Back to resultsCoached, Coordinated, Enhanced Neonatal Transition (CCENT) (CCENT)
Primary Purpose
Prematurity
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
CCENT Intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Prematurity focused on measuring Neonatal Intensive Care Unit, Mindfulness, Care coordination, Anticipatory guidance, Parental support, Neonatal follow-up, Acceptance and Commitment Therapy
Eligibility Criteria
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
Sites / Locations
- BC Children's Hospital and BC Women's Hospital & Health Centre
- Children's Hospital Eastern Ontario
- Sunnybrook Health Sciences Centre
- The Hospital for Sick Children
- Mount Sinai Hospital
- McGill University Health Centre/Montreal Children's Hospital
- The Ottawa Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
CCENT Intervention group
Control group
Arm Description
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.
Participants will receive the standard medical care at their institution, which involves a primary care provider and/or neonatal follow-up at routine times.
Outcomes
Primary Outcome Measures
Change in Parental Stress
This outcome will be assessed using the Parenting Stress Index 4th Edition (PSI-4) Short Form questionnaire.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Child Development
The Ages and Stages Questionnaire will also be used to assess child development
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.
Full Information
NCT ID
NCT03350243
First Posted
November 1, 2017
Last Updated
April 11, 2023
Sponsor
The Hospital for Sick Children
Collaborators
Sunnybrook Health Sciences Centre, Children's Hospital of Eastern Ontario, MOUNT SINAI HOSPITAL, The Ottawa Hospital, Montreal Children's Hospital of the MUHC, Provincial Health Services Authority
1. Study Identification
Unique Protocol Identification Number
NCT03350243
Brief Title
Coached, Coordinated, Enhanced Neonatal Transition (CCENT)
Acronym
CCENT
Official Title
Coached, Coordinated, Enhanced Neonatal Transition (CCENT): A Multi-centre Mixed-methods Pragmatic Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
January 31, 2018 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
October 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
Collaborators
Sunnybrook Health Sciences Centre, Children's Hospital of Eastern Ontario, MOUNT SINAI HOSPITAL, The Ottawa Hospital, Montreal Children's Hospital of the MUHC, Provincial Health Services Authority
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prematurity
Keywords
Neonatal Intensive Care Unit, Mindfulness, Care coordination, Anticipatory guidance, Parental support, Neonatal follow-up, Acceptance and Commitment Therapy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
275 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CCENT Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participants will receive the standard medical care at their institution, which involves a primary care provider and/or neonatal follow-up at routine times.
Intervention Type
Other
Intervention Name(s)
CCENT Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Parental Stress
Description
This outcome will be assessed using the Parenting Stress Index 4th Edition (PSI-4) Short Form questionnaire.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Parental Quality of Life (QoL)
Description
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.
Time Frame
4 months
Title
Parental Quality of Life (QoL)
Description
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.
Time Frame
12 months
Title
Parental Empowerment
Description
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.
Time Frame
12 months
Title
Child Social and Emotional Development
Description
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.
Time Frame
12 months
Title
Parent and Child Interaction
Description
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.
Time Frame
12 months
Title
Maternal Depression
Description
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.
Time Frame
6 weeks
Title
Maternal Depression
Description
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.
Time Frame
4 months
Title
Maternal Depression
Description
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.
Time Frame
12 months
Title
Child Development
Description
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.
Time Frame
18 months
Title
Healthcare Service Delivery
Description
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.
Time Frame
12 months
Title
Maternal Anxiety
Description
This outcome will be assessed using the State-Trait Anxiety Inventory (STAI) questionnaire, which often used in research as an indicator of caregiver distress.
Time Frame
4 months
Title
Maternal Anxiety
Description
This outcome will be assessed using the State-Trait Anxiety Inventory (STAI) questionnaire, which often used in research as an indicator of caregiver distress.
Time Frame
12 months
Title
Resource Utilization
Description
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.
Time Frame
4 months
Title
Resource Utilization
Description
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.
Time Frame
12 months
Title
Psychology Inflexibility
Description
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.
Time Frame
6 weeks
Title
Psychology Inflexibility
Description
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.
Time Frame
4 months
Title
Psychology Inflexibility
Description
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.
Time Frame
12 months
Title
Psychology Inflexibility
Description
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.
Time Frame
18 months
Title
Child Development
Description
The Ages and Stages Questionnaire will also be used to assess child development
Time Frame
18 months
Title
Parental perception of transition experience
Description
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.
Time Frame
6 weeks post discharge
Other Pre-specified Outcome Measures:
Title
Health System Outcomes
Description
The investigators will link the patient-reported evaluation of the CCENT model with health administrative data housed at the Institute for Clinical Evaluative Sciences (ICES) for consenting participants. Case-costing methods will be used to determine direct health care costs related to inpatient (emergency department) and outpatient (pharmaceutical and home health care) services.
Time Frame
12 months
Title
Social support
Description
The Social Support Questionnaire- Short Form (Sarason et al., 1987) is a 6 item measure of social support. For each of the 6 items, respondents indicate the number of people available to provide support in each of 6 areas and then rate the overall level of satisfaction with the support given in each of the areas. Scores range from 0-54 for number of people available, and satisfaction ranges from 6-36. Higher scores indicate more support.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Months
Maximum Age & Unit of Time
4 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia Orkin, MD
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
BC Children's Hospital and BC Women's Hospital & Health Centre
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Children's Hospital Eastern Ontario
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L1
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
McGill University Health Centre/Montreal Children's Hospital
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
The Ottawa Hospital
City
Ottawa
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34233983
Citation
Orkin J, Major N, Esser K, Parmar A, Couture E, Daboval T, Kieran E, Ly L, O'Brien K, Patel H, Synnes A, Robson K, Barreira L, Smith WL, Rizakos S, Willan AR, Yaskina M, Moretti ME, Ungar WJ, Ballantyne M, Church PT, Cohen E. Coached, Coordinated, Enhanced Neonatal Transition (CCENT): protocol for a multicentre pragmatic randomised controlled trial of transition-to-home support for parents of high-risk infants. BMJ Open. 2021 Jul 7;11(7):e046706. doi: 10.1136/bmjopen-2020-046706.
Results Reference
derived
Learn more about this trial
Coached, Coordinated, Enhanced Neonatal Transition (CCENT)
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