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

NCT ID: NCT03369769

Last Updated: 2019-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-06

Study Completion Date

2019-03-13

Brief Summary

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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

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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.

Conditions

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Child Behavior Autism Spectrum Disorder Psychiatric Hospitalization Veterinary Therapeutics

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors
Coders for the videotaped behavioral data collected via the OHAIRE-M tool were blind to specific study objective.

Study Groups

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Canine & Adult Handler Activity

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

Group Type EXPERIMENTAL

Activity

Intervention Type OTHER

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

Toy and Adult Handler Activity

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

Group Type ACTIVE_COMPARATOR

Activity

Intervention Type OTHER

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

Interventions

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Activity

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

Intervention Type OTHER

Other Intervention Names

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animal-assisted activity (AAA)

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Human Animal Bond Institute for Research

UNKNOWN

Sponsor Role collaborator

Purdue University

OTHER

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robin L Gabriels, Psy.D.

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

References

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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.

Reference Type BACKGROUND
PMID: 30818971 (View on PubMed)

Other Identifiers

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15-1227

Identifier Type: -

Identifier Source: org_study_id

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