跳至主要内容
临床试验/NCT06424366
NCT06424366已完成不适用

ADAPT: Approach to Dance for Autism

Icahn School of Medicine at Mount Sinai1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年7月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
1
主要终点
Development Coordination Disorder Questionnaire

研究概览

简要总结

This study will be a randomized trial that will examine the impact of a recreational ballet program on children with autism spectrum disorder (ASD). The research team are primarily interested in assessing changes in motor skills with secondary objectives focused on the social, psychological, and behavioral effects. The study will aim to collect data from 24 participants with ASD. Participants must be 7-12 years old, have a confirmed diagnosis of ASD, and speak English or Spanish. All participants will be enrolled in a 12 week ballet program. The ballet program is based off the curriculum and structure of Ballet for All Kids, a non-profit organization that has been tailoring ballet classes for children with ASD for over one decade. All research team members and volunteers will be trained in the BFAK program's curriculum and structure. Ballet instruction and all research materials will be provided in both English and Spanish. The research team will randomize the sample into an intervention group and waitlist control. The research team will measure outcomes through validated self-reports that caregivers will complete. For the intervention group, questionnaires will be completed at baseline and throughout the intervention (weeks 4, 8, and 12). For those in the waitlist control group, questionnaires will be completed at baseline, throughout the intervention group's ballet classes, and throughout their own participation in the program. Results of this study will help to determine if how a recreational ballet program can impact the motor, psychological, social, and behavioral skills of a child with ASD, informing the direction of future research and interventions.

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
None

盲法说明

Due to the nature of the intervention (ballet classes) and that caregivers will be completing all questionnaires, masking is not possible.

入排标准

年龄范围
7 Years 至 12 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Confirmed diagnosis of autism spectrum disorder
  • •Fluent in English or Spanish
  • •Between 7-12 years old

排除标准

  • •For any reason the individual appears unable to participate in study procedures per the Principal Investigator
  • •Not fluent in English or Spanish
  • •Unable to commit to at least 8 of the 12 scheduled intervention sessions

研究组 & 干预措施

Immediate Ballet Program

Experimental

12 weeks of ballet classes immediately after recruitment and randomization concludes.

干预措施: Ballet for All Kids (Behavioral)

Deferred Ballet Program

Placebo Comparator

12 weeks of ballet classes after the first arm completes the intervention. Participants in this arm will continue to complete self-reports while they wait to begin the intervention.

干预措施: Ballet for All Kids (Behavioral)

结局指标

主要结局

Development Coordination Disorder Questionnaire

时间窗: at baseline and weeks 4, 8, and 12

Development Coordination Disorder Questionnaire will be completed by caregivers and will assess participants' motor skills throughout the study. Minimum score= 15. Maximum score= 75. A higher score indicates more advanced motor skills.

次要结局

  • Social Responsiveness Scale 2(at baseline and weeks 4, 8, and 12)
  • Aberrant Behavior Checklist(at baseline and weeks 4, 8, and 12)
  • Children's Sleep Habits Questionnaire (Abbreviated)(at baseline and weeks 4, 8, and 12)
  • The Repetitive Behavior Scale(at baseline and weeks 4, 8, and 12)
  • Caregiver Strain Questionnaire(at baseline and weeks 4, 8, and 12)

研究者

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

Alexander Kolevzon

Professor

Icahn School of Medicine at Mount Sinai

研究点 (1)

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