Therapeutic Horseback Riding for Autism Spectrum Disorder

Recruiting at 1 trial location

Overseen By Madison Widick, BAS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Must not be taking: Steroids

Disqualifiers: Significant riding experience, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 10 weeks

250 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Robin L Gabriels, Psy.D.

Principal Investigator

University of Colorado Anzchutz Medical Campus

Eligibility Criteria

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.

Inclusion Criteria

Meet Symptom Criterion score (minimum number of symptoms necessary for a DSM-V (mood, anxiety, or ADHD diagnosis) on CASI-5)

You have been diagnosed with autism spectrum disorder (ASD) and also have another mental health condition.

Your irritability score on the ABC Irritability subscale is 8 or higher.

Exclusion 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.

Ward of the state

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 10-week Therapeutic Horseback Riding (THR) intervention or a Barn Activity (BA) control, with physiological monitoring including salivary cortisol, cardiovascular, and electrodermal activity

10 weeks

Weekly sessions

Follow-up

Participants are monitored for the durability of outcomes six months after the intervention period

6 months

Hybrid Intervention

Participants in the waitlist group undergo a 5-week Barn Activity followed by a 5-week Therapeutic Horseback Riding intervention

10 weeks

Weekly sessions

Treatment Details

Interventions

• Barn Activity
• Hybrid
• Therapeutic Horseback Riding

Trial Overview 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.

Participant Groups

Group I: Therapeutic Horseback Riding Experimental Treatment 1 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: Hybrid Experimental Treatment 1 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 Activity Active Control 1 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: Waitlist Active Control 1 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)

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Salimetrics, LLC

Collaborator

Trials

1

Recruited

250+

Maine Health/Spring Harbor Hospital

Collaborator

Trials

1

Recruited

250+

Baylor University

Collaborator

Trials

65

Recruited

67,600+

Colorado State University

Collaborator

Trials

138

Recruited

38,200+

Hearts and Horses Therapeutic Riding Center

Collaborator

Trials

2

Recruited

270+

Boston Children's Hospital

Collaborator

Trials

801

Recruited

5,584,000+

University of Pittsburgh

Collaborator

Trials

1,820

Recruited

16,360,000+

Maine Health/Spriing Harbor Hospital

Collaborator

Trials

1

Recruited

250+

Riding To The Top Therapeutic Riding Center

Collaborator

Trials

1

Recruited

250+