AutismNCT06682858
Developing a Novel Therapy for Aversive Sensory Experiences in Autism
A study testing Group Cognitive Behavioural Therapy in people with Autism and Autism in Children, run by King's College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 16 years
- Conditions the study is for
- Autism, Autism in Children
- What is being tested?
- Group Cognitive Behavioural Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Nov 2024to 11 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
- Does the intervention improve sensory difficulties and associated anxiety in autistic young people?
- 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.
Read the 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:
- 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.
- Conditions
- Autism, Autism in Children
- Being tested
- Group Cognitive Behavioural Therapy
- Keywords
- sensory processing, anxiety, cognitive behavioural therapy, perception, autism
- Medical subject headings
- Autistic Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Cognitive Behavioural TherapyBehavioural
Participants will complete 8 group sessions of a CBT-based intervention designed to help self-regulate sensory difficulties in autistic young people
| Study group | Role | What they receive |
|---|---|---|
| Group Cognitive Behavioural Therapy | Experimental | Not described Receives: Behavioral: Group Cognitive Behavioural Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability
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
Measured: Acceptability of the intervention will be assessed through study completion, an average of 1 year
Secondary outcomes (3)
Adolescent/Adult Sensory Profile (AASP)
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.
Measured: 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)
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).
Measured: Data collected on 2 visit days for each participant, before and after the intervention, about 12 weeks apart
Interoception Sensory Questionnaire (ISQ-8)
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.
Measured: Data collected on 2 visit days for each participant, before and after the intervention, about 12 weeks apart
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start29 Nov 2024
- Primary completion11 Dec 2025
- Study completion11 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06682858
- Sponsor's protocol ID
- 346716
- Status last verified
- Oct 2024
- First submitted
- 25 Oct 2024
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27639063
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Mechanistically Informed Therapy for Aversive Sensory Experiences With Autistic Youth
- ClinicalTrials.gov ID
- NCT06682858
- Acronym / sponsor ID
- 346716
- Conditions
- Autism, Autism in Children
- Keywords
- sensory processing, anxiety, cognitive behavioural therapy, perception, autism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Study start
- 29 Nov 2024 (actual)
- Primary completion
- 11 Dec 2025 (actual)
- Study completion
- 11 Dec 2025 (actual)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does the intervention improve sensory difficulties and associated anxiety in autistic young people?
- 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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group Cognitive Behavioural Therapy | Experimental | Behavioral: Group Cognitive Behavioural Therapy |
Who may qualify
- Ages
- 11 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group Cognitive Behavioural TherapyParticipants will complete 8 group sessions of a CBT-based intervention designed to help self-regulate sensory difficulties in autistic young people | Behavioural | Group Cognitive Behavioural Therapy |
Primary outcome
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
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Background: PubMed 27639063Edgington 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Cognitive Behavioural Therapy in people with Autism and Autism in Children, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability (time frame: Acceptability of the intervention will be assessed through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06682858, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.