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).
The investigators aim to conduct an open pilot trial of the R-FAM program (Resilient Families) with NICU parents (up to N = 6 dyads) followed by an optional brief exit interview. The investigators will determine if the feasibility, acceptability, and fidelity of the program meet a priori benchmarks. The investigators also hope to establish preliminary efficacy that the program reduces parental emotional distress and other study outcomes described in sections below. The investigators will use qualitative data to optimize the intervention and study procedures for future trials. This Open Pilot trial will include 6 sessions with a clinical psychologist. The intervention will aim to improve coping skills, communication, and stress management. Participants will learn evidence-based skills (e.g., mindfulness, dialectics, problem-solving) to reduce risk for emotional distress. The primary outcomes for the open pilot will be the feasibility, acceptability, and fidelity of the R-FAM program. Preliminary effectiveness outcomes will also be examined, as in primary and secondary targets and exploratory outcomes (e.g., emotional distress, couple satisfaction, and family impact).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Dyadic, resiliency intervention that aims to reduce depression, anxiety, and posttraumatic stress among parents of babies in the NICU
Mass General Brigham
Boston, Massachusetts, United States
Depression
Level of depression endorsed on Hospital Anxiety \& Depression Scale and Edinburgh Postnatal Depression Scale, from 0-30 with 30 indicating highest depression
Time frame: Baseline to end of intervention (6 weeks)
Anxiety
Level of anxiety endorsed on Hospital Anxiety \& Depression Scale, from 0-21 with 21 indicating highest anxiety
Time frame: Baseline to end of intervention (6 weeks)
Posttraumatic Stress
Level of posttraumatic stress endorsed on Impact of Event Scale-6, from 6-24 with 24 indicating highest posttraumatic stress
Time frame: Baseline to end of intervention (6 weeks)
Couple relationship functioning
Couple satisfaction as reported on Couple Satisfaction Index, from 0-21 with 21 indicating highest couple satisfaction
Time frame: Baseline to end of intervention (6 weeks)
Family Impact
Impact of child's illness as reported on Family Impact Scale, Revised, from 0-75 with 75 indicating lowest impact on family
Time frame: Baseline to end of intervention (6 weeks)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.