TreatPaCS = Treatment for Preschool Age Children Who Stutter

Thomas More University of Applied Sciences

Status: Enrolling

Conditions: Stuttering, Developmental

Treatments: Behavioral: Social Cognitive Behavioural Therapy; Behavioral: Mini-KIDS; Behavioral: Lidcombe Program

Study type: Interventional

Funder types: Other

Identifiers

NCT05185726

M-OHC-210048

Details and patient eligibility

About

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

Full 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.

Enrollment: 249 estimated patients

Sex: All

Ages: 24 to 78 months old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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249 participants in 3 patient groups

Mini-KIDS

Experimental group

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.

Treatment:

Behavioral: Mini-KIDS

Social-Cognitive Behaviour Treatment

Experimental group

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.

Treatment:

Behavioral: Social Cognitive Behavioural Therapy

Lidcombe Program

Active Comparator group

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.

Treatment:

Behavioral: Lidcombe Program