Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000537459p
Ethics application status
Not yet submitted
Date submitted
5/05/2025
Date registered
27/05/2025
Date last updated
27/05/2025
Date data sharing statement initially provided
27/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
The Prevalence of Autism and ADHD in Adolescents with ME/CFS
Scientific title
The Prevalence of Autism and Attention-Deficit/Hyperactivity Disorder (ADHD) in Adolescents with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS): A Retrospective Chart Review
Secondary ID [1] 314356 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myalgic Encephalomyelitis/Chronic Fatigue Syndrome 337345 0
Autism 337346 0
Attention-Deficit/Hyperactivity Disorder 337347 0
Condition category
Condition code
Other 333730 333730 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)
Mental Health 333731 333731 0 0
Autistic spectrum disorders
Neurological 333885 333885 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Autism and Attention-Deficit/Hyperactivity Disorder (ADHD) are neurodevelopmental conditions that have been identified in up to 6% of children and adolescents worldwide. Autistic and ADHD individuals have been shown to be at higher risk of also meeting criteria for conditions such as the Ehlers-Danlos Syndromes, Postural Orthostatic Tachycardia Syndrome, Anxiety, and Depression. All of these conditions also commonly co-occur in individuals with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), however there have been no studies estimating the prevalence of autism and ADHD in the ME/CFS population.

The chart review will be undertaken across a 10 year period (January 2015-April 2025) to identify any listed diagnoses of autism and/or ADHD among ME/CFS patients aged 10-19 years seen through the Royal Children's Hospital Adolescent Medicine or General Medicine ME/CFS outpatient clinics, OR, the Monash Children's Hospital Victorian Paediatric Rehabilitation Service ME/CFS outpatient clinic.

There is no further involvement from participants, as this study consists of a chart review of past appointments only.

Patient charts will be reviewed from the time of their first appointment up until a diagnosis of autism and/or ADHD has been identified in their charts, OR, until the end of the designated time period (April 2025) to confirm that they have not received any diagnoses of autism or ADHD.
Intervention code [1] 330972 0
Early Detection / Screening
Comparator / control treatment
The prevalence estimates for autism and ADHD generated as part of this study will be compared to published population prevalence estimates for autism and ADHD in similar age groups.

The diagnostic and demographic profiles of autistic/ADHD adolescents with ME/CFS will be compared to those of non-autistic/ADHD adolescents with ME/CFS to see if there are any significant differences between the two groups.
Control group
Active

Outcomes
Primary outcome [1] 341324 0
Autism diagnostic status
Timepoint [1] 341324 0
All relevant records within the given time period will be reviewed to identify these outcomes, as it is recognised that patients' needs and presentations change over time.
Primary outcome [2] 341523 0
ADHD diagnostic status
Timepoint [2] 341523 0
All relevant records within the given time period will be reviewed to identify these outcomes, as it is recognised that patients' needs and presentations change over time.
Secondary outcome [1] 447115 0
Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Presentation
Timepoint [1] 447115 0
At the time of ME/CFS diagnosis OR at first presentation to the relevant ME/CFS outpatient clinics, whichever comes second
Secondary outcome [2] 447832 0
Patient's broader health status
Timepoint [2] 447832 0
All relevant records within the given time period will be reviewed to identify these outcomes, as it is recognised that patients' needs change over time and we want to capture as much information as possible.

Eligibility
Key inclusion criteria
- At least one attendance at the Royal Children's Hospital Adolescent Medicine or General Medicine ME/CFS outpatient clinic, OR, Monash Children's Hospital Victorian Paediatric Rehabilitation Service ME/CFS outpatient clinic, between January 2015 and April 2025
- An explicitly stated, confirmed diagnosis of ME/CFS as identified in the patient's medical records.
Minimum age
10 Years
Maximum age
19 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patient aged under 10 years at initial attendance.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Retrospective
Statistical methods / analysis
Estimated sample size based on discussions with treating clinicians: N = 350
This should be sufficient to identify at least n = 13 children who have been diagnosed with autism and/or ADHD.

1. Estimating prevalence of autism and ADHD: Generalised linear mixed models with logistic and/or multinominal regression, using autism and ADHD diagnostic status data
2. Characterising the diagnostic/medical profiles of autistic/ADHD and non-autistic/ADHD adolescents: point/count estimates for categorical variables and means/SDs/ranges for continuous variables, using data from ME/CFS presentation and autism/ADHD/medical history variables
3. Characterising demographic profiles of autistic/ADHD and non-autistic/ADHD adolescents: point/count estimates for categorical variables and means/SDs/ranges for continuous variables, using data from the demographic data variables
4. Comparing demographic and diagnostic profiles between autistic/ADHD and non-autistic/ADHD adolescents: chi-square for categorical variables, logistic regression for binary variables, ANOVA/Mann-Whitney/Kruskal-Wallis or GLMM with logistic/multinominal regression for continuous variables.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2025
Actual
Date of last participant enrolment
Anticipated
30/04/2026
Actual
Date of last data collection
Anticipated
30/04/2026
Actual
Sample size
Target
350
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 318876 0
University
Name [1] 318876 0
Monash University
Country [1] 318876 0
Australia
Primary sponsor type
Individual
Name
Dr Tracey Chau - Monash University
Address
Country
Australia
Secondary sponsor category [1] 321339 0
None
Name [1] 321339 0
Address [1] 321339 0
Country [1] 321339 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 317490 0
The Royal Children’s Hospital Human Research Ethics Committee
Ethics committee address [1] 317490 0
Ethics committee country [1] 317490 0
Australia
Date submitted for ethics approval [1] 317490 0
03/06/2025
Approval date [1] 317490 0
Ethics approval number [1] 317490 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 141218 0
Dr Tracey Chau
Address 141218 0
Monash University Department of Paediatrics, Monash Children's Hospital, 246 Clayton Road, Clayton VIC 3168
Country 141218 0
Australia
Phone 141218 0
+61 3 9902 9829
Fax 141218 0
Email 141218 0
[email protected]
Contact person for public queries
Name 141219 0
Tracey Chau
Address 141219 0
Monash University Department of Paediatrics, Monash Children's Hospital, 246 Clayton Road, Clayton VIC 3168
Country 141219 0
Australia
Phone 141219 0
+61 3 9902 9829
Fax 141219 0
Email 141219 0
[email protected]
Contact person for scientific queries
Name 141220 0
Tracey Chau
Address 141220 0
Monash University Department of Paediatrics, Monash Children's Hospital, 246 Clayton Road, Clayton VIC 3168
Country 141220 0
Australia
Phone 141220 0
+61 3 9902 9829
Fax 141220 0
Email 141220 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.