An interventional study of Lidcombe Program and Mini-KIDS in Stuttering, Developmental, sponsored by Thomas More University of Applied Sciences. Recruiting at 1 site in Belgium. Open to participants aged 24 Months to 78 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-04.
Sponsored by Thomas More University of Applied Sciences · Not applicable, Interventional, and Treatment
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
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.
74 studies on the registry are indexed under Stuttering; 23 are open to participants now.
This study's planned enrollment of 249 is above the median of 44 across 57 interventional studies indexed under Stuttering.
Browse Stuttering studies →Thomas More University of Applied Sciences is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
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Preschool age children must
Exclusion Criteria:
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
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
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
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
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.
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
% 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.
Time frame: 18 months post-randomisation
Severity rating of the stuttering
The severity rating of the stuttering will be averaged over home and treatment session and will be compared between the 3 programs
Time frame: 3-, 6-, 9-, 12-, 18-months and 2- and 5-year post-randomisation
Speech attitude (Kiddy CAT) scores
Score on the KiddyCAT will be compared between the 3 programs
Time frame: 18-months post-randomisation
Score on Quality of life questionnaire
Score on the EQ-5D-Y-proxy 2 will be compared between the 3 programs
Time frame: at 18-months, 2- and 5-years post-randomisation
Score on Impact of Stuttering on Parents and Preschooler (ISPP) questionnaire
Score on the ISPP will be compared between the 3 programs
Time frame: at 18-months post-randomisation
% of Syllables Stuttered (%SS)
The %SS 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.
Time frame: 3-, 6-, 9-, 12-months and 2- and 5-year post-randomisation
Treatment duration (number of hours)
Treatment duration will be calculated in number of hours
Time frame: Through study completion, on average 9 months
Treatment duration (number of weeks)
Treatment duration will be calculated in number of weeks
Time frame: Through study completion, on average 9 months
Treatment duration (number of sessions)
Treatment duration will be calculated in number of weeks
Time frame: Through study completion, on average 9 months
Plan to share: No
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Started Apr 2022 (actual). Primary completion is estimated for Apr 2025, 36 months after the start.
Of 37 interventional studies with no phase under Stuttering, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 38. This study's planned 36 months is above that.
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Thomas More University of Applied Sciences