Developing a Novel Therapy for Aversive Sensory Experiences in Autism

April 14, 2026 updated by: King's College London

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group Cognitive Behavioural Therapy
Behavioral: Group Cognitive Behavioural Therapy
Participants will complete 8 group sessions of a CBT-based intervention designed to help self-regulate sensory difficulties in autistic young people

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Acceptability of the intervention will be assessed through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Data collected on 2 visit days for each participant, before and after the intervention, about 12 weeks apart
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).
Data collected on 2 visit days for each participant, before and after the intervention, about 12 weeks apart
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.
Data collected on 2 visit days for each participant, before and after the intervention, about 12 weeks apart

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College London

Collaborators

South London and Maudsley NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2024

Primary Completion (Actual)

December 11, 2025

Study Completion (Actual)

December 11, 2025

Study Registration Dates

First Submitted

October 25, 2024

First Submitted That Met QC Criteria

November 8, 2024

First Posted (Actual)

November 12, 2024

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 346716

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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