Condition category
Mental and Behavioural Disorders
Date applied
03/07/2007
Date assigned
05/09/2007
Last edited
13/10/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Melissa Wake

ORCID ID

Contact details

Royal Children's Hospital
Flemington Road
Parkville
Melbourne
3052
Australia
+61 (0)3 9345 5761
melissa.wake@rch.org.au

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

LLL (Let's Learn Language)

Study hypothesis

To trial a preventive approach to lowering the proportions of slow-to-talk toddlers who progress to expressive language and externalising behaviour problems at ages two and three years.

We hypothesise that:
1. Compared with the non-intervention (control) group at 24 and 36 months, the intervention group will comprise:
1.1. Fewer children with delays in early expressive vocabulary acquisition
1.2. Higher mean vocabulary and Mean Length of Utterance (MLU) scores, as well as scores on standardised measures of receptive and expressive language
1.3. A greater number of responsive linguistic interactions between parents and children
1.4. Lower mean scores on a standardised measure of externalising behaviour problems
2. The intervention will be more efficacious for disadvantaged children
3. The intervention will be acceptable and cost-effective

This is the resulting randomised trial from the pilot study registered under ISRCTN45091963.

Ethics approval

Received approval from the Ethics in Human Research Committee of the Royal Children's Hospital (Australia) on 2nd March 2007 (ref: EHRC 26028B).

Study design

Cluster randomised controlled trial, nested in a preceding population survey process.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Early delay in acquiring expressive vocabulary

Intervention

Cluster randomised controlled trial, with cluster at the level of the well-child centre. Masked randomisation is due to occur in January 2008 after the study team has recruited all clusters. Allocation to group will be a simple randomisation using computerised sequence generation, conducted by an independent statistician and concealed from the principal researchers to the end of the study's life and participants until allocation is complete. Group allocation will be concealed from researchers conducting two- and three-year follow-up direct assessments until data collection is complete.

Arm A - Parent Language Program Group:
A six-week parent language promotion program (six two-hour group sessions) adapted from the Hanen You Make The Difference™ program, offered to parents of slow-to-talk toddlers when the children turn 19 - 20 months old. The Parent Language Program teaches child-centred, interaction-promoting and language-modelling responsive interaction strategies targeting the development of vocabulary and multi-word phrases. The Parent Language Program will be conducted at local community centres, facilitated by an early childhood professional.

Arm B - Usual Care Group:
Usual care from the Maternal and Child Health (MCH) nurses who provide a universal and free surveillance service to Melbourne families in the first five years of life (active control).

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Parent-report of child's expressive vocabulary
2. Direct assessment of child's receptive language ability, child’s mean length of utterance in morphemes from videotaped short narrative
3. Parents' use of responsive language facilitation strategies derived from the videotaped language sample

All collected at two and three years.

Secondary outcome measures

1. Direct assessment of child's expressive language abilities
2. Parent-report of child's externalising behaviour problems

Both collected at two and three years.

Overall trial start date

01/05/2007

Overall trial end date

30/11/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Parents of 12 month-old infants
2. Attending community well-child clinics across three Melbourne local government areas from May to November 2007
3. Parents whose toddlers, at 18 months, are identified by a brief, parent-reported vocabulary questionnaire as having minimal or no expressive vocabulary (e.g., scoring at or below the 20th percentile relative to age and sex norms)

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

Target sample size is 1000 to identify 200 eligible children.

Participant exclusion criteria

1. Children with already-diagnosed (or a referral for) cognitive delay or major medical conditions
2. Children with symptoms of Autism Spectrum Disorder
3. Children with cleft palates
4. Parents with insufficient English to attend a Parent Language Program and complete brief written questionnaires

Recruitment start date

01/05/2007

Recruitment end date

30/11/2009

Locations

Countries of recruitment

Australia

Trial participating centre

Royal Children's Hospital
Melbourne
3052
Australia

Sponsor information

Organisation

Murdoch Childrens Research Institute, Parkville (Australia)

Sponsor details

c/o Associate Professor Melissa Wake
Royal Children's Hospital
Flemington Road
Parkville
Melbourne
3052
Australia
+61 (0)3 9345 5761
melissa.wake@rch.org.au

Sponsor type

Research organisation

Website

http://www.rch.org.au/rch/index.cfm?doc_id=1495

Funders

Funder type

Research council

Funder name

National Health and Medical Research Council (Australia) - Strategic Award (ref: #384491)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21852344

Publication citations

  1. Results

    Wake M, Tobin S, Girolametto L, Ukoumunne OC, Gold L, Levickis P, Sheehan J, Goldfeld S, Reilly S, Outcomes of population based language promotion for slow to talk toddlers at ages 2 and 3 years: Let's Learn Language cluster randomised controlled trial., BMJ, 2011, 343, d4741.

Additional files

Editorial Notes