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?

This trial aims to help parents manage the stress and uncertainty of having a baby in the Neonatal Intensive Care Unit (NICU). It tests a program called Resilient Families (R-FAM), which includes six sessions with a clinician to support parents' emotional well-being and strengthen their relationships. Participants will be randomly assigned to either the R-FAM program or receive educational resources about coping in the NICU. This trial suits parents who have a baby in the NICU, are experiencing emotional distress, and are willing to participate in online sessions. As an unphased trial, it offers parents the opportunity to access potentially beneficial support strategies tailored to their unique challenges.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Resilient Families intervention is safe for parents in the NICU?

Studies have shown that the Resilient Families (R-FAM) program, which aids parents in the Neonatal Intensive Care Unit (NICU) in building resilience, is generally well-received in community settings. Although specific safety data from clinical trials is unavailable, similar family-focused programs have demonstrated positive outcomes. These programs aim to help parents manage stress and improve family relationships. This trial is labeled "not applicable" for traditional clinical phases, indicating a focus on program acceptance rather than safety concerns typical of drug trials. Overall, R-FAM is designed to provide emotional support to parents, suggesting it is a low-risk intervention.12345

Why are researchers excited about this trial?

Researchers are excited about the Resilient Families (R-FAM) program because it offers a new way to support parents dealing with the stress and uncertainty of having a baby in the NICU. Unlike standard educational programs that simply provide information, R-FAM is a resiliency-based intervention involving six clinician-led sessions designed to actively help couples cope with their situation. This personalized approach focuses on building emotional strength and adaptive coping strategies, potentially offering more substantial support than traditional resources. By addressing the emotional and psychological aspects of the NICU experience, R-FAM aims to improve overall family well-being, making it a promising alternative to existing options.

What evidence suggests that the Resilient Families intervention is effective for reducing emotional distress in NICU parents?

Research shows that the Resilient Families (R-FAM) program, which participants in this trial may receive, helps families enhance their well-being and relationships, especially during stressful times, such as when a child is in the Neonatal Intensive Care Unit (NICU). Studies suggest that focusing on family resilience can lead to better communication and stronger family bonds. Participants in similar programs have reported feeling less emotional distress and more preparedness to handle challenges. Additionally, positive parenting programs like R-FAM have successfully helped families identify and manage stress. These findings support R-FAM's potential effectiveness in reducing stress and improving relationships for parents in the NICU.12678

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+

Citations

Study Details | NCT07383948 | Resilient Families

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Research has shown that the Resilient Families (R-FAM) program aims to help families enhance their well-being and relationships, particularly under stress.

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