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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.

Abstract Background Infant crying and sleep problems (e.g. frequent night waking, difficulties settling to sleep) each affect up to 30% of infants and often co-exist. They are costly to manage and associated with adverse outcomes including postnatal depression symptoms, early weaning from breast milk, and later child behaviour problems. Preventing such problems could improve these adverse outcomes and reduce costs to families and the health care system. Anticipatory guidance-i.e. providing parents with information about normal infant sleep and cry patterns, ways to encourage self-settling in infants, and ways to develop feeding and settling routines before the onset of problems-could prevent such problems. This paper outlines the protocol for our study which aims to test an anticipatory guidance approach. Methods/Design 750 families from four Local Government Areas in Melbourne, Australia have been randomised to receive the Baby Business program (intervention group) or usual care (control group) offered by health services. The Baby Business program provides parents with information about infant sleep and crying via a DVD and booklet (mailed soon after birth), telephone consultation (at infant age 6-8 weeks) and parent group session (at infant age 12 weeks). All English speaking parents of healthy newborn infants born at > 32 weeks gestation and referred by their maternal and child health nurse at their first post partum home visit (day 7-10 postpartum), are eligible. The primary outcome is parent report of infant night time sleep as a problem at four months of age and secondary outcomes include parent report of infant daytime sleep or crying as a problem, mean duration of infant sleep and crying/24 hours, parental depression symptoms, parent sleep quality and quantity and health service use. Data will be collected at two weeks (baseline), four months and six months of age. An economic evaluation using a cost-consequences approach will, from a societal perspective, compare costs and health outcomes between the intervention and control groups. Discussion To our knowledge this is the first randomised controlled trial of a program which aims to prevent both infant sleeping and crying problems and associated postnatal depression symptoms. If effective, it could offer an important public health prevention approach to these common, distressing problems. Trial registration number ISRCTN: ISRCTN63834603