PrematurityCCENTNCT03350243
Coached, Coordinated, Enhanced Neonatal Transition (CCENT)
A study testing CCENT Intervention in people with Prematurity, run by The Hospital for Sick Children at 7 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 4 months
- Conditions the study is for
- Prematurity
- What is being tested?
- CCENT Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 275 participants
- Where
- 7 sitesCanada
- Study dates
- 31 Jan 2018to 31 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 4 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Canada7 sites
McGill University Health Centre/Montreal Children's Hospital
Montreal, Quebec
Children's Hospital Eastern Ontario
Ottawa, Ontario, K1H 8L1
The Ottawa Hospital
Ottawa
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Mount Sinai Hospital
Toronto, Ontario
BC Children's Hospital and BC Women's Hospital & Health Centre
Vancouver, British Columbia
About this study
Official title: Coached, Coordinated, Enhanced Neonatal Transition (CCENT): A Multi-centre Mixed-methods Pragmatic Randomized Controlled Trial
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
- Being tested
- CCENT Intervention
- Keywords
- Neonatal Intensive Care Unit, Mindfulness, Care coordination, Anticipatory guidance, Parental support, Neonatal follow-up, Acceptance and Commitment Therapy
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCENT InterventionOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| CCENT Intervention group | Experimental | 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. Receives: Other: CCENT Intervention |
| Control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Change in Parental Stress
This outcome will be assessed using the Parenting Stress Index 4th Edition (PSI-4) Short Form questionnaire.
Measured: 12 months
Secondary outcomes (20)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 18 months
Child Development
The Ages and Stages Questionnaire will also be used to assess child development
Measured: 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.
Measured: 6 weeks post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study start31 Jan 2018
- Primary completion31 Mar 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PrematurityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 275 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- 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 British Columbia
- Responsible party
- Principal investigator, Julia Orkin, The Hospital for Sick Children
- Investigators
- Julia Orkin, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03350243
- Sponsor's protocol ID
- 1000057100
- Acronym
- CCENT
- Status last verified
- Apr 2023
- First submitted
- 1 Nov 2017
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34233983
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coached, Coordinated, Enhanced Neonatal Transition (CCENT): A Multi-centre Mixed-methods Pragmatic Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03350243
- Acronym / sponsor ID
- CCENT / 1000057100
- Conditions
- Prematurity
- Keywords
- Neonatal Intensive Care Unit, Mindfulness, Care coordination, Anticipatory guidance, Parental support, Neonatal follow-up, Acceptance and Commitment Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 275 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- 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 British Columbia
- Study start
- 31 Jan 2018 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 22 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CCENT Intervention group | Experimental | Other: CCENT InterventionParticipants 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. |
| Control group | No intervention | –Participants will receive the standard medical care at their institution, which involves a primary care provider and/or neonatal follow-up at routine times. |
Who may qualify
- Ages
- 0 to 4 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CCENT 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. | Other | CCENT Intervention group |
Primary outcome
Change in Parental Stress
Time frame: 12 months
This outcome will be assessed using the Parenting Stress Index 4th Edition (PSI-4) Short Form questionnaire.
20 secondary outcomes
Parental Quality of Life (QoL)
Time frame: 4 months
Parental Quality of Life (QoL)
Time frame: 12 months
Parental Empowerment
Time frame: 12 months
Child Social and Emotional Development
Time frame: 12 months
Parent and Child Interaction
Time frame: 12 months
Maternal Depression
Time frame: 6 weeks
Maternal Depression
Time frame: 4 months
Maternal Depression
Time frame: 12 months
Child Development
Time frame: 18 months
Healthcare Service Delivery
Time frame: 12 months
Maternal Anxiety
Time frame: 4 months
Maternal Anxiety
Time frame: 12 months
Resource Utilization
Time frame: 4 months
Resource Utilization
Time frame: 12 months
Psychology Inflexibility
Time frame: 6 weeks
Psychology Inflexibility
Time frame: 4 months
Psychology Inflexibility
Time frame: 12 months
Psychology Inflexibility
Time frame: 18 months
Child Development
Time frame: 18 months
Parental perception of transition experience
Time frame: 6 weeks post discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Derived from this study: PubMed 34233983Orkin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia Orkin, MD principal investigator
The Hospital for Sick Children
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CCENT Intervention in people with Prematurity, run by The Hospital for Sick Children at 7 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Parental Stress (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03350243, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.