Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 10:13 PM
Study NCT ID:
NCT06682858
Status:
RECRUITING
Last Update Posted:
2025-01-22
First Post:
2024-10-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Developing a Novel Therapy for Aversive Sensory Experiences in Autism
Sponsor:
King's College London
Organization:
Study Overview
Official Title:
Developing a Mechanistically Informed Therapy for Aversive Sensory Experiences with Autistic Youth
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: