Piloting an Enhanced Protocol of Occupational Therapy in an Equine Environment for Youth With Autism (NCT04482088) | Clinical Trial Compass
CompletedNot Applicable
Piloting an Enhanced Protocol of Occupational Therapy in an Equine Environment for Youth With Autism
United States20 participantsStarted 2020-01-20
Plain-language summary
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.
Who can participate
Age range
6 Years – 13 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* Participated in equine-assisted activities or therapies for 5 or more hours in the last 6 months
* Weigh more than 200 pounds
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Goal Performance using Goal Attainment Scaling