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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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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

Conditions
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Autism Spectrum Disorder, Mental Disorders

Intervention / Treatment
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* Other: Therapeutic Horseback Riding
* Other: Barn Activity
* Other: Hybrid


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial assigned to one of 3 groups: Therapeutic Horseback Riding group Barn Activity group (no-horse control) Waitlist Hybrid group
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapeutic Horseback Riding<br>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. Participants will have an assigned horse and volunteer(s) 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 for five minutes, after this, study personnel will instruct participants to place the 10cm long foam swab rod under their tongue for two minutes while watching a 1-minute sand timer, then, 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 20 minutes followed by doing another saliva sample. | Other: Therapeutic Horseback Riding<br>* Horse therapy<br>* Other names: Equine Assisted Activity;|
| Active Comparator: Barn Activity<br>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 counselor. Participants will have one assigned volunteer and will have no contact with horses at the riding center, just view horses at a distance. There will be a life-sized stuffed horse in 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 for five minutes, after this, study personnel will instruct participants to place the 10cm long foam swab rod under their tongue for two minutes while watching a 1-minute sand timer. Each week after conclusion of the BA intervention, participants will again sit with their group at an art table for 20 minutes followed by doing another saliva sample | Other: Barn Activity<br>* Horsemanship group<br>* Other names: No Horse control;|
| No Intervention: Waitlist<br>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: Hybrid<br>Participants who complete the Waitlist Arm and post assessments, will begin a Hybrid group that will consist of a 5- week one hour Barn Activity (BA) group condition that consists of a small group (2-4 participants) led by a THR instructor and co-led by a mental health counselor. Participants will have one assigned volunteer and will have no contact with horses at the riding center, just view horses at a distance. There will be a life-sized stuffed horse in for hands-on learning related to the weekly topic per the BA study manual. Group times will be between 1:00-5:00 PM. After the first 5 weeks of BA, participants will then 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 as outlined in the study's THR manual. Participants will have an assigned horse and volunteer(s) Group times will be between 1:00-5:00 PM. | Other: Hybrid<br>* Ground and riding activities<br>* Other names: Equine Assisted Activity;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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human-animal intervention, physiology, mechanisms of action, children, adolescents, emotion regulation, cortisol, heart rate, electrodermal activity