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.

Abstract

Parents of infants hospitalized in a neonatal intensive care unit (NICU) experience increased anxiety and stress, which may persist after discharge. The rationale and design of a randomized clinical trial assessing the impact of a 1-year, post-discharge, peer support intervention (parent navigation) on parental mental health and infant health care utilization is described. Qualitative methods guided the adaptation of an existing parent support program to target emotional and resource-related needs of NICU families. Approximately 300 parent-infant dyads were enrolled at discharge and randomized to either receive a care notebook (control group) or a parent navigator and a care notebook (intervention group). We aim to determine if the parent navigator intervention: 1) increases self-efficacy and decreases stress in parents, 2) decreases overall levels of anxiety and depression in parents, 3) decreases infant hospitalizations and emergency department visits, and 4) increases adherence to infant vaccination recommendations during 1 year of follow-up. Standardized, self-reported psychological scales to assess parent depression, anxiety, self-efficacy and social support were administered at baseline (NICU discharge) and at 1-week, 1-, 3-, 6- and 12-month intervals. Infant immunization status and health care utilization during the study period were also assessed. This paper reviews challenges and successes during implementation. If this intervention improves outcomes, NICUs may choose to provide similar parent navigation services for infants and families transitioning from the NICU to home. This study was registered with ClinicalTrials.gov (NCT02643472) on December 31, 2015.

Keywords: Hospital discharge; Neonatal intensive care; Parent depression; Parent navigator; Parent stress; Peer support.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Anxiety / diagnosis
  • Anxiety / etiology
  • Anxiety / prevention & control*
  • Depression / diagnosis
  • Depression / etiology
  • Depression / prevention & control*
  • District of Columbia
  • Emergency Service, Hospital / statistics & numerical data
  • Female
  • Hospitalization / statistics & numerical data
  • Humans
  • Infant, Newborn
  • Intensive Care Units, Neonatal*
  • Male
  • Maryland
  • Parents / psychology*
  • Patient Acceptance of Health Care / statistics & numerical data*
  • Patient Discharge
  • Self Efficacy
  • Self Report
  • Single-Blind Method
  • Social Support*
  • Stress, Psychological / diagnosis
  • Stress, Psychological / etiology
  • Stress, Psychological / prevention & control*
  • Virginia

Associated data

  • ClinicalTrials.gov/NCT02643472