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NCT Number: NCT07383948

Resilient Families Feasibility Trial

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.

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Key information

Conditions

Parents

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resilient Families (R-FAM)

Other

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.

Educational Resources & Program

Other

Parents will receive educational resources on how to cope with and adjust to the NICU stay.

Primary outcomes

  1. Anxiety

    Time frame: Time Frame: Baseline to end of intervention (6 weeks)

    Level of anxiety endorsed on Hospital Anxiety & Depression Scale, from 0-21 with 21 indicating highest anxiety

  2. Depression

    Time frame: Time Frame: Baseline to end of intervention (6 weeks)

    Level of depression endorsed on Hospital Anxiety & Depression Scale, from 0-21, with 21 indicating highest depression.

  3. Posttraumatic Stress

    Time frame: Time Frame: Baseline to end of intervention (6 weeks)

    Level of posttraumatic stress endorsed on Impact of Event Scale-6, from 6-24 with 24 indicating highest posttraumatic stress

Secondary outcomes

  1. Couple relationship functioning

    Time frame: Time Frame: Baseline to end of intervention (6 weeks)

    Couple satisfaction as reported on Couple Satisfaction Index, from 0-21 with 21 indicating highest couple satisfaction

  2. Family Impact

    Time frame: Baseline to end of intervention (6 weeks)]

    Impact of child's illness as reported on Family Impact Scale, Revised, from 0-75 with 75 indicating lowest impact on family

Study contacts

Contact information is provided by the study sponsor or research team.

Victoria A Grunberg, PhD

CONTACT

[email protected]

617-643-4133

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Enhancing Parental Well-being in the NICU

Acronym: R-FAM

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Feb 3, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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