Improving outcomes of preschool language delay in the community

ISRCTN ISRCTN03981121
DOI https://doi.org/10.1186/ISRCTN03981121
Secondary identifying numbers HREC 3011A
Submission date
23/02/2010
Registration date
23/06/2010
Last edited
29/01/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Melissa Wake
Scientific

Royal Children's Hospital
50 Flemington Road
Parkville
3052
Australia

Phone +61 (0)3 9345 5761
Email melissa.wake@rch.org.au

Study information

Study designLarge-scale single-centre randomised (concealed randomisation) controlled trial nested within a cross-sectional study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleImproving outcomes of preschool language delay in the community: a large-scale randomised controlled trial
Study acronymL4L (Language for Learning)
Study objectivesThis 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(s)Ethics in Human Research Committee of the Royal Children’s Hospital, Melbourne, Australia, pending approval as of 24/02/2010
Health condition(s) or problem(s) studiedLanguage delay at four years of age
InterventionAllocation 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 typeOther
Primary outcome measureDirect assessment of child’s expressive and receptive language ability and expressive and receptive vocabulary; all collected at 5 and 6 years.
Secondary outcome measures1. 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 study start date01/03/2010
Completion date01/03/2014

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit4 Years
Upper age limit4 Years
SexBoth
Target number of participantsTarget sample size is 1500 to identify 240 eligible children
Key inclusion criteriaThe 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
Key exclusion criteria1. 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.
Date of first enrolment01/03/2010
Date of final enrolment01/03/2014

Locations

Countries of recruitment

  • Australia

Study participating centre

Royal Children's Hospital
Parkville
3052
Australia

Sponsor information

Royal Children's Hospital (Australia)
Hospital/treatment centre

50 Flemington Road
Parkville
3052
Australia

Phone +61 (0)3 9345 5761
Email melissa.wake@rch.org.au
Website http://www.rch.org.au
ROR logo "ROR" https://ror.org/02rktxt32

Funders

Funder type

Research council

National Health and Medical Research Council (Australia) - Project Grant Application (ref: 607407)
Government organisation / National government
Alternative name(s)
NHMRC
Location
Australia

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/10/2013 Yes No
Results article results 01/10/2015 Yes No

Editorial Notes

29/01/2016: Publication reference added.