跳至主要内容
临床试验/NCT06488196
NCT06488196已完成不适用

Feasibility, Acceptability, and Fidelity of Motivational Interviewing Targeting Ethnically-, Linguistically-, and Racially-diverse Mothers' Neonatal Intensive Care Unit (NICU) Bedside Presence

Johns Hopkins All Children's Hospital2 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2018年11月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
95
试验地点
2
主要终点
Feasibility, as assessed by >75% of MI-randomized mothers receiving at least one MI session

研究概览

简要总结

Maternal presence in the NICU during an infant's hospitalization is critical for the infant's medical recovery and overall neurodevelopmental trajectory. However, despite the importance of maternal presence in these settings, the current literature shows that families are often absent at bedside. To date, no behavioral interventions have been conducted to promote increased maternal visitation patterns in NICU settings. This project will aim to fill this gap in the literature by conducting a pilot study that uses a motivational interviewing intervention with the aim of increasing maternal visitation rates to a level IV NICU.

详细描述

This study will be conducted as a randomized controlled pilot trial of a motivational interviewing intervention. Mothers will be contacted for enrollment in the study within the first 48-72 hours of the infant's NICU admission. Contact with the mother will occur in-person within those first 48-72 hours of admission. If mother is unavailable in person within the first 72 hours, a telephone call will be made to her. Should the mother agree to participate in the study, written consent will be obtained if the meeting is taking place in person. If the first contact takes place via telephone, then verbal consent alone will be obtained at that time followed by written consent during the first in-person meeting with mother (see below for detailed consent procedures). Once enrolled, the mother will be assigned to one of two study arms - the treatment group or the treatment-as-usual (comparison) group. Mothers will not be provided with information about study arm assignment.

Cluster randomization: Group assignment will be determined by location of the infant in the NICU. The comparison group will be assigned to the North side of the unit while the treatment group will be assigned to the South side of the unit. Assignment to each side of the unit (i.e., North or South) is routinely determined based on census capacity/availability and not based on other factors that may inhibit the randomization process.

Both study groups will receive 6 sessions with the experimental group receiving motivation interviewing (MI) and the control group receiving support as usual. Additional supportive interventions will continue as needed and determined by the clinical needs and consistent with current treatment as usual (TAU). All families will also complete a discharge study visit within 7 days of NICU discharge; hence, participants will receive a total of at least 7 study visits throughout infant's hospitalization. The goal of the first session will be to establish rapport and obtain information about the sources of stress and distress to target in later sessions. Weekly follow-up visits with all families will continue utilization of supportive and problem-solving approaches to manage stressors identified in the initial session. If mothers cannot be reached in person for projected visits at various time points, attempts will be made to connect with mothers via telephone irrespective of study assignment.

More specifically, the first consultation will consist of a semi-structured clinical interview that will assess the following general topics: (1) family-reported psychosocial factors related to the perinatal period (i.e., antepartum, labor/delivery, postpartum, NICU hospitalization, possible NICU discharge periods); (2) perceptions of the caregiver-infant relationship; (3) family psychosocial stressors; (4) family adjustment to the NICU setting; (5) family self-report of coping; (6) family self-report of barriers to visiting the NICU.

All sessions will be audio-recorded in the treatment arm of the study while a portion of the sessions will be recorded in the comparison group (see data analysis section). All audiotaped sessions will be reviewed for fidelity to motivational interviewing treatment protocol by an MI-certified trainer for English sessions while the Spanish sessions will be reviewed by a doctoral-level graduate student with training in MI and under the supervision of the certified trainer reviewer.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • English- or Spanish-speaking mothers >18 years-old with a NICU-hospitalized infant

排除标准

  • Suicidality, cognitive disability preclude consent/participation, or psychotic/manic symptoms

结局指标

主要结局

Feasibility, as assessed by >75% of MI-randomized mothers receiving at least one MI session

时间窗: 3 years

Feasibility as assessed by \>75% of MI-randomized mothers receiving \> one MI session

次要结局

  • Acceptability as assessed by the number of mothers' open to completing additional MI session/s(3 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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