Ignite Creation Date:
2024-05-06 @ 10:47 AM
Last Modification Date:
2024-10-26 @ 12:35 PM
Study NCT ID:
NCT03350243
Status:
COMPLETED
Last Update Posted:
2023-04-13
First Post:
2017-11-01
Brief Title:
Coached Coordinated Enhanced Neonatal Transition CCENT
Sponsor:
The Hospital for Sick Children
Organization:
The Hospital for Sick Children
Study Overview
Official Title:
Coached Coordinated Enhanced Neonatal Transition CCENT A Multi-centre Mixed-methods Pragmatic Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2023-04
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:
CCENT
Brief Summary:
This study will evaluate a new neonatal follow-up model that offers additional support and coping resources for parents during their childs NICU admission as well as during their transition home The Coached Coordinated Enhanced Neonatal Transition CCENT model involves a key worker who will be the primary support for families during the first year of their childs life The key workers role involves 1 parental coaching using an Acceptance and Commitment Therapy approach 2 coordinating care across various levels of care as well as supporting families in system and resource navigation and 3 provided proactive education targeting normal challenges in caring for a child who required intensive care support The goal is to improve the psychosocial support and medical care coordination beyond the neonatal intensive care unit as many of the medical and social concerns do not end at the time of discharge Primary objective is parent stress at 12 months
Detailed Description:
None
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