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
Protocol serial number	N/A
Sponsor	Erasmus Medical Centre (The Netherlands)
Funder	Netherlands Organisation for Health Research and Development

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

Erasmus University
Afdeling iBMG
P.O. Box 1738
Rotterdam
3000 DR
Netherlands

Phone	+31 (0)10 408 8617
Email	desonneville@bmg.eur.nl

Study information

Primary study design	Interventional
Study design	Multicentre single-blinded randomised active-controlled parallel-group trial
Secondary study design	Randomised controlled trial
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(s)	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.
Key secondary outcome measure(s)	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.
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	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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