Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000636651
Ethics application status
Approved
Date submitted
16/05/2023
Date registered
13/06/2023
Date last updated
13/06/2023
Date data sharing statement initially provided
13/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Early communication intervention for infants with or at risk of cerebral palsy
Scientific title
Efficacy of early communication intervention on communication skills in infants with or at risk of cerebral palsy: A randomised controlled trial
Secondary ID [1] 307408 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral palsy 326738 0
High risk of cerebral palsy 330162 0
Condition category
Condition code
Physical Medicine / Rehabilitation 323971 323971 0 0
Speech therapy
Neurological 326983 326983 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Immediate intervention group. "It Takes Two to Talk®" (ITTT) – The Hanen Program® involves 8 x 150-minute small group parent educational sessions (either in-person or via telepractice) and 4 x 90 minute individual home visits, conducted by a Hanen-certified speech pathologist. The first of the home visits will be completed before the parent education sessions begin as part of a “pre-intervention consult”. The remaining 3 home visits will be conducted throughout the 8 x parent education sessions across a 12-week period. As a summary, the 12-week schedule is: week 1 = parent education session (orientation), week 2 = pre-intervention consult home visit, week 3 = parent education session 1, week 4 = parent education session 2, week 5 = home visit 1, week 6 = parent education session 3, week 7 = parent education session 4, week 8 = home visit 2, week 9 = parent education session 5, week 10 = parent education session 6, week 11 = home visit 3, and week 12 = parent education session 7. During the parent education sessions, parent learn how to create communication opportunities, to encourage and respond to their infant’s early communication attempts, and to incorporate these strategies into play and their everyday routines. During the home visits, the clinician will observe and video the parent and child's planned interaction, applying the strategies that parents have learnt during the education sessions. Together, the clinician and parent review of the videoed footage, to allow parents the opportunity to “see”, review, and discuss what is helping their child, and reflect on what went well during the parent and infant interaction. They will then have another opportunity to video the interaction, and review the improved interactions. Infants in the intervention group will be able to access usual care speech pathology intervention throughout the study period. In order to monitor adherence to the intervention during the parent education sessions and the home visits, we will document participant attendance.
Intervention code [1] 323845 0
Rehabilitation
Comparator / control treatment
Waitlist control group. Participants in this group will be able to access standard care speech pathology intervention. Standard care is variable, however typically it is completed on an individual basis 1-2 times per month, at a community-based centre, as a home visit, or via telehealth. Parents in both groups will keep a regular log of all speech therapy appointments during the study period, and will complete a parent questionnaire at quarterly intervals to provide information about the dose of speech therapy related to communication that the infant and parent have completed.
Participants in the control group will receive the "It Takes Two to Talk®" (ITTT) – The Hanen Program® intervention after their child turns 2 years old and they have completed the final research assessment.
Control group
Active

Outcomes
Primary outcome [1] 331772 0
Child communication skills as measured by the Communication and Symbolic Behaviour Scales (CSBS)
Timepoint [1] 331772 0
CSBS to be completed at baseline and assessment time 2. Baseline assessment to be completed when an infant is aged between 6 months and 12 months corrected age. Assessment time 2 will be completed when the infant turns 24 months corrected age.
Secondary outcome [1] 411080 0
Communication skills as measured by the Rossetti Infant Toddler Language Scales (RI-TLS).
Timepoint [1] 411080 0
RI-TLS to be completed at baseline and at 24 months corrected age.
Secondary outcome [2] 411081 0
Language measured by Bayley Scales Infant Development (BSID-IV) scaled scores
Timepoint [2] 411081 0
BSID-IV language scales to be completed at baseline and at 24 months corrected age.
Secondary outcome [3] 411082 0
Social-Emotional measured by the BSID-IV social-emotional scaled score.
Timepoint [3] 411082 0
Social-Emotional BSID-IV questionnaire to be completed at baseline and at 24 months corrected age.
Secondary outcome [4] 421801 0
Parent-infant interactions as measured through detailed video coding and PaRRis rating scale, based on a 8 minute free play parent-child interaction.
Timepoint [4] 421801 0
Video coding to be completed at assessment time 2 when the infant turns 24 months corrected age
Secondary outcome [5] 422186 0
Cognition measured by Bayley Scales Infant Development (BSID-IV) scaled scores
Timepoint [5] 422186 0
BSID-IV cognition scale to be completed at baseline and at 24 months corrected age.
Secondary outcome [6] 422381 0
Adaptive Behavior measured by the BSID-IV adaptive behavior scaled score.
Timepoint [6] 422381 0
Adaptive Behavior BSID-IV questionnaire to be completed at baseline and at 24 months corrected age.

Eligibility
Key inclusion criteria
We will include infants who are:
• Diagnosed with cerebral palsy or “high risk” of cerebral palsy based on International Guidelines (Novak et al., 2017)
• Between 6- and 12-months corrected age (CA) at intervention commencement
• Score >40 on Hammersmith Infant Neurological Examination (HINE) at 6 months CA
• Live in Sydney, Central Coast or Newcastle Regions

Novak, I., Morgan, C., Adde, L., Blackman, J., Boyd, R. N., Brunstrom-Hernandez, J., . . . Badawi, N. (2017). Early, Accurate Diagnosis and Early Intervention in Cerebral Palsy: Advances in Diagnosis and Treatment. JAMA pediatrics, 171(9), 897-907. doi:10.1001/jamapediatrics.2017.1689
Minimum age
6 Months
Maximum age
12 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
We will exclude infants with:
• Hearing impairment
• Severe vision impairment
• Uncontrolled epilepsy
• Parents who have already completed a Hanen course
• Families who speak a primary language other than English at home

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)
After consent and baseline measures, infants will be centrally randomised to immediate intervention or waitlist control intervention through central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed using an online program.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We will conduct the primary analysis by intention-to-treat to preserve randomisation. All available participant data will be analysed in the group the participant was randomised to, including in the presence of post-randomisation events such as discontinuation of the intervention or participation in a Hanen program outside of the trial.

The effect of the intervention on the primary outcome measure will be assessed using an ANCOVA model, to estimate the difference at 24 months, while controlling for measures at baseline. This ANCOVA model will include random effects terms for small group and for geographical cluster. Parent DASS-21 scores will be investigated as a potential effect modifier or confounder of the intervention effect on the primary and secondary outcomes.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/06/2023
Actual
Date of last participant enrolment
Anticipated
1/10/2024
Actual
Date of last data collection
Anticipated
1/01/2026
Actual
Sample size
Target
172
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 40361 0
2176 - Prairiewood
Recruitment postcode(s) [2] 40362 0
2112 - Ryde
Recruitment postcode(s) [3] 40363 0
2747 - Kingswood
Recruitment postcode(s) [4] 40365 0
2222 - Penshurst
Recruitment postcode(s) [5] 40366 0
2250 - Erina
Recruitment postcode(s) [6] 40367 0
2280 - Croudace Bay
Recruitment postcode(s) [7] 40368 0
2259 - Tuggerah
Recruitment postcode(s) [8] 40369 0
2100 - Allambie Heights

Funding & Sponsors
Funding source category [1] 311685 0
Charities/Societies/Foundations
Name [1] 311685 0
The Research Foundation of Cerebral Palsy Alliance
Country [1] 311685 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
The University of Sydney
NSW 2006
Country
Australia
Secondary sponsor category [1] 315643 0
None
Name [1] 315643 0
Address [1] 315643 0
Country [1] 315643 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311139 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 311139 0
Ethics committee country [1] 311139 0
Australia
Date submitted for ethics approval [1] 311139 0
27/09/2022
Approval date [1] 311139 0
03/02/2023
Ethics approval number [1] 311139 0
2022/817

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

Contacts
Principal investigator
Name 120078 0
Dr Cathy Morgan
Address 120078 0
Cerebral Palsy Alliance Research Institute
Brain and Mind Centre
Level 4, 88 Mallett St
Camperdown NSW 2050
Country 120078 0
Australia
Phone 120078 0
+61408 205 542
Fax 120078 0
Email 120078 0
[email protected]
Contact person for public queries
Name 120079 0
Ashleigh Hines
Address 120079 0
Cerebral Palsy Alliance Research Institute
Brain and Mind Centre
Level 4, 88 Mallett St
Camperdown NSW 2050
Country 120079 0
Australia
Phone 120079 0
+61497 674 471
Fax 120079 0
Email 120079 0
[email protected]
Contact person for scientific queries
Name 120080 0
Ashleigh Hines
Address 120080 0
Cerebral Palsy Alliance Research Institute
Brain and Mind Centre
Level 4, 88 Mallett St
Camperdown NSW 2050
Country 120080 0
Australia
Phone 120080 0
+61497 674 471
Fax 120080 0
Email 120080 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


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.