Contact information
Type
Scientific
Primary contact
Mrs Caroline de Sonneville Koedoot
ORCID ID
Contact details
Erasmus University
Afdeling iBMG
P.O. Box 1738
Rotterdam
3000 DR
Netherlands
+31 (0)10 408 8617
desonneville@bmg.eur.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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)
Acronym
RESTART
Study hypothesis
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
Ethics board of the Erasmus University in Rotterdam (Medisch Ethische Toetsings Commissie [METC]), 10/05/2007, ref: MEC-2006-349
Study design
Multicentre single-blinded randomised active-controlled parallel-group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Stuttering pre-schoolers
Intervention
Demands and Capacities Model based treatment versus Lidcombe Programme.
Intervention type
Other
Phase
Not Specified
Drug names
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 trial start date
01/08/2007
Overall trial end date
01/12/2011
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
196
Participant 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
Recruitment start date
01/08/2007
Recruitment end date
01/12/2011
Locations
Countries of recruitment
Netherlands
Trial participating centre
Erasmus University
Rotterdam
3000 DR
Netherlands
Sponsor information
Organisation
Erasmus Medical Centre (The Netherlands)
Sponsor details
Department of Health Policy and Management
P.O. Box 1738
Rotterdam
3000 DR
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Netherlands Organisation for Health Research and Development
Alternative name(s)
Netherlands Organisation for Health Research and Development
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
Netherlands
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
Basic results (scientific)
Publication list
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26218228