Preliminary Efficacy of Occupational Therapy Integrating Horses on Self-regulation in Youth With Autism Spectrum Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 2
- 主要终点
- Change in Aberrant Behavior Checklist, Community
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The research assistant that rates goal attainment at the conclusion of therapy will be asked to participants' intervention assignment (OTEE HORS v OT Clinic).
入排标准
- 年龄范围
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in Aberrant Behavior Checklist, Community
时间窗: Week 1 & Week 10
Parent-report checklist of problematic behaviors related to hyperactivity and irritability
次要结局
- Change in Emotional Dysregulation Inventory(Week 1 & Week 10)
- Change in Concentration of Salivary Cortisol(Week 1, Week 6, Week 10)
- Change in Concentration of Salivary Alpha-amylase(Week 1, Week 6, Week 10)
- Goal Attainment using Goal Attainment Scale(Week 10)