Clinical Trials Directory

Trials / Completed

CompletedNCT03350243

Coached, Coordinated, Enhanced Neonatal Transition (CCENT)

Coached, Coordinated, Enhanced Neonatal Transition (CCENT): A Multi-centre Mixed-methods Pragmatic Randomized Controlled Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
275 (actual)
Sponsor
The Hospital for Sick Children · Academic / Other
Sex
All
Age
0 Months – 4 Months
Healthy volunteers
Not accepted

Summary

This study will evaluate a new neonatal follow-up model that offers additional support and coping resources for parents during their child's 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 child's life. The key worker's 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.

Conditions

Interventions

TypeNameDescription
OTHERCCENT Intervention1. Acceptance and Commitment Therapy approach: engaging families through structured individual or group sessions within the NICU and continue this support once discharged. 2. Care coordination: supporting providers in clear communication when liaising across various levels of care as well as supporting families in system and resource navigation. 3. Anticipatory guidance: proactive education targeting normal challenges in caring for a child who required intensive care support.

Timeline

Start date
2018-01-31
Primary completion
2022-03-31
Completion
2022-10-31
First posted
2017-11-22
Last updated
2023-04-13

Locations

7 sites across 1 country: Canada

Source: ClinicalTrials.gov record NCT03350243. Inclusion in this directory is not an endorsement.