Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000265572
Ethics application status
Approved
Date submitted
14/02/2024
Date registered
15/03/2024
Date last updated
29/08/2024
Date data sharing statement initially provided
15/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Trial of Raupi te Raupo, an early support programme for children with social communication differences.
Scientific title
Randomised controlled trial of the effect of Raupi te Raupo compared to community support on parent synchronous responses to children with communication differences.
Secondary ID [1] 311541 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
social communication differences 332895 0
signs of autism 333077 0
Condition category
Condition code
Mental Health 329613 329613 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Raupi te Raupo has been developed based on advice and suggestions from an autistic advisory group and a Maori advisory group. The name was generously gifted by Associate Professor Mere Skerrett (Ngai Tahu, Ngati Rakiamoa, Ngati Ruahikihiki, Ngati Mahuta, Ngati Unu, Ngati Maniapoto, Ngati Pikiao, Ngati Te Rangiunuora, Ngati Pukeko). Raupi is about nurturing, taking care of, and cherishing. The wetlands where Raupo (bulrush) grow are the lungs of the land and are essential for survival and wellbeing. Raupo had many traditional uses for Maori including as a covering for poi, in weaving, for canoe sails, and as food. As such, our tomorrow will be filled with a sense of wellbeing when we cherish our youngest ones just as we should cherish raupo.

Raupi te Raupo will involve 17 sessions for the main participating whanau/family members over 20 weeks. The programme will involve weekly discussion sessions online over Zoom, which will be replaced once a month with a practical session, usually in the family home. Whanau/families can also choose "additional support people" who will attend four discussion sessions in total. The programme is delivered by trained coaches from a variety of backgrounds, including educational psychology, teaching, and music therapy, and by parents of autistic children. Correct use of Raupi te Raupo techniques during practical and discussion sessions will be monitored using a fidelity checklist.

The discussion sessions will involve the coach and whanau/family members discussing strategies and reflecting on the most recent practical session. These sessions will last up to 1.5 hours. The child will not be present for these sessions, which will usually take place online via a platform such as Zoom, without the child present. These sessions will involve: (a) checking in at the beginning of the session and supporting with plans for referrals to other supports and agencies; (b) the coach offering information about strategy use in a variety of formats (e.g., written, illustrations, videos), (c) reflecting on videos of the whanau/family member or coach interacting with the child, and (d) selecting manageable goals for the whanau/family to focus on each week.

In the monthly practical sessions, the coach and the whanau members will play and interact with the child in the home or another familiar, comfortable location for the child. These sessions will last up to 1 hour and the coach will support the whanau/family members by (a) checking in at the beginning of each session, (b) interacting with and getting to know the child, (c) modelling use of strategies with the child, (d) videoing interactions between the child and the coach and/or whanau/family members for later reflection, and (e) providing in-the-moment tips and support.

Five key Maori values (Nga whanonga pono) underpin Raupi te Raupo. These values will be used to inform the coaches’ practice including the way in which they support the child and their family and whanau. Coaches will also support the family and whanau to embed nga whanonga pono with their child.

Raupi te Raupo covers a range of content related to supporting the child and whanau/family. The coach and whanau/family will discuss possible strategies and content in the discussion sessions and then practice these in the practical sessions. Raupi te Raupo has 10 modules and family and whanau can generally decide which content is relevant to the child, and the order in which to discuss this content. The content in many modules will only be relevant to some whanau/families, and each will move through Raupi te Raupo at their own pace. The topics covered in Raupi te Raupo are as follows:
- Understanding your child (compulsory)
-Looking after yourself and finding support
-Following your child’s interests and preferences
-Co-regulation
-Creating a safe and comfortable environment
-Supporting communication
-Visuals and social stories
-Supporting learning and growth
-Navigating everyday life and routines
-Tips for the tricky stuff (Understanding behaviours that cause harm, Sleep issues, Feeding issues, Running away, Toileting, and Screentime)
Intervention code [1] 327998 0
Other interventions
Comparator / control treatment
Whanau/families in the community support only group (comparison group) will receive 30-minute support phone or Zoom calls from the project manager or another consistent researcher once a month for five months. The researcher will listen to parents’ thoughts and concerns, give general advice in response to their questions, and assist with referrals if requested. The support calls will not include any content from Raupi te Raupo. Some calls will be recorded to monitor treatment adherence.
Control group
Active

Outcomes
Primary outcome [1] 337401 0
Parent Synchrony
Timepoint [1] 337401 0
Baseline and immediately following support, 24 weeks later
Secondary outcome [1] 431684 0
Child communication with parent
Timepoint [1] 431684 0
Baseline and immediately following support, 24 weeks later
Secondary outcome [2] 431686 0
Child communication with researcher
Timepoint [2] 431686 0
Baseline and immediately following support, 24 weeks later
Secondary outcome [3] 431687 0
Parent positive comments towards their child
Timepoint [3] 431687 0
Baseline and immediately following support, 24 weeks later
Secondary outcome [4] 431688 0
Composite measure of child treatment outcomes related to understanding, communication and interaction, daily routines, support, and wellbeing
Timepoint [4] 431688 0
Baseline and immediately following support, 24 weeks later
Secondary outcome [5] 431689 0
Child Wellbeing and Quality of Life
Timepoint [5] 431689 0
Baseline and immediately following support, 24 weeks later
Secondary outcome [6] 431691 0
Composite measure of parent treatment outcomes related to understanding, communication, connecting and interacting, safety, support, and wellbeing.
Timepoint [6] 431691 0
Baseline and immediately following support, 24 weeks later
Secondary outcome [7] 431694 0
Parent Stress
Timepoint [7] 431694 0
Baseline and immediately following support, 24 weeks later
Secondary outcome [8] 431695 0
Parent Sense of competence
Timepoint [8] 431695 0
Baseline and immediately following support, 24 weeks later
Secondary outcome [9] 431697 0
Composite measure of perceptions of the acceptability, appropriateness and feasibility of Raupi te Raupo
Timepoint [9] 431697 0
Raupi te Raupo group only, immediately following 24 weeks of support
Secondary outcome [10] 431700 0
Family Quality of Life
Timepoint [10] 431700 0
Baseline and immediately following support, 24 weeks later

Eligibility
Key inclusion criteria
1. The child is aged between 1 year 0 months and 5 years 0 months at pre-assessment,
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),
3. The child does not have a sibling or twin who is already participating in the study
4. The child does not have a genetic condition which is associated with “autism-like” characteristics (e.g., Rett Syndrome, Fragile X, 22q deletion),
5. Each participating whanau/family member can commit to 17 sessions of up to one-and-a-half hours across 20 weeks, including weekly sessions without the child present either at home, in a clinic, or via Zoom, replace once a month by home-based sessions with the child present, and
6. The primary whanau/family member speaks sufficient English to understand the requirements of the study and to participate in the coaching sessions,
7. The primary whanau/family member intends to remain in Wellington for the duration of the study (13 months including pre-, post-, and potential follow-up assessments), and
8. The whanau/family do not intend to receive more than 10 hours of autism-specific parent/whanau coaching from a single source for the duration of the study.
Minimum age
12 Months
Maximum age
60 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children who have a clinical diagnosis of autism prior to pre-assessment will not be eligible to participate. Children who are diagnosed in the course of the study, however, will not be excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This randomisation process will be managed by a statistical expert who will not be involved in the provision of support and will be blind to whether Group A or B will receive Raupi te Raupo.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Following the pre-assessment, participants will be randomised using the Urn method of random allocation (Lachin et al., 1998) to a group who will receive Raupi te Raupo or a group who will be assisted to access existing supports in the community. Randomisation will be determined by a computer algorithm which will allocate either “Group A” or “Group B.”
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
R will be used for all analyses. We will test changes in the primary and secondary outcomes with a 2 (group allocation: receiving Raupi te Raupo; community support only) x 2 (time: pre and post) repeated measures ANOVA, comparing changes in the group who receives Raupi te Raupo relative to the group who receives community support.


Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2024
Actual
24/04/2024
Date of last participant enrolment
Anticipated
1/05/2026
Actual
Date of last data collection
Anticipated
18/12/2026
Actual
Sample size
Target
60
Accrual to date
15
Final
Recruitment outside Australia
Country [1] 26145 0
New Zealand
State/province [1] 26145 0

Funding & Sponsors
Funding source category [1] 315837 0
Government body
Name [1] 315837 0
Royal Society of New Zealand
Country [1] 315837 0
New Zealand
Primary sponsor type
University
Name
Te Herenga Waka - Victoria University of Wellington
Address
Country
New Zealand
Secondary sponsor category [1] 317968 0
None
Name [1] 317968 0
Address [1] 317968 0
Country [1] 317968 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314692 0
Northern A Health and Disability Ethics Committee 
Ethics committee address [1] 314692 0
Ethics committee country [1] 314692 0
New Zealand
Date submitted for ethics approval [1] 314692 0
06/07/2023
Approval date [1] 314692 0
04/09/2023
Ethics approval number [1] 314692 0
2023 FULL 18346

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

Contacts
Principal investigator
Name 132414 0
Dr Hannah Waddington
Address 132414 0
Victoria University of Wellington, 15C Waiteata Road, Kelburn, Wellington, 6012, NEW ZEALAND
Country 132414 0
New Zealand
Phone 132414 0
+64 04 463 9773
Fax 132414 0
Email 132414 0
[email protected]
Contact person for public queries
Name 132415 0
Hannah Waddington
Address 132415 0
Victoria University of Wellington, 15C Waiteata Road, Kelburn, Wellington, 6012, NEW ZEALAND
Country 132415 0
New Zealand
Phone 132415 0
+64 04 463 9773
Fax 132415 0
Email 132415 0
[email protected]
Contact person for scientific queries
Name 132416 0
Hannah Waddington
Address 132416 0
Victoria University of Wellington, 15C Waiteata Road, Kelburn, Wellington, 6012, NEW ZEALAND
Country 132416 0
New Zealand
Phone 132416 0
+64 04 463 9773
Fax 132416 0
Email 132416 0
[email protected]

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 for this.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24066Study protocolN/A   387339-(Uploaded-05-08-2024-06-32-28)-Protocol - Randomised Controlled Trial Raupo te Raupo.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.