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Trial registered on ANZCTR


Registration number
ACTRN12623000927628p
Ethics application status
Submitted, not yet approved
Date submitted
14/08/2023
Date registered
29/08/2023
Date last updated
29/08/2023
Date data sharing statement initially provided
29/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot of an Aotearoa-specific early autism support programme.
Scientific title
Feasibility, appropriateness, and acceptability of an Aotearoa-specific early autism support programme for autistic children and their whanau/families.
Secondary ID [1] 310382 0
Nil
Universal Trial Number (UTN)
U1111-1296-6306
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autistic children and those showing signs of autism. 331125 0
Condition category
Condition code
Mental Health 327908 327908 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will involve an Aotearoa-specific programme of support developed alongside Maori and autistic people.

The programme will involve one session that is up to one hour long per week for 8 weeks. Sessions will alternate between discussion sessions, and practical sessions. Sessions will be delivered by trained coaches with experience in supporting autistic and/or young children and their whanau/families. Each family will be given a booklet outlining the key strategies.

Discussion sessions will involve whanau/family members talking with a coach without the child around. They will talk about strategies, reflect on videos of a family/whanau member and/or the coach supporting the child, plan access to other relevant supports, and set achievable fortnightly goals. Whanau/families can choose whether to have the sessions in their home, in the Autism Clinic (20 Sydney Street, Petone), or online using a platform such as Zoom.

Practical sessions will involve whanau/family members, and the coach playing and interacting with the child. This will include everyone practicing strategies that they have learned during the discussion sessions. Some of these interactions might be videoed to support reflection during the discussion sessions. Practical sessions will take place on opposite weeks to the discussion sessions in the home.

Adherence to the programme will be monitored by taking weekly attendance data and family/whanau will take a weekly log of the amount of time they had spent using strategies.

Training for the coaches
The researchers who developed the programme will train the coaches together in a group during two three-hour-long in-person workshops. This training will take place at least one week prior to the start of the programme. These workshops will include written training materials, PowerPoint presentations, role plays, reflection, and discussion.
Intervention code [1] 326784 0
Treatment: Other
Comparator / control treatment
No comparison group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335758 0
Acceptability of the intervention assessed using the AIM survey (Weiner et al., 2017).
Timepoint [1] 335758 0
Immediately following completion of the programme (week 9).
Primary outcome [2] 335759 0
Neurodiversity affirming outcomes survey, designed specifically for this study.
Timepoint [2] 335759 0
Immediately prior to (week 0) and following (week 9) completion of the programme.
Primary outcome [3] 335760 0
Semi-structured interview about: (a) experiences of the programme, (b) facilitators and challenges, and (c) programme improvements. Families/whanau will choose whether to complete the survey face-to-face or remotely, e.g., via video or teleconference.
Timepoint [3] 335760 0
Immediately following completion of the programme (week 9).
Secondary outcome [1] 425489 0
Family/whanau attendance at sessions using a session attendance checklist.
Timepoint [1] 425489 0
Collected each week of accessing the support
Secondary outcome [2] 425490 0
Family/whanau use of strategies using a weekly form completed by the coach.
Timepoint [2] 425490 0
Collected each week of accessing the support
Secondary outcome [3] 425817 0
This outcome is also primary: Appropriateness of the intervention assessed using the IAM survey (Weiner et al., 2017).
Timepoint [3] 425817 0
Immediately following completion of the programme (week 9).
Secondary outcome [4] 425818 0
This outcome is also primary: Feasibility of the intervention assessed using the FIM survey (Weiner et al., 2017).
Timepoint [4] 425818 0
Immediately following completion of the programme (week 9).

Eligibility
Key inclusion criteria
Whanau/family will be eligible to participate in the pilot study of the early autism support programme if:

1. The child is aged between 1 and 5 years 11 months at the start of the programme (week 1 of receiving the support),
2. The child is showing signs of autism/social communication differences on the Social Attention and Communication Surveillance Tool - Revised (SACS-R; Barbaro et al., 2022) or has a clinical diagnosis of Autism Spectrum Disorder,
3. The child does not have a genetic condition which is associated with “autism-like” characteristics (e.g., Rett Syndrome, Fragile X, 22q deletion),
4. Each participating whanau/family member can commit to one, 45-minute to 1-hour long, session per week for 9 weeks, including alternating fortnightly home-based sessions with the child present, and fortnightly sessions without the child present either at home, in a clinic, or via Zoom.
5. The primary whanau/family member speaks sufficient English to understand the requirements of the study and to participate in the coaching sessions.
6. The primary whanau/family member intends to remain in Wellington for the duration of the pilot study (11-weeks)
Minimum age
12 Months
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No additional exclusion criteria aside from not meeting the above inclusion criteria.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive analysis of all variables except the interview responses, which will be coded using conventional content analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/09/2023
Actual
Date of last participant enrolment
Anticipated
30/10/2023
Actual
Date of last data collection
Anticipated
31/01/2024
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 25718 0
New Zealand
State/province [1] 25718 0
Wellington

Funding & Sponsors
Funding source category [1] 314582 0
Charities/Societies/Foundations
Name [1] 314582 0
Royal Society Rutherford Discovery Fellowship
Country [1] 314582 0
New Zealand
Primary sponsor type
University
Name
Te Herenga Waka - Victoria University of Wellington
Address
Victoria University of Wellington
PO Box 600
Wellington 6140
New Zealand
Country
New Zealand
Secondary sponsor category [1] 316547 0
None
Name [1] 316547 0
None
Address [1] 316547 0
N/A
Country [1] 316547 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 313617 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 313617 0
Ministry of Health Health and Disability Ethics Committees
PO Box 5013.
Wellington
6140
Ethics committee country [1] 313617 0
New Zealand
Date submitted for ethics approval [1] 313617 0
03/08/2023
Approval date [1] 313617 0
Ethics approval number [1] 313617 0

Summary
Brief summary
This programme of research involves the evaluation of a new programme of support designed specifically for young children who are autistic or showing signs of autism/social communication differences, their whanau/families, and their broader support people in Aotearoa New Zealand. This programme has been developed alongside an autistic advisory ropu (group), a Maori advisory ropu, and a professional advisory ropu. It will be a pilot of the programme involving up to ten whanau/families. The purpose of the pilot is to understand the feasibility, appropriateness, and acceptability of the programme and to identify any barriers, facilitators, and necessary improvements. Participants will complete two surveys and an interview about their perceptions of the programme and child and whanau/family outcomes during the programme.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128762 0
Dr Hannah Waddington
Address 128762 0
Victoria University of Wellington
15c Waiteata Road
Kelburn
Wellington
6012
Country 128762 0
New Zealand
Phone 128762 0
+64 4 463 9773
Fax 128762 0
Email 128762 0
hannah.waddington@vuw.ac.nz
Contact person for public queries
Name 128763 0
Dr Hannah Waddington
Address 128763 0
Victoria University of Wellington
15c Waiteata Road
Kelburn
Wellington
6012
Country 128763 0
New Zealand
Phone 128763 0
+64 4 463 9773
Fax 128763 0
Email 128763 0
hannah.waddington@vuw.ac.nz
Contact person for scientific queries
Name 128764 0
Dr Hannah Waddington
Address 128764 0
Victoria University of Wellington
15c Waiteata Road
Kelburn
Wellington
6012
Country 128764 0
New Zealand
Phone 128764 0
+64 4 463 9773
Fax 128764 0
Email 128764 0
hannah.waddington@vuw.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We do not have ethical approval to share this for all participants.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20011Study protocol    386426-(Uploaded-14-08-2023-13-54-14)-Study-related document.docx



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
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