Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Victoria A Grunberg, PhD
CONTACT
Lead
Massachusetts General Hospital
With
The investigators aim to conduct a pilot feasibility randomized clinical trial (RCT) of R-FAM (Resilient Families) with NICU parents (up to N = 70 dyads) followed by a 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 and data from the R-FAM open pilot to optimize the intervention and study procedures for future trials. The investigators will conduct a single-blinded randomized clinical trial comparing the feasibility and acceptability of Resilient Families (R-FAM)-a resiliency intervention-with a one session educational program (minimally enhanced usual control) for parental couples ("dyads") of babies in the NICU. The investigators will also explore preliminary changes in outcomes and mechanisms to inform future trials. See Figure 1 for iterative development of R-FAM (the study is in years 3 and 4). After enrollment, participants will be randomized to either the "Resilient Families" intervention or to the educational program (control). Dyads will be randomly assigned in a 1:1 ratio to intervention or control to ensure comparability between groups. The randomization schedule will be prepared using permuted blocks of size 2 and 4 by the unblinded study statistician and implemented in REDCap. All subjects will be given baseline psychological and behavioral assessments that will assess depression, anxiety, PTSD symptoms, and other psychological constructs.
Age
18–any
Sex
ALL
Healthy volunteers
Accepted
