ASSIST: Child Apraxia Speech Treatment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Speech Accuracy of Treated Items
研究概览
简要总结
Childhood apraxia of speech (CAS) is a pediatric motor speech disorder that impairs the planning of movements needed for intelligible speech. Children with CAS often show little or slow progress in standard speech therapy. This research is a Phase 1 study that tests initial efficacy and optimal parameters of a theoretically based integral stimulation treatment called ASSIST (Apraxia of Speech Systematic Integral Stimulation Treatment). In four small randomized group design studies across three recruitment cycles (N=20 per cycle), children receive 16 hours of individual ASSIST. The studies systematically investigate the effect of treatment (ASSIST vs. no ASSIST; Study 1), the effect of complexity (complex vs. simple utterances; Study 2), the effect of lexicality (word vs. nonword targets; Study 3), and the effect of treatment intensity (Massed vs. Distributed ASSIST; Study 4). Studies 1 and 4 also systematically examine the effect of treatment on functional outcome measures, including parent ratings of intelligibility and communicative participation, and objective intelligibility measures obtained from unfamiliar listeners.
详细描述
This research involves a hypothesis-driven series of Phase 1 studies using comparative group designs to investigate a new integral stimulation treatment program for children with CAS, called ASSIST (Apraxia of Speech Systematic Integral Stimulation Treatment). The overall objective of this research is to test the initial efficacy of ASSIST and determine its optimal parameters.
Specific Aim 1: To test the initial efficacy of intensive ASSIST for children with CAS, by examining short-term improvements on the primary outcome measure of speech accuracy. Forty children (combined across two studies) will be randomly assigned to a treatment or a control group (who will receive the treatment). The central hypothesis is that ASSIST enhances speech motor skill, and predicts greater improvements after 2 weeks (16 hours) for the treatment group than for the control group (who have not yet received treatment). (Study 1)
Specific Aim 2: To determine the optimal parameters of ASSIST for children with CAS. In three studies, children (N=20 each) will be randomly assigned to condition, to address three critical treatment parameters:
Aim 2a: COMPLEXITY: simple vs. complex targets (Study 2). Simple targets may enhance motivation through greater success during treatment, but more complex targets may facilitate greater transfer.
Aim 2b: LEXICALITY: real word vs. nonword targets (Study 3). Real words may enhance motivation through functional relevance, but nonwords may facilitate transfer through a focus on underlying speech motor skills rather than existing lexical or speech motor representations.
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
Data Collector also masked.
入排标准
- 年龄范围
- 4 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 4;0 and 9;11 (years;months) at enrollment, based on parent report.
- •From homes where the primary language spoken is English, based on parent report.
- •Verbal output (50+ words) and communicative intent, as determined by the clinician and parent report.
- •Speech sound disorder, as determined by a score <16th percentile on the Diagnostic Evaluation of Articulation and Phonology (DEAP) Articulation Assessment (Dodd et al., 2006) and/or the Goldman-Fristoe Test of Articulation (Goldman & Fristoe, 2015).
- •CAS as a primary speech diagnosis, based on the following criteria:
- •An average rating > 1 across three expert speech-language pathologists (SLPs), who will independently rate presence of CAS in children live or from video recordings of the assessment using a 3-point scale (0 = no CAS, 1 = possible CAS, 2 = CAS). These judgments will be based on perceptual speech features of CAS (inconsistent vowel and consonant errors, difficulties achieving and transitioning into articulatory configurations, abnormal prosody).
- •An Apraxia Score of 1 or 2 on a Maximum Performance protocol in which they sustain vowels and fricatives as long as possible and repeat syllables as fast as possible (Rvachew et al., 2005; Thoonen et al., 1999).
- •Normal hearing based on parent report or passing a standard pure-tone audiometry hearing screening at 500, 1000, 2000, and 4000 Hz (ASHA, 1997).
- •Typical nonverbal cognition as determined by a T-score within 1.5 standard deviation (SD) of the mean on nonverbal subtests of the Reynolds Intellectual Assessment Scales (Reynolds & Kamphaus, 2003).
排除标准
- •Diagnosis of disorder that significantly affects communication and/or social interactions (e.g., autism), as per referral diagnosis.
- •Uncorrected vision impairments that may interfere with ability to process visual cues used in treatment, as per parent report.
- •Significant impairments of oral structure (e.g., cleft palate) as judged by the SLP based on an oral mechanism exam (Robbins & Klee, 1987).
- •A primary diagnosis of dysarthria, as judged by the SLP.
- •Unrelated health concerns that prevent children from participating, per parent report.
- •Inability to meet toileting needs independently or separate from parent for a full day (as needed for camp), based on parent report.
结局指标
主要结局
Speech Accuracy of Treated Items
时间窗: 1 week post treatment
Perceptual accuracy of treated items, judged by blinded listeners. Will be used to address Aim 1 (initial efficacy of ASSIST) and Aims 2 (optimal parameters of ASSIST).
次要结局
- Speech Accuracy of Untreated Generalization Items(1 week post treatment)
- TOCS+ Intelligibility (percentage words correctly understood)(1 week post treatment)
- ICS Average Score(1 week post treatment)
- FOCUS-34 Total Score(1 week post treatment)