TreatPaCS = Treatment for Preschool Age Children Who Stutter

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Stuttering, Developmental

Intervention / Treatment
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* Behavioral: Lidcombe Program
* Behavioral: Mini-KIDS
* Behavioral: Social Cognitive Behavioural Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: - have a syndrome such as Down Syndrome.

Ages Eligible for Study
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Minimum Age: 24 Months
Maximum Age: 78 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A three arm 1:1:1 randomised, multicentre, open-label non-inferiority parallel group pragmatic trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mini-KIDS<br>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. | Behavioral: Mini-KIDS<br>* Mini-KIDS for 4-6-year old PCWS consists of four stages: Stage 1 = desensitization, Stage 2 = identification, Stage 3 = modification and Stage 4 = generalization. The program for 2-4-year old child does not include stage 2. SLT and parent(s) are the speech model for the child. They add normal disfluencies and pseudo-stuttering to their speech at first to make sure the child dares to stutter and the child as well as the parent(s) are desensitized for it. Later on in treatment and if necessary, child learn to recognise and alter their stuttering moments. The maintenance phase starts when the child and parent(s) achieved the goals of Stage 4. Usually the stuttering is reduced to (near) zero stuttering. Treatment sessions to monitor if achieved goals are maintained are scheduled with an interval of 2, 2, 4, 4, 8, 8 and 16 weeks.<br>|
| Experimental: Social-Cognitive Behaviour Treatment<br>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. | Behavioral: Social Cognitive Behavioural Therapy<br>* A parent training is organised for parents with children who stutters who receive SCBT. The parent training exists of 10 one-hour group evening sessions for parents to discuss and offer education topics about what stuttering is, how stuttering looks like, ... The program is delivered in 5 phases and each phase takes as long as is necessary for the PCWS (variable): (1) conditioning speaking activities, (2) cognitive training focused on emotions, (3) cognitive training focused on cognitions, (4) emotional training and (5) skill training. The maintenance phase starts when the child and parent(s) achieved the goals of the 5 phases. During the maintenance sessions, the SLT asks the parent(s) to report about the child and observes the speech of the child.<br>* Other names: SCBT;|
| Active Comparator: Lidcombe Program<br>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. | Behavioral: Lidcombe Program<br>* The LP consists of Stage 1 and Stage 2. Stage 1 aims at reducing the stuttering of the PCWS to (near) zero levels of stuttering. During stage 1, parents learn to provide verbal contingencies during daily, 10-minute practice sessions with their PCWS. During Stage 1, treatment sessions are scheduled weekly. When the child has typical scores of 0 and 1 on the SR-scale with more 0s than 1s per week for three consecutive weeks, and the stuttering is rated as 0 or 1 during the treatment session, the child can proceed to stage 2. The maintenance phase starts when the stuttering is reduced to (near) zero stuttering and parents are able to implement the practice sessions when it is necessary (when stuttering relapses). Treatment sessions to monitor if achieved goals are maintained are scheduled with an interval of 2, 2, 4, 4, 8, 8 and 16 weeks.<br>* Other names: LP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % of Syllables Stuttered (%SS) | 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. | 18 months post-randomisation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity rating of the stuttering | The severity rating of the stuttering will be averaged over home and treatment session and will be compared between the 3 programs | 3-, 6-, 9-, 12-, 18-months and 2- and 5-year post-randomisation | 
| Speech attitude (Kiddy CAT) scores | Score on the KiddyCAT will be compared between the 3 programs | 18-months post-randomisation | 
| Score on Quality of life questionnaire | Score on the EQ-5D-Y-proxy 2 will be compared between the 3 programs | at 18-months, 2- and 5-years post-randomisation | 
| Score on Impact of Stuttering on Parents and Preschooler (ISPP) questionnaire | Score on the ISPP will be compared between the 3 programs | at 18-months post-randomisation | 
| % of Syllables Stuttered (%SS) | 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. | 3-, 6-, 9-, 12-months and 2- and 5-year post-randomisation | 
| Treatment duration (number of hours) | Treatment duration will be calculated in number of hours | Through study completion, on average 9 months | 
| Treatment duration (number of weeks) | Treatment duration will be calculated in number of weeks | Through study completion, on average 9 months | 
| Treatment duration (number of sessions) | Treatment duration will be calculated in number of weeks | Through study completion, on average 9 months |