TreatPaCS = Treatment for Preschool Age Children Who Stutter

NCT05185726 | Unknown DMC

• 1 other identifier: M-OHC-210048
• Study Type: interventional
• Target: 249
• Locations: 1 country
• Sites: 1

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

Conditions

Stuttering, Developmental

Outcome Measures

Primary Outcomes (1)

• % 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 Outcomes (8)

• Severity rating of the stuttering

  3-, 6-, 9-, 12-, 18-months and 2- and 5-year post-randomisation

• Speech attitude (Kiddy CAT) scores

  18-months post-randomisation

• Score on Quality of life questionnaire

  at 18-months, 2- and 5-years post-randomisation

• Score on Impact of Stuttering on Parents and Preschooler (ISPP) questionnaire

  at 18-months post-randomisation

• % of Syllables Stuttered (%SS)

  3-, 6-, 9-, 12-months and 2- and 5-year post-randomisation

Study Arms (3)

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.

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.

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.

Behavioral: Lidcombe Program

Interventions

Lidcombe Program 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.

Also known as: LP

Lidcombe Program

Mini-KIDS 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.

Mini-KIDS

Social Cognitive Behavioural Therapy 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.

Also known as: SCBT

Social-Cognitive Behaviour Treatment

Eligibility Criteria

• Age: 24 Months - 78 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• \- have a syndrome such as Down Syndrome.

Sponsors & Collaborators

• Thomas More University of Applied Sciences: lead
• Universiteit Antwerpen: collaborator
• University of Liege: collaborator
• Artevelde University of Applied Sciences: collaborator

Study Sites (1)

Sabine Van Eerdenbrugh

Antwerp, Belgie, 2000, Belgium

RECRUITING

MeSH Terms

Conditions

Stuttering

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sabine Van Eerdenbrugh, Dr

  Thomas More

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sabine Van Eerdenbrugh, Dr

CONTACT

+3234324040; sabine.vaneerdenbrugh@thomasmore.be

Anne-Lise Leclercq, Dr

CONTACT

+32479355044; al.leclercq@uliege.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Videos of speech will be scores for %SS by assessors who are blinded for the treatment arm in which the child belongs.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A three arm 1:1:1 randomised, multicentre, open-label non-inferiority parallel group pragmatic trial

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: January 11, 2022
• Study Start: April 1, 2022
• Primary Completion: April 1, 2025
• Study Completion: November 1, 2025
• Last Updated: November 4, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)