Preventing early language delay in the primary care setting: cluster randomised trial
| ISRCTN | ISRCTN20953675 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20953675 |
| Secondary identifying numbers | N/A |
- Submission date
- 03/07/2007
- Registration date
- 05/09/2007
- Last edited
- 13/10/2011
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Melissa Wake
Scientific
Scientific
Royal Children's Hospital
Flemington Road
Parkville
Melbourne
3052
Australia
| Phone | +61 (0)3 9345 5761 |
|---|---|
| melissa.wake@rch.org.au |
Study information
| Study design | Cluster randomised controlled trial, nested in a preceding population survey process. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | LLL (Let's Learn Language) |
| Study objectives | 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(s) | Received approval from the Ethics in Human Research Committee of the Royal Children's Hospital (Australia) on 2nd March 2007 (ref: EHRC 26028B). |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 1. Parent-report of child's expressive vocabulary 2. Direct assessment of child's receptive language ability, childs 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 study start date | 01/05/2007 |
| Completion date | 30/11/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | Target sample size is 1000 to identify 200 eligible children. |
| Key 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) |
| 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. Children with cleft palates 4. Parents with insufficient English to attend a Parent Language Program and complete brief written questionnaires |
| Date of first enrolment | 01/05/2007 |
| Date of final enrolment | 30/11/2009 |
Locations
Countries of recruitment
- Australia
Study participating centre
Royal Children's Hospital
Melbourne
3052
Australia
3052
Australia
Sponsor information
Murdoch Childrens Research Institute, Parkville (Australia)
Research organisation
Research organisation
c/o Associate Professor Melissa Wake
Royal Children's Hospital
Flemington Road
Parkville
Melbourne
3052
Australia
| Phone | +61 (0)3 9345 5761 |
|---|---|
| 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 council
National Health and Medical Research Council (Australia) - Strategic Award (ref: #384491)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 18/08/2011 | Yes | No |
