Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000312549p
Ethics application status
Submitted, not yet approved
Date submitted
26/02/2024
Date registered
22/03/2024
Date last updated
22/03/2024
Date data sharing statement initially provided
22/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Is Hanen’s More Than Words© suitable and helpful for parents of autistic children from Culturally and Linguistically Diverse backgrounds?
Scientific title
Feasibility, acceptability and preliminary efficacy of Hanen's ‘More than Words’© program for Culturally and Linguistically Diverse (CALD) caregivers who have children with autism or suspected autism
Secondary ID [1] 311610 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder 333031 0
Social Communication Disorder 333032 0
Condition category
Condition code
Mental Health 329714 329714 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Hanen's More Than Words© is a group-based intervention program to support caregivers of autistic children/children with social communication differences to develop their child’s social communication and play skills. Parents are provided with 8 weekly face-to-face group-based sessions (~2-3 hours; without their children) and 3 face-to-face individual sessions (~1 hour; with their children) delivered by a Hanen-certified Speech Pathologist. Individual sessions will occur in week 2, 4 and 7 following the completion of the group-based sessions in those weeks. The overall duration of the intervention will be 8 weeks. Attendance will be collected at both group and individual sessions.

Parents are exposed to the following content in the program:
- Learning how their child communicates at the moment and the next steps in their child's communication.
- Learning how their child learns best and how to take advantage of this.
- Learning what motivates their children to communicate.
- Learning how to turn everyday activities into communication opportunities.
- Learning how to support their child's understanding of communication and language.
- Learning how to develop their child's play skills.
- Learning how to support their child's development of friendships with peers.

The mode of training in the group sessions includes: presentations, observation of video clips, group discussions, role plays and generation of homework strategies to practice each week.

The three individual sessions involve both parents and children. During individual sessions, parents and children will be videoed interacting for 10 minutes and the videos will be jointly watched with parents to identify parents' use of strategies taught in the group-based sessions. Parents will be provided with Hanen's More Than Words© textbook to support their group-based learning.

All sessions with take place at La Trobe University.
Intervention code [1] 328062 0
Treatment: Other
Intervention code [2] 328182 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337511 0
Feasibility of More Than Words©
Timepoint [1] 337511 0
1-month post-intervention
Primary outcome [2] 337512 0
Acceptability of More Than Words©
Timepoint [2] 337512 0
1-month post-intervention
Primary outcome [3] 337513 0
Parent responsivity
Timepoint [3] 337513 0
1-month post-intervention
Secondary outcome [1] 432157 0
Time and healthcare costs associated with More Than Words© participation (a composite outcome)
Timepoint [1] 432157 0
1-month post-intervention
Secondary outcome [2] 432158 0
Parent wellbeing
Timepoint [2] 432158 0
1-month post-intervention
Secondary outcome [3] 432159 0
Parent coping
Timepoint [3] 432159 0
1-month post-intervention
Secondary outcome [4] 432160 0
Parent expressed emotion
Timepoint [4] 432160 0
1-month post-intervention
Secondary outcome [5] 432161 0
Family experiences
Timepoint [5] 432161 0
1-month post-intervention
Secondary outcome [6] 432162 0
Child communication
Timepoint [6] 432162 0
1-month post-intervention
Secondary outcome [7] 433195 0
Child communication
Timepoint [7] 433195 0
1-month post-intervention
Secondary outcome [8] 433196 0
Child communication
Timepoint [8] 433196 0
1-month post-intervention

Eligibility
Key inclusion criteria
Children will be eligible for the study if they:
1. Have an Autism Spectrum Disorder:
a. Evidenced via a community clinical ASD diagnosis and exceeding ASD threshold on the Autism Diagnostic Observation Schedule – 2nd Edition (ADOS; Lord, et al., 2013), Modules T, 1 or 2; or
b. Exceeding ASD threshold on the ADOS and meeting Clinical Best Estimate diagnosis of ASD by the senior researcher;
2. Are aged < 6 years;

Parents will be eligible for the study if:
1. Their children meet the criteria listed above AND
2. They are from a Chinese or South Asian background and completed their formal schooling (up to 18 years) in their home country.
Minimum age
0 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Parental intention not to remain in Melbourne for the trial period.
2. Parent prior completion of a More Than Words© program.
3. Parent unable to attend La Trobe University for More Than Words© sessions and research assessments.

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
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2024
Actual
Date of last participant enrolment
Anticipated
31/07/2024
Actual
Date of last data collection
Anticipated
30/11/2024
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 315918 0
University
Name [1] 315918 0
La Trobe University
Country [1] 315918 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Country
Australia
Secondary sponsor category [1] 318075 0
None
Name [1] 318075 0
Address [1] 318075 0
Country [1] 318075 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314763 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 314763 0
Ethics committee country [1] 314763 0
Australia
Date submitted for ethics approval [1] 314763 0
28/02/2024
Approval date [1] 314763 0
Ethics approval number [1] 314763 0

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

Contacts
Principal investigator
Name 132650 0
Dr Jodie Smith
Address 132650 0
La Trobe University, Bundoora VIC 3086
Country 132650 0
Australia
Phone 132650 0
+61 03 94796591
Fax 132650 0
Email 132650 0
[email protected]
Contact person for public queries
Name 132651 0
Jodie Smith
Address 132651 0
La Trobe University, Bundoora VIC 3086
Country 132651 0
Australia
Phone 132651 0
+61 03 94796591
Fax 132651 0
Email 132651 0
[email protected]
Contact person for scientific queries
Name 132652 0
Jodie Smith
Address 132652 0
La Trobe University, Bundoora VIC 3086
Country 132652 0
Australia
Phone 132652 0
+61 03 94796591
Fax 132652 0
Email 132652 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
Sample will be from small, marginalised communities in Melbourne, Australia where there may be a risk of identification from any data.


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.