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

NCT04606966 | Completed

• 2 other identifiers: 19-19621R01HD097693-01A1
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Autism Spectrum Disorder; Mental Disorders

Keywords

human-animal intervention; physiology; mechanisms of action; children; adolescents; emotion regulation; cortisol; heart rate; electrodermal activity

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (3)

• Change in Salivary Cortisol

  Baseline, Midpoint Intervention (about Week 5), Week 10

• Change in Electrodermal Activity

  Baseline, Midpoint Intervention (about Week 5), Week 10

• Change in Heart Rate/Heart Rate Variability

  Baseline, Midpoint Intervention (about Week 5), Week 10

Study Arms (4)

Therapeutic Horseback Riding

EXPERIMENTAL

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

Barn Activity

ACTIVE COMPARATOR

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

Waitlist

NO 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)

Hybrid

EXPERIMENTAL

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

Interventions

Therapeutic Horseback Riding OTHER

Horse therapy

Also known as: Equine Assisted Activity

Therapeutic Horseback Riding

Barn Activity OTHER

Horsemanship group

Also known as: No Horse control

Barn Activity

Hybrid OTHER

Ground and riding activities

Also known as: Equine Assisted Activity

Hybrid

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Maine Health/Spring Harbor Hospital: collaborator
• Riding To The Top Therapeutic Riding Center: collaborator
• Hearts and Horses Therapeutic Riding Center: collaborator
• Salimetrics, LLC: collaborator
• Baylor University: collaborator
• University of Pittsburgh: collaborator
• Colorado State University: collaborator
• Boston Children's Hospital: collaborator

Study Sites (2)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80218, United States

Location

Maine Health

Portland, Maine, 04102, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Mental Disorders; Emotional Regulation

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Self-Control; Social Behavior; Behavior

Study Officials

• Robin L Gabriels, Psy.D.

  University of Colorado Anzchutz Medical Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Speech therapist evaluator will be blinded to participants' intervention condition assignment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial assigned to one of 3 groups: Therapeutic Horseback Riding group Barn Activity group (no-horse control) Waitlist Hybrid group

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: October 28, 2020
• Study Start: December 22, 2020
• Primary Completion: February 22, 2025
• Study Completion: February 22, 2025
• Last Updated: October 24, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)