Contact information
Type
Scientific
Primary contact
Prof Melissa Wake
ORCID ID
Contact details
Royal Children's Hospital
50 Flemington Road
Parkville
3052
Australia
+61 (0)3 9345 5761
melissa.wake@rch.org.au
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HREC 3011A
Study information
Scientific title
Improving outcomes of preschool language delay in the community: a large-scale randomised controlled trial
Acronym
L4L (Language for Learning)
Study hypothesis
This trial aims to trial a population approach to improving language and important related outcomes in 4 year olds with language delay. We hypothesise that:
1. Compared to the control group, benefits to the intervention group at 5 and 6 years will include better mean scores on standardised tests of:
1.1. Expressive/receptive language (primary outcomes) and vocabulary
1.2. Other secondary outcomes:
1.2.1. Social skills and relationships
1.2.2. Emotional and behavioural well-being
1.2.3. Early literacy
1.2.4. Health-related quality of life
1.2.5. "School readiness", measured by the Australian Early Development Index
2. The intervention will be acceptable and cost-effective (against common decision thresholds)
Ethics approval
Ethics in Human Research Committee of the Royal Childrens Hospital, Melbourne, Australia, pending approval as of 24/02/2010
Study design
Large-scale single-centre randomised (concealed randomisation) controlled trial nested within a cross-sectional study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Language delay at four years of age
Intervention
Allocation to the intervention 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 5- and 6-year follow-up direct assessments until data collection is complete.
Arm A: Intervention group -
A 20-session, year-long program will be offered to parents of children who have a language delay at four years of age, when their child turns approximately 50 - 52 months old. It comprises 18 weekly sessions in three 6-week bursts starting every 3 months; the 5-year-old blinded assessment; and an exit feedback/planning session in the following month. Sessions will be delivered in a private room at a local centre (e.g., Maternal and Child Health Centres [MCH]) by a trained researcher-therapist experienced with parents and children and knowledgeable about child health and development. Sessions include activities that encompass four domains, chosen for their importance to language, social and educational outcomes and demonstrated feasibility for standardised large-scale intervention delivered without specialised speech pathologist skills.
Arm B: Usual care group -
Usual care from the MCH nurses who provide a universal and free surveillance service to Melbourne families in the first 5 years of life (active control).
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Direct assessment of childs expressive and receptive language ability and expressive and receptive vocabulary; all collected at 5 and 6 years.
Secondary outcome measures
1. Parent reported pragmatic skills, behaviour, health related quality of life and service utilisation
2. Direct assessment of child's word recognition, sentence comprehension and a proxy for non-verbal intelligence quotient (IQ)
3. Teacher reported language, social, emotional, cognitive and physical wellbeing
Overall trial start date
01/03/2010
Overall trial end date
01/03/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
The trial will involve all subjects who as babies and toddlers participated in two completed population-based trials - Let's Read and Let's Learn Language (ISRCTN20953675). These were conducted in eight local government areas across Melbourne, Australia. Children will be invited into the new trial as they turn 4 years old.
Eligible participants will be
1. Children who, at 4 years of age, have expressive and/or receptive language scores more than 1 SD below the normative mean on the CELF-P2
2. Their parents
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
Target sample size is 1500 to identify 240 eligible children
Participant exclusion criteria
1. Intellectual disability
2. Major medical conditions
3. Hearing loss greater than 40 dB Hearing Loss (HL) Scale in the better ear
4. Autism spectrum disorders
5. Parents who need an interpreter
Most such children are already excluded as they have demonstrated competence in their previous research trial.
Recruitment start date
01/03/2010
Recruitment end date
01/03/2014
Locations
Countries of recruitment
Australia
Trial participating centre
Royal Children's Hospital
Parkville
3052
Australia
Sponsor information
Organisation
Royal Children's Hospital (Australia)
Sponsor details
50 Flemington Road
Parkville
3052
Australia
+61 (0)3 9345 5761
melissa.wake@rch.org.au
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research council
Funder name
National Health and Medical Research Council (Australia) - Project Grant Application (ref: 607407)
Alternative name(s)
NHMRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Australia
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
Basic results (scientific)
Publication list
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24043276
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26347428
Publication citations
-
Results
Wake M, Tobin S, Levickis P, Gold L, Ukoumunne OC, Zens N, Goldfeld S, Le H, Law J, Reilly S, Randomized trial of a population-based, home-delivered intervention for preschool language delay., Pediatrics, 2013, 132, 4, e895-904, doi: 10.1542/peds.2012-3878.
-
Results
Wake M, Levickis P, Tobin S, Gold L, Ukoumunne OC, Goldfeld S, Zens N, Le HN, Law J, Reilly S, Two-Year Outcomes of a Population-Based Intervention for Preschool Language Delay: An RCT, Pediatrics, 2015, 136, 4, e838-e847, doi: 10.1542/peds.2015-1337.