Coached, Coordinated, Enhanced Neonatal Transition (CCENT)

Study Overview
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Brief Summary
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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.

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

Conditions
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Prematurity

Intervention / Treatment
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* Other: CCENT Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (meets at least one of the following criteria): Infant born ≤ 26+6 weeks of gestational age (GA) Infant born between 27-29+6 weeks GA with ≥ 1 of the following risk factors: i)≥ Grade III intraventricular hemorrhage with post hemorrhagic hydrocephalus ii)Retinopathy of prematurity requiring intraocular bevacizumab/ anti-vascular endothelial growth factor or laser surgery therapy iii)Requires invasive (e.g., intubated) or non-invasive (e.g., CPAP or BiPAP) at ≥ 34 weeks GA and/or supplemental oxygen at ≥ 37 weeks gestational age iv)Requires surgery for management of necrotizing enterocolitis (NEC)- stage 3 Infant with ≥ 2 major congenital anomalies as defined by EUROCAT(13) (e.g., congenital heart disease, spina bifida, cleft palate, etc. Not including minor congenital anomalies, e.g., dysmorphic facies), and length of stay in recruiting institution ≥ 14 days. Infant with hypoxic ischemic encephalopathy (HIE) requiring therapeutic hypothermia and in the recruiting institution for ≥ 14 days. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 0 Months
Maximum Age: 4 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CCENT Intervention group<br>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. | Other: CCENT Intervention<br>* Acceptance and Commitment Therapy approach: engaging families through structured individual or group sessions within the NICU and continue this support once discharged. Care coordination: supporting providers in clear communication when liaising across various levels of care as well as supporting families in system and resource navigation. Anticipatory guidance: proactive education targeting normal challenges in caring for a child who required intensive care support.<br>|
| No Intervention: Control group<br>Participants will receive the standard medical care at their institution, which involves a primary care provider and/or neonatal follow-up at routine times. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Parental Stress | This outcome will be assessed using the Parenting Stress Index 4th Edition (PSI-4) Short Form questionnaire. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parental Quality of Life (QoL) | 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. | 4 months | 
| Parental Quality of Life (QoL) | 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. | 12 months | 
| Parental Empowerment | 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. | 12 months | 
| Child Social and Emotional Development | 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. | 12 months | 
| Parent and Child Interaction | 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. | 12 months | 
| Maternal Depression | 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 between 0 to 30 will be recorded, with a score of 10 or greater indicating possible depression. | 6 weeks | 
| Maternal Depression | 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 between 0 to 30 will be recorded, with a score of 10 or greater indicating possible depression. | 4 months | 
| Maternal Depression | 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. | 12 months | 
| Child Development | The Bayley Scales of Infant and Toddler Development (3rd Edition) will be used to assess neurodevelopment with separate composite scores (mean 100 ± SD 15) for cognition, language, and motor skills. | 18 months | 
| Healthcare Service Delivery | 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. | 12 months | 
| Maternal Anxiety | This outcome will be assessed using the State-Trait Anxiety Inventory (STAI) questionnaire, which often used in research as an indicator of caregiver distress. | 4 months | 
| Maternal Anxiety | This outcome will be assessed using the State-Trait Anxiety Inventory (STAI) questionnaire, which often used in research as an indicator of caregiver distress. | 12 months | 
| Resource Utilization | 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. | 4 months | 
| Resource Utilization | 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. | 12 months | 
| Psychology Inflexibility | 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. | 6 weeks | 
| Psychology Inflexibility | 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. | 4 months | 
| Psychology Inflexibility | 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. | 12 months | 
| Psychology Inflexibility | 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. | 18 months | 
| Child Development | The Ages and Stages Questionnaire will also be used to assess child development | 18 months | 
| Parental perception of transition experience | 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. | 6 weeks post discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neonatal Intensive Care Unit, Mindfulness, Care coordination, Anticipatory guidance, Parental support, Neonatal follow-up, Acceptance and Commitment Therapy