TreatPaCS = Treatment for Preschool Age Children Who Stutter

NCT ID: NCT05185726

Last Updated: 2022-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

249 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2025-11-01

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.

Conditions

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Stuttering, Developmental

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Videos of speech will be scores for %SS by assessors who are blinded for the treatment arm in which the child belongs.

Study Groups

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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.

Group Type EXPERIMENTAL

Mini-KIDS

Intervention Type BEHAVIORAL

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 Behaviour Treatment

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.

Group Type EXPERIMENTAL

Social Cognitive Behavioural Therapy

Intervention Type BEHAVIORAL

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.

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.

Group Type ACTIVE_COMPARATOR

Lidcombe Program

Intervention Type BEHAVIORAL

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.

Interventions

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Lidcombe Program

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

Mini-KIDS

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

Social Cognitive Behavioural Therapy

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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LP SCBT

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.
Minimum Eligible Age

24 Months

Maximum Eligible Age

78 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universiteit Antwerpen

OTHER

Sponsor Role collaborator

University of Liege

OTHER

Sponsor Role collaborator

Artevelde University of Applied Sciences

UNKNOWN

Sponsor Role collaborator

Thomas More University of Applied Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sabine Van Eerdenbrugh, Dr

Role: PRINCIPAL_INVESTIGATOR

Thomas More

Locations

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Sabine Van Eerdenbrugh

Antwerp, Belgie, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Sabine Van Eerdenbrugh, Dr

Role: CONTACT

+3234324040

Anne-Lise Leclercq, Dr

Role: CONTACT

+32479355044

Facility Contacts

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Sabine Van Eerdenbrugh, Dr

Role: primary

0485152033

Other Identifiers

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M-OHC-210048

Identifier Type: -

Identifier Source: org_study_id

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