Resilient Families for Parenting Challenges

(R-FAM Trial)

VA
Overseen ByVictoria A Grunberg, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Massachusetts General Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this 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.

Who Is on the Research Team?

VA

Victoria A Grunberg, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for adult parents or legal guardians (and their partners) of babies recently admitted to the NICU. Participants must be over 18, fluent in English, willing to join live video sessions, in an intimate relationship and planning to live with the baby post-NICU. At least one partner should show signs of emotional distress.

Inclusion Criteria

I am an adult parent or guardian of a baby in the NICU.
I can speak and read English fluently.
I can and am willing to join live video sessions.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the R-FAM intervention or an educational program over 6 weeks

6 weeks
6 sessions with a clinician

Follow-up

Participants are monitored for changes in anxiety, depression, PTSD symptoms, and couple relationship functioning

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Resilient Families (R-FAM)

Trial Overview

The study tests 'Resilient Families' (R-FAM), a program designed to ease emotional distress and strengthen relationships among NICU parents. Participants are randomly assigned either R-FAM or basic mental health resources and coping strategies for comparison.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: R-FAM InterventionExperimental Treatment1 Intervention
Group II: Educational ProgramActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

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

Collaborator

Trials
2,103
Recruited
2,760,000+