Physiological Mechanisms of Therapeutic Horseback Riding Intervention Effects in a Psychiatric Po… (NCT04606966) | Clinical Trial Compass
CompletedNot Applicable
Physiological Mechanisms of Therapeutic Horseback Riding Intervention Effects in a Psychiatric Population of ASD Youth
United States250 participantsStarted 2020-12-22
Plain-language summary
This randomized control trial (RCT) seeks to assess the mechanisms underlying Therapeutic Horseback Riding's (THR) previously observed significant positive effects on ASD youth, particularly those with co-occurring psychiatric disorders, and to refine information on the durability, dose and sub-population effects of the intervention.
Who can participate
Age range
6 Years – 17 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:
* documented ASD diagnosis and a co-occurring psychiatric disorder
* ABC Irritability subscale score ≥8
* Leiter-III Nonverbal IQ ≥ 40
* meet Symptom Criterion score (minimum number of symptoms necessary for a DSM-V (mood, anxiety, or ADHD diagnosis) on CASI-5)
* meet ASD cut-offs on the SCQ (≥ 11) and on ADOS-2
* Only one child with ASD per family to maintain independent observations
* a consistent caregiver (i.e., parent or legal guardian) to complete study outcome measures
Exclusion Criteria:
* medical or behavioral issues that prevent participation
* ward of the state
* judged during riding center screen to have significant riding experience
* smoking or regular use of oral, inhaled, or topical steroids on a regular basis, factors known to affect cortisol levels
* Participants weighing 200 pounds or greater will be excluded due to the riding center's safety policies
* Participants will not be allowed to begin baseline assessments until at least six months have passed from the time they last engaged in mounted EAAT, given pilot evidence for the six-month maintenance of THR effects.
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 Aberrant Behavior Checklist-Community (ABC-C)
Timeframe: Baseline, week 10, 6 months
2
Change in Social Responsiveness Scale™, Second Edition
Timeframe: Baseline, week 10, 6 months
3
Change in Emotion Dysregulation Inventory (EDI)
Timeframe: Baseline, week 10, 6 months
4
Change in World Health Organization's Quality of Life Instrument (WHOQOL-BREF)
Timeframe: Baseline, week 10, 6 months
5
Change in Systematic Analysis of Language Transcripts (SALT)