ANZCTR - Registration

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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]

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

Condition category

Condition code

Other

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]

Treatment: Other

Intervention code [2]

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]

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]

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]

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]

Primary outcome [3]

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]

Secondary outcome [1]

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]

Secondary outcome [2]

Eyberg Child Behavior Inventory

Timepoint [2]

Secondary outcome [3]

Parenting Scale

Timepoint [3]

Secondary outcome [4]

Parenting Tasks Checklist

Timepoint [4]

Secondary outcome [5]

Client Satisfaction Questionnaire

Timepoint [5]

Post-test (on one occasion within days of intervention program ending/8 weeks after baseline assessments).

Secondary outcome [6]

Parent Knowledge of Early Language Survey

Timepoint [6]

Secondary outcome [7]

FOCUS-34 measuring children's functional communication by way of parent-report.

Timepoint [7]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Queensland

Address [1]

School of Psychology
Sir Fred Schonell Drive
St Lucia QLD 4072

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Dymocks Children's Charities

Address [2]

Level 6, 428 George Street
Sydney NSW 2000

Country [2]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Queensland Human Research Ethics Committee B

Ethics committee address [1]

Level 3, Brian Wilson Chancellery
The University of Queensland
St Lucia QLD 4072

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

16/07/2021

Approval date [1]

20/09/2021

Ethics approval number [1]

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

Ms Melinda McBryde

Address

Parenting and Family Support Centre
The University of Queensland
13 Upland Road
St LUCIA QLD 4072

Country

Australia

Phone

+61431862107

Fax

melinda.mcbryde@uqconnect.edu.au

Contact person for public queries

Name

Melinda McBryde

Address

Parenting and Family Support Centre
The University of Queensland
13 Upland Road
St LUCIA QLD 4072

Country

Australia

Phone

+61431862107

Fax

melinda.mcbryde@uqconnect.edu.au

Contact person for scientific queries

Name

Melinda McBryde

Address

Parenting and Family Support Centre
The University of Queensland
13 Upland Road
St LUCIA QLD 4072

Country

Australia

Phone

+61 431862107

Fax

melinda.mcbryde@uqconnect.edu.au

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.	Type	Other Details	Attachment
12605	Study protocol		382424-(Uploaded-22-09-2021-11-48-17)-Study-related document.docx
12606	Statistical analysis plan	To be provided after recruitment.
12607	Informed consent form		382424-(Uploaded-22-09-2021-11-50-19)-Study-related document.docx
12608	Ethical approval		382424-(Uploaded-14-10-2021-16-07-38)-Study-related document.pdf

Results publications and other study-related documents

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