结合马的作业疗法对自闭症青少年自我调节的初步疗效
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
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Colorado
-
Denver、Colorado、美国、80216
- Temple Grandin Equine Center
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
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
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
合作者
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
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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)?
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
研究美国 FDA 监管的设备产品
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