此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

结合马的作业疗法对自闭症青少年自我调节的初步疗效

2026年9月30日 更新者:Colorado State University

整合马的作业疗法对自闭症谱系障碍青少年自我调节的初步疗效

The goal of this clinical trial is to learn about occupational therapy integrating horses for autistic youth. The main questions it aims to answer are:

  • Does occupational therapy integrating horses improve self-regulation in autistic youth
  • Does occupational therapy integrating horses affect salivary cortisol and alpha-amylase

Participants will receive 10 weeks of occupational therapy, and will be asked to provide saliva samples each week.

Researchers will compare occupational therapy integrating horses to occupational therapy in a clinic to see if integrating horses affects self-regulation.

研究概览

详细说明

The goal of this project is to quantify the unique benefits of integrating horses in occupational therapy compared to occupational therapy in a clinic (i.e., OTEE HORS vs. OT Clinic) for improving self-regulation in youth with ASD.

To address both aims we will randomize 64 youth with ASD ages 6-11 years old to OTEE HORS or OT clinic.

Specific Aim 1: Examine the preliminary efficacy of OTEE HORS compared to OT Clinic on self-regulation. Hypotheses: The OTEE HORS group will demonstrate significantly larger improvements than the OT Clinic group in five domains of self-regulation (hyperactivity [primary], irritability, emotional reactivity, dysphoria, and individual goal attainment).

Specific Aim 2: Identify potential physiological mechanisms that explain how integration of horses in occupational therapy impacts self-regulation in youth with ASD. Hypotheses 2A & B: The OTEE HORS group will demonstrate significantly larger decreases in salivary cortisol after each 60-minute therapy session and after the 10-week treatment course in comparison to the OT Clinic group. Hypotheses 2C & 2D: The OTEE HORS group will demonstrate significantly greater increases in salivary alpha-amylase after each 60-minute therapy session, and significantly greater decreases in salivary alpha-amylase over time as measured after the 10-week treatment course in comparison to the OT Clinic group. Exploratory Hypothesis 2E: Changes in physiological measures will significantly correlate with changes in Aim 1 behavioral measures.

研究类型

介入性

注册 (实际的)

72

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Colorado
      • Denver、Colorado、美国、80216
        • Temple Grandin Equine Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

6年 至 11年 (孩子)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • meet clinical cut-offs for ASD on the Autism Diagnostic Observation Schedule, Second Edition(ADOS-2) and Social Communication Questionnaire (≥ 11)
  • nonverbal IQ≥65 on Leiter International Performance Scale Third Edition (Leiter-3)
  • verbally fluent defined by meeting standard administration criteria for ADOS-2 module 3
  • score >10 on the irritability subscale of the aberrant behavior checklist
  • able to tolerate a helmet and ride a horse for 10 minutes while following safety rules
  • and able to provide a saliva sample

Exclusion Criteria:

  • weigh more than 200 pounds
  • smoke or regularly use steroids
  • receive outpatient occupational therapy
  • have 10+ hours horseback riding experience in the previous 6 months
  • history of animal abuse or phobia of horses
  • have a sibling previously enrolled in the study

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Occupational Therapy Integrating Horses

10 weeks of occupational therapy focused on self-regulation skills, provided while participants are riding horses

10 weeks of occupational therapy focused on teaching and practicing self-regulation skills, provided while participants are riding horses

有源比较器:Occupational Therapy in a Clinic

10 weeks of occupational therapy focused on self-regulation skills, provided in a traditional clinic environment

10 weeks of occupational therapy focused on teaching and practicing self-regulation skills, provided in a traditional clinic

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in Hyperactivity
大体时间:Week 1 & Week 10

The Hyperactivity subscale of the Aberrant Behavior Checklist, Second Edition (ABC-2) measures parent/caregiver-reported hyperactive and impulsive behaviors, including excessive activity, impulsivity, and difficulty remaining still or attending. The subscale consists of 16 items, with total scores ranging from 0-48. Higher scores indicate greater hyperactivity and more severe behavioral difficulties, while lower scores indicate less hyperactivity and better behavioral functioning. Item scores are summed to produce the subscale score.

Week 1 & Week 10

次要结果测量

结果测量
措施说明
大体时间
Change in Irritability
大体时间:Week 1 & Week 10

The Irritability subscale of the Aberrant Behavior Checklist, Second Edition (ABC-2) measures behaviors associated with irritability, including aggression, self-injury, tantrums, and mood instability. The subscale consists of 15 items, with total scores ranging from 0-45. Higher scores indicate greater irritability and more severe behavioral difficulties, while lower scores indicate less irritability and better behavioral functioning. Items are rated based on the presence and severity of behaviors, and item scores are summed to produce the subscale score.

Week 1 & Week 10
Change in Emotional Reactivity
大体时间:Week 1 & Week 10

The Emotional Reactivity subscale of the Emotion Dysregulation Inventory (EDI) measures the tendency to experience intense, rapidly escalating, and prolonged negative emotional responses. T-scores are standardized scores derived from the raw Emotional Reactivity score and have a mean of 50 and standard deviation of 10 in the normative sample. Higher T-scores indicate greater emotional reactivity and more severe emotion dysregulation, while lower T-scores indicate less emotional reactivity and better emotional regulation.

Week 1 & Week 10
Change in Dysphoria
大体时间:Week 1 & Week 10

The Dysphoria subscale of the Emotion Dysregulation Inventory (EDI) measures symptoms of negative mood, including sadness, hopelessness, and emotional distress. T-scores are standardized scores derived from the raw Dysphoria score and have a mean of 50 and standard deviation of 10 in the normative sample. Higher T-scores indicate greater dysphoria and more severe negative mood symptoms, while lower T-scores indicate less dysphoria and better emotional well-being.

Week 1 & Week 10
Change in Concentration of Salivary Cortisol
大体时间:Pre-session, Post-session, Post-session + 20 min, averaged across Intervention Weeks 2, 6 and 10

Change in Concentration of Salivary Cortisol from before-session, after-session, and 20 mins after-session. Saliva samples from Weeks 2, 6, and 10 at pre-session, post-session, and post-session +20, were assayed for cortisol content and included in the linear mixed model analyses.

Pre-session, Post-session, Post-session + 20 min, averaged across Intervention Weeks 2, 6 and 10
Change in Concentration of Salivary Alpha-amylase
大体时间:Pre-session, Within-session, Post-session + 20 min, averaged across Intervention Weeks 2, 6 and 10

Change in concentration of salivary alpha-amylase from before-session, during-session, and 20 mins after-session. Saliva samples from Weeks 2, 6, and 10 at pre-session, within-session, and post-session +20, were assayed for alpha-amylase content and included in the linear mixed model analyses.

Pre-session, Within-session, Post-session + 20 min, averaged across Intervention Weeks 2, 6 and 10
Emotional Awareness Goal Attainment
大体时间:Week 10

Attainment of individualized emotional awareness goal. Goal attainment scales range from -2 to +2 where higher values indicate greater progress towards individual goal, level 0 indicates goal was met.

Week 10
Self-regulation Tool Identification Goal Attainment
大体时间:Week 10

Attainment of individualized goal related to identifying self-regulation tools. Goal attainment scales range from -2 to +2 where higher values indicate greater progress towards individual goal, level 0 indicates goal was met.

Week 10
Self-regulation Tool Use Goal Attainment
大体时间:Week 10

Attainment of individualized goal related to using self-regulation tools. Goal attainment scales range from -2 to +2 where higher values indicate greater progress towards individual goal, level 0 indicates goal was met.

Week 10

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Brittany C Peters, PhD、Colorado State University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2023年3月21日

初级完成 (实际的)

2025年4月23日

研究完成 (实际的)

2025年11月1日

研究注册日期

首次提交

2023年4月7日

首先提交符合 QC 标准的

2023年4月26日

首次发布 (实际的)

2023年5月6日

研究记录更新

最后更新发布 (实际的)

2026年10月2日

上次提交的符合 QC 标准的更新

2026年9月30日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • 4049
  • 1R21HD109957-01 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

De-identified data will be shared in an appropriate data repository, such as the "Data and Specimen Hub" (DASH) or the "National Database for Autism Research" (NDAR). Data will be shared no later than the acceptance for publication of the main findings from the final dataset. Salimetrics will discard saliva samples after testing, and therefore saliva samples will not be available for sharing.

IPD 共享时间框架

We will share in an appropriate data repository indefinitely, no later than the acceptance for publication of the main findings from the final dataset

IPD 共享支持信息类型

  • 国际碳纤维联合会

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅