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CompletedNCT03369769Updated May 20, 2019

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

An interventional study of Activity in Child Behavior, Autism Spectrum Disorder and Psychiatric Hospitalization, sponsored by University of Colorado, Denver. Completed. Open to participants aged 4 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-20.

Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 2 years 2 months after the study started (first participant enrolled Aug 2015, registered Oct 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Non-randomized
Ages
4 Years to 16 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Child Behavior
  • Autism Spectrum Disorder
  • Psychiatric Hospitalization
  • Veterinary Therapeutics
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In context

Child Behavior

224 studies on the registry are indexed under Child Behavior; 41 are open to participants now.

This study's enrollment of 75 is below the median of 140 across 197 interventional studies indexed under Child Behavior.

Browse Child Behavior studies →

Lead sponsor

University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.

Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
4 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
75 participants (actual)

Study arms

  • Experimental
    Canine & Adult Handler Activity

    Unstructured 10-minute small group interaction with canine \& handler

    Other: Activity

  • Active comparator
    Toy and Adult Handler Activity

    Unstructured 10-minute small group interaction with toy \& handler

    Other: Activity

Interventions

  • OtherActivity

    10 minutes interaction with therapy dog and adult handler in small group (2-4 participants).

    Also known as: animal-assisted activity (AAA)

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline; 90 minutes

Secondary outcomes

  1. 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.

    Time frame: Two 10-minute conditions (experimental and control) on two separate days.

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 30818971 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03369769
Collaborators
Human Animal Bond Institute for Research, Purdue University
Responsible party
Sponsor
First posted
Dec 12, 2017
Start date
Aug 6, 2015
Primary completion
Feb 27, 2017
Completion
Mar 13, 2019
Last update
May 20, 2019

Study contacts

Robin L Gabriels, Psy.D.
principal investigator · University of Colorado, Denver

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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