Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: GPS (Giving Parents Support): Parent Navigation After NICU Discharge
Brief 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 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.


Options:
A: Arm Label: Usual Care; Type: ACTIVE_COMPARATOR; Interventions: Other: light support, Other: 3 preventive home visits by a nurse | Arm Label: UP Protocol; Type: EXPERIMENTAL; Interventions: Other: Case Manager, Other: 3 preventive home visits by a nurse | Arm Label: UP-TECH Protocol; Type: EXPERIMENTAL; Interventions: Other: Case Manager, Other: Assistive Technologies, Other: 3 preventive home visits by a nurse | Intervention Type: OTHER; Name: Case Manager; Assigned to Arm(s): UP Protocol, UP-TECH Protocol | Intervention Type: OTHER; Name: Assistive Technologies; Assigned to Arm(s): UP-TECH Protocol | Intervention Type: OTHER; Name: light support; Assigned to Arm(s): Usual Care | Intervention Type: OTHER; Name: 3 preventive home visits by a nurse; Assigned to Arm(s): UP Protocol, UP-TECH Protocol, Usual Care
B: Arm Label: Care Notebook; Type: OTHER; Interventions: Behavioral: Care Notebook | Arm Label: Care Notebook + Parent Navigator; Type: EXPERIMENTAL; Interventions: Behavioral: Parent Navigator, Behavioral: Care Notebook | Intervention Type: BEHAVIORAL; Name: Parent Navigator; Assigned to Arm(s): Care Notebook + Parent Navigator | Intervention Type: BEHAVIORAL; Name: Care Notebook; Assigned to Arm(s): Care Notebook, Care Notebook + Parent Navigator
C: Arm Label: intervention; Type: EXPERIMENTAL; Interventions: Other: structured support groups | Arm Label: control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: structured support groups; Assigned to Arm(s): intervention
D: Arm Label: Behavioral Activation; Type: EXPERIMENTAL; Interventions: Behavioral: Behavioral activation, Other: Psychoeducation | Arm Label: Psychoeducation; Type: ACTIVE_COMPARATOR; Interventions: Other: Psychoeducation | Intervention Type: BEHAVIORAL; Name: Behavioral activation; Assigned to Arm(s): Behavioral Activation | Intervention Type: OTHER; Name: Psychoeducation; Assigned to Arm(s): Behavioral Activation, Psychoeducation

Answer: B