Physiological Mechanisms of Therapeutic Horseback Riding Intervention Effects in a Psychiatric Population of ASD Youth

Physiological Mechanisms of Action Relating to Immediate and Long-term Therapeutic Horseback Riding Intervention Effects in a Psychiatric Population of Youth With Autism Spectrum Disorder

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.

Study Overview

• Status: Recruiting
• Conditions: Mental Disorders; Autism Spectrum Disorder
• Intervention / Treatment: Other: Therapeutic Horseback Riding; Other: Barn Activity; Other: Hybrid

Detailed Description

This randomized control trial (RCT) will test the hypothesis that physiological response patterns of salivary cortisol, cardiovascular, and electrodermal activity account for our previously observed significant outcomes (i.e., reduced irritability and hyperactivity, and improved social and communication), and additional outcomes (emotion regulation caregiver quality of life and crisis mental health care usage), in youth ages 6-16 yrs. with ASD and co-occurring psychiatric diagnoses randomized to a 10-week manualized THR intervention compared to a no-horse Barn Activity (BA) control (Aim 1). We will evaluate the durability of Aim 1 outcomes in the THR group compared to the BA control group six-months after the intervention period (Aim 2). Finally, we will explore dose and sub-population effects of THR and BA interventions by comparing effect size differences in THR and BA groups to (a) a 10-week wait-list control group; (b) a Hybrid intervention group (five weeks BA followed by five weeks THR); and (c) a subsample of the THR study population randomized following psychiatric hospitalization (Aim 3).

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Madison Widick, BAS; Phone Number: 970-217-4044; Email: Madison.widick@cuanschutz.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80218
      • Recruiting
      • University of Colorado Anschutz Medical Campus
      • Principal Investigator: Robin L Gabriels, Psy.D.
      • Contact: Madison Widick; Phone Number: 970-217-4044; Email: Madison.widick@cuanschutz.edu
      • Contact: Katharine Weimann; Email: Katharine.weimann@cuanschutz.edu
  • Maine
    • Portland, Maine, United States, 04102
      • Terminated
      • Maine Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Waitlist; 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)
Experimental: Therapeutic Horseback Riding; 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.	Other: Therapeutic Horseback Riding; Horse therapy; Other Names: Equine Assisted Activity
Active Comparator: Barn Activity; 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.	Other: Barn Activity; Horsemanship group; Other Names: No Horse control
Experimental: Hybrid; 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).	Other: Hybrid; Ground and riding activities; Other Names: Equine Assisted Activity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Aberrant Behavior Checklist-Community (ABC-C)	58-item symptom presence and severity (0-3, not a problem to severe problem) checklist of problem behaviors of children and adults with developmental disabilities in community settings. The 58 items resolve into five subscales: (1) Irritability, Agitation, (2) Lethargy, Social Withdrawal, (3) Stereotypic Behavior, (4) Hyperactivity, and (5) Inappropriate Speech.Irritability and Hyperactivity behaviors	Baseline, week 10, 6 months
Change in Social Responsiveness Scale™, Second Edition	social awareness, social cognition, social communication, social motivation, autistic mannerisms. Results in a T-score that indicates severity level ranges.	Baseline, week 10, 6 months
Change in Emotion Dysregulation Inventory (EDI)	24 -item Reactivity behaviors of intense, rapidly escalating, sustained, and poorly regulated negative emotional reactions, and 6-item Dysphoria behaviors of minimal positive affect and motivation, and the presence of nervousness and sadness.Both the Dysphoria Scale and Reactivity Short Form have IRT-based theta scores, which have a mean of 0 and SD of 1, and provide superior discriminative ability to raw scores.	Baseline, week 10, 6 months
Change in World Health Organization's Quality of Life Instrument (WHOQOL-BREF)	Quality of life for caregiver	Baseline, week 10, 6 months
Change in Systematic Analysis of Language Transcripts (SALT)	Expressive Language Sample	Baseline, week 10, 6 months
Change in Crisis Mental Health Care Usage Survey	crisis mental health care usage	Baseline, week 10, 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Salivary Cortisol	Mediator	Baseline, Midpoint Intervention (about Week 5), Week 10
Change in Electrodermal Activity	Change in skin conductance will be reported. Electrodes will be attached to the underside of the wrist of their non-dominant hand to record electrodermal activity (EDA). EDA measures individual differences in endocrine sweat gland activity.	Baseline, Midpoint Intervention (about Week 5), Week 10
Change in Heart Rate/Heart Rate Variability	Mediator	Baseline, Midpoint Intervention (about Week 5), Week 10

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); University of Pittsburgh; Boston Children's Hospital; Baylor University; Colorado State University; Riding To The Top Therapeutic Riding Center; Hearts and Horses Therapeutic Riding Center; Salimetrics, LLC; Maine Health/Spring Harbor Hospital
• Investigators: Principal Investigator: Robin L Gabriels, Psy.D., University of Colorado Anzchutz Medical Campus

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2020
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: October 15, 2020
• First Submitted That Met QC Criteria: October 22, 2020
• First Posted (Actual): October 28, 2020

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: children; adolescents; cortisol; heart rate; emotion regulation; physiology; electrodermal activity; human-animal intervention; mechanisms of action
• Additional Relevant MeSH Terms: Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Mental Disorders; Autism Spectrum Disorder
• Other Study ID Numbers: 19-1962; 1R01HD097693-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No