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

NCT03369769 | Completed

• 1 other identifier: 15-1227
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Child Behavior; Autism Spectrum Disorder; Psychiatric Hospitalization; Veterinary Therapeutics

Outcome Measures

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.

  Baseline; 90 minutes

Secondary Outcomes (1)

• Observation of Human Animal Interaction for Research (OHAIRE-modified)

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

Study Arms (2)

Canine & Adult Handler Activity

EXPERIMENTAL

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

Other: Activity

Toy and Adult Handler Activity

ACTIVE COMPARATOR

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

Other: Activity

Interventions

Activity OTHER

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

Also known as: animal-assisted activity (AAA)

Canine & Adult Handler Activity; Toy and Adult Handler Activity

Eligibility Criteria

• Age: 4 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Human Animal Bond Institute for Research: collaborator
• Purdue University: collaborator

Related Publications (1)

• 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.

  PMID: 30818971 BACKGROUND

MeSH Terms

Conditions

Child Behavior; Autism Spectrum Disorder

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Robin L Gabriels, Psy.D.

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Coders for the videotaped behavioral data collected via the OHAIRE-M tool were blind to specific study objective.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 24, 2017
• First Posted: December 12, 2017
• Study Start: August 6, 2015
• Primary Completion: February 27, 2017
• Study Completion: March 13, 2019
• Last Updated: May 20, 2019

Record last verified: 2019-05