Ignite Creation Date:
2024-05-06 @ 10:49 AM
Last Modification Date:
2024-10-26 @ 12:36 PM
Study NCT ID:
NCT03369769
Status:
COMPLETED
Last Update Posted:
2019-05-20
First Post:
2017-10-24
Brief Title:
Wellness Effects of Animal-assisted Activities With Autism Spectrum Disorder Youth in a Specialized Psychiatric Hospital
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
Physiological Wellness Effects of Animal-assisted Activities in Children With Autism Spectrum Disorder in a Specialized Psychiatric Hospital Program
Status:
COMPLETED
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 programs inpatient andor 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 v1
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 programs inpatient andor 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 v1
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 programs inpatient andor 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 v1
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 programs inpatient andor 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 v1
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None