Stuttering, DevelopmentalTreatPaCSNCT05185726
TreatPaCS = Treatment for Preschool Age Children Who Stutter
A study testing Lidcombe Program, Mini-KIDS and Social Cognitive Behavioural Therapy in people with Stuttering, Developmental, run by Thomas More University of Applied Sciences at 1 site in Belgium.
Trial 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 Read more about this study
- Who is it for?
- Ages 24 to 78 monthsHealthy volunteers can take part
- Conditions the study is for
- Stuttering, Developmental
- What is being tested?
- Lidcombe Program, Mini-KIDS and Social Cognitive Behavioural Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 249 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Apr 2022to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 78 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- have a syndrome such as Down Syndrome.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Sabine Van Eerdenbrugh
Antwerp, Belgie, 2000
Sabine Van Eerdenbrugh, Dr, 0485152033, sabine.vaneerdenbrugh@thomasmore.be
About this study
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
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
Read the 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.
- Conditions
- Stuttering, Developmental
- Being tested
- Lidcombe Program, Mini-KIDS, Social Cognitive Behavioural Therapy
- Medical subject headings
- Stuttering
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidcombe ProgramBehavioural
Also called LP
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.
Mini-KIDSBehavioural
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.
Social Cognitive Behavioural TherapyBehavioural
Also called SCBT
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.
| Study group | Role | What they receive |
|---|---|---|
| Mini-KIDS | Experimental | 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. Receives: Behavioral: Mini-KIDS |
| Social-Cognitive Behaviour Treatment | Experimental | 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. Receives: Behavioral: Social Cognitive Behavioural Therapy |
| Lidcombe Program | Active comparator | 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. Receives: Behavioral: Lidcombe Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
% 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.
Measured: 18 months post-randomisation
Secondary outcomes (8)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: Through study completion, on average 9 months
Treatment duration (number of weeks)
Treatment duration will be calculated in number of weeks
Measured: Through study completion, on average 9 months
Treatment duration (number of sessions)
Treatment duration will be calculated in number of weeks
Measured: Through study completion, on average 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start1 Apr 2022
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stuttering, DevelopmentalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A three arm 1:1:1 randomised, multicentre, open-label non-inferiority parallel group pragmatic trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 249 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas More University of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Universiteit Antwerpen, University of Liege, Artevelde University of Applied Sciences
- Responsible party
- Sponsor
- Investigators
- Sabine Van Eerdenbrugh, Dr, Principal investigator, Thomas More
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05185726
- Sponsor's protocol ID
- M-OHC-210048
- Acronym
- TreatPaCS
- Status last verified
- Nov 2022
- First submitted
- 8 Dec 2021
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Leclercq AL, Waelkens V, Roelant E, Allegaert M, Verhaegen I, Claes K, Dauvister E, Snijders S, Eggers K, Moyse A, Van Eerdenbrugh S. Treatment for preschool age children who stutter: Protocol of a randomised, non-inferiority parallel group pragmatic trial with Mini-KIDS, social cognitive behaviour treatment and the Lidcombe Program-TreatPaCS. PLoS One. 2024 Jul 11;19(7):e0304212. doi: 10.1371/journal.pone.0304212. eCollection 2024.
PubMed 38990808
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05185726
- Acronym / sponsor ID
- TreatPaCS / M-OHC-210048
- Conditions
- Stuttering, Developmental
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 249 participants (estimated)
- Lead sponsor
- Thomas More University of Applied SciencesUniversity, hospital or other
- Collaborators
- Universiteit Antwerpen, University of Liege, Artevelde University of Applied Sciences
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- A three arm 1:1:1 randomised, multicentre, open-label non-inferiority parallel group pragmatic trial
| Arm | Type | Receives |
|---|---|---|
| Mini-KIDS | Experimental | Behavioral: Mini-KIDSMini-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 | Experimental | Behavioral: Social Cognitive Behavioural TherapyThe 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. |
| Lidcombe Program | Active comparator | Behavioral: Lidcombe ProgramThe 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. |
Who may qualify
- Ages
- 24 to 78 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- have a syndrome such as Down Syndrome.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidcombe ProgramAlso: LPThe 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. | Behavioural | Lidcombe Program |
| Mini-KIDSMini-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. | Behavioural | Mini-KIDS |
| Social Cognitive Behavioural TherapyAlso: SCBTA 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. | Behavioural | Social-Cognitive Behaviour Treatment |
Primary outcome
% of Syllables Stuttered (%SS)
Time frame: 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.
8 secondary outcomes
Severity rating of the stuttering
Time frame: 3-, 6-, 9-, 12-, 18-months and 2- and 5-year post-randomisation
Speech attitude (Kiddy CAT) scores
Time frame: 18-months post-randomisation
Score on Quality of life questionnaire
Time frame: at 18-months, 2- and 5-years post-randomisation
Score on Impact of Stuttering on Parents and Preschooler (ISPP) questionnaire
Time frame: at 18-months post-randomisation
% of Syllables Stuttered (%SS)
Time frame: 3-, 6-, 9-, 12-months and 2- and 5-year post-randomisation
Treatment duration (number of hours)
Time frame: Through study completion, on average 9 months
Treatment duration (number of weeks)
Time frame: Through study completion, on average 9 months
Treatment duration (number of sessions)
Time frame: Through study completion, on average 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Derived from this study: PubMed 38990808Leclercq AL, Waelkens V, Roelant E, Allegaert M, Verhaegen I, Claes K, Dauvister E, Snijders S, Eggers K, Moyse A, Van Eerdenbrugh S. Treatment for preschool age children who stutter: Protocol of a randomised, non-inferiority parallel group pragmatic trial with Mini-KIDS, social cognitive behaviour treatment and the Lidcombe Program-TreatPaCS. PLoS One. 2024 Jul 11;19(7):e0304212. doi: 10.1371/journal.pone.0304212. eCollection 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabine Van Eerdenbrugh, Dr principal investigator
Thomas More
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidcombe Program, Mini-KIDS and Social Cognitive Behavioural Therapy in people with Stuttering, Developmental, run by Thomas More University of Applied Sciences at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sabine Van Eerdenbrugh, Dr (+3234324040, sabine.vaneerdenbrugh@thomasmore.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% of Syllables Stuttered (%SS) (time frame: 18 months post-randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05185726, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022.