TreatPaCS: Behandlung für stotternde Kinder im Vorschulalter: eine randomisierte, multizentrische, nicht unterlegene pragmatische Parallelgruppenstudie mit Mini-KIDS, sozialer kognitiver Verhaltenstherapie und dem Lidcombe-Programm (KCE-201257)

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.
SCBT contains 5 treatment phases: (1) conditioning speaking activities, (2) cognitive training focused on emotions, (3) cognitive training focused on cognitions, (4) emotional training and (5) skill training. This treatment is mainly directed at the child’s cognitive and emotional aspects that surround the stuttering..

Control (C)

Outcome (O)

Primary outcome: Percentage Syllables Stuttered (%SS, measured in videorecorded speech samples) at 18-months post-randomisation.
Secondary outcomes: %SS and SR at 3, 6, 9, 12 months + SR, QOL (EQ-5D-Y proxy 2), KiddyCAT scores and Impact of Stuttering on Preschoolers and Parents at 18 months + %SS, SR and QOL (EQ-5D-Y proxy 2) at 2 and 5 years post-randomisation. Treatment hours until end of treatment.

Trial Design

A three arm 1:1:1 randomised, multicentre, open-label non-inferiority parallel group pragmatic trial

Sample Size

249

Trial duration

First Patient In

Budget

1 890 000 euro