TreatPaCS = Treatment for Preschool Age Children Who Stutter
- Conditions
- Stuttering, Developmental
- Interventions
- Behavioral: Lidcombe ProgramBehavioral: Mini-KIDSBehavioral: Social Cognitive Behavioural Therapy
- Registration Number
- NCT05185726
- Lead Sponsor
- Thomas More University of Applied Sciences
- Brief Summary
Treatment for preschool age children who stutter: a randomised, multicentre, non-inferiority parallel group pragmatic trial with Mini-KIDS, the social cognitive behaviour therapy and the Lidcombe Program with 249 children
- Detailed Description
Three treatment approaches for preschool age children who stutter are delivered and %Syllables Stuttered at 18 months post-randomisation of the three arms are compared .
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 = modification, Stage 3 = identification and Stage 4 = generalization. The program for 2-4-year old children does not include stage 3. Speech therapist and parent(s) are the speech model for the child. They add normal dysfluencies to their speech. Later on in treatment and if necessary, children learn to recognise and alter their stuttering moments.
The social cognitive behaviour therapy 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 (Boey, 2010). This treatment is not directed at the speech of the children, but rather at the cognitive and emotional aspects that surround the stuttering.
The Lidcombe Program (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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 249
Preschool age children must
- stutter (identified by the Speech-Language Therapist)
- be aged between 2 - 6.5 years
- have normal hearing reported by the parent(s)
- have, if bilingual, a parent who speaks a language that the SLT understands and speaks to allow clear communication
- have at least one parent agreeing to be intensively involved in treatment and knowing that s/he will implement treatment at home
- have at least one parent who is willing and able to videorecord his/her child regularly
- have a syndrome such as Down Syndrome.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lidcombe Program Lidcombe Program The Lidcombe Program (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. Mini-KIDS Mini-KIDS 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 = modification, Stage 3 = identification and Stage 4 = generalization. The program for 2-4-year old children does not include stage 3. Speech therapist and parent(s) are the speech model for the child. They add normal dysfluencies to their speech. Later on in treatment and if necessary, children learn to recognise and alter their stuttering moments. Social-Cognitive Behaviour Treatment Social Cognitive Behavioural Therapy The social cognitive behaviour therapy 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 (Boey, 2010). This treatment is not directed at the speech of the children, but rather at the cognitive and emotional aspects that surround the stuttering.
- Primary Outcome Measures
Name Time Method % of Syllables Stuttered (%SS) 18 months post-randomisation The %SS at 18 months post-randomisation will be determined in two video samples (at home and in the treatment session) and the average will be used. They will be conpared between the 3 programs.
- Secondary Outcome Measures
Name Time Method Score on Quality of life questionnaire at 18-months, 2- and 5-years post-randomisation Score on the EQ-5D-Y-proxy 2 will be compared between the 3 programs
Treatment duration (number of sessions) Through study completion, on average 9 months Treatment duration will be calculated in number of weeks
% of Syllables Stuttered (%SS) 3-, 6-, 9-, 12-months and 2- and 5-year post-randomisation The %SS will be determined in two video samples (at home and in the treatment session) and the average will be used. They will be conpared between the 3 programs.
Severity rating of the stuttering 3-, 6-, 9-, 12-, 18-months and 2- and 5-year post-randomisation The severity rating of the stuttering will be averaged over home and treatment session and will be compared between the 3 programs
Speech attitude (Kiddy CAT) scores 18-months post-randomisation Score on the KiddyCAT will be compared between the 3 programs
Treatment duration (number of hours) Through study completion, on average 9 months Treatment duration will be calculated in number of hours
Treatment duration (number of weeks) Through study completion, on average 9 months Treatment duration will be calculated in number of weeks
Score on Impact of Stuttering on Parents and Preschooler (ISPP) questionnaire at 18-months post-randomisation Score on the ISPP will be compared between the 3 programs
Trial Locations
- Locations (1)
Sabine Van Eerdenbrugh
🇧🇪Antwerpen, Belgie, Belgium