Cost-effectiveness of the demands and capacities model-based treatment compared to the Lidcombe Programme of early stuttering intervention: a randomised trial (the Rotterdam Evaluation study of Stuttering Treatment in children- A Randomized Trial)
| ISRCTN | ISRCTN24362190 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24362190 |
| Secondary identifying numbers | N/A |
- Submission date
- 05/09/2007
- Registration date
- 05/09/2007
- Last edited
- 29/07/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mrs Caroline de Sonneville Koedoot
Scientific
Scientific
Erasmus University
Afdeling iBMG
P.O. Box 1738
Rotterdam
3000 DR
Netherlands
| Phone | +31 (0)10 408 8617 |
|---|---|
| desonneville@bmg.eur.nl |
Study information
| Study design | Multicentre single-blinded randomised active-controlled parallel-group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Cost-effectiveness of the demands and capacities model-based treatment compared to the Lidcombe Programme of early stuttering intervention: a randomised trial (the Rotterdam Evaluation study of Stuttering Treatment in children- A Randomized Trial) |
| Study acronym | RESTART |
| Study objectives | The Lidcombe Programme for early stuttering intervention is more cost-effective than the Demands and Capacities Model-based treatment. On 10/01/2012 the overall trial end date was changed from 30/07/2010 to 01/12/2011. |
| Ethics approval(s) | Ethics board of the Erasmus University in Rotterdam (Medisch Ethische Toetsings Commissie [METC]), 10/05/2007, ref: MEC-2006-349 |
| Health condition(s) or problem(s) studied | Stuttering pre-schoolers |
| Intervention | Demands and Capacities Model based treatment versus Lidcombe Programme. |
| Intervention type | Other |
| Primary outcome measure | 1. The percentage of recovered children at 18 months post randomisation 2. The costs for a recovered child All primary outcome measures will be measured at 3, 6, 12 and 18 months post starting the therapy. |
| Secondary outcome measures | 1. The frequency of stuttering outside the clinic at 18 months post randomisation 2. The Health Utility Index 3. Visual Analogue Scale (Euroqol VAS proxy) 4. Child Health Questionnaire 5. Children Behaviour Check List All secondary outcome measures will be measured at 3, 6, 12 and 18 months post starting the therapy, except the Children Behavioural Check List, which will be measured at 18 months only. |
| Overall study start date | 01/08/2007 |
| Completion date | 01/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 3 Years |
| Upper age limit | 6.3 Years |
| Sex | Both |
| Target number of participants | 196 |
| Key inclusion criteria | 1. Aged 3.0 to 6.3 years 2. Frequency of stuttering at least 3% 3. Parent and one therapist agree the child stutters 4. Parent rating of stuttering severity on an 8-point scale of at least 2 5. Proficiency in Dutch for children and parents |
| Key exclusion criteria | 1. Onset of stuttering within 6 months before recruitment 2. Treatment for stuttering during the previous 12 months 3. Diagnosed language disorder 4. Neurological, emotional, cognitive, behavioural or autism spectrum disorder |
| Date of first enrolment | 01/08/2007 |
| Date of final enrolment | 01/12/2011 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus University
Rotterdam
3000 DR
Netherlands
3000 DR
Netherlands
Sponsor information
Erasmus Medical Centre (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Health Policy and Management
P.O. Box 1738
Rotterdam
3000 DR
Netherlands
| Website | http://www.erasmusmc.nl/content/englishindex.htm |
|---|---|
"ROR" |
https://ror.org/018906e22 |
Funders
Funder type
Research organisation
Netherlands Organisation for Health Research and Development
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Netherlands Organisation for Health Research and Development
- Location
- Netherlands
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 28/07/2015 | Yes | No |
