Clinical trial NCT04606966: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Mental Disorders
Keywords: human-animal intervention
physiology
mechanisms of action
children
adolescents
emotion regulation
cortisol
heart rate
electrodermal activity
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Maine Health/Spring Harbor Hospital
name: Riding To The Top Therapeutic Riding Center
name: Hearts and Horses Therapeutic Riding Center
name: Salimetrics, LLC
name: Baylor University
name: University of Pittsburgh
name: Colorado State University
name: Boston Children's Hospital
First posted: 2020-10-28
Enrollment: 250
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial assigned to one of 3 groups:

Therapeutic Horseback Riding group Barn Activity group (no-horse control) Waitlist Hybrid group
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Change in Aberrant Behavior Checklist-Community (ABC-C)
timeFrame: Baseline, week 10, 6 months
measure: Change in Social Responsiveness Scale™, Second Edition
timeFrame: Baseline, week 10, 6 months
measure: Change in Emotion Dysregulation Inventory (EDI)
timeFrame: Baseline, week 10, 6 months
measure: Change in World Health Organization's Quality of Life Instrument (WHOQOL-BREF)
timeFrame: Baseline, week 10, 6 months
measure: Change in Systematic Analysis of Language Transcripts (SALT)
timeFrame: Baseline, week 10, 6 months
measure: Change in Crisis Mental Health Care Usage Survey
timeFrame: Baseline, week 10, 6 months
Secondary outcomes:
Other outcomes:
measure: Change in Salivary Cortisol
timeFrame: Baseline, Midpoint Intervention (about Week 5), Week 10
measure: Change in Electrodermal Activity
timeFrame: Baseline, Midpoint Intervention (about Week 5), Week 10
measure: Change in Heart Rate/Heart Rate Variability
timeFrame: Baseline, Midpoint Intervention (about Week 5), Week 10
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
city: Portland
country: United States
facility: Maine Health
state: Maine
Study officials:
affiliation: University of Colorado Anzchutz Medical Campus
name: Robin L Gabriels, Psy.D.
role: PRINCIPAL_INVESTIGATOR
References: