/or depression. The RCADS can also yield subscales for separation anxiety disorder, social phobia, generalized anxiety disorder, panic disorder, obsessive compulsive disorder, and low mood (major depressive disorder).

  3. Interoception Sensory Questionnaire (ISQ-8)

    Time frame: Data collected on 2 visit days for each participant, before and after the intervention, about 12 weeks apart

    The Interoception Sensory Questionnaire short-form (ISQ-8) is an 8-item self-report questionnaire that measures interoceptive challenges (confusion about bodily states) in autistic individuals. Raw total scores can range 8-40 (T-score range 33-78), with higher scores indicating a greater difficulty with registering or interpreting interoceptive sensations.

Sponsors and collaborators

Lead sponsor

King's College London

Other

Collaborators

  • South London and Maudsley NHS Foundation Trust

Registry information

Official study title

Developing a Mechanistically Informed Therapy for Aversive Sensory Experiences With Autistic Youth

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 12, 2024
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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