Therapeutic Horseback Riding for Autism Spectrum Disorder

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how Therapeutic Horseback Riding (THR) can help children with Autism Spectrum Disorder (ASD) who also have other mental health conditions, such as anxiety or ADHD. The researchers seek to understand how long the positive effects last, determine the ideal "dose" of THR, and identify which specific groups benefit the most. Participants will be divided into different groups: some will engage directly in horseback riding activities, while others will participate in related activities without direct horse interaction. Children with an ASD diagnosis and another psychiatric disorder, who experience frequent irritability, might be a good fit for this study. As an unphased trial, this study offers a unique opportunity to contribute to pioneering research that could enhance therapeutic options for children with ASD.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, it does exclude participants who regularly use steroids, as these can affect cortisol levels.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that therapeutic horseback riding (THR) is generally well-received by children with autism spectrum disorder (ASD). In earlier studies, parents observed improvements in 70% of the behaviors monitored during therapy, with 63% of these improvements persisting after therapy ended. One study found that while THR didn't change some behaviors, it helped children sit up straighter during sessions. These studies reported no serious side effects, indicating that THR is a safe option for children with ASD. These findings support the safety of THR as a treatment method. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about therapeutic horseback riding (THR) for autism spectrum disorder because it offers a unique, engaging approach compared to traditional therapies like behavioral interventions and medications. THR combines physical activity with emotional and social engagement, which can help improve motor skills, communication, and emotional regulation in a natural setting. The hybrid approach, which includes both mounted activities and a barn activity component with life-sized stuffed horses, provides a comprehensive experience that promotes learning horsemanship skills and enhances sensory integration. This treatment's innovative blend of therapeutic components has the potential to offer benefits beyond those of standard care options.

What evidence suggests that this trial's treatments could be effective for Autism Spectrum Disorder?

Research has shown that Therapeutic Horseback Riding (THR), one of the treatments in this trial, can greatly benefit children with Autism Spectrum Disorder (ASD). For example, one study found that 70% of specific behaviors improved during the therapy, and 63% of these improvements persisted after the therapy ended. In another study, children who participated in 10 weeks of THR showed noticeable improvements in irritability, hyperactivity, and other behaviors. Additionally, a review of several studies found that horse-assisted therapy positively affects social skills. These findings suggest that THR could be a promising way to enhance social and behavioral skills in children with ASD. ^{1 2 3 5 6}

Who Is on the Research Team?

Robin L Gabriels, Psy.D.

Principal Investigator

University of Colorado Anzchutz Medical Campus

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4136476/

Therapeutic Horseback Riding Outcomes of Parent ... We examined whether different doses of therapeutic riding influenced parent-nominated target behaviors of children with autism spectrum disorder (ASD)

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4475278/

Randomized Controlled Trial of Therapeutic Horseback ... Therapeutic horseback riding outcomes of parent identified goals for children with autism spectrum disorder: An ABA multiple case design examining dosing ...

3. tandfonline.com tandfonline.com/doi/abs/10.1080/01612840.2024.2364236

A Scoping Review of Equine-Assisted Therapies on the ... Therapeutic Horseback Riding Outcomes of Parent-Identified Goals for Children with Autism Spectrum Disorder: An ABA′ Multiple Case Design ...

4. frontiersin.org frontiersin.org/journals/veterinary-science/articles/10.3389/fvets.2018.00156/full

Long-Term Effect of Therapeutic Horseback Riding in ... This is the first known study to examine and demonstrate the longer-term effects of THR for individuals with ASD and warrants a more thorough evaluation.

5. tandfonline.com tandfonline.com/doi/full/10.1080/01612840.2024.2364236

A Scoping Review of Equine-Assisted Therapies on the ... Therapeutic Horseback Riding Outcomes of Parent-Identified Goals for Children with Autism Spectrum Disorder: An ABA′ Multiple Case Design ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04606966?tab=history&a=4

Record History | ver. 4: 2022-06-06 | NCT04606966 This randomized control trial (RCT) seeks to assess the mechanisms underlying Therapeutic Horseback Riding's (THR) previously observed significant positive ...