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Clinical Trials/NCT06682858
NCT06682858
Completed
N/A

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

King's College London1 site in 1 country25 target enrollmentNovember 29, 2024

Overview

Phase
N/A
Intervention
Group Cognitive Behavioural Therapy
Conditions
Not specified
Sponsor
King's College London
Enrollment
25
Locations
1
Primary Endpoint
Acceptability
Status
Completed
Last Updated
17 days ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 29, 2024
End Date
December 11, 2025
Last Updated
17 days ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Arms & Interventions

Group Cognitive Behavioural Therapy

Intervention: Group Cognitive Behavioural Therapy

Outcomes

Primary Outcomes

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

  • Adolescent/Adult Sensory Profile (AASP)(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)(Data collected on 2 visit days for each participant, before and after the intervention, about 12 weeks apart)
  • Interoception Sensory Questionnaire (ISQ-8)(Data collected on 2 visit days for each participant, before and after the intervention, about 12 weeks apart)

Study Sites (1)

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