Autism Spectrum Disorder, Mental Disorders
Conditions
Keywords
human-animal intervention, physiology, mechanisms of action, children, adolescents, emotion regulation, cortisol, heart rate, electrodermal activity
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).
Interventions
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Maine Health/Spring Harbor Hospital
Riding To The Top Therapeutic Riding Center
Hearts and Horses Therapeutic Riding Center
Salimetrics, LLC
Baylor University
University of Pittsburgh
Colorado State University
Boston Children's Hospital
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Speech therapist evaluator will be blinded to participants' intervention condition 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 group
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Crisis Mental Health Care Usage Survey | Baseline, week 10, 6 months | crisis mental health care usage |
| 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 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Change in Salivary Cortisol | Baseline, Midpoint Intervention (about Week 5), Week 10 | Mediator |
Countries
United States
Outcome results
None listed