Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000677404
Ethics application status
Approved
Date submitted
25/01/2025
Date registered
26/06/2025
Date last updated
26/06/2025
Date data sharing statement initially provided
26/06/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Neurodiversity training for autistic teenagers which aims to to promote identity, self-esteem & mental health
Scientific title
The effectiveness of an interdisciplinary neurodiversity group to promote identity, self-esteem & mental health in autistic adolescents
Secondary ID [1] 313811 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism 336450 0
Condition category
Condition code
Mental Health 332970 332970 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
Each topic will be presented through a powerpoint presentation with both text and visual images . Relevant videos from autistic content creators or advocates will also be used to support understanding and prompt discussion on the different topics. Questions will be posed by the facilitators on the content presented to support self-reflection in the attendees.

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.

Group attendance will be monitored to assess adherence.
Intervention code [1] 330402 0
Behaviour
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). Treatment as usual can include uni- or inter-disciplinary input in relation to intervention goals set by the family but unrelated to their goal in relation to neurodiversity. Any clinical input from the team during this period will be documented by the study.
Control group
Active

Outcomes
Primary outcome [1] 340508 0
Change in autistic identity score pre and post intervention
Timepoint [1] 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 questionnaire on the same time scale as the intervention group.
Primary outcome [2] 340882 0
Change in self-esteem score pre and post intervention
Timepoint [2] 340882 0
Baseline (pre-intervention) and approximately 6 weeks later (post-intervention). The same timeline will be applied to the waitlist control group.
Primary outcome [3] 341824 0
Change in mood score pre and post intervention
Timepoint [3] 341824 0
Baseline (pre-intervention) and approximately 6 weeks later (post-intervention). The same timeline will be applied to the waitlist control group.
Secondary outcome [1] 444302 0
Change in anxiety symptoms pre and post intervention
Timepoint [1] 444302 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] 448782 0
Change in masking score pre and post intervention
Timepoint [2] 448782 0
Baseline (pre-intervention) and approximately 6 weeks later (post-intervention). The same timeline will be applied to the waitlist control group.
Secondary outcome [3] 448783 0
Change in social identity score pre and post intervention
Timepoint [3] 448783 0
Baseline (pre-intervention) and approximately 6 weeks later (post-intervention). The same timeline will be applied 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
12 Years
Maximum age
18 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. Allocation was not concealed.
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
15
Final
Recruitment outside Australia
Country [1] 26843 0
Ireland
State/province [1] 26843 0
Dublin

Funding & Sponsors
Funding source category [1] 318278 0
Other
Name [1] 318278 0
St. Michael's House Child & Young Person Disability Services
Country [1] 318278 0
Ireland
Primary sponsor type
Individual
Name
Helen O'Reilly - St. Michael's House
Address
Country
Ireland
Secondary sponsor category [1] 320664 0
None
Name [1] 320664 0
Address [1] 320664 0
Country [1] 320664 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316920 0
St. Michael's House Research Ethics Committee
Ethics committee address [1] 316920 0
Ethics committee country [1] 316920 0
Ireland
Date submitted for ethics approval [1] 316920 0
18/11/2024
Approval date [1] 316920 0
10/12/2024
Ethics approval number [1] 316920 0

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

Contacts
Principal investigator
Name 139430 0
Dr Helen O'Reilly
Address 139430 0
Coastal Children's Disability Network Team, St. Michael's House, Baldoyle, Dublin 13, Ireland
Country 139430 0
Ireland
Phone 139430 0
+353 860837198
Fax 139430 0
Email 139430 0
[email protected]
Contact person for public queries
Name 139431 0
Helen O'Reilly
Address 139431 0
Coastal Children's Disability Network Team, St. Michael's House, Baldoyle, Dublin 13, Ireland
Country 139431 0
Ireland
Phone 139431 0
+353 860837198
Fax 139431 0
Email 139431 0
[email protected]
Contact person for scientific queries
Name 139432 0
Helen O'Reilly
Address 139432 0
Coastal Children's Disability Network Team, St. Michael's House, Baldoyle, Dublin 13, Ireland
Country 139432 0
Ireland
Phone 139432 0
+353 860837198
Fax 139432 0
Email 139432 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?
Persons/groups eligible to request access:
• Other academic research institutions for research in the area of autism and neurodiversity. Any information shared will be fully anonymised to protect participant identity. All information will only be shared subject to ethical approval and will comply with GDPR.

Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Studies testing whether findings can be repeated or confirmed
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: Principal Investigator, Helen O'Reilly, [email protected]

• Access subject to approval by Principal Investigator, Dr. Helen O'Reilly ([email protected])

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    HO'R REC letter of approval.pdf
Informed consent form    Appendix 5_Teen Informed Consent Form.docx
Informed consent form    Appendix 4_Parent Informed Consent Form.docx
Study protocol    Research protocol.docx


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.