Premature Birth of NewbornGPSNCT02643472
GPS (Giving Parents Support): Parent Navigation After NICU Discharge
A study testing Parent Navigator and Care Notebook in people with Premature Birth of Newborn and Family, run by Children's National Research Institute at 1 site in United States.
Trial summary
BACKGROUND: Annually >400,000 US newborns require neonatal intensive care unit (NICU) care.1/3 will require ongoing or specialty care after discharge. Some NICU graduates can be classified as children with special health care needs (CSHCN) who will require health and related services of a type or amount beyond that… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Premature Birth of Newborn, Family, Immature Newborn
- What is being tested?
- Parent Navigator and Care Notebook
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Mar 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- parents of neonates receiving care in the Children's National NICU
Who cannot join
- infant is not being discharged with a custodial parent (e.g., in custody of Child Protection Services)
- neither parent can complete an interview in English,
- the parent who will be providing most of the care is younger than 18 years of age,
- those with insufficient knowledge of English to participate in the telephone interviews
- the parent/caregiver has plans to leave the District of Columbia (DC) metropolitan area permanently within the following year.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's National Medical Center
Washington D.C., District of Columbia, 20010
About this study
BACKGROUND: Annually >400,000 US newborns require neonatal intensive care unit (NICU) care.1/3 will require ongoing or specialty care after discharge. Some NICU graduates can be classified as children with special health care needs (CSHCN) who will require health and related services of a type or amount beyond that required by children generally. NICU parents report increased anxiety and stress during their stay and transition home from the NICU. Short-term peer-to -peer programs during hospitalization decrease stress, anxiety and depression for mothers, however, no studies have evaluated the effects of long term post-discharge peer support. Children's National (CN) provides medical home services to CSHCN through its Parent Navigator Program (PNP). Parent Navigators (PNs) are CSHCN parents who provide peer emotional support, access to community resources, and assistance with navigating complicated health systems. NICU graduates and their caregivers may benefit from support provided by PNs after discharge. No data regarding the impact of PNs on patient and family outcomes of the NICU graduate are available.
OBJECTIVE: To assess the impact of a PNP on a parent's self-efficacy, stress, anxiety, depression; infant health care utilization, and immunization status.
Read more
METHODS: 300 NICU graduates will be randomized to receive either PN for 12 months (intervention group) or usual care (comparison group). Baseline data at 1 week, 1, 3, 6, and 12 months after discharge will be collected from caregivers in both groups including scales for self-efficacy, stress, anxiety, and depression, infant healthcare utilization and immunization status. Outcomes will be compared at 12 months.
PATIENT OUTCOMES (PROJECTED) The study outcomes are parental self-efficacy, stress, anxiety, and depression; infant health care utilization and immunization status.
ANTICIPATED IMPACT Prior studies utilizing small samples have suggested that peer support in the NICU can reduce anxiety and depression in caregivers. It is unclear whether peer support after discharge, when a family is faced with the total care of their child without structured supports, can significantly impact parents' ability to care for their child. The investigators anticipate that this simple intervention will increase self-efficacy in caregivers, reduce stress, anxiety, and depression, in turn resulting in improved health outcomes for their child.
Read the detailed description
Specific Aims:
Infants who are discharged from the neonatal intensive care unit (NICU) almost invariably have high levels of health care needs in the first year after discharge, requiring multiple sub specialist visits, medications, and/or medical technology needs. Parents of NICU infants are often overwhelmed by the needs of their infants after they are discharged home and frequently have few supports to help them cope. This study will investigate the impact of peer to peer support through a Parent Navigation program for NICU graduates and their parents. The study aims will be achieved through a randomized controlled trial of Parent Navigation using a care resource notebook as the control intervention.
The specific aims of this study are to:
- Determine if Parent Navigation increases overall parental self-efficacy and decreases stress among parents caring for a child with a special health care need (CSHCN) when measured at repeated time points during the 12 months after NICU discharge. Hypothesis 1a: Parent Navigation will increase parental self-efficacy, when compared with the control group. Hypothesis 1b: Parent Navigation will decrease parenting stress, when compared with the control group.
- Determine if Parent Navigation improves overall levels of anxiety and depression in parents of children with special health care needs when measured repeatedly during the 12 months after NICU discharge. Hypothesis 2a: Parent Navigation will improve parent anxiety, compared with control group. Hypothesis 2b: Parent Navigation will lessen parent depression, compared with control group.
- Determine if Parent Navigation positively impacts on infant health outcomes during the 12 months after NICU discharge.
Hypothesis 3a: Parent Navigation/Intervention group will have significantly fewer hospitalizations when compared with control group.
Hypothesis 3b: Parent Navigation will have significantly fewer emergency department (ED) visits, when compared with control group.
Hypothesis 3c: Parent Navigation will result in improved immunization status, when compared with control group.
Hypothesis 3d. By supporting parents' emotional function, infant developmental progress will be enhanced.
Background :
NICU parents experience high levels of stress, anxiety, and depression, and low levels of self-efficacy. Neonates comprise one of the largest groups of medically complex infants in the United States. Of the 4 million live births in 2012, 11.5% (~460,000) were born preterm at < 37 weeks gestation. The District of Columbia alone has a higher rate (12.8%) of preterm infants, which is 11% higher than the national average. The vast majority of infants born preterm and ~1% of full term infants with significant illnesses at birth (e.g., congenital anomalies) will require care in a neonatal intensive care unit (NICU), and ~30% of infants being discharged from the NICU ("NICU graduates") annually (110,000 babies) require supplementary short -term or ongoing specialty care and have increased risk of long- term disability, including cerebral palsy, deafness, blindness, and neurodevelopmental impairment. At discharge, this large cohort of neonates and their families face tremendous challenges as they transition from a highly structured medical environment to a less structured home environment. Some challenges identified include feeling unprepared to care for their infant at home despite extensive teaching in the NICU setting, feeling socially isolated as the typical celebratory process of giving birth and going home with baby has been disrupted by a serious medical condition and prolonged hospital stay. Additionally, depression and anxiety among mothers of infants have been shown to be associated with infant feeding difficulties, suboptimal parenting practices, and altered health care utilization.
Parent navigation is a unique patient -centered intervention in which parents with experience caring for their own child with special health care need offer peer to peer support and mentoring to another parent of a child with a special health care need. In 2008, Children's National instituted a Parent Navigation program, in which Parent Navigators (PNs), who are parents of children with special health care needs, are employed by CN to provide peer to peer support to other parents of children with special health care need . These parents provide their own personal experience and expertise in navigating the often confusing and frustrating health care systems. Although the PN model is based on self-efficacy and social support models, there are no published studies on the impact of PN on parental self-efficacy, depression, stress, and infant health outcomes. The investigators believe that neonates and their caregivers would benefit from peer to peer support provided by PNs after discharge. Currently, there are no data regarding the impact of PNs on patient and family outcomes of the NICU graduate.
Preliminary Studies:
As a first phase of this study, the investigators conducted focus groups with parents of recently discharged NICU infants (4 focus groups, n=18 participants), parent navigators (1 focus group n=3), parents (n=2), NICU social workers, case managers, and nurses (1 focus group, n=23); NICU providers (1 focus group, n=5) and community providers (n=2). The investigators' intervention is informed by this data.
- Conditions
- Premature Birth of Newborn, Family, Immature Newborn, Newborn Morbidity, Infant Newborn Disease
- Being tested
- Parent Navigator, Care Notebook
- Keywords
- neonate, newborn, neonatal intensive care unit, NICU, NICU discharge, parent navigator, peer to peer, peer coaching
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent NavigatorBehavioural
Also called Peer to Peer Support
Parents will be contacted by the parent navigator within 2 business days after discharge to assess how the family is coping, answer questions, and provide necessary resources. Navigators will be in touch with families monthly and according to the parent's needs. They will assist the parent in making and keeping appointments, answer questions about insurance coverage, medical equipment and supplies, and serve as a liaison between parent and healthcare providers. However, the specific PN intervention for each family will be based on each family's needs and therefore may differ.
Care NotebookBehavioural
A care notebook will be provided to all parents at discharge. The notebook was created to provide resources and serve as an organizer for appointments for parents of NICU graduates. It was based on peer to peer feedback from former NICU parents, in addition, to community resources developed by current Parent Navigator Program at Children's National Health System.
| Study group | Role | What they receive |
|---|---|---|
| Care Notebook | Other | Parents of infants who were discharged from the Children's National NICU will be randomized to receive enhanced usual care by provision of a NICU care resource notebook. Parents will be notified about group assignment prior to discharge. Stratification will occur according to birth weight. Receives: Behavioral: Care Notebook |
| Care Notebook + Parent Navigator | Experimental | Parents of infants who were discharged from the Children's National NICU will be randomized to receive a care notebook + Parent Navigation. Parents will be notified about group assignment prior to discharge. Stratification will occur according to the birth weight. Receives: Behavioral: Parent Navigator; Behavioral: Care Notebook |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental Self-Efficacy
Parental self-efficacy was measured using the Perceived Maternal Parenting Self-Efficacy Questionnaire (PMPS-E). Mean scores were determined and compared between groups. PMPS-E scores can range from 20-80, and higher scores indicate higher levels of parental self-efficacy.
Measured: baseline; 1 week, 1 month, 3 months, 6 months, 12 months after discharge
Secondary outcomes (9)
Parental Anxiety
Parental anxiety was measured using the State Trait Anxiety Inventory (STAI). Mean scores were determined and compared between groups. The trait portion (Y-2) was only administered at baseline, while the state portion (Y-1) was administered at every interval and used for longitudinal analyses. STAI scores can range from 20-80, and higher scores indicate higher levels of anxiety.
Measured: baseline; 1 week, 1 month, 3 months, 6 months, 12 months after discharge
Parental Stress
Parental stress was measured using the Parental Stress Scale (PSS). Mean scores were determined and compared between groups. PSS scores can range from 18-90, and higher scores indicate higher levels of parental stress.
Measured: baseline; 1 week, 1 month, 3 months, 6 months, 12 months after discharge
General Stress
General stress was measured using the Perceived Stress Scale (PSS-10), a 10-item instrument which asks respondents to consider their feelings and thoughts during the last month. Total scores range from 0-40, with higher scores indicating higher levels of stress
Measured: baseline, 1 week, 1 mo, 3 mo, 6 mo, 12 months after discharge
Parental Stress in the Neonatal Intensive Care Unit
The Parental Stressor Scale:Neonatal Intensive Care Unit (PSS:NICU) was used to measure NICU-specific stress. Mean total and subscale scores were determined using Metric 1 (applicable stress) and compared between groups. PSS:NICU scores can range from 1-5, and higher scores indicate higher levels of NICU-specific stress.
Measured: Baseline
Parental Depression
Parental depression was measured using the 10-item Center for Epidemiological Study Depression Scale (CES-D 10). Mean scores were determined and compared between groups. CES-D 10 scores can range from 0-30, and a score >=10 indicates the presence of depressive symptoms.
Measured: baseline; 1 month, 3 months, 6 months, 12 months after discharge
ED Visits
Infant ED visits were parent-reported and totaled over a period of 12 months.
Measured: One year
Hospitalizations
Infant hospitalizations were parent-reported and totaled over a period of 12 months.
Measured: One year
Infant Immunization Status
Infant immunization status was either provider-reported or accessed via a state registry. The number of neonates with a complete immunization series within 12 months after discharge were compared between groups. Complete immunization status was defined as receipt of 3 diphtheria tetanus acellular pertussis (DTaP) vaccines, 3 pneumococcal conjugate vaccines (PCV13), and either 2 or 3 Hemophilus influenzae b (HIB) vaccines, depending on vaccine type (e.g. PedvaxHIB at 2 and 4 months, ActHIB at 2, 4, and 6 months).
Measured: One year
Infant Developmental Status
Infant developmental status was measured using the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley III). The Bayley III was administered between 11-13 months of study follow-up, and it used corrected infant age to account for prematurity. Composite scores for cognitive, language, and motor domains were determined and compared between groups. Bayley scores can range from 40-160, and higher scores indicate higher levels of infant development.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionFeb 2017
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Premature Birth of NewbornStudies of the same condition, open and under way.
- More trials run by Children's National Research InstituteThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's National Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Karen Fratantoni, Children's National Research Institute
- Investigators
- Karen Fratantoni, MD, MPH, Principal investigator, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02643472
- Sponsor's protocol ID
- IHS-1403-11567
- Acronym
- GPS
- Status last verified
- Feb 2019
- First submitted
- 22 Dec 2015
- Last updated
- 5 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Sadjadpour F, Hosseinichimeh N, Abedi V, Soghier LM. Comparative analysis of machine learning versus traditional method for early detection of parental depression symptoms in the NICU. Front Public Health. 2024 May 28;12:1380034. doi: 10.3389/fpubh.2024.1380034. eCollection 2024.
PubMed 38864019Younge T, Jacobs M, Tuchman L, Streisand R, Soghier L, Fratantoni K. Sociodemographic risk factors, parental stress and social support in the neonatal intensive care unit. Arch Dis Child Fetal Neonatal Ed. 2023 Mar;108(2):165-169. doi: 10.1136/archdischild-2022-324119. Epub 2022 Sep 6.
PubMed 36805477Fratantoni K, Soghier L, Kritikos K, Jacangelo J, Herrera N, Tuchman L, Glass P, Streisand R, Jacobs M. Giving parents support: a randomized trial of peer support for parents after NICU discharge. J Perinatol. 2022 Jun;42(6):730-737. doi: 10.1038/s41372-022-01341-5. Epub 2022 Mar 8.
PubMed 35260824Carty CL, Soghier LM, Kritikos KI, Tuchman LK, Jiggetts M, Glass P, Streisand R, Fratantoni KR. The Giving Parents Support Study: A randomized clinical trial of a parent navigator intervention to improve outcomes after neonatal intensive care unit discharge. Contemp Clin Trials. 2018 Jul;70:117-134. doi: 10.1016/j.cct.2018.05.004. Epub 2018 May 5.
PubMed 29733982
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GPS (Giving Parents Support): Parent Navigation After NICU Discharge
- ClinicalTrials.gov ID
- NCT02643472
- Acronym / sponsor ID
- GPS / IHS-1403-11567
- Conditions
- Premature Birth of Newborn, Family, Immature Newborn, Newborn Morbidity, Infant Newborn Disease
- Keywords
- neonate, newborn, neonatal intensive care unit, NICU, NICU discharge, parent navigator, peer to peer, peer coaching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Children's National Research InstituteUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- Jan 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 31 Dec 2015 (estimated)
- Results
- Posted 5 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
BACKGROUND: Annually >400,000 US newborns require neonatal intensive care unit (NICU) care.1/3 will require ongoing or specialty care after discharge. Some NICU graduates can be classified as children with special health care needs (CSHCN) who will require health and related services of a type or amount beyond that required by children generally. NICU parents report increased anxiety and stress during their stay and transition home from the NICU. Short-term peer-to -peer programs during hospitalization decrease stress, anxiety and depression for mothers, however, no studies have evaluated the effects of long term post-discharge peer support. Children's National (CN) provides medical home services to CSHCN through its Parent Navigator Program (PNP). Parent Navigators (PNs) are CSHCN parents who provide peer emotional support, access to community resources, and assistance with navigating complicated health systems. NICU graduates and their caregivers may benefit from support provided by PNs after discharge. No data regarding the impact of PNs on patient and family outcomes of the NICU graduate are available.
OBJECTIVE: To assess the impact of a PNP on a parent's self-efficacy, stress, anxiety, depression; infant health care utilization, and immunization status.
METHODS: 300 NICU graduates will be randomized to receive either PN for 12 months (intervention group) or usual care (comparison group). Baseline data at 1 week, 1, 3, 6, and 12 months after discharge will be collected from caregivers in both groups including scales for self-efficacy, stress, anxiety, and depression, infant healthcare utilization and immunization status. Outcomes will be compared at 12 months.
PATIENT OUTCOMES (PROJECTED) The study outcomes are parental self-efficacy, stress, anxiety, and depression; infant health care utilization and immunization status.
ANTICIPATED IMPACT Prior studies utilizing small samples have suggested that peer support in the NICU can reduce anxiety and depression in caregivers. It is unclear whether peer support after discharge, when a family is faced with the total care of their child without structured supports, can significantly impact parents' ability to care for their child. The investigators anticipate that this simple intervention will increase self-efficacy in caregivers, reduce stress, anxiety, and depression, in turn resulting in improved health outcomes for their child.
Detailed description
Specific Aims:
Infants who are discharged from the neonatal intensive care unit (NICU) almost invariably have high levels of health care needs in the first year after discharge, requiring multiple sub specialist visits, medications, and/or medical technology needs. Parents of NICU infants are often overwhelmed by the needs of their infants after they are discharged home and frequently have few supports to help them cope. This study will investigate the impact of peer to peer support through a Parent Navigation program for NICU graduates and their parents. The study aims will be achieved through a randomized controlled trial of Parent Navigation using a care resource notebook as the control intervention.
The specific aims of this study are to:
- Determine if Parent Navigation increases overall parental self-efficacy and decreases stress among parents caring for a child with a special health care need (CSHCN) when measured at repeated time points during the 12 months after NICU discharge. Hypothesis 1a: Parent Navigation will increase parental self-efficacy, when compared with the control group. Hypothesis 1b: Parent Navigation will decrease parenting stress, when compared with the control group.
- Determine if Parent Navigation improves overall levels of anxiety and depression in parents of children with special health care needs when measured repeatedly during the 12 months after NICU discharge. Hypothesis 2a: Parent Navigation will improve parent anxiety, compared with control group. Hypothesis 2b: Parent Navigation will lessen parent depression, compared with control group.
- Determine if Parent Navigation positively impacts on infant health outcomes during the 12 months after NICU discharge.
Hypothesis 3a: Parent Navigation/Intervention group will have significantly fewer hospitalizations when compared with control group.
Hypothesis 3b: Parent Navigation will have significantly fewer emergency department (ED) visits, when compared with control group.
Hypothesis 3c: Parent Navigation will result in improved immunization status, when compared with control group.
Hypothesis 3d. By supporting parents' emotional function, infant developmental progress will be enhanced.
Background :
NICU parents experience high levels of stress, anxiety, and depression, and low levels of self-efficacy. Neonates comprise one of the largest groups of medically complex infants in the United States. Of the 4 million live births in 2012, 11.5% (~460,000) were born preterm at < 37 weeks gestation. The District of Columbia alone has a higher rate (12.8%) of preterm infants, which is 11% higher than the national average. The vast majority of infants born preterm and ~1% of full term infants with significant illnesses at birth (e.g., congenital anomalies) will require care in a neonatal intensive care unit (NICU), and ~30% of infants being discharged from the NICU ("NICU graduates") annually (110,000 babies) require supplementary short -term or ongoing specialty care and have increased risk of long- term disability, including cerebral palsy, deafness, blindness, and neurodevelopmental impairment. At discharge, this large cohort of neonates and their families face tremendous challenges as they transition from a highly structured medical environment to a less structured home environment. Some challenges identified include feeling unprepared to care for their infant at home despite extensive teaching in the NICU setting, feeling socially isolated as the typical celebratory process of giving birth and going home with baby has been disrupted by a serious medical condition and prolonged hospital stay. Additionally, depression and anxiety among mothers of infants have been shown to be associated with infant feeding difficulties, suboptimal parenting practices, and altered health care utilization.
Parent navigation is a unique patient -centered intervention in which parents with experience caring for their own child with special health care need offer peer to peer support and mentoring to another parent of a child with a special health care need. In 2008, Children's National instituted a Parent Navigation program, in which Parent Navigators (PNs), who are parents of children with special health care needs, are employed by CN to provide peer to peer support to other parents of children with special health care need . These parents provide their own personal experience and expertise in navigating the often confusing and frustrating health care systems. Although the PN model is based on self-efficacy and social support models, there are no published studies on the impact of PN on parental self-efficacy, depression, stress, and infant health outcomes. The investigators believe that neonates and their caregivers would benefit from peer to peer support provided by PNs after discharge. Currently, there are no data regarding the impact of PNs on patient and family outcomes of the NICU graduate.
Preliminary Studies:
As a first phase of this study, the investigators conducted focus groups with parents of recently discharged NICU infants (4 focus groups, n=18 participants), parent navigators (1 focus group n=3), parents (n=2), NICU social workers, case managers, and nurses (1 focus group, n=23); NICU providers (1 focus group, n=5) and community providers (n=2). The investigators' intervention is informed by this data.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Care Notebook | Other | Behavioral: Care NotebookParents of infants who were discharged from the Children's National NICU will be randomized to receive enhanced usual care by provision of a NICU care resource notebook. Parents will be notified about group assignment prior to discharge. Stratification will occur according to birth weight. |
| Care Notebook + Parent Navigator | Experimental | Behavioral: Parent Navigator, Behavioral: Care NotebookParents of infants who were discharged from the Children's National NICU will be randomized to receive a care notebook + Parent Navigation. Parents will be notified about group assignment prior to discharge. Stratification will occur according to the birth weight. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- parents of neonates receiving care in the Children's National NICU
Key exclusion criteria (5 listed)
- infant is not being discharged with a custodial parent (e.g., in custody of Child Protection Services)
- neither parent can complete an interview in English,
- the parent who will be providing most of the care is younger than 18 years of age,
- those with insufficient knowledge of English to participate in the telephone interviews
- the parent/caregiver has plans to leave the District of Columbia (DC) metropolitan area permanently within the following year.
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 |
|---|---|---|
| Parent NavigatorAlso: Peer to Peer SupportParents will be contacted by the parent navigator within 2 business days after discharge to assess how the family is coping, answer questions, and provide necessary resources. Navigators will be in touch with families monthly and according to the parent's needs. They will assist the parent in making and keeping appointments, answer questions about insurance coverage, medical equipment and supplies, and serve as a liaison between parent and healthcare providers. However, the specific PN intervention for each family will be based on each family's needs and therefore may differ. | Behavioural | Care Notebook + Parent Navigator |
| Care NotebookA care notebook will be provided to all parents at discharge. The notebook was created to provide resources and serve as an organizer for appointments for parents of NICU graduates. It was based on peer to peer feedback from former NICU parents, in addition, to community resources developed by current Parent Navigator Program at Children's National Health System. | Behavioural | Care Notebook, Care Notebook + Parent Navigator |
Primary outcome
Parental Self-Efficacy
Time frame: baseline; 1 week, 1 month, 3 months, 6 months, 12 months after discharge
Parental self-efficacy was measured using the Perceived Maternal Parenting Self-Efficacy Questionnaire (PMPS-E). Mean scores were determined and compared between groups. PMPS-E scores can range from 20-80, and higher scores indicate higher levels of parental self-efficacy.
9 secondary outcomes
Parental Anxiety
Time frame: baseline; 1 week, 1 month, 3 months, 6 months, 12 months after discharge
Parental Stress
Time frame: baseline; 1 week, 1 month, 3 months, 6 months, 12 months after discharge
General Stress
Time frame: baseline, 1 week, 1 mo, 3 mo, 6 mo, 12 months after discharge
Parental Stress in the Neonatal Intensive Care Unit
Time frame: Baseline
Parental Depression
Time frame: baseline; 1 month, 3 months, 6 months, 12 months after discharge
ED Visits
Time frame: One year
Hospitalizations
Time frame: One year
Infant Immunization Status
Time frame: One year
Infant Developmental Status
Time frame: One year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38864019Sadjadpour F, Hosseinichimeh N, Abedi V, Soghier LM. Comparative analysis of machine learning versus traditional method for early detection of parental depression symptoms in the NICU. Front Public Health. 2024 May 28;12:1380034. doi: 10.3389/fpubh.2024.1380034. eCollection 2024.
- Derived from this study: PubMed 36805477Younge T, Jacobs M, Tuchman L, Streisand R, Soghier L, Fratantoni K. Sociodemographic risk factors, parental stress and social support in the neonatal intensive care unit. Arch Dis Child Fetal Neonatal Ed. 2023 Mar;108(2):165-169. doi: 10.1136/archdischild-2022-324119. Epub 2022 Sep 6.
- Derived from this study: PubMed 35260824Fratantoni K, Soghier L, Kritikos K, Jacangelo J, Herrera N, Tuchman L, Glass P, Streisand R, Jacobs M. Giving parents support: a randomized trial of peer support for parents after NICU discharge. J Perinatol. 2022 Jun;42(6):730-737. doi: 10.1038/s41372-022-01341-5. Epub 2022 Mar 8.
- Derived from this study: PubMed 29733982Carty CL, Soghier LM, Kritikos KI, Tuchman LK, Jiggetts M, Glass P, Streisand R, Fratantoni KR. The Giving Parents Support Study: A randomized clinical trial of a parent navigator intervention to improve outcomes after neonatal intensive care unit discharge. Contemp Clin Trials. 2018 Jul;70:117-134. doi: 10.1016/j.cct.2018.05.004. Epub 2018 May 5.
- 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.
Karen Fratantoni, MD, MPH principal investigator
Children's National Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent Navigator and Care Notebook in people with Premature Birth of Newborn and Family, run by Children's National Research Institute at 1 site in United States.
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 1 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 5 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 5 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Parental Self-Efficacy (time frame: baseline; 1 week, 1 month, 3 months, 6 months, 12 months after discharge). 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 NCT02643472, which also lists 4 linked publications.
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 5 Aug 2019.