A randomised controlled trial of speech and language therapy (SLT) for pre-school children
ISRCTN | ISRCTN63638157 |
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DOI | https://doi.org/10.1186/ISRCTN63638157 |
Secondary identifying numbers | C/PHYSDIS/02/05-10-94/ENDERBY/D |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 10/02/2010
- 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
Prof Sue Roulstone
Scientific
Scientific
Frenchay SLT Research Unit
Frenchay Hospital
Frenchay Park Road
Bristol
BS16 1LE
United Kingdom
Phone | +44 (0)117 9701212 x2294 |
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sue@speech-therapy.org.uk |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Not Specified |
Scientific title | |
Study objectives | To compare the progress made by children during a 12 month period of watchful waiting with that made by the children who had immediate access to therapy. The study will recruit 372 subjects, standardised speech and language tests will assist to stratify the subjects in order to examine the outcomes of different sub-groups. A taped speech and language sample will be analysed blind to test the validity of the findings on the standardised procedures. |
Ethics approval(s) | Added 15/01/10 (see publication): Local research ethics committees for the three participating healthcare trusts gave approval for the trial |
Health condition(s) or problem(s) studied | Behavioural disorders |
Intervention | 1. Children received conventional Speech and Language Therapy provided in the community clinics 2. Watchful waiting - i.e. no therapy |
Intervention type | Other |
Primary outcome measure | Four quantitative measures of speech and language assessed at 6 and 12 months; a binary variable indicating improvement, by 12 months on the entry criterion |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/05/1995 |
Completion date | 31/07/1999 |
Eligibility
Participant type(s) | Patient |
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Age group | Child |
Sex | Both |
Target number of participants | 159 |
Key inclusion criteria | 159 pre-school children with significant speech and/or language difficulties who fulfilled entry criteria for admission to Speech and Language Therapy and whose parents consented for them to participate. |
Key exclusion criteria | Does not match inclusion criteria |
Date of first enrolment | 01/05/1995 |
Date of final enrolment | 31/07/1999 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Frenchay SLT Research Unit
Bristol
BS16 1LE
United Kingdom
BS16 1LE
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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dhmail@doh.gsi.org.uk | |
Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive South West (UK)
No information available
Results and Publications
Intention to publish date | |
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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 on parents views | 01/07/2000 | Yes | No | |
Results article | results | 14/10/2000 | Yes | No | |
Results article | results of parent views | 01/10/2001 | Yes | No | |
Results article | results on scale to measure parent views | 01/10/2001 | Yes | No | |
Other publications | evaluation of multimethod approach | 01/11/2002 | Yes | No | |
Results article | results | 01/07/2003 | Yes | No |