Ignite Creation Date:
2024-05-06 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05803343
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2023-03-15
Brief Title:
Evaluating Additive Effects of Including Canines in Regulating Together
Sponsor:
Childrens Hospital Medical Center Cincinnati
Organization:
Childrens Hospital Medical Center Cincinnati
Study Overview
Official Title:
Evaluating Additive Effects of Including Canines in Regulating Together A Group Treatment to Address Emotion Dysregulation in Youth With Autism Spectrum Disorder
Status:
RECRUITING
Status Verified Date:
2024-07
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:
The primary objective is to evaluate the potential additive effect of animal-assisted intervention AAI on a manualized behavioral treatment targeting emotion dysregulation ED in children with autism spectrum disorder ASD
Aim 1 Evaluate whether Regulating Together-Canine demonstrates earlier and greater improvement in emotion dysregulation than Regulating Together-Standard
Aim 2 Evaluate if Regulating Together-Canine increases child engagement and learning compared to Regulating Together-Standard
Exploratory Aim Explore association of physiological arousal via heart rate tracking with emotion dysregulation treatment engagement and learning
Aim 1 Evaluate whether Regulating Together-Canine demonstrates earlier and greater improvement in emotion dysregulation than Regulating Together-Standard
Aim 2 Evaluate if Regulating Together-Canine increases child engagement and learning compared to Regulating Together-Standard
Exploratory Aim Explore association of physiological arousal via heart rate tracking with emotion dysregulation treatment engagement and learning
Detailed Description:
Children between the ages of 8 years 0 months and 15 years 11 months with Autism Spectrum Disorder ASD and emotion dysregulation ED and their caregivers will participate in 5 research visits and 10 group intervention sessions They are randomly assigned to either Regulating Together-Standard group no dog or Regulating Together-Canine group with dog Characterization measures will be completed at Screen T1 All outcome measures will be completed at Baseline T2 Post-treatment 1-2 weeks following treatment completion T3 10 week post treatment completion follow up T4 and 6 month post treatment completion follow up T5
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