Contact information
Type
Scientific
Primary contact
Prof Sue Roulstone
ORCID ID
Contact details
Frenchay SLT Research Unit
Frenchay Hospital
Frenchay Park Road
Bristol
BS16 1LE
United Kingdom
+44 (0)117 9701212 x2294
sue@speech-therapy.org.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
C/PHYSDIS/02/05-10-94/ENDERBY/D
Study information
Scientific title
Acronym
Study hypothesis
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
Added 15/01/10 (see publication):
Local research ethics committees for the three participating healthcare trusts gave approval for the trial
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/05/1995
Overall trial end date
31/07/1999
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
159
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/05/1995
Recruitment end date
31/07/1999
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Frenchay SLT Research Unit
Bristol
BS16 1LE
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive South West (UK)
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
1. 2000 results in http://www.ncbi.nlm.nih.gov/pubmed/11030677
2. 2000 results on parents views in http://www.ncbi.nlm.nih.gov/pubmed/10963021
3. 2001 results on scale to measure parent views in http://www.ncbi.nlm.nih.gov/pubmed/11802500
4. 2001 results of parent views in http://www.ncbi.nlm.nih.gov/pubmed/11340839
5. 2002 evaluation of multimethod approach in http://www.ncbi.nlm.nih.gov/pubmed/12568481
6. 2004 results in http://www.ncbi.nlm.nih.gov/pubmed/12823329
Publication citations
-
Results on parents views
Glogowska M, Campbell R, Investigating parental views of involvement in pre-school speech and language therapy., Int J Lang Commun Disord, 35, 3, 391-405.
-
Results on scale to measure parent views
Glogowska M, Campbell R, Peters TJ, Roulstone S, Enderby P, Developing a scale to measure parental attitudes towards preschool speech and language therapy services., Int J Lang Commun Disord, 36, 4, 503-513.
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Results
Roulstone S, Peters TJ, Glogowska M, Enderby P, A 12-month follow-up of preschool children investigating the natural history of speech and language delay., Child Care Health Dev, 2003, 29, 4, 245-255.
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Glogowska M, Roulstone S, Enderby P, Peters TJ, Randomised controlled trial of community based speech and language therapy in preschool children., BMJ, 2000, 321, 7266, 923-926.
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Glogowska M, Roulstone S, Enderby P, Peters T, Campbell R, Who's afraid of the randomised controlled trial? Parents' views of an SLT research study., Int J Lang Commun Disord, 2001, 36 Suppl, 499-504.
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Glogowska M, Campbell R, Peters TJ, Roulstone S, Enderby P, A multimethod approach to the evaluation of community preschool speech and language therapy provision., Child Care Health Dev, 2002, 28, 6, 513-521.