Autism Spectrum DisorderEarly Phase 1NCT06989151
Cognitive Remediation for Autistic Adolescents
A Early Phase 1 study testing Cognitive Remediation Therapy in people with Autism Spectrum Disorder, run by South London and Maudsley NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 16 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Cognitive Remediation Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 May 2024to 1 May 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Not currently receiving alternative psychological intervention
- Not actively self-harming or deemed at risk to themselves or others
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of Cognitive Remediation Therapy 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.
Read the 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:
- 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Cognitive Remediation Therapy
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Remediation TherapyBehavioural
8 session psychological intervention.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Single arm for pilot study Receives: Behavioral: Cognitive Remediation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability 1 - Drop out rate
Number of participants who drop-out from the study
Measured: 8 weeks
Acceptability 2 - session attendance rate:
total number of sessions attended out of a maximum of 8 per participant
Measured: 8 weeks
Acceptability 3 - adherence to the therapy protocol
Completion rates of between session work - recorded as percentage.
Measured: 8 weeks
Acceptability 4 - Semi-structured qualitative interviews post intervention
Measured: 8 weeks
Secondary outcomes (5)
Cognitive Flexibility Scale
Questionnaire measure of flexibility
Measured: 8 weeks
DFLEX
Detail and Flexibility Questionnaire
Measured: 8 weeks
Revised Child Anxiety and Depression Scale
Measured: 8 weeks
Mood and Feelings Questionnaire
Measured: 8 weeks
Work and Social Adjustment Scale
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start8 May 2024
- Primary completion1 May 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- South London and Maudsley NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06989151
- Sponsor's protocol ID
- 338473
- Status last verified
- May 2025
- First submitted
- 7 May 2025
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Cognitive Remediation Therapy for Autistic Adolescents
- ClinicalTrials.gov ID
- NCT06989151
- Acronym / sponsor ID
- 338473
- Conditions
- Autism Spectrum Disorder
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- South London and Maudsley NHS Foundation TrustUniversity, hospital or other
- Study start
- 8 May 2024 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Cognitive Remediation TherapySingle arm for pilot study |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Not currently receiving alternative psychological intervention
- Not actively self-harming or deemed at risk to themselves or others
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Remediation Therapy8 session psychological intervention. | Behavioural | Intervention |
Primary outcome
Acceptability 1 - Drop out rate
Time frame: 8 weeks
Number of participants who drop-out from the study
Acceptability 2 - session attendance rate:
Time frame: 8 weeks
total number of sessions attended out of a maximum of 8 per participant
Acceptability 3 - adherence to the therapy protocol
Time frame: 8 weeks
Completion rates of between session work - recorded as percentage.
Acceptability 4 - Semi-structured qualitative interviews post intervention
Time frame: 8 weeks
5 secondary outcomes
Cognitive Flexibility Scale
Time frame: 8 weeks
DFLEX
Time frame: 8 weeks
Revised Child Anxiety and Depression Scale
Time frame: 8 weeks
Mood and Feelings Questionnaire
Time frame: 8 weeks
Work and Social Adjustment Scale
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Cognitive Remediation Therapy in people with Autism Spectrum Disorder, run by South London and Maudsley NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability 1 - Drop out rate (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.