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Completed
NCT06239571
Resilient Families Open Pilot: Dyadic Resiliency Intervention
Conditions: Parents
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 12
Sponsor: Massachusetts General Hospital
Location: Mass General Brigham Boston Massachusetts
Summary
The goal is to develop, refine, and 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, my aims are three-fold: (1) develop R-FAM using stakeholder input from interviews with parent dyads and focus groups with NICU staff; (2) optimize R-FAM through an open pilot with pre/post assessments and exit interviews; and (3) test R-FAM for feasibility and acceptability through a randomized clinical trial of R-FAM compared with a minimally enhanced usual control (MEUC).
Eligibility 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
Source: ClinicalTrials.gov (NCT06239571). StuddyBuddy aggregates publicly available trial information.