Condition category
Mental and Behavioural Disorders
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
10/02/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.doh.gov.uk

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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Additional files

Editorial Notes