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

Autism Spectrum Disorder Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04606966
• Other study ID #: 19-1962
• Secondary ID: 1R01HD097693-01A
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 22, 2020
• Est. completion date: February 2025

Study information

• Verified date: May 2024
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: February 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Mental Disorders

Intervention

Other:
• Therapeutic Horseback Riding
Horse therapy
• Barn Activity
Horsemanship group
• Hybrid
Ground and riding activities

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado
United States	Maine Health	Portland	Maine

Sponsors (10)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Salivary Cortisol	Mediator	Baseline, Midpoint Intervention (about Week 5), Week 10
Other	Change in Electrodermal Activity	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.	Baseline, Midpoint Intervention (about Week 5), Week 10
Other	Change in Heart Rate/Heart Rate Variability	Mediator	Baseline, Midpoint Intervention (about Week 5), Week 10
Primary	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
Primary	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
Primary	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
Primary	Change in World Health Organization's Quality of Life Instrument (WHOQOL-BREF)	Quality of life for caregiver	Baseline, week 10, 6 months
Primary	Change in Systematic Analysis of Language Transcripts (SALT)	Expressive Language Sample	Baseline, week 10, 6 months
Primary	Change in Crisis Mental Health Care Usage Survey	crisis mental health care usage	Baseline, week 10, 6 months