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| ID | Type | Description | Link |
|---|---|---|---|
| 5K23HD110597-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
The investigators aim to conduct a pilot feasibility randomized clinical trial (RCT) of R-FAM (Resilient Families) with NICU parents (up to N = 70 dyads) followed by a 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 and data from the R-FAM open pilot to optimize the intervention and study procedures for future trials.
The investigators will conduct a single-blinded randomized clinical trial comparing the feasibility and acceptability of Resilient Families (R-FAM)-a resiliency intervention-with a one session educational program (minimally enhanced usual control) for parental couples ("dyads") of babies in the NICU. The investigators will also explore preliminary changes in outcomes and mechanisms to inform future trials. See Figure 1 for iterative development of R-FAM (the study is in years 3 and 4).
After enrollment, participants will be randomized to either the "Resilient Families" intervention or to the educational program (control). Dyads will be randomly assigned in a 1:1 ratio to intervention or control to ensure comparability between groups. The randomization schedule will be prepared using permuted blocks of size 2 and 4 by the unblinded study statistician and implemented in REDCap. All subjects will be given baseline psychological and behavioral assessments that will assess depression, anxiety, PTSD symptoms, and other psychological constructs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| R-FAM Intervention | Other | A resiliency based intervention that includes 6-sessions with a clinician to help couples cope with the uncertainty and stress of the NICU admission. |
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| Educational Program | Active Comparator | Participants will receive educational resources about adjusting to the NICU and coping with their stay. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resilient Families (R-FAM) | Other | R-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. |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety | Level of anxiety endorsed on Hospital Anxiety & Depression Scale, from 0-21 with 21 indicating highest anxiety | Time Frame: Baseline to end of intervention (6 weeks) |
| Depression | Level of depression endorsed on Hospital Anxiety & Depression Scale, from 0-21, with 21 indicating highest depression. | Time Frame: Baseline to end of intervention (6 weeks) |
| Posttraumatic Stress | Level of posttraumatic stress endorsed on Impact of Event Scale-6, from 6-24 with 24 indicating highest posttraumatic stress | Time Frame: Baseline to end of intervention (6 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Couple relationship functioning | Couple satisfaction as reported on Couple Satisfaction Index, from 0-21 with 21 indicating highest couple satisfaction | Time Frame: Baseline to end of intervention (6 weeks) |
| Family Impact |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Victoria A Grunberg, PhD | Contact | 617-643-4133 | vgrunberg@mgh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Victoria A Grunberg, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mass General Brigham | Boston | Massachusetts | 02114 | United States |
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| Educational Resources & Program | Other | Parents will receive educational resources on how to cope with and adjust to the NICU stay. |
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Impact of child's illness as reported on Family Impact Scale, Revised, from 0-75 with 75 indicating lowest impact on family
| Baseline to end of intervention (6 weeks)] |