Ignite Creation Date:
2024-05-06 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05803369
Status:
RECRUITING
Last Update Posted:
2024-04-05
First Post:
2023-03-14
Brief Title:
DOD Regulating Together Intervention
Sponsor:
Childrens Hospital Medical Center Cincinnati
Organization:
Childrens Hospital Medical Center Cincinnati
Study Overview
Official Title:
Regulating Together Randomized Controlled Trial Examining Predictors Facilitators and Barriers to Treatment Success in Emotion Dysregulation and Autism Spectrum Disorder ASD
Status:
RECRUITING
Status Verified Date:
2024-04
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:
Our long-term goal is to validate Regulating Together emotion regulation intervention and improve psychosocial outcomes for youth with autism spectrum disorder and emotion dysregulation
Detailed Description:
144 children ages 8-12 years old with autism spectrum disorder will be enrolled in the study and randomized to Regulating Together RT or Achieving Independence and Mastery in School AIMS groups Participants will complete assessments at five time points Screen T1 Week 0 - where they will complete consent Baseline T2 Week 7 Post Active Treatment includes semi-structured interviews T3 Week 16 Post Generalization T4 Week 29 Final outcome visit T5 Participants will receive 5 weeks of intervention twice per week following the T2 visit
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDMRP-AR210169 | OTHER_GRANT | Department of Defense | None |