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van CCT (UK)

van CCT (UK)

Cost-effectiveness of the Demands and Capacities Model based treatment compared to the Lidcombe Programme of early stuttering intervention: Randomised Trial.

- candidate number2668
- NTR NumberNTR1024
- Date ISRCTN created5-sep-2007
- date ISRCTN requested31-aug-2007
- Date Registered NTR23-jul-2007
- Secondary IDs 
- Public TitleCost-effectiveness of the Demands and Capacities Model based treatment compared to the Lidcombe Programme of early stuttering intervention: Randomised Trial.
- Scientific TitleCost-effectiveness of the Demands and Capacities Model based treatment compared to the Lidcombe Programme of early stuttering intervention: Randomised Trial.
- hypothesisThe Lidcombe Programme for early stuttering intervention is more cost-effective than the Demands and Capacities Model based treatment.
- Healt Condition(s) or Problem(s) studiedStuttering pre-schoolers
- Inclusion criteria1. Age 3.0-6.3; 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.
- Exclusion criteria1. Onset of stuttering within 6 months before recruitment; 2. Treatment for stuttering during the previous 12 months; 3. Diagnosed language disorder; 4. Neurologic, emotional, cognitive, behavioral or autism spectrum disorder.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-aug-2007
- planned closingdate30-jul-2010
- Target number of participants196
- InterventionsDemands and Capacities Model based treatment versus Lidcombe Programme
- Primary outcome1. The percentage of recovered children at 18 months post randomization; 2. The costs for a recovered child.
- Secondary outcome1. The frequency of stuttering outside the clinic at 18 months post randomization. The Health Utility Index, visual analogue scale (Euroqol VAS proxy), Child Health Questionnaire, Children Behaviour Check List.
- Timepoints
- Trial web site
- statusopen: patient inclusion
- Sponsor/Initiator Erasmus Medical Center, Department of Health Policy and Management
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsFranken, M.C.J., Kielstra-van der Schalk, C.J. & Boelens, H. (2005). Experimental treatment of early stuttering: a preliminary study. Journal of Fluency Disorders, 30 (3), 189-199. Jones, M., Onslow, M. Packman, A., Williams, S., Ormond, T., Schwarz, I., Gebski, V. (2005). Randomised controlled trial of the Lidcombe programme of early stuttering intervention. British Medical Journal, 331, 659-661. Gottwald, S.R. & Starkweather, C,W. (1999). Stuttering prevention and early intervention: a multiprocess approach. in; M. Onslow & A. Packman (eds.) The handbook of early stuttering intervention, 53-82. San Diego/London: Singular Publishing Group.
- Brief summaryStuttering is a frequent problem in three to six year olds: about 5% of children begin to stutter (Bloodstein 1995). The recovery rate four years after onset without intervention is 74% (Yairi & Ambrose 2005). The consensus is that all stuttering children should be treated in the preschool years (Jones et al 2005), because of a higher chance on succesful treatment outcome, presumably so because neural plasticity decreases with age. Also, it is nog yet possible to predict for an individual case who will or will not recover from stuttering. In the Netherlands, the Demands and Capacities Model based treatment is the standard (DCM, Starkweather et al 1990). This treatment uses an indirect approach. The Lidcombe Programme (LP) is the Australian standard for treating pre-school children who stutter. This is a direct treatment, because it aims to increase fluent and decrease stuttered speech. Evidence suggests that both treatments are effective. A RCT with the LP showed that at 9 months after randomization, children who were treated with the LP were stuttering less than children in the no treatment arm (Jones et al 2005). Efficacy of the DCM has been shown in a randomized pilot trial in which the effects of DCM and LP treatment after 12 weeks were compared to each other (Franken et al 2005). To improve the evidence basis underlying stuttertherapies, a cost-effective evaluation of stuttering therapy is relevant. The objective of this study is to determine the relative effectiveness, cost-effectiveness and cost-utility of the Dutch standard for treating stuttering in pre-school children (DCM) compared to the Australian standard (LP). Outcomes will be analyzed at baseline and at 3, 6, 12 and 18 months post randomization.
- Main changes (audit trail)
- RECORD23-jul-2007 - 24-sep-2007

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