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

Sponsor

University of Colorado, Denver (Other)

Overall Status

Recruiting

CT.gov ID

NCT04606966

Collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH), Maine Health/Spriing Harbor Hospital (Other), Riding To The Top Therapeutic Riding Center (Other), Hearts and Horses Therapeutic Riding Center (Other), Salimetrics, LLC (Other), Baylor University (Other)

192

Enrollment

Locations

Arms

46.3

Anticipated Duration (Months)

Patients Per Site

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Autism Spectrum Disorder Mental Disorders	Other: Therapeutic Horseback Riding Other: Barn Activity Other: Hybrid	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

192 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Single (Outcomes Assessor)

Masking Description:

Speech therapist evaluator will be blinded to participants' intervention condition assignment

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 22, 2020

Anticipated Primary Completion Date :

Nov 1, 2024

Anticipated Study Completion Date :

Nov 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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. 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 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 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 Horsemanship group Other Names: No Horse control
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: Hybrid 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 Ground and riding activities Other Names: Equine Assisted Activity

Outcome Measures

Primary Outcome Measures

Change in Aberrant Behavior Checklist-Community (ABC-C) [Baseline, week 10, 6 months]
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
Change in Social Responsiveness Scale™, Second Edition [Baseline, week 10, 6 months]
social awareness, social cognition, social communication, social motivation, autistic mannerisms. Results in a T-score that indicates severity level ranges.
Change in Emotion Dysregulation Inventory (EDI) [Baseline, week 10, 6 months]
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.
Change in World Health Organization's Quality of Life Instrument (WHOQOL-BREF) [Baseline, week 10, 6 months]
Quality of life for caregiver
Change in Systematic Analysis of Language Transcripts (SALT) [Baseline, week 10, 6 months]
Expressive Language Sample
Change in Crisis Mental Health Care Usage Survey [Baseline, week 10, 6 months]
crisis mental health care usage

Other Outcome Measures

Change in Salivary Cortisol [Baseline, Midpoint Intervention (about Week 5), Week 10]
Mediator
Change in Electrodermal Activity [Baseline, Midpoint Intervention (about Week 5), Week 10]
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.
Change in Heart Rate/Heart Rate Variability [Baseline, Midpoint Intervention (about Week 5), Week 10]
Mediator

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado Anschutz Medical Campus	Aurora	Colorado	United States	80218
2	Maine Health	Portland	Maine	United States	04102

Sponsors and Collaborators

University of Colorado, Denver
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Maine Health/Spriing Harbor Hospital
Riding To The Top Therapeutic Riding Center
Hearts and Horses Therapeutic Riding Center
Salimetrics, LLC
Baylor University