Resilient Families for NICU Parents
Official title: Enhancing Parental Well-being in the NICU
Run by Massachusetts General Hospital · NCT07383948 · Data updated 2026-11-12
This study tests a dyadic resiliency program called Resilient Families (R-FAM) to see if it can reduce distress and improve relationships for NICU parents, compared with a single-session educational control.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | April 1, 2026 |
| Main results expected | October 1, 2027 |
| Study ends | March 31, 2028 |
| Registry record updated | July 14, 2026 |
| Trial ID | NCT07383948 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adult parents or loving guardians of a baby in the NICU who are in an intimate relationship, live with the baby after discharge, and have at least one distressed partner (GAD ≥ 10 or PHQ ≥ 10) and can participate via live video in English.
✕Probably not a fit
Participants without significant caregiver distress or without stable partner involvement may see limited or no personal benefit from the intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a feasibility randomized trial enrolling NICU parents in couples (dyads) to compare the Resilient Families (R-FAM) intervention with a minimally enhanced usual care control that provides educational resources. The study aims to assess feasibility, acceptability, and fidelity of the R-FAM program and to gather preliminary signals of efficacy on parental distress and related outcomes. Up to 70 dyads will be randomized 1:1, with follow-up and qualitative exit interviews to refine procedures for future trials. The trial is conducted as a single-blind study with permuted-block randomization, led by Massachusetts General Hospital in collaboration with NICHD, across Mass General Brigham sites.
Why it matters
Potential benefit: If successful, parents may experience reduced emotional distress and strengthened relationships, potentially easing transitions after NICU discharge.
How similar studies have gone: Prior work with dyadic, resilience-focused interventions in stressful medical settings has shown feasibility and user acceptability, but this exact NICU parent dyad approach is being tested in this pilot.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 (GAD\>=10 or PHQ \>= 10) * 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
Where it's running
-
Mass General Brigham
Boston, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Victoria A Grunberg, PhD — Massachusetts General Hospital
- Study coordinator: Victoria A Grunberg, PhD
- Email: vgrunberg@mgh.harvard.edu
- Phone: 617-643-4133
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.