Improving outcomes of preschool language delay in the community
ISRCTN | ISRCTN03981121 |
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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
Scientific
Royal Children's Hospital
50 Flemington Road
Parkville
3052
Australia
Phone | +61 (0)3 9345 5761 |
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melissa.wake@rch.org.au |
Study information
Study design | Large-scale single-centre randomised (concealed randomisation) controlled trial nested within a cross-sectional study |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Other |
Study type | Quality of life |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | Improving outcomes of preschool language delay in the community: a large-scale randomised controlled trial |
Study acronym | L4L (Language for Learning) |
Study objectives | 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(s) | Ethics in Human Research Committee of the Royal Childrens Hospital, Melbourne, Australia, pending approval as of 24/02/2010 |
Health condition(s) or problem(s) studied | 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 |
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 study start date | 01/03/2010 |
Completion date | 01/03/2014 |
Eligibility
Participant type(s) | Patient |
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Age group | Child |
Lower age limit | 4 Years |
Upper age limit | 4 Years |
Sex | Both |
Target number of participants | Target sample size is 1500 to identify 240 eligible children |
Key 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 |
Key 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. |
Date of first enrolment | 01/03/2010 |
Date of final enrolment | 01/03/2014 |
Locations
Countries of recruitment
- Australia
Study participating centre
Royal Children's Hospital
Parkville
3052
Australia
3052
Australia
Sponsor information
Royal Children's Hospital (Australia)
Hospital/treatment centre
Hospital/treatment centre
50 Flemington Road
Parkville
3052
Australia
Phone | +61 (0)3 9345 5761 |
---|---|
melissa.wake@rch.org.au | |
Website | http://www.rch.org.au |
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
Government organisation / National government
- Alternative name(s)
- NHMRC
- Location
- Australia
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not 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.