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Improving outcomes of preschool language delay in the community
DOI 10.1186/ISRCTN03981121
ClinicalTrials.gov identifier
EudraCT number
Public title Improving outcomes of preschool language delay in the community
Scientific title Improving outcomes of preschool language delay in the community: a large-scale randomised controlled trial
Acronym L4L (Language for Learning)
Serial number at source HREC 3011A
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)
Lay summary Not provided at time of registration
Ethics approval Ethics in Human Research Committee of the Royal Children’s 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
Countries of recruitment Australia
Disease/condition/study domain Language delay at four years of age
Participants - 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
Participants - 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.
Anticipated start date 01/03/2010
Anticipated end date 01/03/2014
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants Target sample size is 1500 to identify 240 eligible children
Interventions 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).
Primary outcome measure(s) Direct assessment of child’s expressive and receptive language ability and expressive and receptive vocabulary; all collected at 5 and 6 years.
Secondary outcome measure(s) 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
Sources of funding National Health and Medical Research Council (NHMRC) (Australia) - Project Grant Application (ref: 607407)
Trial website
Publications 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24043276
Contact name Prof  Melissa  Wake
  Address Royal Children's Hospital
50 Flemington Road
  City/town Parkville
  Zip/Postcode 3052
  Country Australia
  Tel +61 (0)3 9345 5761
  Fax +61 (0)3 9345 5900
  Email melissa.wake@rch.org.au
Sponsor Royal Children's Hospital (Australia)
  Address 50 Flemington Road
  City/town Parkville
  Zip/Postcode 3052
  Country Australia
  Tel +61 (0)3 9345 5761
  Fax +61 (0)3 9345 5900
  Email melissa.wake@rch.org.au
  Sponsor website: http://www.rch.org.au
Date applied 23/02/2010
Last edited 04/10/2013
Date ISRCTN assigned 23/06/2010
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