Skip to content

Early communication intervention for infants with or at risk of cerebral palsy

Efficacy of early communication intervention on communication skills in infants with or at risk of cerebral palsy: A randomised controlled trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623000636651
Enrollment
172
Registered
2023-06-13
Start date
2023-06-13
Completion date
2024-10-01
Last updated
2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

University of Sydney
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
6 Months to 12 Months
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026