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
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
-
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.