Parents
Conditions
Keywords
Neonatal Intensive Care Unit, Parental mental health, Parental relationships
Brief 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).
Detailed description
The investigators aim to conduct an open pilot trial of the R-FAM program (Resilient Families) with NICU parents (up to N = 6 dyads) followed by an optional brief exit interview. The investigators will determine if the feasibility, acceptability, and fidelity of the program meet a priori benchmarks. The investigators also hope to establish preliminary efficacy that the program reduces parental emotional distress and other study outcomes described in sections below. The investigators will use qualitative data to optimize the intervention and study procedures for future trials. This Open Pilot trial will include 6 sessions with a clinical psychologist. The intervention will aim to improve coping skills, communication, and stress management. Participants will learn evidence-based skills (e.g., mindfulness, dialectics, problem-solving) to reduce risk for emotional distress. The primary outcomes for the open pilot will be the feasibility, acceptability, and fidelity of the R-FAM program. Preliminary effectiveness outcomes will also be examined, as in primary and secondary targets and exploratory outcomes (e.g., emotional distress, couple satisfaction, and family impact).
Interventions
BEHAVIORALResilient Families (R-FAM)
Dyadic, resiliency intervention that aims to reduce depression, anxiety, and posttraumatic stress among parents of babies in the NICU
Sponsors
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression | Baseline to end of intervention (6 weeks) | Level of depression endorsed on Hospital Anxiety \& Depression Scale and Edinburgh Postnatal Depression Scale, from 0-30 with 30 indicating highest depression |
| Anxiety | Baseline to end of intervention (6 weeks) | Level of anxiety endorsed on Hospital Anxiety \& Depression Scale, from 0-21 with 21 indicating highest anxiety |
| Posttraumatic Stress | Baseline to end of intervention (6 weeks) | Level of posttraumatic stress endorsed on Impact of Event Scale-6, from 6-24 with 24 indicating highest posttraumatic stress |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Couple relationship functioning | Baseline to end of intervention (6 weeks) | Couple satisfaction as reported on Couple Satisfaction Index, from 0-21 with 21 indicating highest couple satisfaction |
| Family Impact | Baseline to end of intervention (6 weeks) | Impact of child's illness as reported on Family Impact Scale, Revised, from 0-75 with 75 indicating lowest impact on family |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORVictoria Grunberg
Massachusetts General Hospital
Outcome results
None listed