Resilient Families Feasibility Trial
ConditionParents
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About 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.
Eligibility criteria
Qualifiers
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 (GAD>=10 or PHQ >= 10)
English fluency/literacy
Disqualifiers
Baby is expected to pass away (as determined by medical team)
Current, untreated psychosis or substance dependence/abuse
Current self-report of suicidal ideation
Trial design
Treatments tested in this trial
- Resilient Families (R-FAM)
- Educational Resources & Program
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Massachusetts General Hospital
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov