Clinical trial NCT05185726: TreatPaCS = Treatment for Preschool Age Children Who Stutter
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
Overall status: RECRUITING
Phase: NA
Conditions: Stuttering, Developmental
Lead sponsor: Thomas More University of Applied Sciences
Sponsor class: OTHER
Collaborators: name: Universiteit Antwerpen
name: University of Liege
name: Artevelde University of Applied Sciences
First posted: 2022-01-11
Enrollment: 249
Sex: ALL
Minimum age (years): 24
Maximum age (years): 78
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A three arm 1:1:1 randomised, multicentre, open-label non-inferiority parallel group pragmatic trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: % of Syllables Stuttered (%SS)
timeFrame: 18 months post-randomisation
Secondary outcomes:
measure: Severity rating of the stuttering
timeFrame: 3-, 6-, 9-, 12-, 18-months and 2- and 5-year post-randomisation
measure: Speech attitude (Kiddy CAT) scores
timeFrame: 18-months post-randomisation
measure: Score on Quality of life questionnaire
timeFrame: at 18-months, 2- and 5-years post-randomisation
measure: Score on Impact of Stuttering on Parents and Preschooler (ISPP) questionnaire
timeFrame: at 18-months post-randomisation
measure: % of Syllables Stuttered (%SS)
timeFrame: 3-, 6-, 9-, 12-months and 2- and 5-year post-randomisation
measure: Treatment duration (number of hours)
timeFrame: Through study completion, on average 9 months
measure: Treatment duration (number of weeks)
timeFrame: Through study completion, on average 9 months
measure: Treatment duration (number of sessions)
timeFrame: Through study completion, on average 9 months
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: Sabine Van Eerdenbrugh
state: Belgie
Study officials:
affiliation: Thomas More
name: Sabine Van Eerdenbrugh, Dr
role: PRINCIPAL_INVESTIGATOR
References: