Stuttering is a speech disorder in which the flow of speech is disrupted by involuntary repetitions of sounds, syllables, words or phrases, stretched sounds or silent pauses in which the person is unable to produce sounds. Treatment success is the highest if stuttering is treated before the age of 6 years, before it develops into “persistent” stuttering. Stuttering treatment programs that focus directly on the speech of the child, like the Lidcombe Program (LP), have shown to be effective in this age group. Mini-KIDS is also a treatment that focuses directly on the speech of the child. It is possible that capturing the increased brain plasticity at this age in combination with creating optimal conditions for recovery underlie these treatments’ success rate. A treatment focusing on the cognitions, emotions and behaviour of the child, the social cognitive behaviour treatment (SCBT), is also frequently delivered in Belgium. In this study we want to compare these three treatment programs: Mini-KIDS, SCBT and the LP.
In this trial, 249 children will be allocated to one of three treatment groups. Stuttering specialists will treat the child (and guide the parents) with Mini-KIDS, the SCBT or the LP. They will be recruited in the Dutch- and French-speaking parts of Belgium. They will be trained to deliver the programs meticulously.
At 18 months after randomisation, the speech fluency of the child and the attitude of the child and parent(s) towards speech will be measured. It is expected that the 3 programs will achieve the same (near) zero levels of stuttering in nearly all children and a positive attitude towards speech at 18 months after the start of treatment. The amount of treatment hours to reach the (near)zero levels of stuttering will be compared between the different programmes. For families as well as for the health system this could generate important information.
| TRIAL DESCRIPTION | |
|---|---|
| Title | KCE-201257: Treatment for preschool age children who stutter: a randomised, multicentre, non-inferiority parallel group pragmatic trial with Mini-KIDS, social cognitive behaviour treatment and the Lidcombe Program - TreatPaCS |
|
Participants (P) |
Preschool age children treated by stuttering specialists in private practice settings. Parents are always intensively involved in treatment. |
|
Intervention (I) |
Mini-KIDS is a direct treatment based on principles of stuttering modification, with pseudo-stuttering, that is, deliberate stuttering, as one of the main components. The program for 4-6-year old children consists of four stages: Stage 1 = desensitization, Stage 2 = identification, Stage 3 = modification and Stage 4 = generalization. The program for 2-4-year old children does not include stage 3 because of metacognitive development at that age. Speech-Language Therapist (SLT) and parent(s) are the speech model for the child. They add normal disfluencies and pseudo-stuttering to their speech. Later on in treatment and if necessary, children learn to recognise and alter their stuttering moments. |
|
Control (C) |
The LP is an operant program that directly provides verbal feedback to the child’s stutter-free speech (mainly) and the child’s stuttering (occasionally). The program comprises two stages: Stage 1 in which (near) zero levels of stuttering are achieved and Stage 2 in which the achieved (near) zero levels of stuttering are maintained for a long period of time. The LP usually takes between 11 to 23 (60-minute) treatment sessions to achieve the goals of Stage 1, i.e. (near) zero levels of stuttering. |
|
Outcome (O) |
Primary outcome: Percentage Syllables Stuttered (%SS, measured in videorecorded speech samples) at 18-months post-randomisation. |
|
Trial Design |
A three arm 1:1:1 randomised, multicentre, open-label non-inferiority parallel group pragmatic trial |
|
Sample Size |
249 |
|
Trial duration |
47 months |
|
First Patient In |
01/04/2022 |
| Trial Report | 01/03/2026 |
|
Budget |
1 890 000 euro |
|
Sponsor |
Thomas More Mechelen-Antwerpen vzw |
|
Chief Investigator |
Sabine Van Eerdenbrugh |
|
External Partners |
UZA |
|
Number of Participating sites |
+/- 30 |
Clinicaltrials.gov: NCT05185726
Webpage:
