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Cognitive Remediation for Autistic Adolescents

A Pilot Study of Cognitive Remediation Therapy for Autistic Adolescents

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06989151
Enrollment
20
Registered
2025-05-25
Start date
2024-05-08
Completion date
2025-05-01
Last updated
2025-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

Brief summary

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

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.

Interventions

BEHAVIORALCognitive Remediation Therapy

8 session psychological intervention.

Sponsors

South London and Maudsley NHS Foundation Trust
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to 16 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Acceptability 1 - Drop out rate8 weeksNumber of participants who drop-out from the study
Acceptability 2 - session attendance rate:8 weekstotal number of sessions attended out of a maximum of 8 per participant
Acceptability 3 - adherence to the therapy protocol8 weeksCompletion rates of between session work - recorded as percentage.
Acceptability 4 - Semi-structured qualitative interviews post intervention8 weeks

Secondary

MeasureTime frameDescription
Cognitive Flexibility Scale8 weeksQuestionnaire measure of flexibility
Work and Social Adjustment Scale8 weeks
DFLEX8 weeksDetail and Flexibility Questionnaire
Revised Child Anxiety and Depression Scale8 weeks
Mood and Feelings Questionnaire8 weeks

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026