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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 249
- Locations
- 1
- Primary Endpoint
- % of Syllables Stuttered (%SS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Videos of speech will be scores for %SS by assessors who are blinded for the treatment arm in which the child belongs.
Eligibility Criteria
- Ages
- 24 Months to 78 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
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.
Intervention: Mini-KIDS (Behavioral)
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.
Intervention: Social Cognitive Behavioural Therapy (Behavioral)
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.
Intervention: Lidcombe Program (Behavioral)
Outcomes
Primary Outcomes
% 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.
Secondary Outcomes
- Score on Quality of life questionnaire(at 18-months, 2- and 5-years post-randomisation)
- Treatment duration (number of sessions)(Through study completion, on average 9 months)
- % of Syllables Stuttered (%SS)(3-, 6-, 9-, 12-months and 2- and 5-year post-randomisation)
- 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)
- Treatment duration (number of hours)(Through study completion, on average 9 months)
- Treatment duration (number of weeks)(Through study completion, on average 9 months)
- Score on Impact of Stuttering on Parents and Preschooler (ISPP) questionnaire(at 18-months post-randomisation)