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Behavioural Intervention
Therapeutic Horseback Riding for Autism Spectrum Disorder
N/A
Recruiting
Led By Robin L Gabriels, Psy.D.
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 10, 6 months
Awards & highlights
Study Summary
This trial will help assess how effective therapeutic horseback riding is for kids with ASD, especially those with co-occurring psychiatric disorders.
Who is the study for?
This trial is for youths with Autism Spectrum Disorder (ASD) who also have a psychiatric condition like mood, anxiety, or ADHD. They must score above certain thresholds on specific ASD and irritability tests and cannot be experienced riders or weigh over 200 pounds due to safety policies.Check my eligibility
What is being tested?
The study is testing the effects of Therapeutic Horseback Riding (THR) on ASD youth with additional mental health issues. It's a randomized control trial that will look into how THR helps these individuals and which specific groups benefit most from it.See study design
What are the potential side effects?
While not explicitly listed, potential side effects may include physical discomfort from riding, allergic reactions to animals or dust in the barn environment, and emotional distress if there are challenges during the intervention.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 10, 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 10, 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Aberrant Behavior Checklist-Community (ABC-C)
Change in Crisis Mental Health Care Usage Survey
Change in Emotion Dysregulation Inventory (EDI)
+3 moreOther outcome measures
Change in Electrodermal Activity
Change in Heart Rate/Heart Rate Variability
Change in Salivary Cortisol
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Therapeutic Horseback RidingExperimental Treatment1 Intervention
This Arm is a 10 week one hour small group (2-4 participants) led by a THR instructor. The group will include a 45-minute mounted activity to learn horsemanship skills as outlined in the study's THR manual, . Group times will be between 1:00-5:00 PM to collect salivary cortisol. Weekly, participants will follow a consistent routine of wearing both their electro dermal activity and heart rate monitoring devices, sit at a group art table before class, after this, study personnel will instruct participants to place the 10cm long foam swab rod under their tongue for one minute while watching a 1-minute timer. Participants will then don their riding helmets and enter the riding arena. Each week after conclusion of the THR intervention, participants will again sit with their group at an art table for 5 minutes followed by doing another saliva sample.
Group II: HybridExperimental Treatment1 Intervention
Participants completing the Wait list Arm and post assessments, will begin a Hybrid group between 1:00-5:00 PM. The group consists of a 5- week 1 -hour BA small group (2-4 participants) led by a THR instructor and co-led by a mental health counselor or OT. Participants will have one assigned volunteer and have no physical contact with horses at the riding center, just view horses at a distance. There will be a life-sized stuffed horse for hands-on learning weekly topics per BA study manual. Group. Then, participants will complete 5-weeks of Therapeutic Horseback Riding small group (2-4 participants) led by a THR instructor. The group will include a 45-minute mounted activity to learn horsemanship skills followed by a 15-minute unmounted horse grooming and tacking activity per THR manual. Participants will have an assigned horse and volunteer(s).
Group III: Barn ActivityActive Control1 Intervention
This Arm is a 10 week one hour small group (2-4 participants) led by a THR instructor and co-led by a mental health or Occupational therapy provider. Participants will have one assigned volunteer and will have no physical contact with horses at the riding center, just view horses from a distance. There will be a life-sized stuffed toy horse for hands-on learning related to the weekly topic per the BA study manual. Group times will be between 1:00-5:00 PM to collect salivary cortisol. Weekly, participants will follow a consistent routine of wearing both their electro dermal activity and heart rate monitoring devices, sit at a group art table before class, after this, study personnel will instruct participants to place the 10cm long foam swab rod under their tongue for one minute while watching a 1-minute timer. Each week after conclusion of the BA intervention, participants will again sit with their group at an art table for 5 minutes followed by doing another saliva sample.
Group IV: WaitlistActive Control1 Intervention
Those assigned to the waitlist group will not have any horse-related intervention during a 10-week waiting period. Following this waiting period and the completion of post assessments, participants in this condition will begin a Hybrid group (see Hybrid Arm)
Find a Location
Who is running the clinical trial?
Salimetrics, LLCUNKNOWN
Maine Health/Spring Harbor HospitalUNKNOWN
Baylor UniversityOTHER
56 Previous Clinical Trials
64,944 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I weigh less than 200 pounds.You have medical or behavioral issues that make it difficult for you to take part in the study.I haven't participated in horseback therapy for at least six months.You have been diagnosed with autism spectrum disorder (ASD) and also have another mental health condition.I regularly use steroids or smoke.Your irritability score on the ABC Irritability subscale is 8 or higher.You have a certain number of symptoms that are needed to be diagnosed with a mood disorder, anxiety disorder, or ADHD, as determined by a psychiatric evaluation tool called CASI-5.
Research Study Groups:
This trial has the following groups:- Group 1: Hybrid
- Group 2: Therapeutic Horseback Riding
- Group 3: Barn Activity
- Group 4: Waitlist
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How can I register to take part in this clinical investigation?
"This clinical trial is searching for 192 autistic patients aged between 6 and 17. Those interested in participating must meet the aforementioned criteria to qualify."
Answered by AI
Does this research endeavor encompass individuals over 45 years of age?
"This study seeks to enrol paediatric patients who are between 6 and 17 years old."
Answered by AI
How many participants are included in this research project?
"Affirmative. Clinicaltrials.gov displays information that this clinical trial, first published on December 22nd 2020, is currently recruiting participants. 192 people are needed from two different study sites."
Answered by AI
Are there any vacancies available for individuals to take part in this clinical trial?
"Affirmative. Information on clinicaltrials.gov establishes that this research is currently enrolling participants; initially posted December 22nd 2020 and recently modified October 24th 2022, the study requires 192 patients to join from 2 separate medical centres."
Answered by AI
Who else is applying?
What state do they live in?
New York
Pennsylvania
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
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