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Completed

NCT Number: NCT03350243

Coached, Coordinated, Enhanced Neonatal Transition (CCENT)

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.

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Key information

Conditions

Prematurity Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

0 month–4 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BC Children's Hospital and BC Women's Hospital & Health Centre, Vancouver, British Columbia, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CCENT Intervention

Other
  • 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 outcomes

  1. 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.

Secondary outcomes

  1. Parental Quality of Life (QoL)

    Time frame: 4 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.

  2. Parental Quality of Life (QoL)

    Time frame: 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.

  3. Parental Empowerment

    Time frame: 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.

  4. Child Social and Emotional Development

    Time frame: 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.

  5. Parent and Child Interaction

    Time frame: 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.

  6. Maternal Depression

    Time frame: 6 weeks

    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.

  7. Maternal Depression

    Time frame: 4 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 between 0 to 30 will be recorded, with a score of 10 or greater indicating possible depression.

  8. Maternal Depression

    Time frame: 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.

  9. Child Development

    Time frame: 18 months

    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.

  10. Healthcare Service Delivery

    Time frame: 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.

  11. Maternal Anxiety

    Time frame: 4 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.

  12. Maternal Anxiety

    Time frame: 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.

  13. Resource Utilization

    Time frame: 4 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.

  14. Resource Utilization

    Time frame: 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.

  15. Psychology Inflexibility

    Time frame: 6 weeks

    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.

  16. Psychology Inflexibility

    Time frame: 4 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.

  17. Psychology Inflexibility

    Time frame: 12 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.

  18. Psychology Inflexibility

    Time frame: 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.

  19. Child Development

    Time frame: 18 months

    The Ages and Stages Questionnaire will also be used to assess child development

  20. Parental perception of transition experience

    Time frame: 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.

Other outcomes

  1. Health System Outcomes

    Time frame: 12 months

    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.

  2. Social support

    Time frame: Baseline

    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.

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • Children's Hospital of Eastern Ontario
  • MOUNT SINAI HOSPITAL
  • Montreal Children's Hospital of the MUHC
  • Provincial Health Services Authority British Columbia
  • Sunnybrook Health Sciences Centre
  • The Ottawa Hospital

Registry information

Official study title

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

Acronym: CCENT

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Nov 22, 2017
Registry last updated
Apr 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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