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临床试验/NCT02902952
NCT02902952已完成不适用

Physical Exercise to Reduce Anxiety in Underserved Children With Autism Spectrum Disorders

University of California, Irvine4 个研究点 分布在 1 个国家目标入组 148 人开始时间: 2016年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
148
试验地点
4
主要终点
Anxiety rating

研究概览

简要总结

Anxiety is one of the most frequent comorbidities in children with ASD leading to poor clinical outcomes. Physical exercise has been shown to be a promising and easy to implement intervention for reducing anxiety. However, little is known about the feasibility and efficacy of physical exercise to reduce anxiety in children with ASD from underserved, low-income families. Children with ASD, ages 6 - 12 years old from low-income and Latino families will be recruited for the study and assigned to an exercise intervention group and a sedentary control group. The physical exercise program is an eight-week program, administered three times per week in small groups. Compliance, parent-rated anxiety, and salivary cortisol will be measured before and after completion of the exercise and control group 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

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

  • Autism Spectrum Disorder (ASD) Diagnosis 6-12 years old
  • ≥ 93rd percentile on CBCL or total score of ≥ 25 on SCARED
  • Able to attend 3x/week for 8 consecutive weeks
  • Able to follow instructions
  • CalOptima Insurance or Medicaid and ability to participate in moderate physical exercise

排除标准

  • Danger to themselves or others
  • Medical conditions that may pose a risk during exercise
  • Unable to participate in moderate physical exercise
  • Joining a regular physical exercise program in the last 4 weeks or planning to start or discontinue a regular physical exercise program in the next 8 weeks
  • Unable to attend 3x/week for 8 consecutive weeks
  • Visual, auditory or motor impairments, which would preclude participation in study activities

结局指标

主要结局

Anxiety rating

时间窗: Change from baseline at Week 8

Anxiety rating on the Child Behavior Checklist

次要结局

  • Salivary Cortisol(Change from baseline at Week 8)

研究者

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

Jean Gehricke

Associate Professor

University of California, Irvine

研究点 (4)

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