Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000809730
Ethics application status
Not yet submitted
Date submitted
18/07/2013
Date registered
23/07/2013
Date last updated
23/07/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Chatter Matters Study: Early Language Intervention for Children Admitted for an Extended Stay in Hospital.
Scientific title
In medically-complex children aged 4-36 months in the acute inpatient setting, does group speech-language therapy compared to individual speech-language therapy improve language development outcomes - a controlled trial.
Secondary ID [1] 282806 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Communication delay in young, medically-complex infants hospitalised for an extended stay. 289579 0
Condition category
Condition code
Public Health 289914 289914 0 0
Health service research
Physical Medicine / Rehabilitation 289999 289999 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group Speech-Language Therapy: Communication intervention and parent education provided by a Speech Pathologist for two sessions per week for five weeks (for approximately 1 hour) to children and their caregivers in a group context. Communication intervention will be provided in the format of a structured parent-training program based on key concepts for speech and language development. Parents will be able to practise these activities with their children within the group context and brainstorm ways to implement these activities in the ward environment. To monitor adherence, case notes will be kept by the treating Speech Pathologist.
Intervention code [1] 287491 0
Prevention
Intervention code [2] 287565 0
Treatment: Other
Intervention code [3] 287566 0
Behaviour
Comparator / control treatment
Individual Speech-Language Therapy: Communication intervention and parent education provided by a Speech Pathologist. The intervention will consist of two sessions per week for five weeks (for approximately 1 hour) to children and their caregivers on an individualised basis. Communication intervention will consist of play-based speech and language stimulation and parent information around key concepts for speech and language development. [Standard Care]. To monitor adherence, case notes will be kept by the treating Speech Pathologist.
Control group
Active

Outcomes
Primary outcome [1] 289967 0
Speech-Language Competence: As measured by a test battery of standardised communication assessments. The test battery will include: The Rossetti Infant-Toddler Language Scale, Infant Monitor of Vocal Production, Communication and Symbolic Behavior Scales (CSBS) Infant-Toddler Checklist, MacArthur-Bates Communicative Development Inventory (CDI).
Timepoint [1] 289967 0
Post-Intervention Assessment (in the two weeks after the intervention cycle has finished).
Primary outcome [2] 289968 0
Parent-Child Interaction: Nursing Child Assessment Satellite Training (NCAST) Parent-Child Interaction (PCI) Teaching Scale.
Timepoint [2] 289968 0
Post-Intervention Assessment (in the two weeks after the intervention cycle has finished).
Primary outcome [3] 289973 0
Parent Satisfaction & Parent Knowledge: Parental satisfaction for both groups will be assessed on a purposive questionnaire, with additional questions about the group therapy approach measured on a 10 point visual analogue scale for the parents of group therapy children. Parental knowledge will be measured via parental survey on language development and stimulation principles.
Timepoint [3] 289973 0
Post-Intervention Assessment (in the two weeks after the intervention cycle has finished).
Secondary outcome [1] 303882 0
Nil
Timepoint [1] 303882 0
Nil

Eligibility
Key inclusion criteria
Inclusion Criteria: Group Speech-Language Therapy [n=17] -Children in the General Medical Ward; aged 4-36 months; no diagnosed global developmental delay. Individual Speech-Language Therapy [n=17] - Children in the Surgical and Infectious Diseases Wards aged 4-36 months; no diagnosed global developmental delay. Due to bed configuration and the risk of infection from children on alternative wards it is not appropriate to individually allocate children to treatments groups via randomisation. Children who can mix freely on general medical wards will be assigned to group intervention.
Minimum age
4 Months
Maximum age
36 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children admitted for a short stay (e.g. less than 5 months, shorter than the treatment period); patients for whom English is not their primary language (e.g. assessments are only validated for children for whom English is their primary language). Children with global developmental delay, or acquired brain injury, neurological impairment, hearing impairment, visual impairment, seizures, genetic syndrome with associated cognitive impairment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The Infant Team / Speech Pathology Department therapists will identify children who meet the inclusion / exclusion criteria from new referrals and will contact the researcher. The research will contact the families either in person or via the telephone and upon receiving consent will assign the patients to groups. Potential participants will be provided with an information brochure and verbal information about the study by the principal researcher. Written consent will be sought prior to making further contact with the potential participant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Non-randomised controlled trial. Children are allocated to treatment groups based on their ward location due to universal infection control procedures.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We are aiming to recruit 20 participants in each group to allow for participant attrition. We require 17 participants in each group to obtain 80% power to detect a 1 SD difference between groups with alpha=0.05. We shall compare characteristics at study completion using linear regression (continuous outcomes) and logistic regression (binary outcomes). Group allocation will be included in all models as the main effect, and we will adjust models for any between group characteristics significantly different at baseline.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/07/2013
Actual
Date of last participant enrolment
Anticipated
20/12/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
34
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 287588 0
Government body
Name [1] 287588 0
Queensland Health:Health Practitioner Research Grant Scheme 2013-2014
Country [1] 287588 0
Australia
Primary sponsor type
Government body
Name
Queensland Health.
Address
Royal Children's Hospital,
Herston Road Herston,
QLD 4029
Country
Australia
Secondary sponsor category [1] 286335 0
None
Name [1] 286335 0
Address [1] 286335 0
Country [1] 286335 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289561 0
Children’s Health Services Human Research Ethics Committee
Ethics committee address [1] 289561 0
Ethics committee country [1] 289561 0
Australia
Date submitted for ethics approval [1] 289561 0
10/07/2013
Approval date [1] 289561 0
Ethics approval number [1] 289561 0
HREC/13/QRCH/129

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41326 0
Ms Sarah Kilcoyne
Address 41326 0
Speech Pathology Department,
Level 4, Coles Building,
Royal Children's Hospital,
Herston Road,
Herston, QLD 4029
Country 41326 0
Australia
Phone 41326 0
+61 (07) 3636 8508
Fax 41326 0
Email 41326 0
[email protected]
Contact person for public queries
Name 41327 0
Sarah Kilcoyne
Address 41327 0
Speech Pathology Department,
Level 4, Coles Building,
Royal Children's Hospital,
Herston Road,
Herston, QLD 4029
Country 41327 0
Australia
Phone 41327 0
+61 (07) 3636 8508
Fax 41327 0
Email 41327 0
[email protected]
Contact person for scientific queries
Name 41328 0
Sarah Kilcoyne
Address 41328 0
Speech Pathology Department,
Level 4, Coles Building,
Royal Children's Hospital,
Herston Road,
Herston, QLD 4029
Country 41328 0
Australia
Phone 41328 0
+61 (07) 3636 8508
Fax 41328 0
Email 41328 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.