Recruiting

Resilient Families

Sponsor:

Massachusetts General Hospital

Code:

NCT07383948

Conditions

Parents

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Resilient Families (R-FAM)

Educational Resources & Program

Study Details

Brief summary:

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.

Conditions

Parents

Study ID

NCT07383948

Start date

Apr 1, 2026

Status verified date

Jul, 2026

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Oct 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

active comparator: Educational Program

Participants will receive educational resources about adjusting to the NICU and coping with their stay.

Interventions

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.

Educational Resources & Program

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

Primary outcome measure

  • Anxiety [ Time Frame: Time Frame: Baseline to end of intervention (6 weeks) ]
  • Depression [ Time Frame: Time Frame: Baseline to end of intervention (6 weeks) ]
  • Posttraumatic Stress [ Time Frame: Time Frame: Baseline to end of intervention (6 weeks) ]

Central Contacts and Locations

Central contacts

Victoria A Grunberg, PhD

617-643-4133vgrunberg@mgh.harvard.edu

Locations

Mass General Brigham

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Victoria A Grunberg, PhD

617-643-4133vgrunberg@mgh.harvard.edu

Cindy Liu, PhD

CHLIU@BWH.HARVARD.EDU

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Jul 14, 2026

Last verified

Jul, 2026

Keywords

  • Neonatal Intensive Care Unit
  • Parent Mental Health
  • Parent relationships

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-07-14.