Resilient Families: A Dyadic Resiliency Intervention for Parents of Babies in the NICU
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Depression
研究概览
简要总结
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).
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Baby is expected to pass away (as determined by medical team)
- •Current, untreated psychosis or substance dependence/abuse
- •Current self-report of suicidal ideation
研究组 & 干预措施
Dyadic Resiliency Intervention
All participants will receive the intervention, a brief dyadic resiliency intervention
干预措施: Resilient Families (R-FAM) (Behavioral)
结局指标
主要结局
Depression
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
- Couple relationship functioning(Baseline to end of intervention (6 weeks))
- Family Impact(Baseline to end of intervention (6 weeks))
研究者
Victoria A. Grunberg, PhD
Clinical Psychologist
Massachusetts General Hospital