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Purpose

The goal is to develop, refine, and test the feasibility and acceptability of a dyadic, resiliency intervention ("Resilient Families;" R-FAM) that aims to reduce emotional distress and improve relationships among parents in the Neonatal Intensive Care Unit (NICU). To achieve this goal, my aims are three-fold: (1) develop R-FAM using stakeholder input from interviews with parent dyads and focus groups with NICU staff; (2) optimize R-FAM through an open pilot with pre/post assessments and exit interviews; and (3) test R-FAM for feasibility and acceptability through a randomized clinical trial of R-FAM compared with a minimally enhanced usual control (MEUC).

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Adult parent/legal guardian (and/or their partner) of a baby admitted to the NICU within past week (age ≥ 18) - Currently in an intimate relationship and will live with baby after NICU discharge - At least one dyad member is emotionally distressed (HADS >7 on depression or anxiety subscale) - English fluency/literacy - Ability and willingness to participate via live video

Exclusion Criteria

  • Baby is expected to pass away (as determined by medical team) - Current, untreated psychosis or substance dependence/abuse - Current self-report of suicidal ideation

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Dyadic Resiliency Intervention 		All participants will receive the intervention, a brief dyadic resiliency intervention
  • Behavioral: Resilient Families (R-FAM)
    Dyadic, resiliency intervention that aims to reduce depression, anxiety, and posttraumatic stress among parents of babies in the NICU

Recruiting Locations

Mass General Brigham
Boston, Massachusetts 02114
Contact:
Victoria A Grunberg, PhD
617-643-4133
vgrunberg@mgh.harvard.edu

More Details

Status
Recruiting
Sponsor
Massachusetts General Hospital

Study Contact

Grunberg, PhD
617-643-4133
vgrunberg@mgh.harvard.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.