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临床试验/NCT07216768
NCT07216768已完成不适用

ADAPT: Approach to Dance for Autism

Icahn School of Medicine at Mount Sinai2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2025年8月25日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
2
主要终点
Change in Developmental Coordination Disorder Questionnaire (DCDQ)

研究概览

简要总结

It is well documented that motor impairments are associated with a diagnosis of autism spectrum disorder (ASD). Yet, appropriate therapies are scarce. Dance has been shown to not only promote fine and gross motor skills, but also psychological well-being, cognition, and social participation in neurotypical dancers. Little research has been conducted to gauge if these benefits translate to those with ASD. Ballet for all Kids (BFAK) is a recreational dance program that has been teaching ballet to children with ASD for over a decade, but has yet to be empirically studied. This study expands on the goals of former STUDY 24-00144, Approach to Dance for Autism (ADAPT), NCT06424366, to elucidate the impact of participation in a recreational dance program on children with ASD.

详细描述

The researchers aim to expand upon the pilot randomized trial (STUDY-24-00144) using BFAK's curriculum and structure to elucidate the impact of a recreational ballet program on the motor function and psychological, social, and behavioral skills of children with ASD. For the primary objective, the researchers hypothesize that after 12 weeks of participation in BFAK, children with ASD will improve their motor function. For the secondary objectives, the researchers hypothesize that after 12 weeks of participation in BFAK, children with ASD will improve their behavior and mood. This is a single site, randomized trial with 32 individuals diagnosed with ASD.

Participants will be placed in either Level 1 or Level 2 based on prior experience with BFAK. Participants returning from our pilot study will be placed into Level 2 at the discretion of the program coordinators, and all newly recruited participants will be placed in Level 1. BFAK ballet classes will begin in September and run for 45 minutes once a week for the intervention group. The waitlist control group will begin classes in January for 45 minutes once a week, ending in March 2026.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

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

入选标准

  • 6-12 years age
  • understand English or Spanish
  • Autism Spectrum Disorder diagnosis
  • not currently taking ballet class

排除标准

  • 未提供

研究组 & 干预措施

Cohort 1 - Classes in fall

Experimental

Participants randomly assigned to cohort 1 will begin classes in fall 2025. Parents/guardians will complete surveys just one time over the 12 week intervention

干预措施: Ballet Class (Behavioral)

Cohort 2 - Classes in spring

Experimental

This cohort is a waitlist control. Parents/guardians will complete all surveys during the fall while their children do not receive the intervention. They will then receive the intervention in the spring and surveys will be completed again.

干预措施: Ballet Class (Behavioral)

结局指标

主要结局

Change in Developmental Coordination Disorder Questionnaire (DCDQ)

时间窗: baseline, week 6,and week 12

The change in scores on the DCDQ at baseline and weeks 6 and 12 of the BFAK program. The DCDQ is a 15 item questionnaire designed to screen for coordination challenges in children from 5 to 15 years old and has long been used in children with ASD. It comprises 3 subscales: (1) Control during movement (scale 9-45), (2) Fine Motor/Handwriting (scale 11-55), and (3) General Coordination (scale 10-50). Scores are calculated by weighting the domains as follows: (Control during movement/30) + (Fine Motor/Handwriting/20) + (General Coordination/25) = TOTAL, reported as a range from 15-75. Higher scores indicate better coordination. For Children Ages 5 years 0 months to 7 years 11 months: 5-46 indication of DCD or suspect DCD; 47-75 probably not DCD For Children Ages 8 yrs 0 mos to 9 yrs 11 mos: 15-55 indication of DCD or suspect DCD; 56-75 probably not DCD For Children Ages 10 yrs 0 mos to 15 yrs: 15-57 indication of DCD or suspect DCD; 58-75 probably not DCD

Change in Pediatric Balance Scale

时间窗: baseline and week 12

The difference in participants' scores on the Pediatric Balance scale at baseline and week 12. The Pediatric Balance Scale is a 14-item questionnaire that prompts children to complete certain movements such as standing unsupported, turning 360 degrees, and retrieving an object from the floor. Completion of movements are scored on a scale from 0 to 4. Full scale is scored 0-56, with higher scores corresponding to more advanced motor skills.

Change in Movement Assessment Battery for Children.

时间窗: baseline and weeks12

The difference in participants' scores on the Movement Assessment Battery for Children (MABC) at baseline and week 12. The MABC is a standardized tool used to identify and describe motor impairments in children. It assesses fine and gross motor skills across everyday movement domains, and is commonly used for diagnosing Developmental Coordination Disorder (DCD) and related difficulties. The MABC is divided into three domains: (1) Manual Dexterity (0-15), (2) Aiming \& Catching (0-10), (3) Balance (0-15). Full scale is scored from 0-40 as a sum of the three domains. A higher total score indicates greater motor difficulty/impairment. Lower scores indicate better motor competence.

次要结局

  • Aberrant Behavior Checklist (ABC)(baseline, week 6, week 12)
  • Swanson, Nolan and Pelham (SNAP-IV)(baseline, week 6, week 12)
  • Number of classes attended(baseline, week 6, week 12)

研究者

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

Alexander Kolevzon

Director of Child and Adolescent Psychiatry for the Mount Sinai Health System; Clinical Director of the Seaver Autism Center

Icahn School of Medicine at Mount Sinai

研究点 (2)

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