Condition category
Mental and Behavioural Disorders
Date applied
05/09/2007
Date assigned
05/09/2007
Last edited
29/07/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.erasmusmc.nl/content/englishindex.htm

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

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26218228

Publication citations

Additional files

Editorial Notes