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临床试验/NCT03206996
NCT03206996已完成不适用

Treatment for Auditory Hyper-Reactivity Behavior in Children With Autism Using Exposure and Response Prevention Principles

University of Florida4 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2017年9月30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
5
试验地点
4
主要终点
Participant Subjective Unit of Distress (SUD) Level

研究概览

简要总结

Auditory hyper-reactivity affects up to 66% of children with autism spectrum disorder (ASD) and has been linked to greater stress and anxiety for children and their families. Exposure and Response Prevention (E/RP) is highly effective for reducing obsessive/compulsive behaviors in children with both OCD and ASD. This study is the first to assess the feasibility and efficacy of E/RP for auditory sensory hyper-reactivity in ASD.

详细描述

Sensory processing difficulties have been well documented in children with Autism Spectrum Disorder (ASD). In fact, "hyper- or hypo-reactivity to sensory input" has recently been added to the diagnostic criteria of this disorder. Hyper-reactivity features are particularly disruptive to children's abilities to engage in everyday activities and pose a significant problem for patients and their families. In children with high functioning pervasive developmental disorder, hyper-sensitivity is associated with symptoms of anxiety and depression. For sensory processing difficulties, children with ASD are primarily referred to Occupational Therapy (OT) services for treatment. These patients are also often seen by mental health professionals to address related disorders such as anxiety, ADHD and behavior problems. Currently, there are no evidence based approaches for specifically addressing auditory hyper-reactivity in ASD. Exposure and response prevention (E/RP), derived from systematic desensitization, is highly effective at reducing avoidance behaviors associated with phobias and obsessive and compulsive disorder (OCD). In mental healthcare settings, ER/P has been shown to be effective for reducing compulsive behaviors in children with OCD and concurrent ASD. E/RP has also been piloted for treating restricted, repetitive behaviors in ASD and demonstrates good feasibility. E/RP may also be useful for reducing aversive responses to auditory stimuli in children with ASD. Occupational Therapists (OT) are the primary service for providing treatment for sensory processing and arousal level modulation difficulties in children with ASD. Thus, OTs are potentially well suited to provide an E/RP aimed at reducing sensory hyper-reactivity in ASD. This study will investigate the feasibility and efficacy of utilizing an E/RP approach for treating auditory hyper-reactivity in ASD.

研究设计

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

入排标准

年龄范围
5 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Participant Subjective Unit of Distress (SUD) Level

时间窗: weekly for approximately 20 weeks from intake to exit

The Subjective Unit of Distress (SUD) scale is a 0-10 scale used for the child and/or caregiver to report level of distress (i.e., pain, stress, anxiety, discomfort) before, during and/or after exposures to stimuli. We expect that SUDS levels will decrease over time indicating improved ability to tolerate auditory stimuli.

次要结局

  • Autism Symptoms(intake (week 1) and exit (final session approximately 20 weeks after intake))
  • Parent Stress Index(intake, end of baseline, end of treatment and exit (up to 4 times over approximately 20 weeks from intake to exit))
  • Spence Child Anxiety Scale(intake, end of baseline, end of treatment and exit (up to 4 times over approximately 20 weeks from intake to exit))
  • Modified Khalfa Hyperacusis Questionnaire(intake, end of baseline, end of treatment and exit (up to 4 times over approximately 20 weeks from intake to exit))
  • Sensory Profile(intake, end of baseline, end of treatment and exit (up to 4 times over approximately 20 weeks from intake to exit))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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