NCT07383948

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
23mo left

Started Mar 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress9%
Mar 2026Mar 2028

First Submitted

Initial submission to the registry

January 22, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 3, 2026

Completed
26 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Last Updated

February 4, 2026

Status Verified

February 1, 2026

Enrollment Period

1.4 years

First QC Date

January 22, 2026

Last Update Submit

February 2, 2026

Conditions

Parents

Keywords

Neonatal Intensive Care UnitParent Mental HealthParent relationships

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Couple relationship functioning

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

  • Family Impact

    Baseline to end of intervention (6 weeks)]

Study Arms (2)

R-FAM Intervention

OTHER

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)

Educational Program

ACTIVE COMPARATOR

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

Other: Educational Resources & Program

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.

R-FAM Intervention
Educational Resources & ProgramOTHER

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

Educational Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Baby is expected to pass away (as determined by medical team)
  • Current, untreated psychosis or substance dependence/abuse
  • Current self-report of suicidal ideation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mass General Brigham

Boston, Massachusetts, 02114, United States

Location

Study Officials

  • Victoria A Grunberg, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Victoria A Grunberg, PhD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Psychologist

Study Record Dates

First Submitted

January 22, 2026

First Posted

February 3, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

March 31, 2028

Last Updated

February 4, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)