Resilient Families Program for Parenting
(R-FAM Trial)
Trial Summary
What is the purpose of this trial?
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).
Eligibility Criteria
This trial is for adult parents or legal guardians (and their partners) of a baby in the NICU. They must be over 18, in an intimate relationship, planning to live with the baby after discharge, and at least one partner should be emotionally distressed. Participants need to speak English and join via live video.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Intervention Development
Develop R-FAM using stakeholder input from interviews with parent dyads and focus groups with NICU staff
Pilot Optimization
Optimize R-FAM through an open pilot with pre/post assessments and exit interviews
Treatment
Participants receive the dyadic resiliency intervention (R-FAM) for 6 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Resilient Families (R-FAM)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor