Condition category
Not Applicable
Date applied
23/05/2007
Date assigned
25/06/2007
Last edited
19/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.letsread.com.au/pages/clusterTrial.php?PHPSESSID=7da7edffe748e8a0e22a982b243c6f82

Contact information

Type

Scientific

Primary contact

Mr Richard Kaa

ORCID ID

Contact details

Centre for Community Child Health
6th Floor South East Building
Royal Children's Hospital
Flemington Road
Parkville
Victoria
3052
Australia
richard.kaa@mcri.edu.au

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

LP0561522

Study information

Scientific title

Acronym

LR CRCT - Let’s Read Cluster Randomised Control Trial

Study hypothesis

This trial aims to examine the efficacy of Let’s 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 Let’s Read are:
1. Training community based professionals so they can show and support parents to have fun reading with their child and develop their children’s 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. Let’s 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.

Ethics approval

Royal Children’s Hospital Human Research Ethics Committee (HREC), approved on 20 January 2006. Ref: 25018C

Study design

Cluster-randomised controlled trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Other

Patient information sheet

Condition

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

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 child’s 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 trial start date

09/03/2006

Overall trial end date

30/12/2011

Reason abandoned

Eligibility

Participant 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, Hobson’s Bay, Frankston and Dandenong.

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

At least 900 parents

Participant exclusion criteria

Only parents who require the use of interpreters to verbally communicate will be excluded from the study.

Recruitment start date

09/03/2006

Recruitment end date

30/12/2011

Locations

Countries of recruitment

Australia

Trial participating centre

Centre for Community Child Health
Victoria
3052
Australia

Sponsor information

Organisation

Australian Research Council (ARC)

Sponsor details

1st Floor
8 Brindabella Circuit
Brindabella Business Park
Canberra Airport ACT 2609
GPO Box 2702
Canberra
2601
Australia
+61 2 6287 6600
richard.kaa@kaaconsulting.com.au

Sponsor type

Government

Website

http://www.arc.gov.au

Funders

Funder type

Government

Funder name

Australian Research Council

Alternative name(s)

ARC

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Australia

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

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

Publication citations

  1. Goldfeld S, Napiza N, Quach J, Reilly S, Ukoumunne OC, Wake M, Outcomes of a universal shared reading intervention by 2 years of age: the Let's Read trial., Pediatrics, 2011, 127, 3, 445-453, doi: 10.1542/peds.2009-3043.

  2. Goldfeld S, Quach J, Nicholls R, Reilly S, Ukoumunne OC, Wake M, Four-year-old outcomes of a universal infant-toddler shared reading intervention: the let's read trial., Arch Pediatr Adolesc Med, 2012, 166, 11, 1045-1052, doi: 10.1001/archpediatrics.2012.1099.

Additional files

Editorial Notes