Resilient Families Feasibility Trial
ConditionParents
Trial statusRecruiting
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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Resilient Families (R-FAM)
Other interventionR-FAM is a resiliency intervention for couples with an infant admitted to the NICU. Parents will complete 6 guided sessions with a clinical psychologist that cover topics such as managing stress, staying in the present, and coping with uncertainty. Through these sessions, parents will learn skills to manage the "emotional roller-coaster" of the NICU, cope with stress, and connect with each other.
Educational Resources & Program
Other interventionParents will receive educational resources on how to cope with and adjust to the NICU stay.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: R-FAM InterventionOther 1 intervention
Group B: Educational ProgramActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Anxiety
Level of anxiety endorsed on Hospital Anxiety \& Depression Scale, from 0-21 with 21 indicating highest anxiety
Time frame
Time Frame: Baseline to end of intervention (6 weeks)2
Depression
Level of depression endorsed on Hospital Anxiety \& Depression Scale, from 0-21, with 21 indicating highest depression.
Time frame
Time Frame: Baseline to end of intervention (6 weeks)3
Posttraumatic Stress
Level of posttraumatic stress endorsed on Impact of Event Scale-6, from 6-24 with 24 indicating highest posttraumatic stress
Time frame
Time Frame: Baseline to end of intervention (6 weeks)Secondary outcomes
1
Couple relationship functioning
Couple satisfaction as reported on Couple Satisfaction Index, from 0-21 with 21 indicating highest couple satisfaction
Time frame
Time Frame: Baseline to end of intervention (6 weeks)2
Family Impact
Impact of child's illness as reported on Family Impact Scale, Revised, from 0-75 with 75 indicating lowest impact on family
Time frame
Baseline to end of intervention (6 weeks)]Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov