Resilient Families Feasibility Trial

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT07383948
Status
Not Yet Recruiting

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Conditions

  • Parents

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Mar 1, 2026
Status verified
Feb 2026
Primary completion
Aug 1, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Anxiety [ Time Frame: Time Frame: Baseline to end of intervention (6 weeks) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mass General BrighamBostonMassachusetts02114
Victoria A Grunberg, PhD
[email protected]
617-643-4133
Cindy Liu, PhD
[email protected]

Find similar trials in Boston, MA

By research site
Mass General Brigham· Boston, MA

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