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Clinical Trials/NCT03369769
NCT03369769
Completed
Not Applicable

Physiological Wellness Effects of Animal-assisted Activities in Children With Autism Spectrum Disorder in a Specialized Psychiatric Hospital Program

University of Colorado, Denver0 sites75 target enrollmentAugust 6, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Child Behavior
Sponsor
University of Colorado, Denver
Enrollment
75
Primary Endpoint
Change in physiological measurements with the wristband device from baseline through 90 minutes.
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 6, 2015
End Date
March 13, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Change in physiological measurements with the wristband device from baseline through 90 minutes.

Time Frame: Baseline; 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 Outcomes

  • Observation of Human Animal Interaction for Research (OHAIRE-modified)(Two 10-minute conditions (experimental and control) on two separate days.)

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