Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2025-12-25 @ 8:28 PM
Study NCT ID:
NCT05803369
Status:
RECRUITING
Last Update Posted:
2024-04-05
First Post:
2023-03-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
DOD Regulating Together Intervention
Sponsor:
Children's Hospital Medical Center, Cincinnati
Organization:
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:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| CDMRP-AR210169 | OTHER_GRANT | Department of Defense | View |