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Trial registered on ANZCTR


Registration number
ACTRN12625000082404
Ethics application status
Approved
Date submitted
19/02/2025
Date registered
19/02/2025
Date last updated
19/02/2025
Date data sharing statement initially provided
19/02/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Testing IPD changes 18Feb2025
Scientific title
Testing IPD changes 18Feb2025
Secondary ID [1] 313816 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism 336448 0
Condition category
Condition code
Mental Health 332969 332969 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 5-week psychoeducational in-person group based on neurodiversity theory for autistic teenagers. The neurodiversity group will be run by clinicians across the four St Michael’s House Children's Disability Network Teams (Coastal, Ballymun, Coolock & Kilbarrack) including Speech & Language Therapists, Occupational Therapists and Psychologists. Each group session will be 1 hour 15 minutes in duration and will be held in the local Children's Disability Network Team clinic. The 5-week group will focus on the following topics:
1. Understanding neurodiversity
2. Autism – strengths and differences
3. Self-advocacy
4. Masking
5. Sensory experiences & regulation

Parents will be offered a parent information session prior to the 5-week group outlining the neurodiversity movement, changes in clinical practice and structure of the group.
Intervention code [1] 330401 0
Treatment: Other
Comparator / control treatment
A waitlist control group will be adopted. Participants in the waitlist control group will remain on the waitlist for the neurodviersity group and will be offered this when it is next run by the clinical team. Participants assigned to the waitlist control group will participate in their usual care with their Children's Disability Network Team (treatment as usual).
Control group
Active

Outcomes
Primary outcome [1] 340507 0
changes in self-esteem
Timepoint [1] 340507 0
Baseline (1 week before starting the intervention) and 6 weeks later on completion of the intervention. The waitlist control group will complete the questionnaires (primary outcome measures) on the same time scale as the intervention group.
Primary outcome [2] 340508 0
changes in identity
Timepoint [2] 340508 0
Baseline (1 week before starting the intervention) and 6 weeks later on completion of the intervention. The waitlist control group will complete the questionnaires (primary outcome measures) on the same time scale as the intervention group.
Secondary outcome [1] 444279 0
masking/camouflaging
Timepoint [1] 444279 0
Baseline (1 week before starting the intervention) and 6 weeks later following completion of the intervention. The same timeline will apply to the waitlist control group.
Secondary outcome [2] 444280 0
Anxiety
Timepoint [2] 444280 0
Baseline (1 week before starting the intervention) and 6 weeks later following completion of the intervention. The same timeline will apply to the waitlist control group.

Eligibility
Key inclusion criteria
Adolescents with a diagnosis of autism accepted to their local Children's Disability Network Team.
Minimum age
13 Years
Maximum age
19 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Adolescents with a comorbid diagnosis of a moderate to profound intellectual disability as the group material requires a level of cognitive functioning and language ability to engage with reflective psychoeducation material
Adolescents who do not have a confirmed diagnosis of autism.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation to group was completed by the Principal Investigator after the participant expressed interest in participating in the research study and were deemed eligible based on age and diagnosis.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random sequence generator (https://www.random.org/sequences/) was used to randomly assign participants to intervention versus control group.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
6/01/2025
Date of last participant enrolment
Anticipated
19/12/2025
Actual
Date of last data collection
Anticipated
30/01/2026
Actual
Sample size
Target
50
Accrual to date
7
Final
Recruitment outside Australia
Country [1] 26842 0
Ireland
State/province [1] 26842 0
Dublin

Funding & Sponsors
Funding source category [1] 318283 0
Self funded/Unfunded
Name [1] 318283 0
Country [1] 318283 0
Primary sponsor type
Individual
Name
Helen O'Reilly
Address
Country
Ireland
Secondary sponsor category [1] 320671 0
None
Name [1] 320671 0
Address [1] 320671 0
Country [1] 320671 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316926 0
St. Michael's House Research Ethics Committee
Ethics committee address [1] 316926 0
Ethics committee country [1] 316926 0
Ireland
Date submitted for ethics approval [1] 316926 0
18/11/2024
Approval date [1] 316926 0
10/12/2024
Ethics approval number [1] 316926 0

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

Contacts
Principal investigator
Name 139458 0
Dr Helen O'Reilly
Address 139458 0
Coastal Children's Disability Network Team, St. Michael's House, Baldoyle, Dublin 13, Ireland
Country 139458 0
Ireland
Phone 139458 0
+353 860837198
Fax 139458 0
Email 139458 0
[email protected]
Contact person for public queries
Name 139459 0
Helen O'Reilly
Address 139459 0
Coastal Children's Disability Network Team, St. Michael's House, Baldoyle, Dublin 13, Ireland
Country 139459 0
Ireland
Phone 139459 0
+353 860837198
Fax 139459 0
Email 139459 0
[email protected]
Contact person for scientific queries
Name 139460 0
Helen O'Reilly
Address 139460 0
Coastal Children's Disability Network Team, St. Michael's House, Baldoyle, Dublin 13, Ireland
Country 139460 0
Ireland
Phone 139460 0
+353 860837198
Fax 139460 0
Email 139460 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Who can request access to individual participant data?
Researchers
Are there any conditions for requesting access to individual participant data?
No requirements
What individual participant data might be shared?
De-identified individual participant data Published results Safety data
What types of analyses could be done with individual participant data?
Any type of analysis (i.e. no restrictions on data re-use)
Other
Any purpose for research in the area of autism and neurodiversity.

When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
A finite period of 4 years
Where can requests to access individual participant data be made, or data be obtained directly?
Email of trial custodian, sponsor or committee
Access subject to approvals by Principal Investigator, Dr. Helen O'Reilly ([email protected]) Would there be any additional conditions or processes regarding requests for and access to individual participant data? E.g. are there associated costs, requirements for accessing a specific platform, typical response times, link to institutional policies on data sharing (if available), etc.

Data repository
Would there be any additional conditions or processes regarding requests for and access to individual participant data? E.g. are there associated costs, requirements for accessing a specific platform, typical response times, link to institutional policies on data sharing (if available), etc.

Data sharing request system
Would there be any additional conditions or processes regarding requests for and access to individual participant data? E.g. are there associated costs, requirements for accessing a specific platform, typical response times, link to institutional policies on data sharing (if available), etc.

Journal publication or its supplementary materials
Would there be any additional conditions or processes regarding requests for and access to individual participant data? E.g. are there associated costs, requirements for accessing a specific platform, typical response times, link to institutional policies on data sharing (if available), etc.

Postal address
Would there be any additional conditions or processes regarding requests for and access to individual participant data? E.g. are there associated costs, requirements for accessing a specific platform, typical response times, link to institutional policies on data sharing (if available), etc.

Other
Would there be any additional conditions or processes regarding requests for and access to individual participant data? E.g. are there associated costs, requirements for accessing a specific platform, typical response times, link to institutional policies on data sharing (if available), etc.

Are there extra considerations when requesting access to individual participant data?
Yes
Would there be any additional conditions or processes regarding requests for and access to individual participant data? E.g. are there associated costs, requirements for accessing a specific platform, typical response times, link to institutional policies on data sharing (if available), etc.

Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




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.