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临床试验/NCT07383948
NCT07383948
尚未招募
不适用

Enhancing Parental Well-being in the NICU

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年3月1日最近更新:

概览

阶段
不适用
状态
尚未招募
入组人数
50
试验地点
1
主要终点
Anxiety

概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

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 (GAD\>=10 or PHQ \>= 10)
  • 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

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.

干预措施: Resilient Families (R-FAM) (Other)

Educational Program

Active Comparator

Participants will receive educational resources about adjusting to the NICU and coping with their stay.

干预措施: Educational Resources & Program (Other)

结局指标

主要结局

Anxiety

时间窗: Time Frame: Baseline to end of intervention (6 weeks)

Level of anxiety endorsed on Hospital Anxiety \& Depression Scale, from 0-21 with 21 indicating highest anxiety

Depression

时间窗: Time Frame: Baseline to end of intervention (6 weeks)

Level of depression endorsed on Hospital Anxiety \& Depression Scale, from 0-21, with 21 indicating highest depression.

Posttraumatic Stress

时间窗: Time Frame: 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(Time Frame: Baseline to end of intervention (6 weeks))
  • Family Impact(Baseline to end of intervention (6 weeks)])

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Victoria A. Grunberg, PhD

Clinical Psychologist

Massachusetts General Hospital

研究点 (1)

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