跳至主要内容
临床试验/NCT05880225
NCT05880225招募中不适用

Musical Rhythm Sensitivity to Scaffold Social Engagement in Autism Spectrum Disorder

Vanderbilt University Medical Center2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年7月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
2
主要终点
Change in rhythmically entrained eye-looking (eye-tracking)

研究概览

简要总结

The primary goal of this study is to examine rhythm sensitivity as a predictor of response to naturalistic developmental behavioral intervention (NDBIs) in autistic toddlers. Toddlers receive either Reciprocal Imitation Training (RIT), an evidence-based NDBI that supports children's imitation and social communication skills, or a music-enhanced version of RIT. Throughout their participation in the intervention, toddlers will complete study procedures of viewing naturalistic videos of infant-directed singing and other social scenes while eye gaze data is collected.

详细描述

Social communication makes use of predictable, rhythmic behaviors and children are sensitive to the rhythm of social interaction from infancy. The goal of the current study is to investigate if social rhythm sensitivity, measured via children' entrained eye-looking when viewing videos of infant-directed singing, predicts autistic toddlers' response to naturalistic developmental behavioral intervention (NDBI). Following eligibility testing and baseline assessments, children are randomized to receive either 30 sessions of Reciprocal Imitation Training (RIT), an NDBI that uses evidence-based strategies to support children's imitation and social communication development, or a music-enhanced version of RIT that embeds music and rhythm within the RIT platform (meRIT). Children's imitation skills are assessed before and after the intervention programs. Children's rhythm sensitivity is assessed via repeated eye-tracking sessions throughout baseline, intervention, and two-weeks after the intervention ends.

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)

入排标准

年龄范围
18 Months 至 36 Months(Child)
性别
All
接受健康志愿者

入选标准

  • diagnosis of autism / autism spectrum disorder
  • 18-36 months of age

排除标准

  • Major hearing or visual impairment (e.g., congenital nystagmus), seizure disorder, genetic syndromes, or gestational age <=34 weeks.

研究组 & 干预措施

Music-Enhanced Reciprocal Imitation Training (meRIT)

Experimental

Children (n=20) receive 30 sessions of music-enhanced Reciprocal Imitation Training (meRIT), delivered in 40-60 minute sessions 2-3 times/week.

干预措施: music-enhanced Reciprocal Imitation Training (Behavioral)

Reciprocal Imitation Training (RIT)

Active Comparator

Children (n=20) receive 30 sessions of Reciprocal Imitation Training (RIT), delivered in 40-60 minute sessions 2-3 times/week.

干预措施: Reciprocal Imitation Training (Behavioral)

结局指标

主要结局

Change in rhythmically entrained eye-looking (eye-tracking)

时间窗: Change from baseline through 2-week follow-up post-intervention

Trajectories of rhythmically entrained eye-looking to predictable and unpredictable child-directed singing assessed via passive eye-tracking.

次要结局

  • Change in overall fixation to eyes (eye-tracking)(Change from baseline through 2-week follow-up post-intervention)
  • Change in child spontaneous motor imitation(Change from baseline to 2-weeks follow-up after intervention)
  • Change in child elicited motor imitation(Change from baseline to 2-weeks follow-up after intervention)

研究者

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

Miriam Lense

Assistant Professor

Vanderbilt University Medical Center

研究点 (2)

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