Wellness Effects of Animal-assisted Activities With Autism Spectrum Disorder Youth in a Specialized Psychiatric Hospital
Primary Purpose
Child Behavior, Autism Spectrum Disorder, Psychiatric Hospitalization
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Activity
Sponsored by
About this trial
This is an interventional health services research trial for Child Behavior
Eligibility Criteria
Inclusion Criteria:
- Admitted to a specialized psychiatric unit for children with developmental disabilities
- Meeting standard cut-off scores for ASD on the Social Communication Questionnaire Screener (> 12) and Autism Diagnostic Observation Schedule-2nd Ed
- English speaking
Exclusion Criteria:
- Unwillingness to wear wristband & be videotaped
- Allergies or phobias to canines
- Inability to attend to and participate in a social group
- Prisoner status or ward of the state
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Canine & Adult Handler Activity
Toy and Adult Handler Activity
Arm Description
Unstructured 10-minute small group interaction with canine & handler
Unstructured 10-minute small group interaction with toy & handler
Outcomes
Primary Outcome Measures
Change in physiological measurements with the wristband device from baseline through 90 minutes.
The Wristband device is worn by the participant for 90 minutes during the day of the experimental condition. Physiological measure of Galvanic skin response, heart rate, heart rate variability will be assessed at baseline through 90 minutes. Collection points during this day includes comparison from baseline, social group, and experimental condition.
Secondary Outcome Measures
Observation of Human Animal Interaction for Research (OHAIRE-modified)
The Observation of Human-Animal Interaction for Research (OHAIRE) is a timed interval coding system intended to capture the unique interactions between humans and animals. It was originally developed and piloted with children with autism spectrum disorder (ASD) interacting with typically-developing peers in a small group school setting with guinea pigs compared to toys.
Full Information
NCT ID
NCT03369769
First Posted
October 24, 2017
Last Updated
May 16, 2019
Sponsor
University of Colorado, Denver
Collaborators
Human Animal Bond Institute for Research, Purdue University
1. Study Identification
Unique Protocol Identification Number
NCT03369769
Brief Title
Wellness Effects of Animal-assisted Activities With Autism Spectrum Disorder Youth in a Specialized Psychiatric Hospital
Official Title
Physiological Wellness Effects of Animal-assisted Activities in Children With Autism Spectrum Disorder in a Specialized Psychiatric Hospital Program
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
August 6, 2015 (Actual)
Primary Completion Date
February 27, 2017 (Actual)
Study Completion Date
March 13, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Human Animal Bond Institute for Research, Purdue 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
Background: Children with Autism Spectrum Disorder (ASD) are at higher risk for developing co-existing mental health conditions and consequently experiencing psychiatric hospitalization, compared to the general pediatric population. However, hospital environments can be exceptionally stressful for this population, given their social-communication deficits, ineffective emotional regulation skills and heightened physiological arousal. While the use of animal-assisted activities (AAA) show potential for various improvements in children with ASD in community settings, these "stress-reducing" and "social-buffering" benefits have not yet been studied within a psychiatric hospital setting for youth with ASD.
Objectives: Evaluate whether an AAA with canines can lead to reduced physiological arousal and improvements in social-communication as well as aberrant behaviors in children and adolescents diagnosed with ASD in a specialized psychiatric hospital setting.
Methods: Participants were recruited from the Neuropsychiatric Special Care (NSC) program's inpatient and/or partial day-treatment program. Prior to study participation, baseline demographic measures were acquired from caregivers and participants' ASD diagnosis was confirmed. Participants experienced two, randomly assigned 35-minute sessions (AAA and Control Condition) with a minimum two-day washout period between groups. Each session included a baseline 20-minute social skills group immediately followed by a 10 minute experimental or control condition. The AAA condition introduced a canine and volunteer handler for free interaction time while the control condition introduced a novel toy and a volunteer for free interaction. Participants' physiological arousal was continuously assessed throughout all conditions via the Empatica E-4 wristbands (Empatica Inc. 2014). All sessions were videotaped for behavioral coding using the Observation of Human Animal Interaction for Research - Modified, v.1.
Detailed Description
Background: Children with ASD are at higher risk for developing co-existing mental health conditions and consequently experiencing psychiatric hospitalization, compared to the general pediatric population. However, hospital environments can be exceptionally stressful for this population, given their social-communication deficits, ineffective emotional regulation skills and heightened physiological arousal. While the use of animal-assisted activities (AAA) show potential for various improvements in children with ASD in community settings, these "stress-reducing" and "social-buffering" benefits have not yet been studied within a psychiatric hospital setting for youth with ASD.
Objectives: Evaluate whether an AAA with canines can lead to reduced physiological arousal and improvements in social-communication as well as aberrant behaviors in children and adolescents diagnosed with ASD in a specialized psychiatric hospital setting.
Methods: Participants were recruited from the Neuropsychiatric Special Care (NSC) program's inpatient and/or partial day-treatment program. Prior to study participation, baseline demographic measures were acquired from caregivers and participants' ASD diagnosis was confirmed. Participants experienced two, randomly assigned 35-minute sessions (AAA and Control Condition) with a minimum two-day washout period between groups. Each session included a baseline 20-minute social skills group immediately followed by a 10 minute experimental or control condition. The AAA condition introduced a canine and volunteer handler for free interaction time while the control condition introduced a novel toy and a volunteer for free interaction. Participants' physiological arousal was continuously assessed throughout all conditions via the Empatica E-4 wristbands (Empatica Inc. 2014). All sessions were videotaped for behavioral coding using the Observation of Human Animal Interaction for Research - Modified, v.1.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child Behavior, Autism Spectrum Disorder, Psychiatric Hospitalization, Veterinary Therapeutics
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
To investigate the effect of canine animal assisted activities (AAA) on physiological arousal levels in children and adolescents with autism spectrum disorder (ASD) (ages 4 to 17 years) in a specialized psychiatric hospital program. It is hypothesized that children with ASD will demonstrate lower physiological arousal in the presence of canines, compared to a non-animal control.
Masking
Outcomes Assessor
Masking Description
Coders for the videotaped behavioral data collected via the OHAIRE-M tool were blind to specific study objective.
Allocation
Non-Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Canine & Adult Handler Activity
Arm Type
Experimental
Arm Description
Unstructured 10-minute small group interaction with canine & handler
Arm Title
Toy and Adult Handler Activity
Arm Type
Active Comparator
Arm Description
Unstructured 10-minute small group interaction with toy & handler
Intervention Type
Other
Intervention Name(s)
Activity
Other Intervention Name(s)
animal-assisted activity (AAA)
Intervention Description
10 minutes interaction with therapy dog and adult handler in small group (2-4 participants).
Primary Outcome Measure Information:
Title
Change in physiological measurements with the wristband device from baseline through 90 minutes.
Description
The Wristband device is worn by the participant for 90 minutes during the day of the experimental condition. Physiological measure of Galvanic skin response, heart rate, heart rate variability will be assessed at baseline through 90 minutes. Collection points during this day includes comparison from baseline, social group, and experimental condition.
Time Frame
Baseline; 90 minutes
Secondary Outcome Measure Information:
Title
Observation of Human Animal Interaction for Research (OHAIRE-modified)
Description
The Observation of Human-Animal Interaction for Research (OHAIRE) is a timed interval coding system intended to capture the unique interactions between humans and animals. It was originally developed and piloted with children with autism spectrum disorder (ASD) interacting with typically-developing peers in a small group school setting with guinea pigs compared to toys.
Time Frame
Two 10-minute conditions (experimental and control) on two separate days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Admitted to a specialized psychiatric unit for children with developmental disabilities
Meeting standard cut-off scores for ASD on the Social Communication Questionnaire Screener (> 12) and Autism Diagnostic Observation Schedule-2nd Ed
English speaking
Exclusion Criteria:
Unwillingness to wear wristband & be videotaped
Allergies or phobias to canines
Inability to attend to and participate in a social group
Prisoner status or ward of the state
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robin L Gabriels, Psy.D.
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
30818971
Citation
Germone MM, Gabriels RL, Guerin NA, Pan Z, Banks T, O'Haire ME. Animal-assisted activity improves social behaviors in psychiatrically hospitalized youth with autism. Autism. 2019 Oct;23(7):1740-1751. doi: 10.1177/1362361319827411. Epub 2019 Feb 28.
Results Reference
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Wellness Effects of Animal-assisted Activities With Autism Spectrum Disorder Youth in a Specialized Psychiatric Hospital
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