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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 249
- 试验地点
- 1
- 主要终点
- % of Syllables Stuttered (%SS)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Videos of speech will be scores for %SS by assessors who are blinded for the treatment arm in which the child belongs.
入排标准
- 年龄范围
- 24 Months 至 78 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •have a syndrome such as Down Syndrome.
研究组 & 干预措施
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.
干预措施: 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.
干预措施: 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.
干预措施: Lidcombe Program (Behavioral)
结局指标
主要结局
% of Syllables Stuttered (%SS)
时间窗: 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.
次要结局
- 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)