Condition category
Mental and Behavioural Disorders
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
08/08/2011
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

Ms Jan Broomfield

ORCID ID

Contact details

Tees and North East Yorkshire NHS Trust
157 Southfield Road
Middlesbrough
Teesside
TS1 3HF
United Kingdom
+44 (0)1642 246603
jan@speechtherapy4kids.co.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RCT66 Broomfield

Study information

Scientific title

Acronym

Study hypothesis

Is Speech and Language Therapy Effective with Children who have a primary Speech and Language Disability?

Sub-questions are:
1. Is the timing of such intervention significant?
2. Are there early prognostic indicators as compared with outcome?

Ethics approval

Not provided at time of registration

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

Mental and Behavioural Disorders: Speech disorders

Intervention

1. Brief immediate
2. Brief deferred and ongoing intervention

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Statistical analyses of variance and regression will compare effects of intervention and prognostic indicators on outcome. The key outcome measure will be the reduction in the severity of the primary speech/language disability.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

02/01/1999

Overall trial end date

08/01/2001

Reason abandoned

Eligibility

Participant inclusion criteria

Those children who are referred to Speech and Language Therapy (SLT) who have a primary speech/language disability in the absence of an attributable causal condition e.g. hearing loss, developmental disability or physical disability.

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

02/01/1999

Recruitment end date

08/01/2001

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Tees and North East Yorkshire NHS Trust
Teesside
TS1 3HF
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 Northern and Yorkshire (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. 2011 results in http://onlinelibrary.wiley.com/doi/10.1111/j.1460-6984.2011.00039.x/abstract

Publication citations

Additional files

Editorial Notes