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Improving outcomes of preschool language delay in the community

Improving outcomes of preschool language delay in the community: a large-scale randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN03981121
Enrollment
1500
Registered
2010-06-23
Start date
2010-03-01
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Language delay at four years of age Mental and Behavioural Disorders Specific developmental disorders of speech and language

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
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-the

Sponsors

Royal Children's Hospital (Australia)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Direct assessment of child?s expressive and receptive language ability and expressive and receptive vocabulary; all collected at 5 and 6 years.

Secondary

MeasureTime frame
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

Countries

Australia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 26, 2026