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

Primary Purpose

Autism Spectrum Disorder, Mental Disorders

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Therapeutic Horseback Riding
Barn Activity
Hybrid
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring human-animal intervention, physiology, mechanisms of action, children, adolescents, emotion regulation, cortisol, heart rate, electrodermal activity

Eligibility Criteria

6 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Colorado Anschutz Medical CampusRecruiting
  • Maine Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

No Intervention

Experimental

Arm Label

Therapeutic Horseback Riding

Barn Activity

Waitlist

Hybrid

Arm Description

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.

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

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)

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.

Outcomes

Primary Outcome Measures

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
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.
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.
Change in World Health Organization's Quality of Life Instrument (WHOQOL-BREF)
Quality of life for caregiver
Change in Systematic Analysis of Language Transcripts (SALT)
Expressive Language Sample
Change in Crisis Mental Health Care Usage Survey
crisis mental health care usage

Secondary Outcome Measures

Full Information

First Posted
October 15, 2020
Last Updated
January 25, 2023
Sponsor
University of Colorado, Denver
Collaborators
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
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1. Study Identification

Unique Protocol Identification Number
NCT04606966
Brief Title
Physiological Mechanisms of Therapeutic Horseback Riding Intervention Effects in a Psychiatric Population of ASD Youth
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 22, 2020 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Mental Disorders
Keywords
human-animal intervention, physiology, mechanisms of action, children, adolescents, emotion regulation, cortisol, heart rate, electrodermal activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
Speech therapist evaluator will be blinded to participants' intervention condition assignment
Allocation
Randomized
Enrollment
192 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Therapeutic Horseback Riding
Arm Type
Experimental
Arm Description
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.
Arm Title
Barn Activity
Arm Type
Active Comparator
Arm Description
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
Arm Title
Waitlist
Arm Type
No Intervention
Arm Description
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)
Arm Title
Hybrid
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Therapeutic Horseback Riding
Other Intervention Name(s)
Equine Assisted Activity
Intervention Description
Horse therapy
Intervention Type
Other
Intervention Name(s)
Barn Activity
Other Intervention Name(s)
No Horse control
Intervention Description
Horsemanship group
Intervention Type
Other
Intervention Name(s)
Hybrid
Other Intervention Name(s)
Equine Assisted Activity
Intervention Description
Ground and riding activities
Primary Outcome Measure Information:
Title
Change in Aberrant Behavior Checklist-Community (ABC-C)
Description
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
Time Frame
Baseline, week 10, 6 months
Title
Change in Social Responsiveness Scale™, Second Edition
Description
social awareness, social cognition, social communication, social motivation, autistic mannerisms. Results in a T-score that indicates severity level ranges.
Time Frame
Baseline, week 10, 6 months
Title
Change in Emotion Dysregulation Inventory (EDI)
Description
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.
Time Frame
Baseline, week 10, 6 months
Title
Change in World Health Organization's Quality of Life Instrument (WHOQOL-BREF)
Description
Quality of life for caregiver
Time Frame
Baseline, week 10, 6 months
Title
Change in Systematic Analysis of Language Transcripts (SALT)
Description
Expressive Language Sample
Time Frame
Baseline, week 10, 6 months
Title
Change in Crisis Mental Health Care Usage Survey
Description
crisis mental health care usage
Time Frame
Baseline, week 10, 6 months
Other Pre-specified Outcome Measures:
Title
Change in Salivary Cortisol
Description
Mediator
Time Frame
Baseline, Midpoint Intervention (about Week 5), Week 10
Title
Change in Electrodermal Activity
Description
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.
Time Frame
Baseline, Midpoint Intervention (about Week 5), Week 10
Title
Change in Heart Rate/Heart Rate Variability
Description
Mediator
Time Frame
Baseline, Midpoint Intervention (about Week 5), Week 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hannah Christensen, BAS
Phone
720-777-9255
Email
Hannah.christensen@ucdenver.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robin L Gabriels, Psy.D.
Organizational Affiliation
University of Colorado Anzchutz Medical Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hannah Christensen
Phone
720-777-9255
Email
hannah.christensen@cuanschutz.edu
First Name & Middle Initial & Last Name & Degree
Veronica Henderson-Davis
Email
veronica.hendersho-davis@cuanschutz.edu
First Name & Middle Initial & Last Name & Degree
Robin L Gabriels, Psy.D.
Facility Name
Maine Health
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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

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