Resilient Families Feasibility Trial (R-FAM)

Enhancing Parental Well-being in the NICU

The goal of this study is to 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, the investigators are developing a randomized control trial where patients will be randomized to either the R-FAM condition or a minimally enhanced usual control (MEUC), which includes resources on parent mental health and coping in the NICU.

Study Overview

• Status: Not yet recruiting
• Conditions: Parents
• Intervention / Treatment: Other: Resilient Families (R-FAM); Other: Educational Resources & Program

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Victoria A Grunberg, PhD; Phone Number: 617-643-4133; Email: vgrunberg@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Mass General Brigham
      • Contact: Victoria A Grunberg, PhD; Phone Number: 617-643-4133; Email: vgrunberg@mgh.harvard.edu
      • Contact: Cindy Liu, PhD; Email: CHLIU@BWH.HARVARD.EDU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Educational Program; Participants will receive educational resources about adjusting to the NICU and coping with their stay.	Other: Educational Resources & Program; Parents will receive educational resources on how to cope with and adjust to the NICU stay.
Other: R-FAM Intervention; A resiliency based intervention that includes 6-sessions with a clinician to help couples cope with the uncertainty and stress of the NICU admission.	Other: Resilient Families (R-FAM); R-FAM is a resiliency intervention for couples with an infant admitted to the NICU. Parents will complete 6 guided sessions with a clinical psychologist that cover topics such as managing stress, staying in the present, and coping with uncertainty. Through these sessions, parents will learn skills to manage the "emotional roller-coaster" of the NICU, cope with stress, and connect with each other.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Depression	Level of depression endorsed on Hospital Anxiety & Depression Scale, from 0-21, with 21 indicating highest depression.	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline to end of intervention (6 weeks)]

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Victoria A Grunberg, PhD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: January 22, 2026
• First Submitted That Met QC Criteria: January 26, 2026
• First Posted (Actual): February 3, 2026

Study Record Updates

• Last Update Posted (Actual): February 4, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Neonatal Intensive Care Unit; Parent Mental Health; Parent relationships
• Other Study ID Numbers: 2025P003422; 5K23HD110597-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No