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

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

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.

Study Overview

• Status: Completed
• Conditions: Mental Disorders; Autism Spectrum Disorder
• Intervention / Treatment: Other: Therapeutic Horseback Riding; Other: Barn Activity; Other: Hybrid

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).

• Study Type: Interventional
• Enrollment (Actual): 236
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80218
      • University of Colorado Anschutz Medical Campus
  • Maine
    • Portland, Maine, United States, 04102
      • Maine Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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)
Experimental: 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.	Other: Therapeutic Horseback Riding; Horse therapy; Other Names: Equine Assisted Activity
Active Comparator: 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.	Other: Barn Activity; Horsemanship group; Other Names: No Horse control
Experimental: 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).	Other: Hybrid; Ground and riding activities; Other Names: Equine Assisted Activity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aberrant Behavior Checklist-Community (ABC-C) - Baseline	The ABC-C is a 58-item caregiver-completed symptom checklist of 5 behavior subscales (i.e. Irritability, Lethargy, Stereotypy, Hyperactivity, Inappropriate Speech) capturing problem behaviors of children and adults with developmental disabilities in community settings on each subscale. THIS MEASURE DOES NOT GENERATE A TOTAL SCORE. Subscale symptom presence and severity scores range from 0 "not a problem" to higher scores indicating more severe problems. The Irritability subscale scores can range between 0-45; The Lethargy subscale scores can range between 0-48; The Stereotypy subscale scores can range between 0-21; The Hyperactivity subscale scores can range between 0-48; The Inappropriate Speech subscale scores can range between 0-12.	Baseline
Aberrant Behavior Checklist-Community (ABC-C) - End of Treatment	The ABC-C is a 58-item caregiver-completed symptom checklist of 5 behavior subscales (i.e. Irritability, Lethargy, Stereotypy, Hyperactivity, Inappropriate Speech) capturing problem behaviors of children and adults with developmental disabilities in community settings on each subscale. THIS MEASURE DOES NOT GENERATE A TOTAL SCORE. Subscale symptom presence and severity scores range from 0 "not a problem" to higher scores indicating more severe problems. The Irritability subscale scores can range between 0-45; The Lethargy subscale scores can range between 0-48; The Stereotypy subscale scores can range between 0-21; The Hyperactivity subscale scores can range between 0-48; The Inappropriate Speech subscale scores can range between 0-12.	End of Treatment
Aberrant Behavior Checklist-Community (ABC-C) - 6 Months Post Treatrment	The ABC is a 58-item caregiver-completed symptom checklist of 5 behavior subscales (i.e. Irritability, Lethargy, Stereotypy, Hyperactivity, Inappropriate Speech) capturing problem behaviors of children and adults with developmental disabilities in community settings on each subscale. THIS MEASURE DOES NOT GENERATE A TOTAL SCORE. Subscale symptom presence and severity scores range from 0 "not a problem" to higher scores indicating more severe problems. The Irritability subscale scores can range between 0-45; The Lethargy subscale scores can range between 0-48; The Stereotypy subscale scores can range between 0-21; The Hyperactivity subscale scores can range between 0-48; The Inappropriate Speech subscale scores can range between 0-12.	6 months post intervention
Social Responsiveness Scale™, Second Edition - Baseline	The SOCIAL RESPONSIVENESS SCALE™, Second Edition is a 65-item caregiver-report measure that evaluates social impairments in ASD. The Social Responsiveness Scale™-Second Edition generates raw scores and t-scores for both the combined total score as well as for each of the 5 subscales (social awareness, social cognition, social communication, social motivation, and restricted/repetitive behaviors). NOTE: THIS STUDY USED THE RAW SCORES FOR ANALYSES. The combined Social Responsiveness Scale™-Second Edition total raw scores RANGE from a MINIMUM score of 0 to 2 to a MAXIMUM score of 134. HIGHER SCORES ON THIS SCALE INDICATE WORSE OUTCOMES. The Social Awareness raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 19. HIGHER SCORES ON THIS SUBSCALE INDICATE WORSE OUTCOMES. The Social Cognition raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 28. HIGHER SCORES ON THIS SUBSCALE.	Baseline
Social Responsiveness Scale™, Second Edition - End of Treatment	The SOCIAL RESPONSIVENESS SCALE™, Second Edition is a 65-item caregiver-report measure that evaluates social impairments in ASD. THIS STUDY USED RAW SCORES FOR ANALYSES. FOR ALL SCALES, HIGHER RAW SCORES INDICATE WORSE OUTCOME. Combined Social Responsiveness Scale total raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 134. Social Awareness raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 19. Social Cognition raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of g 28. Social Communication raw scores range from a MINIMUM score of 0 to a MAXIMUM score of 47. Social Motivation raw scores range from a MINIMUM score of 0 to a MAXIMUM score of 26. Restricted/Repetitive Behavior raw scores range from a MINIMUM score of 0 to a MAXIMUM score of 28.	End of Treatment
Social Responsiveness Scale™, Second Edition - 6 Months Post Treatment	The SOCIAL RESPONSIVENESS SCALE™, Second Edition is a 65-item caregiver-report measure that evaluates social impairments in ASD. THIS STUDY USED RAW SCORES FOR ANALYSES. FOR ALL SCALES, HIGHER RAW SCORES INDICATE WORSE OUTCOME. Combined Social Responsiveness Scale total raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 134. Social Awareness raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 19. Social Cognition raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 28. Social Communication raw scores range from a MINIMUM score of 0 to a MAXIMUM score of 47. Social Motivation raw scores range from a MINIMUM score of 0 to a MAXIMUM score of 26. Restricted/Repetitive Behavior raw scores range from a MINIMUM score of 0 to a MAXIMUM score of 28.	6 months post intervention
Emotion Dysregulation Inventory (EDI) - Baseline	The EDI is a 30-item caregiver report form that is comprised of a 24-item EDI Reactivity scale and 6-item Dysphoria scales that are scored separately. The Reactivity subscale captures intense, rapidly escalating, sustained, and poorly regulated negative emotional reactions. The Dysphoria scale captures minimal positive affect and motivation along with the presence of nervousness and sadness. Each scale (Reactivity and Dysphoria) raw scores were converted into t-scores using the Clinical (ASD) sample t-score with a mean= 50 and standard deviation = 10 (citation here). The theoretical bound of both subscale t-scores is 20-80 and higher scores indicate more symptom severity.	Baseline
Emotion Dysregulation Inventory (EDI) - End of Treatment	The EDI is a 30-item caregiver report form that is comprised of a 24-item EDI Reactivity scale and 6-item Dysphoria scales that are scored separately. The Reactivity subscale captures intense, rapidly escalating, sustained, and poorly regulated negative emotional reactions. The Dysphoria scale captures minimal positive affect and motivation along with the presence of nervousness and sadness. Each scale (Reactivity and Dysphoria) raw scores were converted into t-scores using the Clinical (ASD) sample t-score with a mean= 50 and standard deviation = 10 (citation here). The theoretical bound of both subscale t-scores is 20-80 and higher scores indicate more symptom severity.	End of Treatment
Emotion Dysregulation Inventory (EDI) - 6 Months Post Treatment	The EDI is a 30-item caregiver report form that is comprised of a 24-item EDI Reactivity scale and 6-item Dysphoria scales that are scored separately. The Reactivity subscale captures intense, rapidly escalating, sustained, and poorly regulated negative emotional reactions. The Dysphoria scale captures minimal positive affect and motivation along with the presence of nervousness and sadness. For each scale (Reactivity and Dysphoria), raw scores were converted into t-scores using the Clinical (ASD) sample t-score with a mean= 50 and standard deviation = 10 (citation here). The theoretical bound of both subscale t-scores is 20-80 and higher scores indicate more symptom severity.	6 months post intervention
Systematic Analysis of Language Transcripts (SALT) - Baseline	Systematic Analysis of Language Transcripts (SALT) provides standardized guidelines to elicit, transcribe, and analyze language samples from individuals, including those with ASD. The SALT also provides language analysis programs to compute a vocabulary diversity quotient from transcripts entered into the database. A five-minute expressive language sample was elicited by each participant and recorded by the project's Speech Therapist, blind to participants' randomized group assignment. Participant's total number of words and total number of different words is dependent on their verbal output during the 5-minute speech sample and use of more words during the language sample is optimal.	Baseline
Systematic Analysis of Language Transcripts (SALT) - End of Treatment	Systematic Analysis of Language Transcripts (SALT) provides standardized guidelines to elicit, transcribe, and analyze language samples from individuals, including those with ASD. The SALT also provides language analysis programs to compute a vocabulary diversity quotient from transcripts entered into the database. A five-minute expressive language sample was elicited by each participant and recorded by the project's Speech Therapist, blind to participants' randomized group assignment. Participant's total number of words and total number of different words is dependent on their verbal output during the 5-minute speech sample and use of more words during the language sample is optimal.	End of Treatment
Systematic Analysis of Language Transcripts (SALT) - 6 Months Post Treatment	Systematic Analysis of Language Transcripts (SALT) provides standardized guidelines to elicit, transcribe, and analyze language samples from individuals, including those with ASD. The SALT also provides language analysis programs to compute a vocabulary diversity quotient from transcripts entered into the database. A five-minute expressive language sample was elicited by each participant and recorded by the project's Speech Therapist, blind to participants' randomized group assignment. Participant's total number of words and total number of different words is dependent on their verbal output during the 5-minute speech sample and use of more words during the language sample is optimal.	6 months post treatment
World Health Organization's Quality of Life Instrument (WHOQOL-BREF) - Baseline	The WHOQOL-BREF is a validated self-report instrument consisting of 26 Likert-scale items rated on a five-point scale. Four primary domain scores of well-being were calculated from 24 items: physical health (7 items), psychological health (6 items), social relationships (3 items), and environment (8 items). Domain scores were transformed to a 0-100 scale by dividing the raw domain score by the potential maximum score and multiplying by 100, with higher scores indicating better quality of life; these transformed scores are reported here. Therefore, for each of the scales (i.e., physical health, psychological health, social relationships, and environment) the minimum score is a value of 0 and the maximum score is a value of 100 with higher scores indicating better quality of life.	Baseline
World Health Organization's Quality of Life Instrument (WHOQOL-BREF) - End of Treatment	The WHOQOL-BREF is a validated self-report instrument consisting of 26 Likert-scale items rated on a five-point scale. Four primary domain scores of well-being were calculated from 24 items: physical health (7 items), psychological health (6 items), social relationships (3 items), and environment (8 items). Domain scores were transformed to a 0-100 scale by dividing the raw domain score by the potential maximum score and multiplying by 100, with higher scores indicating better quality of life; these transformed scores are reported here. Therefore, for each of the scales (i.e., physical health, psychological health, social relationships, and environment) the minimum score is a value of 0 and the maximum score is a value of 100 with higher scores indicating better quality of life.	End of Treatment
World Health Organization's Quality of Life Instrument (WHOQOL-BREF) - 6 Months Post Treatment	The WHOQOL-BREF is a validated self-report instrument consisting of 26 Likert-scale items rated on a five-point scale. Four primary domain scores of well-being were calculated from 24 items: physical health (7 items), psychological health (6 items), social relationships (3 items), and environment (8 items). Domain scores were transformed to a 0-100 scale by dividing the raw domain score by the potential maximum score and multiplying by 100, with higher scores indicating better quality of life; these transformed scores are reported here.Therefore, for each of the scales (i.e., physical health, psychological health, social relationships, and environment) the minimum score is a value of 0 and the maximum score is a value of 100 with higher scores indicating better quality of life.	6 months post intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Salivary Cortisol - Baseline Baseline	Each participant donated approximately 0.5-1 mL of saliva at the riding center within 5 minutes before (i.e., "Pre-session") and 20 minutes after (i.e., "Post-Session) each THR or BA group session weeks 1-10. Salivary cortisol collected pre- and -post intervention activities were analyzed separately.	Baseline sample was taken from each participant's viable cortisol sample from week 1 or if not a viable sample, then from the closest following week (i.e., either week 2 or 3).
Salivary Cortisol - Mid-Point	Each participant donated approximately 0.5-1 mL of saliva at the riding center within 5 minutes before and 20 minutes after each THR or BA group session weeks 1-10. Salivary cortisol collected pre- and -post intervention activities were analyzed.	Mid point sample was taken from each participant's viable cortisol sample from week 5 or if not a viable sample, then from the closest following week (i.e., either week 6 or 7)
Salivary Cortisol - End of Treatment	Each participant donated approximately 0.5-1 mL of saliva at the riding center within 5 minutes before and 20 minutes after each THR or BA group session weeks 1-10. Salivary cortisol collected pre- and -post intervention activities were analyzed.	Endpoint sample was taken from each participant's viable cortisol sample from week 10 or if not a viable sample, then from the closest preceding week (i.e., either week 9 or 8).
Heart Rate Variability - Baseline	The Shimmer3 cardiac (ECG) monitor was used in this study. This cardiovascular monitor was specifically developed to record electrocardiographic signals while participants are active or in motion. The form factor is compact (about 2" by 1"), lightweight (13g), and designed to wear continuously and unobtrusively. It samples ECG and HRV up to 2,048 Hz, which is sufficient for research.125 It has a built-in accelerometer for quantifying periods of physical activity, necessary to identify signal artifacts in post-processing. Participants' Shimmer3 ECG assessments were measured continuously during the intervention lesson. Unit of measure is ms log-10 transformed.	Baseline ECG was taken from each participant's viable ECG data recording from week 1 or if not viable ECG data, then from the closest following week (i.e., either week 3 or 4).
Heart Rate Variability - Mid-point	The Shimmer3 cardiac (ECG) monitor was used in this study. This cardiovascular monitor was specifically developed to record electrocardiographic signals while participants are active or in motion. The form factor is compact (about 2" by 1"), lightweight (13g), and designed to wear continuously and unobtrusively. It samples ECG and HRV up to 2,048 Hz, which is sufficient for research.125 It has a built-in accelerometer for quantifying periods of physical activity, necessary to identify signal artifacts in post-processing. Participants' Shimmer3 ECG assessments were measured continuously during the intervention lesson. Unit of measure is ms log-10 transformed.	Mid-point ECG was taken from each participant's viable ECG data recording from week 5 or if not viable ECG data, then from the closest following week (i.e., either week 6 or 7).
Heart Rate Variability - End of Treatment	The Shimmer3 cardiac (ECG) monitor was used in this study. This cardiovascular monitor was specifically developed to record electrocardiographic signals while participants are active or in motion. The form factor is compact (about 2" by 1"), lightweight (13g), and designed to wear continuously and unobtrusively. It samples ECG and HRV up to 2,048 Hz, which is sufficient for research.125 It has a built-in accelerometer for quantifying periods of physical activity, necessary to identify signal artifacts in post-processing. Participants' Shimmer3 ECG assessments were measured continuously during the intervention lesson. Unit of measure is ms log-10 transformed.	Endpoint ECG was taken from each participant's at week 10 or if not viable ECG data, then from the closest preceding week (i.e., either week 9 or 8).
Electrodermal Activity -- Baseline	The Shimmer3 EDA monitor was used to record EDA from participants' ventral area of the wrist using alternating current imperceptibly applied to the skin through two hypoallergenic, durable, and replaceable Ag electrodes. As dry non-adhesive electrodes tend to move on the skin surface during physical activity and destroy signal quality, disposable adhesive electrodes with an appropriate salinity (e.g., 0.5%; EL507) were used. EDA sampling frequency in the Shimmer3 is 4 Hz with a 0.01- 100uS range. Peripheral skin temperature was recorded by the Shimmer3 EDA monitor at 4 Hz in the -40 to 115-Celsius range using optical infrared thermopile. The Shimmer3 EDA recorded motion-based activity up to ±8g at 32 Hz using 3-axis accelerometry. Participants' Shimmer3 EDA assessments were measured during the intervention lesson. Unit of measure is microsiemens.	Baseline EDA was taken from each participant's viable EDA data recording from week 1 or if not viable EDA data, then from the closest following week (i.e., either week 3 or 4).
Electrodermal Activity - Mid-point	The Shimmer3 EDA monitor was used to record EDA from participants' ventral area of the wrist using alternating current imperceptibly applied to the skin through two hypoallergenic, durable, and replaceable Ag electrodes. As dry non-adhesive electrodes tend to move on the skin surface during physical activity and destroy signal quality, disposable adhesive electrodes with an appropriate salinity (e.g., 0.5%; EL507) were used. EDA sampling frequency in the Shimmer3 is 4 Hz with a 0.01- 100uS range. Peripheral skin temperature was recorded by the Shimmer3 EDA monitor at 4 Hz in the -40 to 115-Celsius range using optical infrared thermopile. The Shimmer3 EDA recorded motion-based activity up to ±8g at 32 Hz using 3-axis accelerometry. Participants' Shimmer3 EDA assessments were measured continuously during the intervention lesson. Unit of measure is microsiemens.	Midpoint EDA was taken from each participant's viable EDA data recording from week 5 or if not viable EDA data, then from the closest following week (i.e., either week 6 or 7).
Electrodermal Activity - End of Treatment	The Shimmer3 EDA monitor was used to record EDA from participants' ventral area of the wrist using alternating current imperceptibly applied to the skin through two hypoallergenic, durable, and replaceable Ag electrodes. As dry non-adhesive electrodes tend to move on the skin surface during physical activity and destroy signal quality, disposable adhesive electrodes with an appropriate salinity (e.g., 0.5%; EL507) were used. EDA sampling frequency in the Shimmer3 is 4 Hz with a 0.01- 100uS range. Peripheral skin temperature was recorded by the Shimmer3 EDA monitor at 4 Hz in the -40 to 115-Celsius range using optical infrared thermopile. The Shimmer3 EDA recorded motion-based activity up to ±8g at 32 Hz using 3-axis accelerometry. Participants' Shimmer3 EDA assessments were measured continuously during the intervention lesson. Unit of measure is microsiemens.	Endpoint EDA was taken from each participant's at week 10 or if not viable EDA data, then from the closest preceding week (i.e., either week 9 or 8).

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); University of Pittsburgh; Boston Children's Hospital; Baylor University; Colorado State University; Riding To The Top Therapeutic Riding Center; Hearts and Horses Therapeutic Riding Center; Salimetrics, LLC; Maine Health/Spring Harbor Hospital
• Investigators: Principal Investigator: Robin L Gabriels, Psy.D., University of Colorado Anzchutz Medical Campus

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2020
• Primary Completion (Actual): February 22, 2025
• Study Completion (Actual): February 22, 2025

Study Registration Dates

• First Submitted: October 15, 2020
• First Submitted That Met QC Criteria: October 22, 2020
• First Posted (Actual): October 28, 2020

Study Record Updates

• Last Update Posted (Actual): July 23, 2026
• Last Update Submitted That Met QC Criteria: June 25, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: children; adolescents; cortisol; heart rate; emotion regulation; physiology; electrodermal activity; human-animal intervention; mechanisms of action
• Additional Relevant MeSH Terms: Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Behavior; Social Behavior; Self-Control; Autism Spectrum Disorder; Mental Disorders; Emotional Regulation
• Other Study ID Numbers: 19-1962; 1R01HD097693-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No