| Source of record | UK Trials |
| ISRCTN | ISRCTN94684735 |
| Date ISRCTN assigned | 25/04/2003 |
| Local reference number(s) | HTA 99/36/04 |
| Public title | A randomised controlled trial (RCT) and economic evaluation of direct versus indirect and individual versus group modes of speech and language therapy for children with primary language impairment |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Nervous system diseases: Other nervous system disease |
| 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. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration. |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Children with language impairment |
| Participants - exclusion criteria | Not provided at time of registration. |
| Patient information material |
|
| Anticipated start date | 01/04/2002 |
| Anticipated end date | 30/06/2005 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration. |
| Interventions | 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 |
| Primary outcome measure(s) | Not provided at time of registration. |
| Secondary outcome measure(s) | Not provided at time of registration. |
| Publications | Results: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17610807 |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) |
| Sponsor name | Department of Health (UK) |
| Sponsor details | Quarry House
Quarry Hill
Leeds
United Kingdom
LS2 7UE |
| Sponsor email | Sheila.Greener@doh.gsi.gov.uk |
| Sponsor website | http://www.dh.gov.uk/en/index.htm |
| Contact name | Mr James Boyle |
| Contact details | Department of Psychology
Graham Hills Building
40 George Street
Glasgow
United Kingdom
G1 1QE |
| Contact telephone | +44 (0)141-548 2584 |
| Contact fax | +44 (0)141 548 4001 |
| Contact email | j.boyle@strath.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN94684735 |
| Date last extracted from ISRCTN register | 17/04/2008 |
