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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Cerebral palsy

High risk of cerebral palsy

Condition category

Condition code

Physical Medicine / Rehabilitation

Speech therapy

Neurological

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]

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]

Child communication skills as measured by the Communication and Symbolic Behaviour Scales (CSBS)

Timepoint [1]

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]

Communication skills as measured by the Rossetti Infant Toddler Language Scales (RI-TLS).

Timepoint [1]

RI-TLS to be completed at baseline and at 24 months corrected age.

Secondary outcome [2]

Language measured by Bayley Scales Infant Development (BSID-IV) scaled scores

Timepoint [2]

BSID-IV language scales to be completed at baseline and at 24 months corrected age.

Secondary outcome [3]

Social-Emotional measured by the BSID-IV social-emotional scaled score.

Timepoint [3]

Social-Emotional BSID-IV questionnaire to be completed at baseline and at 24 months corrected age.

Secondary outcome [4]

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]

Video coding to be completed at assessment time 2 when the infant turns 24 months corrected age

Secondary outcome [5]

Cognition measured by Bayley Scales Infant Development (BSID-IV) scaled scores

Timepoint [5]

BSID-IV cognition scale to be completed at baseline and at 24 months corrected age.

Secondary outcome [6]

Adaptive Behavior measured by the BSID-IV adaptive behavior scaled score.

Timepoint [6]

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?

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]

2176 - Prairiewood

Recruitment postcode(s) [2]

2112 - Ryde

Recruitment postcode(s) [3]

2747 - Kingswood

Recruitment postcode(s) [4]

2222 - Penshurst

Recruitment postcode(s) [5]

2250 - Erina

Recruitment postcode(s) [6]

2280 - Croudace Bay

Recruitment postcode(s) [7]

2259 - Tuggerah

Recruitment postcode(s) [8]

2100 - Allambie Heights

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

The Research Foundation of Cerebral Palsy Alliance

Address [1]

The Research Foundation of Cerebral Palsy Alliance
PO Box 171
Forestville NSW 2087

Country [1]

Australia

Primary sponsor type

University

Name

University of Sydney

Address

The University of Sydney
NSW 2006

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 Sydney Human Research Ethics Committee

Ethics committee address [1]

The University of Sydney
NSW 2006
Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

27/09/2022

Approval date [1]

03/02/2023

Ethics approval number [1]

2022/817

Summary

Brief summary

Many people with cerebral palsy (CP) have communication difficulties. Communication is a vital skill for life, with communication difficulties often leading to social, emotional and educational challenges. Research shows that children with CP who are not talking by 2 years of age, are more likely to have permanent communication problems. We know that early targeted training is helpful for infants with CP to learn how to move and walk, but it is less clear when it comes to communication skills. We want to understand if teaching parents communication strategies before their infant is 12 months old leads to better communication skills at 2 years. We will be comparing It Takes Two to Talk® (ITTT) – The Hanen Program® to a usual care group. ITTT teaches parents 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. Hanen programs are effective with other groups of young children with disability including Autism Spectrum Disorder, but there is very little high-quality research on any program focusing on early communication in infants with CP. We will be measuring each infant's communication skills, problem-solving, play, social-emotional skills, and parent- infant interactions. We will complete assessments before the intervention begins, and when each infant is 2 years old, to measure if any change has occurred. This study will help us understand the value of early communication intervention for infants with CP and their parents, to provide future guidance regarding effective early communication intervention. 
We hypothesise that, for infants with or at risk of CP, early parent training with ITTT will be more effective than usual care to improve: 
Primary Hypothesis
[i] Child communication skills on the Communication and Symbolic Behaviour Scales (CSBS), indicated by a difference between groups of 0.5 standard deviations. 
Secondary Hypotheses
[ii] Receptive and expressive communication skills on the Rossetti Infant Toddler Language Scales and/or the Bayley Scales Infant Development (BSID-IV) language scaled scores;
[iii] Cognition measured by Bayley Scales Infant Development (BSID-IV) cognitive scaled scores;
[iv] Social and emotional development measured by BSID-IV social emotional questionnaire;
[v] Parent-infant interactions as measured through detailed video coding and the PaRRis scale at two years of age.

Trial website

https://cerebralpalsy.org.au/sstposts/StoryId1676336068384

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Cathy Morgan

Address

Cerebral Palsy Alliance Research Institute
Brain and Mind Centre
Level 4, 88 Mallett St
Camperdown NSW 2050

Country

Australia

Phone

+61408 205 542

Fax

cmorgan@cerebralpalsy.org.au

Contact person for public queries

Name

Ashleigh Hines

Address

Cerebral Palsy Alliance Research Institute
Brain and Mind Centre
Level 4, 88 Mallett St
Camperdown NSW 2050

Country

Australia

Phone

+61497 674 471

Fax

ahines@cerebralpalsy.org.au

Contact person for scientific queries

Name

Ashleigh Hines

Address

Cerebral Palsy Alliance Research Institute
Brain and Mind Centre
Level 4, 88 Mallett St
Camperdown NSW 2050

Country

Australia

Phone

+61497 674 471

Fax

ahines@cerebralpalsy.org.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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No additional documents have been identified.

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