Condition category
Mental and Behavioural Disorders
Date applied
23/02/2010
Date assigned
23/06/2010
Last edited
29/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 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

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 measures

Direct assessment of child’s 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

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

http://www.rch.org.au

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

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24043276
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26347428

Publication citations

  1. 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.

  2. 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.

Additional files

Editorial Notes

29/01/2016: Publication reference added.