Cognitive Remediation for Autistic Adolescents

NCT ID: NCT06989151

Last Updated: 2025-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-08

Study Completion Date

2025-05-01

Brief Summary

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Autistic youth have extremely high levels of co-occurring mental health difficulties, including rates of depression and anxiety which are between two and four times more common compered to non-autistic people. Cognitive inflexibility is a characteristic which is strongly associated with higher levels of anxiety and depression in autism. Currently, there are no existing treatments which can promote flexible thinking. Cognitive Remediation Therapy is a promising intervention which has been used with different patient groups to improve flexibility. This study aims to develop and adapt the current CRT treatment for use with autistic youth and then conduct a pilot study with 20 participants.

Detailed Description

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The existing evidence that CRT is effective for those with autistic features leads us to hypothesize that with minor adaptations the intervention will be acceptable to those with autism. Given the strong association between CI and anxiety (and other internalizing difficulties such as depression; ref) by targeting this specific trait it is hypothesized that an adapted CRT will a) increase flexible thinking and b) reduce symptoms of anxiety and depression.

Key objectives:

1. To use the existing literature of adapted interventions for autism and input from autistic youth and their parents to adapt CRT for use with autistic youth.
2. To establish the acceptability of adapted CRT by conducting a proof-of-principle pilot study.
3. To gather preliminary outcome data on CI, anxiety and depression, and other key measures such as levels of functional outcomes to inform the design of an acceptability and feasibility RCT for future funding applications.

Methods:

Participants will all complete 8 adapted CRT intervention sessions held twice weekly. Outcome measures will be collected pre- and post intervention. Measures of acceptability of the intervention (e.g., retention rate) will be recorded and qualitative interviews will gather feedback on the intervention.

Conditions

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Autism Spectrum Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

Single arm for pilot study

Group Type EXPERIMENTAL

Cognitive Remediation Therapy

Intervention Type BEHAVIORAL

8 session psychological intervention.

Interventions

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Cognitive Remediation Therapy

8 session psychological intervention.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 12-16 years of age with a confirmed clinical diagnosis of autism (based on verified diagnostic report).
* Verbal/intellectual ability in average range
* Sufficient spoken English to access the intervention.
* Young person must be under the care of a local mental health service who can respond to any changes in routine clinical care / risk issues that arise.

Exclusion Criteria

* Not currently receiving alternative psychological intervention
* Not actively self-harming or deemed at risk to themselves or others
Minimum Eligible Age

12 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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South London and Maudsley NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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King's College London

London, London, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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338473

Identifier Type: -

Identifier Source: org_study_id

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