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

ISRCTN	ISRCTN63638157
DOI	https://doi.org/10.1186/ISRCTN63638157
Protocol serial number	C/PHYSDIS/02/05-10-94/ENDERBY/D
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive South West (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/07/1999

Participant type(s)	Patient
Age group	Child
Sex	All
Target sample size at registration	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

Frenchay SLT Research Unit

Bristol
BS16 1LE
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	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
Results article	results	01/07/2003	Yes	No
Other publications	evaluation of multimethod approach	01/11/2002	Yes	No