NCT06989151

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started May 2024

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 8, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 25, 2025

Completed
Last Updated

May 25, 2025

Status Verified

May 1, 2025

Enrollment Period

12 months

First QC Date

May 7, 2025

Last Update Submit

May 21, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Acceptability 1 - Drop out rate

    Number of participants who drop-out from the study

    8 weeks

  • Acceptability 2 - session attendance rate:

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

    8 weeks

  • Acceptability 3 - adherence to the therapy protocol

    Completion rates of between session work - recorded as percentage.

    8 weeks

  • Acceptability 4 - Semi-structured qualitative interviews post intervention

    8 weeks

Secondary Outcomes (5)

  • Cognitive Flexibility Scale

    8 weeks

  • DFLEX

    8 weeks

  • Revised Child Anxiety and Depression Scale

    8 weeks

  • Mood and Feelings Questionnaire

    8 weeks

  • Work and Social Adjustment Scale

    8 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

Single arm for pilot study

Behavioral: Cognitive Remediation Therapy

Interventions

8 session psychological intervention.

Intervention

Eligibility Criteria

Age12 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Not currently receiving alternative psychological intervention
  • Not actively self-harming or deemed at risk to themselves or others

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King's College London

London, London, SE5, United Kingdom

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2025

First Posted

May 25, 2025

Study Start

May 8, 2024

Primary Completion

May 1, 2025

Study Completion

May 1, 2025

Last Updated

May 25, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations