Clinical trial NCT06989151: Cognitive Remediation for Autistic Adolescents
Official title: A Pilot Study of Cognitive Remediation Therapy for Autistic Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Autism Spectrum Disorder
Lead sponsor: South London and Maudsley NHS Foundation Trust
Sponsor class: OTHER
First posted: 2025-05-25
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acceptability 1 - Drop out rate
timeFrame: 8 weeks
measure: Acceptability 2 - session attendance rate:
timeFrame: 8 weeks
measure: Acceptability 3 - adherence to the therapy protocol
timeFrame: 8 weeks
measure: Acceptability 4 - Semi-structured qualitative interviews post intervention
timeFrame: 8 weeks
Secondary outcomes:
measure: Cognitive Flexibility Scale
timeFrame: 8 weeks
measure: DFLEX
timeFrame: 8 weeks
measure: Revised Child Anxiety and Depression Scale
timeFrame: 8 weeks
measure: Mood and Feelings Questionnaire
timeFrame: 8 weeks
measure: Work and Social Adjustment Scale
timeFrame: 8 weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College London
Study officials:
References: