Condition category
Nervous System Diseases
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
14/09/2011
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

Mr James Boyle

ORCID ID

Contact details

Department of Psychology
Graham Hills Building
40 George Street
Glasgow
G1 1QE
United Kingdom
+44 (0)141-548 2584
j.boyle@strath.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 99/36/04

Study information

Scientific title

Acronym

Study hypothesis

1. To compare direct individual therapy (speech and language therapists working with children), indirect individual therapy (speech and language assistants working directly with children), direct group therapy (SLTs working with small groups of children) & indirect group therapy (SLAs working with small groups of children) with regard to the outcomes for school-age children with persistent primary receptive and/or expressive language impairment relative to a comparison group receiving current models and levels of SLT service.
2. To investigate the long-term benefits for such children from their therapy at 12 months follow-up.
3. To compare the four approaches in terms of cost.

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

Nervous system diseases: Other nervous system disease

Intervention

1. Direct individual therapy (speech and language therapists [SLTs] working with children)
2. Indirect individual therapy (speech and language assistants [SLAs] working directly with children)
3. Direct group therapy (SLTs working with small groups of children)
4. Indirect group therapy (SLAs working with small groups of children)
5. Current models of standard care

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/2002

Overall trial end date

30/06/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Children with language impairment

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

01/04/2002

Recruitment end date

30/06/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Psychology
Glasgow
G1 1QE
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/en/index.htm

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (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

2007 results:http://www.ncbi.nlm.nih.gov/pubmed/17610807

Publication citations

  1. Boyle J, McCartney E, Forbes J, O'Hare A, A randomised controlled trial and economic evaluation of direct versus indirect and individual versus group modes of speech and language therapy for children with primary language impairment., Health Technol Assess, 2007, 11, 25, iii-iv, xi-xii, 1-139.

Additional files

Editorial Notes