Developing a Novel Therapy for Aversive Sensory Experiences in Autism

NCT06682858 | Completed

• 1 other identifier: 346716
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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. 1.Does the intervention improve sensory difficulties and associated anxiety in autistic young people?
2. 2.Does the intervention change brain and biological responses to sensory experiences in autistic young people?

Conditions

Autism; Autism in Children

Keywords

sensory processing; anxiety; cognitive behavioural therapy; perception; autism

Outcome Measures

Primary Outcomes (1)

• 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

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

Secondary Outcomes (3)

• 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 Arms (1)

Group Cognitive Behavioural Therapy

EXPERIMENTAL

Behavioral: Group Cognitive Behavioural Therapy

Interventions

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

Group Cognitive Behavioural Therapy

Eligibility Criteria

• Age: 11 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College London: lead
• South London and Maudsley NHS Foundation Trust: collaborator

Study Sites (1)

King's College London

London, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 27639063 BACKGROUND

MeSH Terms

Conditions

Autistic Disorder; Anxiety Disorders

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: November 12, 2024
• Study Start: November 29, 2024
• Primary Completion: December 11, 2025
• Study Completion: December 11, 2025
• Last Updated: April 15, 2026

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)