Rapid Syllable Transition (ReST) and Related Interventions for Speech Sound Disorders in Children: A Master Protocol Investigating Treatment Approaches, Dose Frequency, and Delivery Modality
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 20
- 试验地点
- 1
研究概览
简要总结
This study will investigate the feasibility of applying the Rapid Syllable Transition Treatment (ReST) protocol in children with Childhood Apraxia of Speech, considering the scarcity of evidence in the context of Brazilian Portuguese and the need to implement evidence-based interventions in clinical practice. The objective is to evaluate the feasibility of the protocol and estimate preliminary effects on articulatory accuracy, prosody, and speech motor planning. This is a randomized clinical trial with a quantitative and qualitative approach. Participants will be children between five and twelve years old, diagnosed with Childhood Apraxia of Speech. The intervention will be carried out over six weeks, with two weekly sessions, using pseudowords structured according to the ReST protocol. After an initial assessment, participants will be randomized to an intervention group or a control group on a waiting list. Pre- and post-intervention assessments and a one-month follow-up will be conducted. Data analysis will be exploratory, focusing on evaluating the feasibility of the procedures and estimating parameters for future studies. Primary outcomes will include feasibility indicators such as recruitment rate, adherence, therapeutic fidelity, acceptability, and retention. Secondary outcomes will include preliminary measures of speech performance and effect size estimation. The results are expected to provide preliminary effect estimates and inform the design of a definitive randomized clinical trial.
详细描述
This research corresponds to the comparison between the group submitted to the intervention with the ReST method and the control group, maintaining the methodological rigor of the experimental design. The interventions will be conducted by different master's students, each responsible for one of the therapeutic approaches, while the doctoral student will be responsible for randomization, evaluations, and methodological supervision. The study design will follow the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) recommendations, and the results will be reported in accordance with the CONSORT (Consolidated Standards of Reporting Trials) guidelines, in their most recent versions, including a checklist and participant flowchart. In addition, as this is a pilot randomized clinical trial, the study will also follow recommendations for pilot and feasibility studies, focusing not only on preliminary effects of the intervention, but also on assessing the feasibility of the procedures and generating parameters for a future confirmatory trial.
All participants and their guardians will receive information about the research and, after agreeing to participate, will sign the Informed Consent Form (ICF), the Assent Form, with the study having been previously submitted to and approved by the Research Ethics Committee. Considering recommendations for pilot studies and the rarity and clinical heterogeneity of the population, the inclusion of approximately 12 to 20 participants is expected. These will be Brazilian, monolingual individuals, aged between five and twelve years, all diagnosed with Childhood Apraxia of Speech (CAS). The sample size will be defined based on methodological justification specific to randomized pilot studies, and not on power calculations for confirmatory efficacy testing.
The inclusion criteria adopted will be: signed informed consent form by the guardians; patients who are native speakers of Brazilian Portuguese; absence of associated comorbidities, verified from a detailed clinical history and information provided by the parents; superior receptive language performance compared to expressive performance, confirmed by clinical observation and simple comprehension tasks; hearing thresholds within normal limits; preserved visual acuity; and age between five and eight years.
Children with significant cognitive impairments or severe comprehension difficulties that prevent participation in the proposed activities will be excluded.
In addition to the eligibility criteria, the diagnosis of AFI will be established by clinical consensus among experienced evaluators, based on multiple diagnostic sources and the presence of the clinical markers described for the disorder, including inconsistency in productions, prolonged and/or interrupted coarticulatory transitions, and prosodic alterations. Complementary instruments will be used to increase diagnostic accuracy and reduce clinical heterogeneity in the sample.
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
Apenas a pessoa que avaliar os resultados pós-tratamento terá conhecimento da alocação dos grupos.
入排标准
- 年龄范围
- 5 Years 至 12 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent form provided by the child's legal guardians
- •Native speakers of Brazilian Portuguese
- •Absence of associated comorbidities, verified through detailed clinical history and parent-reported information
- •Receptive language abilities superior to expressive language abilities, confirmed through clinical observation and simple comprehension tasks
- •Hearing thresholds within normal limits
- •Preserved visual acuity
- •Age between five and eight years
排除标准
- •Significant cognitive impairments;
- •Severe comprehension difficulties that prevent participation in the proposed activities.
研究者
Aline Mara de Oliveira
Principal investigador
Santa Catarina Federal University
