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
| ISRCTN | ISRCTN94684735 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN94684735 |
| Secondary identifying numbers | HTA 99/36/04 |
- Submission date
- 25/04/2003
- Registration date
- 25/04/2003
- Last edited
- 01/04/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr James Boyle
Scientific
Scientific
Department of Psychology
Graham Hills Building
40 George Street
Glasgow
G1 1QE
United Kingdom
| Phone | +44 (0)141-548 2584 |
|---|---|
| j.boyle@strath.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific 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 |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/04/2002 |
| Completion date | 30/06/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | Not provided at time of registration |
| Total final enrolment | 161 |
| Key inclusion criteria | Children with language impairment |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/04/2002 |
| Date of final enrolment | 30/06/2005 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Department of Psychology
Glasgow
G1 1QE
United Kingdom
G1 1QE
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
| Phone | +44 (0)1132 545 843 |
|---|---|
| Sheila.Greener@doh.gsi.gov.uk | |
| Website | http://www.dh.gov.uk/en/index.htm |
"ROR" |
https://ror.org/03sbpja79 |
Funders
Funder type
Government
NIHR Health Technology Assessment Programme - HTA (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/07/2007 | Yes | No | ||
| Results article | 01/11/2009 | 01/04/2022 | Yes | No |
Editorial Notes
01/04/2022: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
