Coached, Coordinated, Enhanced Neonatal Transition (CCENT)
- Conditions
- Prematurity
- Interventions
- Other: CCENT Intervention
- Registration Number
- NCT03350243
- Lead Sponsor
- The Hospital for Sick Children
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 275
Not provided
- Families that do not speak English or French
- Parent will not be involved with child's care over the entirety of the study period (2 years) (e.g., adoption).
- Infant will be followed by an out-of-province neonatal follow-up program or lives a significant distance from the neonatal follow up program and therefore not routinely followed by the team.
- Infant that has previously been discharged home from the NICU/hospital.
- Decision/high likelihood of decision for act of withdrawal of care by clinical teams/families
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CCENT Intervention group CCENT Intervention Participants will be assigned a dedicated key worker that will support families through the child's first year, in addition to standard medical care, which involves a primary care provider and/or neonatal follow-up at routine times.
- Primary Outcome Measures
Name Time Method Change in Parental Stress 12 months This outcome will be assessed using the Parenting Stress Index 4th Edition (PSI-4) Short Form questionnaire.
- Secondary Outcome Measures
Name Time Method Parental Quality of Life (QoL) 12 months The Health Utilities Index (HUI) questionnaire provides a health-related quality of life (HRQL) score for overall health, which will be used to calculate quality-adjusted life years (QALYs) for a cost-utility analysis.
Parent and Child Interaction 12 months This outcome will be assessed using the Nursing Child Assessment Satellite Training Parent-Child Interaction (NCAST-PCI), which is used assess caregiver and infant behaviour during a structured teaching task.
Healthcare Service Delivery 12 months This outcome will be assessed using the Measure of Processes of Care (MPOC20) questionnaire, which is used to measure the parent's perception of the health services they and their child receive.
Child Development 18 months The Ages and Stages Questionnaire will also be used to assess child development
Parental Empowerment 12 months This outcome will be assessed using the Family Empowerment Scale (FES), which measures empowerment across three specific domains: 1) family, 2) service system, and 3) community/political.
Child Social and Emotional Development 12 months This outcome will be assessed using the Brief Infant-Toddler Social Emotional Assessment (BITSEA), which is a parent self-report questionnaire that is designed as a screener to identify children (1-3 years old) at risk for or currently experiencing social-emotional and/or behavioural problems.
Maternal Depression 12 months This outcome will be assessed using the Edinburgh Postnatal Depression Scale (EPDS), which is a screening tool used to identify those with symptoms associated with postnatal depression in the previous 7 days. Composite score is given between 0 to 30. Possible depression is a score of 10 or greater.
Maternal Anxiety 12 months This outcome will be assessed using the State-Trait Anxiety Inventory (STAI) questionnaire, which often used in research as an indicator of caregiver distress.
Resource Utilization 12 months The Resource Use Questionnaire (RUQ) will assess family resource use relating to their child's medical needs, services and programs, as well as parent time losses and family out-of-pocket costs.
Psychology Inflexibility 18 months The Acceptance and Action Questionnaire (AAQ-II) a questionnaire used to measure parent psychological inflexibility or experiential avoidance. The AAQ-II consists of seven items (e.g., "I'm afraid of my feelings," "I worry about not being able to control my worries and feelings") measured on a 1 (never true) to 7 (always true) scale.
Parental perception of transition experience 6 weeks post discharge Parental perception of transition experience will be assessed using the Pediatric Transition Experience Measure (PTEM), an 11 item parent-report questionnaire which measures a parent's perception of transition preparation and support from the hospital.
Trial Locations
- Locations (7)
BC Children's Hospital and BC Women's Hospital & Health Centre
🇨🇦Vancouver, British Columbia, Canada
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
Children's Hospital Eastern Ontario
🇨🇦Ottawa, Ontario, Canada
The Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
McGill University Health Centre/Montreal Children's Hospital
🇨🇦Montreal, Quebec, Canada
The Ottawa Hospital
🇨🇦Ottawa, Canada
Mount Sinai Hospital
🇨🇦Toronto, Ontario, Canada