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TreatPaCS = Treatment for Preschool Age Children Who Stutter (TreatPaCS)

Primary Purpose

Stuttering, Developmental

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Lidcombe Program
Mini-KIDS
Social Cognitive Behavioural Therapy
Sponsored by
Thomas More University of Applied Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stuttering, Developmental

Eligibility Criteria

24 Months - 78 Months (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Sabine Van EerdenbrughRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Mini-KIDS

Social-Cognitive Behaviour Treatment

Lidcombe Program

Arm Description

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.

Outcomes

Primary Outcome Measures

% 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.

Secondary Outcome Measures

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
Speech attitude (Kiddy CAT) scores
Score on the KiddyCAT will be compared between the 3 programs
Score on Quality of life questionnaire
Score on the EQ-5D-Y-proxy 2 will be compared between the 3 programs
Score on Impact of Stuttering on Parents and Preschooler (ISPP) questionnaire
Score on the ISPP will be compared between the 3 programs
% 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.
Treatment duration (number of hours)
Treatment duration will be calculated in number of hours
Treatment duration (number of weeks)
Treatment duration will be calculated in number of weeks
Treatment duration (number of sessions)
Treatment duration will be calculated in number of weeks

Full Information

First Posted
December 8, 2021
Last Updated
November 2, 2022
Sponsor
Thomas More University of Applied Sciences
Collaborators
Universiteit Antwerpen, University of Liege, Artevelde University of Applied Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05185726
Brief Title
TreatPaCS = Treatment for Preschool Age Children Who Stutter
Acronym
TreatPaCS
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
April 1, 2025 (Anticipated)
Study Completion Date
November 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas More University of Applied Sciences
Collaborators
Universiteit Antwerpen, University of Liege, Artevelde University of Applied Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stuttering, Developmental

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A three arm 1:1:1 randomised, multicentre, open-label non-inferiority parallel group pragmatic trial
Masking
Outcomes Assessor
Masking Description
Videos of speech will be scores for %SS by assessors who are blinded for the treatment arm in which the child belongs.
Allocation
Randomized
Enrollment
249 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mini-KIDS
Arm Type
Experimental
Arm Description
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.
Arm Title
Social-Cognitive Behaviour Treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Lidcombe Program
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Lidcombe Program
Other Intervention Name(s)
LP
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mini-KIDS
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Social Cognitive Behavioural Therapy
Other Intervention Name(s)
SCBT
Intervention Description
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.
Primary Outcome Measure Information:
Title
% of Syllables Stuttered (%SS)
Description
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.
Time Frame
18 months post-randomisation
Secondary Outcome Measure Information:
Title
Severity rating of the stuttering
Description
The severity rating of the stuttering will be averaged over home and treatment session and will be compared between the 3 programs
Time Frame
3-, 6-, 9-, 12-, 18-months and 2- and 5-year post-randomisation
Title
Speech attitude (Kiddy CAT) scores
Description
Score on the KiddyCAT will be compared between the 3 programs
Time Frame
18-months post-randomisation
Title
Score on Quality of life questionnaire
Description
Score on the EQ-5D-Y-proxy 2 will be compared between the 3 programs
Time Frame
at 18-months, 2- and 5-years post-randomisation
Title
Score on Impact of Stuttering on Parents and Preschooler (ISPP) questionnaire
Description
Score on the ISPP will be compared between the 3 programs
Time Frame
at 18-months post-randomisation
Title
% of Syllables Stuttered (%SS)
Description
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.
Time Frame
3-, 6-, 9-, 12-months and 2- and 5-year post-randomisation
Title
Treatment duration (number of hours)
Description
Treatment duration will be calculated in number of hours
Time Frame
Through study completion, on average 9 months
Title
Treatment duration (number of weeks)
Description
Treatment duration will be calculated in number of weeks
Time Frame
Through study completion, on average 9 months
Title
Treatment duration (number of sessions)
Description
Treatment duration will be calculated in number of weeks
Time Frame
Through study completion, on average 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Months
Maximum Age & Unit of Time
78 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sabine Van Eerdenbrugh, Dr
Phone
+3234324040
Email
sabine.vaneerdenbrugh@thomasmore.be
First Name & Middle Initial & Last Name or Official Title & Degree
Anne-Lise Leclercq, Dr
Phone
+32479355044
Email
al.leclercq@uliege.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabine Van Eerdenbrugh, Dr
Organizational Affiliation
Thomas More
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sabine Van Eerdenbrugh
City
Antwerpen
State/Province
Belgie
ZIP/Postal Code
2000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Van Eerdenbrugh, Dr
Phone
0485152033
Email
sabine.vaneerdenbrugh@thomasmore.be

12. IPD Sharing Statement

Plan to Share IPD
No

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