Contact information
Type
Scientific
Primary contact
Dr Melissa Wake
ORCID ID
Contact details
Royal Children's Hospital
Flemington Road
Parkville
Melbourne
3052
Australia
+61 (0)3 9345 5761
melissa.wake@rch.org.au
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
LLL (Let's Learn Language)
Study hypothesis
To trial a preventive approach to lowering the proportions of slow-to-talk toddlers who progress to expressive language and externalising behaviour problems at ages two and three years.
We hypothesise that:
1. Compared with the non-intervention (control) group at 24 and 36 months, the intervention group will comprise:
1.1. Fewer children with delays in early expressive vocabulary acquisition
1.2. Higher mean vocabulary and Mean Length of Utterance (MLU) scores, as well as scores on standardised measures of receptive and expressive language
1.3. A greater number of responsive linguistic interactions between parents and children
1.4. Lower mean scores on a standardised measure of externalising behaviour problems
2. The intervention will be more efficacious for disadvantaged children
3. The intervention will be acceptable and cost-effective
This is the resulting randomised trial from the pilot study registered under ISRCTN45091963.
Ethics approval
Received approval from the Ethics in Human Research Committee of the Royal Children's Hospital (Australia) on 2nd March 2007 (ref: EHRC 26028B).
Study design
Cluster randomised controlled trial, nested in a preceding population survey process.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Early delay in acquiring expressive vocabulary
Intervention
Cluster randomised controlled trial, with cluster at the level of the well-child centre. Masked randomisation is due to occur in January 2008 after the study team has recruited all clusters. Allocation to group will be a simple randomisation using computerised sequence generation, conducted by an independent statistician and concealed from the principal researchers to the end of the study's life and participants until allocation is complete. Group allocation will be concealed from researchers conducting two- and three-year follow-up direct assessments until data collection is complete.
Arm A - Parent Language Program Group:
A six-week parent language promotion program (six two-hour group sessions) adapted from the Hanen You Make The Difference™ program, offered to parents of slow-to-talk toddlers when the children turn 19 - 20 months old. The Parent Language Program teaches child-centred, interaction-promoting and language-modelling responsive interaction strategies targeting the development of vocabulary and multi-word phrases. The Parent Language Program will be conducted at local community centres, facilitated by an early childhood professional.
Arm B - Usual Care Group:
Usual care from the Maternal and Child Health (MCH) nurses who provide a universal and free surveillance service to Melbourne families in the first five years of life (active control).
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Parent-report of child's expressive vocabulary
2. Direct assessment of child's receptive language ability, childs mean length of utterance in morphemes from videotaped short narrative
3. Parents' use of responsive language facilitation strategies derived from the videotaped language sample
All collected at two and three years.
Secondary outcome measures
1. Direct assessment of child's expressive language abilities
2. Parent-report of child's externalising behaviour problems
Both collected at two and three years.
Overall trial start date
01/05/2007
Overall trial end date
30/11/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Parents of 12 month-old infants
2. Attending community well-child clinics across three Melbourne local government areas from May to November 2007
3. Parents whose toddlers, at 18 months, are identified by a brief, parent-reported vocabulary questionnaire as having minimal or no expressive vocabulary (e.g., scoring at or below the 20th percentile relative to age and sex norms)
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
Target sample size is 1000 to identify 200 eligible children.
Participant exclusion criteria
1. Children with already-diagnosed (or a referral for) cognitive delay or major medical conditions
2. Children with symptoms of Autism Spectrum Disorder
3. Children with cleft palates
4. Parents with insufficient English to attend a Parent Language Program and complete brief written questionnaires
Recruitment start date
01/05/2007
Recruitment end date
30/11/2009
Locations
Countries of recruitment
Australia
Trial participating centre
Royal Children's Hospital
Melbourne
3052
Australia
Sponsor information
Organisation
Murdoch Childrens Research Institute, Parkville (Australia)
Sponsor details
c/o Associate Professor Melissa Wake
Royal Children's Hospital
Flemington Road
Parkville
Melbourne
3052
Australia
+61 (0)3 9345 5761
melissa.wake@rch.org.au
Sponsor type
Research organisation
Website
Funders
Funder type
Research council
Funder name
National Health and Medical Research Council (Australia) - Strategic Award (ref: #384491)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21852344
Publication citations
-
Results
Wake M, Tobin S, Girolametto L, Ukoumunne OC, Gold L, Levickis P, Sheehan J, Goldfeld S, Reilly S, Outcomes of population based language promotion for slow to talk toddlers at ages 2 and 3 years: Let's Learn Language cluster randomised controlled trial., BMJ, 2011, 343, d4741.