Cluster randomised control trial of an early childhood literacy intervention to improve literacy and language outcomes in preschool aged children

ISRCTN	ISRCTN04602902
DOI	https://doi.org/10.1186/ISRCTN04602902
Secondary identifying numbers	LP0561522

Submission date: 23/05/2007
Registration date: 25/06/2007
Last edited: 24/10/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Mr Richard Kaa
Scientific

Centre for Community Child Health
6th Floor South East Building
Royal Children's Hospital
Flemington Road
Parkville
Victoria
3052
Australia

Email	richard.kaa@mcri.edu.au

Study information

Study design	Cluster-randomised controlled trial.
Primary study design	Interventional
Secondary study design	Cluster randomised trial
Study setting(s)	Community
Study type	Other
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Cluster randomised control trial of an early childhood literacy intervention to improve literacy and language outcomes in preschool aged children
Study acronym	LR CRCT - Lets Read Cluster Randomised Control Trial
Study objectives	This trial aims to examine the efficacy of Lets 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 Lets Read are: 1. Training community based professionals so they can show and support parents to have fun reading with their child and develop their childrens 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. Lets 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. The trialists 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). The trialists will also examine within-cohort predictors of outcomes in the intervention group, hypothesising that the intervention will differentially benefit the most disadvantaged children.
Ethics approval(s)	Royal Childrens Hospital Human Research Ethics Committee (HREC), 20/01/2006, ref: 25018C
Health condition(s) or problem(s) studied	Language and emergent literacy
Intervention	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).
Intervention type	Behavioural
Primary outcome measure	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 childs 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 measures	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 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: Parents 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.
Overall study start date	09/03/2006
Completion date	30/12/2011

Eligibility

Participant type(s)	Other
Age group	Mixed
Sex	Both
Target number of participants	At least 900 parents
Key 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, Hobsons Bay, Frankston and Dandenong.
Key exclusion criteria	Only parents who require the use of interpreters to verbally communicate will be excluded from the study.
Date of first enrolment	09/03/2006
Date of final enrolment	30/12/2011

Locations

Countries of recruitment

Australia

Study participating centre

Royal Children's Hospital

Victoria
3052
Australia

Sponsor information

Australian Research Council (ARC)
Government

1st Floor, 8 Brindabella Circuit
Brindabella Business Park
Canberra Airport ACT 2609
GPO Box 2702
Canberra
2601
Australia

Phone	+61 (0)2 6287 6600
Email	richard.kaa@kaaconsulting.com.au
Website	http://www.arc.gov.au
"ROR"	https://ror.org/05mmh0f86

Funders

Funder type

Government

Australian Research Council
Government organisation / Other non-profit organizations

Alternative name(s): arc_gov_au, The Australian Research Council, Australian Government Australian Research Council (ARC), ARC
Location: Australia

Results and Publications

Intention to publish date
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	Peer reviewed?	Patient-facing?
Results article	2-year results	01/03/2011	Yes	No
Results article	4-year results	01/11/2012	Yes	No
Results article	results	01/03/2018	Yes	No

Editorial Notes

24/10/2017: Publication reference added.