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Open Access Study protocol

Improving outcomes of preschool language delay in the community: protocol for the Language for Learning randomised controlled trial

Melissa Wake123*, Penny Levickis123, Sherryn Tobin12, Naomi Zens123, James Law4, Lisa Gold5, Obioha C Ukoumunne6, Sharon Goldfeld123, Ha ND Le5, Jemma Skeat2 and Sheena Reilly23

Author Affiliations

1 Centre for Community Child Health, Royal Children’s Hospital, Parkville, Australia

2 Murdoch Childrens Research Institute, Parkville, Australia

3 Department of Paediatrics, The University of Melbourne, Parkville, Australia

4 Institute of Health and Society, School of Education, Communication and Language Sciences, University of Newcastle, Newcastle, United Kingdom

5 Deakin Health Economics, Deakin University, Melbourne, Australia

6 PenCLAHRC Peninsula College of Medicine and Dentistry, University of Exeter, Exeter, United Kingdom

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BMC Pediatrics 2012, 12:96  doi:10.1186/1471-2431-12-96

Published: 9 July 2012

Abstract

Background

Early language delay is a high-prevalence condition of concern to parents and professionals. It may result in lifelong deficits not only in language function, but also in social, emotional/behavioural, academic and economic well-being. Such delays can lead to considerable costs to the individual, the family and to society more widely. The Language for Learning trial tests a population-based intervention in 4 year olds with measured language delay, to determine (1) if it improves language and associated outcomes at ages 5 and 6 years and (2) its cost-effectiveness for families and the health care system.

Methods/Design

A large-scale randomised trial of a year-long intervention targeting preschoolers with language delay, nested within a well-documented, prospective, population-based cohort of 1464 children in Melbourne, Australia. All children received a 1.25-1.5 hour formal language assessment at their 4th birthday. The 200 children with expressive and/or receptive language scores more than 1.25 standard deviations below the mean were randomised into intervention or ‘usual care’ control arms. The 20-session intervention program comprises 18 one-hour home-based therapeutic sessions in three 6-week blocks, an outcome assessment, and a final feed-back/forward planning session. The therapy utilises a ‘step up-step down’ therapeutic approach depending on the child’s language profile, severity and progress, with standardised, manualised activities covering the four language development domains of: vocabulary and grammar; narrative skills; comprehension monitoring; and phonological awareness/pre-literacy skills. Blinded follow-up assessments at ages 5 and 6 years measure the primary outcome of receptive and expressive language, and secondary outcomes of vocabulary, narrative, and phonological skills.

Discussion

A key strength of this robust study is the implementation of a therapeutic framework that provides a standardised yet tailored approach for each child, with a focus on specific language domains known to be associated with later language and literacy. The trial responds to identified evidence gaps, has outcomes of direct relevance to families and the community, includes a well-developed economic analysis, and has the potential to improve long-term consequences of early language delay within a public health framework.

Trial registration

Current Controlled Trials ISRCTN03981121.

Keywords:
Language development; Mass screening; Language development disorders; Early intervention; Outcome assessment; Child development; Randomized controlled trial; Population characteristics