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Cluster randomised control trial of an early childhood literacy intervention to improve literacy and language outcomes in preschool aged children
ISRCTN ISRCTN04602902
DOI 10.1186/ISRCTN04602902
ClinicalTrials.gov identifier
EudraCT number
Public title Cluster randomised control trial of an early childhood literacy intervention to improve literacy and language outcomes in preschool aged children
Scientific title
Acronym LR CRCT - Letís Read Cluster Randomised Control Trial
Serial number at source LP0561522
Study hypothesis This trial aims to examine the efficacy of Letís Read an initiative to promote reading with young children 0-5 years. This initiative has been designed to support and empower parents / carers to read with their child, and develop the building blocks that are needed to make the transition to school as easy as possible.

The components of Letís Read are:
1. Training community based professionals so they can show and support parents to have fun reading with their child and develop their childrenís early literacy skills.
2. Resources to give to families, including parent information leaflets, DVDs, suggested book lists and age appropriate books.
3. A community approach to promote the importance of literacy through existing services and systems, to reach as many families as possible and sustain the program for the long term. Letís Read provides a Community Facilitator and a Community Guide to support the planning and implementation of the program in each community. Simple community messages have been developed to support the promotion of literacy.

We hypothesise that, compared to the control group, benefits to the intervention group will comprise:
1. More parent-child interactive language, more literacy episodes and a better literacy environment in the home setting.
2. Better emergent and preschool language and literacy skills (expressive and receptive vocabulary, phonological awareness, and letter knowledge and print conventions).

We will also examine within-cohort predictors of outcomes in the intervention group, hypothesising that the intervention will differentially benefit the most disadvantaged children.
Lay summary Not provided at time of registration
Ethics approval Royal Childrenís Hospital Human Research Ethics Committee (HREC), approved on 20 January 2006. Ref: 25018C
Study design Cluster-randomised controlled trial.
Countries of recruitment Australia
Disease/condition/study domain Language and emergent literacy
Participants - inclusion criteria Parents of infants born May-July 2006 (2-4 weeks of age) attending their local Maternal and Child Health (MCH) centre in the cities of Moreland, Darebin, Hobsonís Bay, Frankston and Dandenong.
Participants - exclusion criteria Only parents who require the use of interpreters to verbally communicate will be excluded from the study.
Anticipated start date 09/03/2006
Anticipated end date 30/12/2011
Status of trial Completed
Patient information material
Target number of participants At least 900 parents
Interventions This cluster-randomised controlled trial is stratified at the level of the Local Government Area (LGA) and clustered at the level of the MCH centres. Clusters will be randomised according to a random number table.

Parents will be recruited consecutively when their infant is approximately 2-4 weeks of age. Over 2 months each MCH nurse will approach all parents of newborn infants attending their initial MCH centre visit to ascertain their interest in participating in the study. The Centre for Community Child Health (CCCH) will telephone interested parents and mail the information sheet and consent form, and organise the baseline face-to-face interviews.

The program is a multi-contact intervention providing age appropriate advice at four routine individual well-child visits when the child is aged 4-8 months, 12 months, 18 months and 3.5 years. Nurses will remind parents to attend for these visits. The first point at which a parent will receive the intervention is when the child is between 4 and 8 months of age and attending their MCHC for a routine visit. At this time nurses will deliver, model and discuss the Let's Read intervention messages and distribute the first Let's Read take home pack (free story book, DVD or video, booklist and guidance messages). The three subsequent Let's Read visits will follow similar formats, each with a free book, booklist and messages tailored to the age of the child (the DVD will be given at the first visit only).
Primary outcome measure(s) The following will be assessed annually from 12 months of age:
Measures of emergent literacy:
1. Who am I? An Australian measure for assessing the cognitive processes that underlie the learning of early literacy and numeracy skills in 4-7 year olds. It provides three numerical sub-scores (copying, symbols and drawing) and a total score out of a possible 44. Normative data are available for more than 4,000 Australian children, and its inclusion at 4 years in the "Growing Up in Australia: Longitudinal Study of Australian Children" (LSAC; an Australian government initiative that addresses a range of questions about children's development and wellbeing) will provide comparative data for a further 10,000 children.
2. Children's Test of Non-Word Repetition (CTNWR) is a measure of phonological memory, which provides information about word decoding ability and word attack skills; it is highly reliable even in preschool children and published norms are available.
3. Concepts About Print (CAP) This is a checklist of knowledge a child has about books and the function and conventions of text and books.
4. Preschool and Primary Inventory of Phonological Awareness (PIPA) This measure has six subtests that assess a childís ability to detect, isolate, manipulate and convert sound units and is normed on Australian children.

Language measures:
5. Peabody Picture Vocabulary Test (PPVT): A widely-used measures of receptive vocabulary, with excellent norms; provides standard scores and is being used in both the "Early Language in Victoria Study" (a longitudinal study of language development in Victorian children funded by the National Health and Medical Research Council) and LSAC.
6. Clinical Evaluation of Language Fundamentals-Preschool (CELF-P): This widely-used language assessment tool provides Total, Receptive and Expressive Language standard scores.
Secondary outcome measure(s) The following will be assessed annually from 12 months of age:
1. Literacy activities and environment: STIM Q is an orally administered questionnaire that assesses cognitive aspects of the home environment. The READ subscale focuses on the number and variety of books in the home and frequency and quality of shared reading activities. It has a 0.55 correlation with the Home Observation for Measurement of the Environment (HOME) inventory, the gold standard of the environment.
2. Measure of language progress: Macarthur Communicative Development Inventories (MCDI; 12 months, 2 years, 3 years): The age-appropriate versions will be completed, i.e. at 12 months - MCDI (Words and Gestures) scale, which focuses on vocabulary comprehension and production; at 2 years - the MCDI (Words and Sentences) scale; and at 3 years Ė the MCDI III, which includes a 100 item vocabulary list, twelve sentence pairs for assessing grammatical complexity and twelve yes/no questions concerning semantics, pragmatics and comprehension. Widely used in Australian and internationally, these measures are acceptable, well validated for English-speaking children, provide continuous standard scores, have known predictive value, and are felt to be among the most reliable early measures of language development.
3. Measure of developmental progress: Parentsí Evaluation of Developmental Status (PEDS): comprises ten questions eliciting parent concern about a broad range of developmental and behavioural domains, including receptive and expressive language, written at a Year 5 level. Sensitivities of 74-80% and specificities of 70-80% have been reported against gold-standard testing for developmental disabilities. The questions will be supplemented with similarly-formatted questions probing concerns about early interest in listening to and looking at books.
Sources of funding Australian Research Council
Trial website http://www.letsread.com.au/pages/clusterTrial.php?PHPSESSID=7da7edffe748e8a0e22a982b243c6f82
Publications 1. 2011 2 year results in http://www.ncbi.nlm.nih.gov/pubmed/21321030
2. 2012 4 year results in http://www.ncbi.nlm.nih.gov/pubmed/22986757
Contact name Mr  Richard  Kaa
  Address Centre for Community Child Health
6th Floor South East Building
Royal Children's Hospital
Flemington Road
Parkville
  City/town Victoria
  Zip/Postcode 3052
  Country Australia
  Email richard.kaa@mcri.edu.au
Sponsor Australian Research Council (ARC)
  Address 1st Floor, 8 Brindabella Circuit
Brindabella Business Park
Canberra Airport ACT 2609
GPO Box 2702
  City/town Canberra
  Zip/Postcode 2601
  Country Australia
  Tel +61 2 6287 6600
  Fax +61 2 6287 6601
  Email richard.kaa@kaaconsulting.com.au
  Sponsor website: http://www.arc.gov.au
Date applied 23/05/2007
Last edited 19/09/2012
Date ISRCTN assigned 25/06/2007
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