Child BehaviorNCT03369769
Wellness Effects of Animal-assisted Activities With Autism Spectrum Disorder Youth in a Specialized Psychiatric Hospital
A study testing Activity in people with Child Behavior and Autism Spectrum Disorder, run by University of Colorado, Denver.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Behavior, Autism Spectrum Disorder, Psychiatric Hospitalization
- What is being tested?
- Activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 6 Aug 2015to 13 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Physiological Wellness Effects of Animal-assisted Activities in Children With Autism Spectrum Disorder in a Specialized Psychiatric Hospital Program
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.
- Conditions
- Child Behavior, Autism Spectrum Disorder, Psychiatric Hospitalization, Veterinary Therapeutics
- Being tested
- Activity
- Medical subject headings
- Child Behavior, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActivityOther
Also called animal-assisted activity (AAA)
10 minutes interaction with therapy dog and adult handler in small group (2-4 participants).
| Study group | Role | What they receive |
|---|---|---|
| Canine & Adult Handler Activity | Experimental | Unstructured 10-minute small group interaction with canine \& handler Receives: Other: Activity |
| Toy and Adult Handler Activity | Active comparator | Unstructured 10-minute small group interaction with toy \& handler Receives: Other: Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Two 10-minute conditions (experimental and control) on two separate days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study start6 Aug 2015
- Primary completion27 Feb 2017
- Study completion13 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child BehaviorStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Human Animal Bond Institute for Research, Purdue University
- Responsible party
- Sponsor
- Investigators
- Robin L Gabriels, Psy.D., Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03369769
- Sponsor's protocol ID
- 15-1227
- Status last verified
- May 2019
- First submitted
- 24 Oct 2017
- Last updated
- 20 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Wellness Effects of Animal-assisted Activities in Children With Autism Spectrum Disorder in a Specialized Psychiatric Hospital Program
- ClinicalTrials.gov ID
- NCT03369769
- Acronym / sponsor ID
- 15-1227
- Conditions
- Child Behavior, Autism Spectrum Disorder, Psychiatric Hospitalization, Veterinary Therapeutics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Human Animal Bond Institute for Research, Purdue University
- Study start
- 6 Aug 2015 (actual)
- Primary completion
- 27 Feb 2017 (actual)
- Study completion
- 13 Mar 2019 (actual)
- First posted
- 12 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Canine & Adult Handler Activity | Experimental | Other: ActivityUnstructured 10-minute small group interaction with canine \& handler |
| Toy and Adult Handler Activity | Active comparator | Other: ActivityUnstructured 10-minute small group interaction with toy \& handler |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ActivityAlso: animal-assisted activity (AAA)10 minutes interaction with therapy dog and adult handler in small group (2-4 participants). | Other | Canine & Adult Handler Activity, Toy and Adult Handler Activity |
Primary outcome
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.
1 secondary outcome
Observation of Human Animal Interaction for Research (OHAIRE-modified)
Time frame: Two 10-minute conditions (experimental and control) on two separate days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2019.
- Background: PubMed 30818971Germone 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robin L Gabriels, Psy.D. principal investigator
University of Colorado, Denver
Questions about this trial
What is this clinical trial studying?
A study testing Activity in people with Child Behavior and Autism Spectrum Disorder, run by University of Colorado, Denver.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in physiological measurements with the wristband device from baseline through 90 minutes. (time frame: Baseline; 90 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03369769, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2019.