Skip to main content
OpenTrials
Completed

NCT Number: NCT06989151

Cognitive Remediation for Autistic Adolescents

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

12 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

King's College London

London, SE5, United Kingdom

About this study

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:

  • 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.
  • To establish the acceptability of adapted CRT by conducting a proof-of-principle pilot study.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Remediation Therapy

Behavioral

8 session psychological intervention.

Primary outcomes

  1. Acceptability 1 - Drop out rate

    Time frame: 8 weeks

    Number of participants who drop-out from the study

  2. Acceptability 2 - session attendance rate:

    Time frame: 8 weeks

    total number of sessions attended out of a maximum of 8 per participant

  3. Acceptability 3 - adherence to the therapy protocol

    Time frame: 8 weeks

    Completion rates of between session work - recorded as percentage.

  4. Acceptability 4 - Semi-structured qualitative interviews post intervention

    Time frame: 8 weeks

Secondary outcomes

  1. Cognitive Flexibility Scale

    Time frame: 8 weeks

    Questionnaire measure of flexibility

  2. DFLEX

    Time frame: 8 weeks

    Detail and Flexibility Questionnaire

  3. Revised Child Anxiety and Depression Scale

    Time frame: 8 weeks

  4. Mood and Feelings Questionnaire

    Time frame: 8 weeks

  5. Work and Social Adjustment Scale

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

South London and Maudsley NHS Foundation Trust

Other

Registry information

Official study title

A Pilot Study of Cognitive Remediation Therapy for Autistic Adolescents

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 25, 2025
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.