Condition category
Mental and Behavioural Disorders
Date applied
03/07/2007
Date assigned
05/09/2007
Last edited
05/09/2007
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.rch.org.au/emplibrary/ccch/TheLetsLearnLanguage.pdf

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 determine the feasibility of conducting a randomised controlled trial investigating a preventative approach to improve children's language development and behaviour problems at two years of age. Aims of this pilot were to:
1. Examine whether families whose children score at or below the 20th percentile on a standardised vocabulary measure agree to be randomised to a six-week Parent Language Program and to a non-intervention group
2. Compare the usefulness of two standardised vocabulary measures for post-test assessment: the SureStart 100 word Vocabulary Checklist (adapted from the MacArthur Bates Communicative Development Inventories [MBCDI] by Roy, Kersley and Law [2005]) or the Vocabulary Checklist from the complete MBCDI (approx 680 words divided into semantic categories)
3. Trial the videotaping of post-test assessment at 21 - 24 months
4. Solicit parents' evaluations of the program's content and format to provide information about program changes that may increase the feasibility of the Parent Language Program for families in Victoria

This is the pilot study to the randomised trial assigned to ISRCTN20953675.

Ethics approval

Received ethics approval from The Royal Children's Hospital Ethics in Humans Research Committee (EHRC) on the 7th June 2007 (ref: 26073A).

Study design

Pilot randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Prevention

Patient information sheet

Condition

Early delay in acquiring expressive vocabulary

Intervention

For each pair of eligible families recruited, one was randomly allocated to the Parent Language Program Group and one to the Usual Care Group. Masking occurred at randomisation, with group allocation concealed from the principal researcher and participants until allocation was complete. Group allocation was concealed from the researcher conducting follow-up direct assessments with intervention (Parent Language Program) families until data collection was 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 when children were 19 - 22 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 was conducted within the family's local community, 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

The primary outcomes are to pilot and refine:
1. Parent interest in, and attendance at, a six-week parent language promotion program
2. Organisation and format of the Parent Language Program sessions, adapted from You Make The Difference™ program
3. The sensitivity of the assessment tools used during the follow-up

Secondary outcome measures

No secondary outcome measures

Overall trial start date

15/06/2006

Overall trial end date

15/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Parents of 18 - 21 month-old toddlers
2. Attending any of eight well-child clinics within one Melbourne local government area
3. 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 was 100 to identify 20 eligible children. Recruitment status achieved was 103, which identified 30 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. Parents with insufficient English to attend a parent language program and complete brief written questionnaires

Recruitment start date

15/06/2006

Recruitment end date

15/12/2006

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 organisation

Funder name

Murdoch Childrens Research Institute, Parkville (Australia)

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

Publication citations

Additional files

Editorial Notes