Resilient Families for Parenting Challenges
(R-FAM Trial)
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?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either the R-FAM intervention or an educational program over 6 weeks
Follow-up
Participants are monitored for changes in anxiety, depression, PTSD symptoms, and couple relationship functioning
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
A resiliency based intervention that includes 6-sessions with a clinician to help couples cope with the uncertainty and stress of the NICU admission.
Participants will receive educational resources about adjusting to the NICU and coping with their stay.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Citations
Study Details | NCT07383948 | Resilient Families
The goal of this study is to test the feasibility and acceptability of a dyadic, resiliency intervention ("Resilient Families;" R-FAM) that aims ...
Resilient Families Open Pilot: Dyadic Resiliency Intervention
The goal is to develop, refine, and test the feasibility and acceptability of a dyadic, resiliency intervention ("Resilient Families;" R-FAM) that aims to ...
Resilient Families Program for Parenting (R-FAM Trial)
Research has shown that the Resilient Families (R-FAM) program aims to help families enhance their well-being and relationships, particularly under stress.
Family Resilience as an Emerging Concept in Neonatology
Family resilience can be observed through specific resilience-promoting processes, namely, shared belief systems, communication, and organizational processes, ...
5.
news.asu.edu
news.asu.edu/20240208-university-news-asu-reach-center-resilient-families-hosts-event-promote-family-resilienceASU REACH Institute, Center for Resilient Families host event ...
' We have seen success with positive parenting interventions helping families identify triggers resulting from the adversity they experience ...
Building resilient families: Developing family interventions for ...
This study will guide the development of Our Family Our Future, a resilience-focused family intervention to prevent adolescent depression.
Study Details | NCT05388864 | Building Resilient Families
The study will evaluate the following: 1) the association between Child-ACE scores and biomarkers of toxic stress at baseline in children age 3-11 years old; 2) ...
Family Resilience And Connection Promote Flourishing ...
This study used 2016 and 2017 NSCH data for US children ages 6–17 to address four objectives: establish the construct validity of a three-item child flourishing ...
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