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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-22

Study Completion Date

2025-02-22

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.

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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).

Conditions

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Autism Spectrum Disorder Mental Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Trial assigned to one of 3 groups:

Therapeutic Horseback Riding group Barn Activity group (no-horse control) Waitlist Hybrid group

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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

Study Groups

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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.

Group Type EXPERIMENTAL

Therapeutic Horseback Riding

Intervention Type OTHER

Horse therapy

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.

Group Type ACTIVE_COMPARATOR

Barn Activity

Intervention Type OTHER

Horsemanship group

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)

Group Type NO_INTERVENTION

No interventions assigned to this group

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).

Group Type EXPERIMENTAL

Hybrid

Intervention Type OTHER

Ground and riding activities

Interventions

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Therapeutic Horseback Riding

Horse therapy

Intervention Type OTHER

Barn Activity

Horsemanship group

Intervention Type OTHER

Hybrid

Ground and riding activities

Intervention Type OTHER

Other Intervention Names

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Equine Assisted Activity No Horse control Equine Assisted Activity

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.

Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes