Intervention for parents in the NICU to improve mental health and relationships
Resilient Families: A Dyadic Resiliency Intervention for Parents of Babies in the NICU
This study is testing a new program to help parents of babies in the NICU feel better emotionally and strengthen their relationships.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06239571 on ClinicalTrials.gov |
What this trial studies
This intervention aims to develop and test a program called Resilient Families (R-FAM) designed to reduce emotional distress and enhance relationships among parents of infants in the Neonatal Intensive Care Unit (NICU). The approach involves gathering input from parents and NICU staff to refine the intervention, followed by an open pilot study to assess its feasibility. Ultimately, a randomized clinical trial will compare the effectiveness of R-FAM against a minimally enhanced usual control to evaluate its acceptability and impact on parental mental health.
Who should consider this trial
Good fit: Ideal candidates include adult parents or legal guardians of infants admitted to the NICU within the past week who are experiencing emotional distress.
Not a fit: Patients whose infants are expected to pass away or those with untreated psychosis or substance dependence may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the emotional well-being and relationship dynamics of parents facing the challenges of having a baby in the NICU.
How similar studies have performed: While this specific intervention is novel, similar approaches targeting parental mental health in high-stress environments have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 (HADS \>7 on depression or anxiety subscale) * English fluency/literacy * Ability and willingness to participate via live video Exclusion Criteria: * Baby is expected to pass away (as determined by medical team) * Current, untreated psychosis or substance dependence/abuse * Current self-report of suicidal ideation
Where this trial is running
Boston, Massachusetts
- Mass General Brigham — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Grunberg, PhD
- Email: vgrunberg@mgh.harvard.edu
- Phone: 617-643-4133
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.