Resilient Families Feasibility Trial

Официальное название

Enhancing Parental Well-being in the NICU

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Resilient Families (R-FAM)
  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.
• Другое Educational Resources & Program
  Parents will receive educational resources on how to cope with and adjust to the NICU stay.

Первичные конечные точки

• Anxiety [Срок оценки: Time Frame: Baseline to end of intervention (6 weeks)]
• Depression [Срок оценки: Time Frame: Baseline to end of intervention (6 weeks)]
• Posttraumatic Stress [Срок оценки: Time Frame: Baseline to end of intervention (6 weeks)]

Вторичные конечные точки (2)

• Couple relationship functioning [Срок оценки: Time Frame: Baseline to end of intervention (6 weeks)]
• Family Impact [Срок оценки: Baseline to end of intervention (6 weeks)]]

Критерии участия

Критерии включения

• 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
• Ability and willingness to participate via live video

Критерии исключения

• Baby is expected to pass away (as determined by medical team)
• Current, untreated psychosis or substance dependence/abuse
• Current self-report of suicidal ideation

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Mass General Brigham — Boston

Идентификаторы

NCT: NCT07383948 · 2025P003422 · 5K23HD110597-03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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