Preventing early language delay: a pilot study

ISRCTN	ISRCTN45091963
DOI	https://doi.org/10.1186/ISRCTN45091963
Secondary identifying numbers	N/A

Submission date: 03/07/2007
Registration date: 05/09/2007
Last edited: 05/09/2007

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr Melissa Wake
Scientific

Royal Children's Hospital
Flemington Road
Parkville
Melbourne
3052
Australia

Phone	+61 (0)3 9345 5761
Email	melissa.wake@rch.org.au

Study information

Study design	Pilot randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Prevention
Scientific title
Study acronym	LLL (Let's Learn Language)
Study objectives	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(s)	Received ethics approval from The Royal Children's Hospital Ethics in Humans Research Committee (EHRC) on the 7th June 2007 (ref: 26073A).
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	15/06/2006
Completion date	15/12/2006

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	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.
Key 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)
Key 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
Date of first enrolment	15/06/2006
Date of final enrolment	15/12/2006

Locations

Countries of recruitment

Australia

Study participating centre

Royal Children's Hospital

Melbourne
3052
Australia

Sponsor information

Murdoch Childrens Research Institute, Parkville (Australia)
Research organisation

c/o Associate Professor Melissa Wake
Royal Children's Hospital
Flemington Road
Parkville
Melbourne
3052
Australia

Phone	+61 (0)3 9345 5761
Email	melissa.wake@rch.org.au
Website	http://www.rch.org.au/rch/index.cfm?doc_id=1495
"ROR"	https://ror.org/048fyec77

Funders

Funder type

Research organisation

Murdoch Childrens Research Institute, Parkville (Australia)

No information available

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