Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001396819
Ethics application status
Approved
Date submitted
19/07/2021
Date registered
15/10/2021
Date last updated
15/10/2021
Date data sharing statement initially provided
15/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Raising Voices: How can parents best support their children's language development?
Scientific title
Raising Voices: Examining the effect of parent-directed interventions on language development in 24-36 month old children with expressive language delay
Secondary ID [1] 304813 0
Nil known
Universal Trial Number (UTN)
U1111-1268-1410
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
expressive language delay 322878 0
Condition category
Condition code
Other 320455 320455 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study has two intervention arms, both parent-directed programs - Group Triple P and Dialogic Reading. Both interventions will be delivered online (via Zoom) in weekly sessions over 8 weeks. The total contact time of the intervention is approximately 660 minutes. In both arms, parents will receive the intervention training in groups of no more than 12.

Arm 1 (Group Triple P): Parents receive training in the key strategies of Triple P. The program is broad-based in its approach and covers topics such as positive parenting, helping children develop, and managing misbehaviour. The program includes role-play scenarios to build skills, homework tasks, and 3 brief individual sessions to troubleshoot parent challenges. Sessions 1-4 and Session 8 will be group sessions of approximately 120 minutes. Brief (15-30 minute) individual meetings comprise Sessions 5-7.

Parents will receive a Group Triple P workbook by mail. These workbooks are available from Triple P International (https://www.triplep.net/glo-en/home/). While session attendance will be monitored, engagement with the workbook will not be monitored or enforced. The intervention sessions will be delivered by the Lead Investigator, Melinda McBryde, who has received the required Triple P training.

Arm 2 (Dialogic Reading): Parents receive training in how to use books as a tool for encouraging child speech and for building early language skills. Dialogic Reading interventions are language-focused and have been used extensively in research as well as community settings. This iteration of the program has been designed to complement the Group Triple P in terms of structure and will take place over 8 weeks in groups of no more than 12 participants. The total contact hours between the interventionist and participant (providing all sessions are attended) is approximately 660 hours. This Dialogic Reading intervention will include group information and practice sessions (Sessions 1-4, Session 8) and 3 brief individual sessions (Sessions 5-7) to troubleshoot parent challenges in implementing the strategies taught.

Parents will receive 2 picture books, by mail, that will be used in the online group sessions. They will also be mailed some notes referencing the key Dialogic Reading strategies and tips for implementing them with success (these notes will be developed for this intervention and will be available in the appendices of any publications stemming from this study). The Lead Investigator, Melinda McBryde, will also be responsible for delivering the Dialogic Reading intervention.
Intervention code [1] 321182 0
Treatment: Other
Intervention code [2] 321443 0
Behaviour
Comparator / control treatment
The control group will be wait-listed until follow up assessment is complete (approximately 5 months after baseline assessments/commencement of the intervention programs). The wait-listed participants can then choose to receive either intervention (Group Triple P or Dialogic Reading). Participants in the control group are not prohibited from seeking support for their child's language delays but this will be monitored (self-report at each assessment timepoint).
Control group
Active

Outcomes
Primary outcome [1] 328289 0
Total words: total number of words that the child utters in observational assessment. 10 minute observational assessments will be recorded via Zoom and then coded by trained research assistants blinded to experimental condition.
Timepoint [1] 328289 0
At baseline (in the days before the interventions begin), post-test (on one occasion within days of intervention program ending/8 weeks after baseline assessments) and follow up (3 months after the post-test outcomes are obtained). Post-test is the primary timepoint,
Primary outcome [2] 328290 0
Mean length of utterance: average length of word combinations/sentences used by child in observational assessment. 10 minute observational assessments will be recorded via Zoom and then coded by trained research assistants blinded to experimental condition.
Timepoint [2] 328290 0
At baseline (in the days before the interventions begin), post-test (on one occasion within days of intervention program ending/8 weeks after baseline assessments) and follow up (3 months after the post-test outcomes are obtained). Post-test is the primary timepoint,
Primary outcome [3] 328291 0
Different words: number of unique/different words used by child in observational assessment. 10 minute observational assessments will be recorded via Zoom and then coded by trained research assistants blinded to experimental condition.
Timepoint [3] 328291 0
At baseline (in the days before the interventions begin), post-test (on one occasion within days of intervention program ending/8 weeks after baseline assessments) and follow up (3 months after the post-test outcomes are obtained). Post-test is the primary timepoint,
Secondary outcome [1] 398376 0
MacArthur-Bates Communicative Development Inventories - Words and Sentences (for children aged 30 months or below)/MacArthur-Bates Communicative Development Inventories-III (for children up to 42 months of age)
Timepoint [1] 398376 0
At baseline (in the days before the interventions begin), post-test (on one occasion within days of intervention program ending/8 weeks after baseline assessments) and follow up (3 months after the post-test outcomes are obtained).
Secondary outcome [2] 399682 0
Eyberg Child Behavior Inventory
Timepoint [2] 399682 0
At baseline (in the days before the interventions begin), post-test (on one occasion within days of intervention program ending/8 weeks after baseline assessments) and follow up (3 months after the post-test outcomes are obtained).
Secondary outcome [3] 399683 0
Parenting Scale
Timepoint [3] 399683 0
At baseline (in the days before the interventions begin), post-test (on one occasion within days of intervention program ending/8 weeks after baseline assessments) and follow up (3 months after the post-test outcomes are obtained).
Secondary outcome [4] 399684 0
Parenting Tasks Checklist
Timepoint [4] 399684 0
At baseline (in the days before the interventions begin), post-test (on one occasion within days of intervention program ending/8 weeks after baseline assessments) and follow up (3 months after the post-test outcomes are obtained).
Secondary outcome [5] 399685 0
Client Satisfaction Questionnaire
Timepoint [5] 399685 0
Post-test (on one occasion within days of intervention program ending/8 weeks after baseline assessments).
Secondary outcome [6] 399686 0
Parent Knowledge of Early Language Survey
Timepoint [6] 399686 0
At baseline (in the days before the interventions begin), post-test (on one occasion within days of intervention program ending/8 weeks after baseline assessments) and follow up (3 months after the post-test outcomes are obtained).
Secondary outcome [7] 401182 0
FOCUS-34 measuring children's functional communication by way of parent-report.
Timepoint [7] 401182 0
At baseline (in the days before the interventions begin), post-test (on one occasion within days of intervention program ending/8 weeks after baseline assessments) and follow up (3 months after the post-test outcomes are obtained).

Eligibility
Key inclusion criteria
Parents with children who are between 24 and 36 months at the commencement of the intervention sessions and screen at or below the 20th percentile relative to age-matched peers on MacArthur-Bates Communicative Development Inventories Short Form (measure of expressive vocabulary). Parents must be willing to attend weekly, online intervention sessions for 8 weeks and have an electronic device with webcam capabilities (e.g., laptop).
Minimum age
24 Months
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those excluded will be parents with children who: (1) are from a bilingual/multilingual household; (2) have abnormal hearing, or physical or intellectual disabilities; (3) have a suspected or confirmed Autism Spectrum Disorder diagnosis; (5) were born preterm (<37 weeks' gestation); or, (6) are currently or have in the past received professional intervention language delay.

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerized sequence generation, stratified by sex (male, female) and age (24-30 months, 31-36 months).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
An a priori power analysis has determined that 81 participants will provide 80% power to detect an effect size for expressive language (f = 0.16) with a two-sided alpha set at 0.05 and measurement at three time points. The effect size was generated in a yet unpublished meta-analysis conducted by this study’s researchers and based on total words produced by the child in observations. Adding 20% to account for potential attrition brings the final target for recruitment to N = 99.

A repeated measures ANOVA will be used to determine differences at three points of assessment (baseline, post-test, 3-month follow up).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
21/10/2021
Actual
Date of last participant enrolment
Anticipated
31/12/2021
Actual
Date of last data collection
Anticipated
30/06/2022
Actual
Sample size
Target
99
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 309183 0
University
Name [1] 309183 0
University of Queensland
Country [1] 309183 0
Australia
Funding source category [2] 309185 0
Charities/Societies/Foundations
Name [2] 309185 0
Dymocks Children's Charities
Country [2] 309185 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
School of Psychology
Sir Fred Schonell Drive
St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 310143 0
None
Name [1] 310143 0
Address [1] 310143 0
Country [1] 310143 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309041 0
The University of Queensland Human Research Ethics Committee B
Ethics committee address [1] 309041 0
Level 3, Brian Wilson Chancellery
The University of Queensland
St Lucia QLD 4072
Ethics committee country [1] 309041 0
Australia
Date submitted for ethics approval [1] 309041 0
16/07/2021
Approval date [1] 309041 0
20/09/2021
Ethics approval number [1] 309041 0
2021/HE001121

Summary
Brief summary
Late talkers are children who show a later onset and slower progression of expressive language than their peers. Although late talking is prevalent in populations of young children, many do not receive early support. Some parent-directed interventions have been specifically created to increase child language skills. In these language-specific interventions, like Dialogic Reading, parents are trained in targeted strategies and techniques to scaffold their children’s language development. Other parent-directed interventions, like Group Triple P, have been designed to improve family functioning, child behaviour, and child development more generally. There is great potential for Group Triple P, which takes a broad-based approach, to also scaffold language learning and improve these outcomes for late-talking toddlers, but at present, studies have tested the intervention’s effectiveness in the language domain. This trial will randomize parents of late-talking 2- to 3-year-old children to either Group Triple P or Dialogic Reading interventions lasting 8 weeks, or a waitlist control group. Primary language outcomes will be assessed at baseline, post-test, and 3-month follow up. Other outcomes include parent-reported child behaviour and parenting style. All interventions and testing will be completed online. The Group Triple P program is disseminated globally by Triple P International, based in Brisbane, Australia (Triple P-Positive Parenting Program). Should this trial demonstrate effectiveness of the program in increasing expressive language performance, this established program can be readily repurposed to meet the needs late-talking toddlers, and their families, in the community.

We anticipate that when parents participate in either intervention (Group Triple P or Dialogic Reading) children will have better language outcomes than those who receive no intervention in the same time period (those in the waitlist control group). We also hypothesize that children whose parents receive Group Triple P will show greater improvements in behaviour than those in the Dialogic Reading and waitlist control group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112754 0
Ms Melinda McBryde
Address 112754 0
Parenting and Family Support Centre
The University of Queensland
13 Upland Road
St LUCIA QLD 4072
Country 112754 0
Australia
Phone 112754 0
+61431862107
Fax 112754 0
Email 112754 0
[email protected]
Contact person for public queries
Name 112755 0
Ms Melinda McBryde
Address 112755 0
Parenting and Family Support Centre
The University of Queensland
13 Upland Road
St LUCIA QLD 4072
Country 112755 0
Australia
Phone 112755 0
+61431862107
Fax 112755 0
Email 112755 0
[email protected]
Contact person for scientific queries
Name 112756 0
Ms Melinda McBryde
Address 112756 0
Parenting and Family Support Centre
The University of Queensland
13 Upland Road
St LUCIA QLD 4072
Country 112756 0
Australia
Phone 112756 0
+61 431862107
Fax 112756 0
Email 112756 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Deidentified outcome data for any of the parent-report measures may be available upon request and provided at the discretion of the research team. The video recordings of the Zoom sessions will not be available, but the raw outcome data produced by the coders may also be available.
When will data be available (start and end dates)?
The raw data will be available for 5 years (around 2027) after the publication of the main results.
Available to whom?
Any requests by email will be considered but vetted, by the primary sponsor, by description/value of project and rationale for the request.
Available for what types of analyses?
The data may be available for meta-analyses or other well-defined analyses approved by the primary sponsor.
How or where can data be obtained?
Access will be subject to approval by the research team/primary sponsor. Requests can be initiated using the contact details provided in the (yet to be published) study reporting primary results.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12605Study protocol    382424-(Uploaded-22-09-2021-11-48-17)-Study-related document.docx
12606Statistical analysis plan    To be provided after recruitment.
12607Informed consent form    382424-(Uploaded-22-09-2021-11-50-19)-Study-related document.docx
12608Ethical approval    382424-(Uploaded-14-10-2021-16-07-38)-Study-related document.pdf



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.