A randomised controlled trial of speech and language therapy (SLT) for pre-school children

ISRCTN ISRCTN63638157
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

Frenchay SLT Research Unit
Frenchay Hospital
Frenchay Park Road
Bristol
BS16 1LE
United Kingdom

Phone +44 (0)117 9701212 x2294
Email sue@speech-therapy.org.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesTo 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) studiedBehavioural disorders
Intervention1. Children received conventional Speech and Language Therapy provided in the community clinics
2. Watchful waiting - i.e. no therapy
Intervention typeOther
Primary outcome measureFour 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 measuresNot provided at time of registration
Overall study start date01/05/1995
Completion date31/07/1999

Eligibility

Participant type(s)Patient
Age groupChild
SexBoth
Target number of participants159
Key inclusion criteria159 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 criteriaDoes not match inclusion criteria
Date of first enrolment01/05/1995
Date of final enrolment31/07/1999

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Frenchay SLT Research Unit
Bristol
BS16 1LE
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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