跳至主要内容
临床试验/NCT04679974
NCT04679974已完成不适用

Melodic-based Communication Therapy for Promoting Spoken Language Development in Individuals With Nonverbal Autism Ages: 3:0 - 10:11

Loma Linda University2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2018年6月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
2
主要终点
Frequency of repetitive and stereotypical behaviors

研究概览

简要总结

The purpose of this study is to determine the efficacy of Melodic Based Communication Therapy (M.B.C.T.) for increasing oral expressive skills in nonverbal children with autism spectrum disorders. MBCT has previously been shown to facilitate an improvement in expressive vocabulary, verbal imitative abilities, number of vocalizations, and social language development in nonverbal children with autism ages 5-7. However, earlier studies were small and did not examine the effects of M.B.C.T. on a younger and older population. This study will examine its effectiveness across a broader sample group. Additionally, this study will examine further predictors of success including but not limited to chronological age, developmental age, the frequency of repetitive/stereotypic behaviors, receptive language score, and social language score.

详细描述

The study will be a repeated measures design as assessments will be taken at baseline and on a weekly basis (baseline, weeks 1-4). All participants in the study will receive Melodic Based Communication Therapy (M.B.C.T.). General procedures involved in (M.B.C.T.) are as follows: 25 common first words are selected as the targets (e.g., apple, ball, car, dog, cat, eat, go, etc.). Pictures and objects will be used as stimulus items. The top 3-5 incentives as identified by parent survey will be given according to the therapies specific reinforcement schedule. All treatment and evaluation sessions will be videotaped for future/further analysis and verification purposes. For the purposes of the study design, the same 25 words will be used for all participants.

  1. Subjects will be male and female children diagnosed with autism.

  2. Subjects will be between 3 years 0 months and 10 years 11 months of age.

  3. In total, subject participation will last approximately 4 weeks.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
3 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Male and female children with autism ages 3-years-0-months to 10-years-11-month who meet the criterion for nonverbal (defined as less than 10 words ever spoken expressively and no functional verbal communication)

排除标准

  • Individuals receiving other language or articulation treatments or therapy at the time of the study, unable to regularly attend four 30 min sessions of therapy weekly for 4 weeks, a history of severe hearing impairment, severe visual impairment/ blindness, a diagnosis of an organic impairment of oral or laryngeal structures, or a significant medical illness or condition which would prevent the child's participation in the treatment procedures. These conditions include, but are not limited to cerebral palsy, paraplegia, spina bifida, uncontrolled seizures, dysarthria, and amputation of arm(s).

结局指标

主要结局

Frequency of repetitive and stereotypical behaviors

时间窗: 4 weeks

Frequency of repetitive or stereotypic movements will be analyzed in the first week of treatment (stimming behavior). This will be evaluated as follows: onset/offset and duration of the behaviors to determine frequency. This will be evaluated by an independent observer through video analysis.

Number of spoken words

时间窗: 4 weeks

Pre/post measures include: number of words reported in home environment by parent pre-vs. post, CASL-2 Pragmatic Language raw score pre-vs. post, number of imitative attempts pre-vs. post, number of words correct in response to the question, "what is this?" and number of vocalizations in response to the question, "what is this?"

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Karen Mainess

Assistant Professor

Loma Linda University

研究点 (2)

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