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临床试验/NCT04482088
NCT04482088已完成不适用

Piloting an Enhanced Protocol of Occupational Therapy in an Equine Environment for Youth With Autism

Colorado State University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年1月20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
20
试验地点
2
主要终点
Change in Goal Performance using Goal Attainment Scaling

研究概览

简要总结

The purpose of this study is to learn about occupational therapy for youth with autism in a traditional clinic environment, and in an equine environment. 20 youth with autism will participate in 10 weeks of occupational therapy in a clinic environment, followed by 10 weeks of occupational therapy in an equine environment. Caregivers will complete online surveys about their child's behavior. Occupational therapists and other stakeholders will provide feedback about the interventions. The therapy sessions that involve horses will be videotaped, and a researcher will look at the behaviors of the horses involved in the intervention. We will use the results of this study to improve the quality of both interventions.

详细描述

The purpose of this study is to assess the feasibility, acceptability, and preliminary efficacy of occupational therapy in an equine environment (OTEE) for youth with autism. As a feasibility study, this study aims to accomplish several key development tasks. Specifically, this study aims to:

  1. Create a safe, feasible, and manualized control group that controls for non-animal critical elements of the OTEE intervention
  2. Assess welfare of the therapy horses that are integrated into the OTEE intervention
  3. Enhance the OTEE manual by increasing standardization, while still allowing for individualization

Design. We will implement a longitudinal design, where caregivers will complete outcomes measures at 1)pre-test, 2) after their child participates in 10 weeks of occupational therapy in a clinic environment and 3) after 10 weeks of occupational therapy in an equine environment.

Participants. Youth with ASD will be screened for inclusion in a 2-part process that includes 1) an online survey and 2) virtual screening visit using Microsoft Teams. After completing 10 weeks of occupational therapy in a clinic environment, youth will then participate in an additional screening visit and re-evaluation for OTEE to ensure they a) are able to mount and ride a horse (with assistance) for 10 minutes while following safety rules, and b) meet all PATH Intl criteria for participation in equine-assisted services. Twenty youth with autism and their caregivers will be enrolled in the study. Occupational therapists that deliver the interventions and other stakeholders (i.e. program coordinators, etc.) will also be asked to be research participants.

Occupational Therapy Evaluation. Each youth and caregiver will participate in an occupational therapy evaluation at Temple Grandin Equine Center (or virtually, depending on COVID guidelines in 2021) that include an occupational profile, semi-structured interview, social skills checklist, and collaborative goal setting. Therapists and caregivers will jointly determine three goals for each youth with autism in the domains of self-regulation, social communication, or social play.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

盲法说明

The occupational therapist that rates goal attainment will be blinded to treatment condition.

入排标准

年龄范围
6 Years 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Score ≥ 15 on the Social Communication Questionnaire
  • Diagnosed with autism by a community provider
  • Meet clinical cut-offs for autism on the ADOS or ADOS-2
  • Can follow 1-step directions
  • Score >10 on ABC-C irritability subscale
  • Meet symptom criterion score of CASI-5 for mood, anxiety, or ADHD diagnosis
  • Meet PATH Intl medical and behavioral standards, and can ride a horse for 10 minutes while following safety rules.

排除标准

  • Participated in equine-assisted activities or therapies for 5 or more hours in the last 6 months
  • Weigh more than 200 pounds

结局指标

主要结局

Change in Goal Performance using Goal Attainment Scaling

时间窗: 10 weeks

Performance on individualized occupational performance goals

次要结局

  • Change in Social Responsiveness Scale, Second Edition(10 weeks)
  • Change in Pediatric Disability Inventory Computer Adaptive Test for Autism Spectrum Disorders(10 weeks)
  • Change in Aberrant Behavior Checklist- Community(10 weeks)
  • Change in Emotional Dysregulation Inventory(10 weeks)
  • Change in World Health Organization Quality of Life- BREF(10 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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