Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT06989151
Status:
COMPLETED
Last Update Posted:
2025-05-25
First Post:
2025-05-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cognitive Remediation for Autistic Adolescents
Sponsor:
South London and Maudsley NHS Foundation Trust
Organization:
Study Overview
Official Title:
A Pilot Study of Cognitive Remediation Therapy for Autistic Adolescents
Status:
COMPLETED
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: