Coached, Coordinated, Enhanced Neonatal Transition (CCENT)

NCT03350243 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 275

Last updated 2023-04-13

No results posted yet for this study

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

  • Prematurity

Interventions

OTHER

CCENT Intervention

1. 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.

Sponsors & Collaborators

  • Sunnybrook Health Sciences Centre

    collaborator OTHER
  • Children's Hospital of Eastern Ontario

    collaborator OTHER
  • MOUNT SINAI HOSPITAL

    collaborator OTHER
  • The Ottawa Hospital

    collaborator OTHER
  • Montreal Children's Hospital of the MUHC

    collaborator OTHER
  • Provincial Health Services Authority

    collaborator OTHER
  • The Hospital for Sick Children

    lead OTHER

Principal Investigators

  • Julia Orkin, MD · The Hospital for Sick Children

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
0 Months
Max Age
4 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-31
Primary Completion
2022-03-31
Completion
2022-10-31

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03350243 on ClinicalTrials.gov