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
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