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Mother Sibling Interactions Following Very Low Birth Weight (VLBW) Infant Homecoming

2013年12月10日 更新者:Duke University
The proposed study will explore longitudinally the impact of a very low birthweight (VLBW) infant on mother-sibling interactions and sibling adjustment. The study will also include a comparison group of fullterm infants to determine which sibling adjustment problems are typical of having a new baby in the home and which are associated with the unique stress of having a VLBW infant. This study will be the initial step in identifying factors affecting the adjustment of siblings of VLBW infants.

研究概览

地位

完全的

详细说明

The proposed 2-year study will use a longitudinal, comparative, mixed method design to explore the impact of a Very Low Birth Weight (VLBW) (≤33 weeks gestational age) infant on mother-sibling interactions and sibling adjustment. A comparison group of full term infants (≥38 weeks gestational age) will be included to elucidate sibling adjustment problems that are typical to having a new baby in the home and sibling adjustment problems that are associated with the unique stress of having to care for a VLBW infant. Participants will be fifty mothers and siblings of VLBW infants and fifty mothers and siblings of full term infants. Data collection will take place within one week of infant discharge from the hospital (enrollment), and at 1 month and 6 months post infant discharge using self-report measures, qualitative interviews, and mother-sibling interaction observation. Variables of interest include mother's worry, anxiety, depression, and post-traumatic stress; mother-sibling interactions including uninvolvement, positive affect, negative affect, talk, looking and playing; internalizing and externalizing behaviors, sleep/somatic problems, and growth in siblings of VLBW and in siblings of the comparison group with full term infants. Mixed modeling and Ordinary Least Squares (OLS) regression modeling will be conducted to identify factors that make siblings vulnerable to psychological and emotional adjustment problems in response to having a VLBW infant in the home. There are no anticipated risks for the infant participants of the study aside from the small risk of violating confidentiality of infant participants and their mothers. No risks for siblings are anticipated aside from the small risk of violating confidentiality.

研究类型

观察性的

注册 (实际的)

300

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • North Carolina
      • Durham、North Carolina、美国、27710
        • Duke University Medical Center
      • Raleigh、North Carolina、美国、27610
        • Wake Medical Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

不超过 4年 (孩子)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Mothers who give birth at Duke University Medical Center, Durham Regional Hospital, or Wake Medical Center, and their siblings.

描述

Inclusion Criteria for siblings:

  • Siblings of very low birth weight or healthy, full-term infants
  • age 4 years old or younger
  • siblings and infants must live with the mother

Inclusion Criteria for mothers:

  • no previous or current diagnosis of major psychological disorder (including bipolar disorder, psychosis, or active substance abuse)
  • age 18 years or older
  • English speaking,
  • living within 1 hour's travel distance from Duke University, for feasibility.
  • Mothers at-risk for preterm birth who meet all other eligibility criteria

Exclusion Criteria:

Mother/sibling pairs of infants who:

  • have congenital neurological problems (congenital hydrocephalus or microcephaly),
  • are symptomatic from substance exposure,
  • are hospitalized longer than 1 month after term, or
  • are technology dependent.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
siblings and mothers of Very Low Birth Weight infants
50 older siblings (closest in age) and mothers of very low birthweight (VLBW) infants, born at <33 weeks gestation and <1500 grams at birth
siblings and mothers of healthy infants
50 siblings (closest in age) and mothers of healthy, full-term infants (between 38-42 weeks gestation and lacking medical conditions that require a hospital stay past the mother's discharge date)

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Differences in level of maternal worry in mothers of very low birthweight (VLBW) infants compared to mothers of full-term infants
大体时间:baseline, one month, six months
Explore how the trajectories of maternal worry about the infant and sibling, anxiety, depression, post traumatic stress, concerns for and expectations of the sibling, and perceptions of sibling growth over the 6-month post discharge period differ between mothers of VLBW infants and mothers of fullterms.
baseline, one month, six months
Differences in mother-sibling interaction between two groups
大体时间:one month and six months
Explore differences in mother-sibling interactions, including involvement, positive/negative affect, talking, looking and playing, at 1 and 6 months after infant discharge between the two groups of siblings and mothers, using a coding schema to score videotaped interactions.
one month and six months
Differences in internalizing and externalizing behaviors between two groups
大体时间:one month and six months
Explore differences in internalizing and externalizing behaviors, vulnerability, and sleep/somatic problems at 6-months post-infant discharge between siblings of VLBW infants and siblings of fullterms, using a coding schema to score videotaped interactions.
one month and six months

次要结果测量

结果测量
措施说明
大体时间
Effects of maternal worry, anxiety, depression and Post-Traumatic Stress Disorder (PTSD) on two groups
大体时间:one month and six months
Examine the effects of maternal worry, anxiety, depression, and post traumatic stress on group differences in mother-sibling interactions at 1 and 6 months after infant discharge.
one month and six months
Change in mother-sibling interactions between groups
大体时间:one month and six months
Examine the effects of changes in mother-sibling interactions from 1 to 6 months after infant discharge on group differences in siblings' internalizing and externalizing behaviors, vulnerability, and sleep/somatic problems.
one month and six months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Julie A Thompson, PhD、Duke University School of Nursing

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2010年1月1日

初级完成 (实际的)

2012年5月1日

研究完成 (实际的)

2012年10月1日

研究注册日期

首次提交

2011年1月20日

首先提交符合 QC 标准的

2011年6月28日

首次发布 (估计)

2011年6月30日

研究记录更新

最后更新发布 (估计)

2013年12月11日

上次提交的符合 QC 标准的更新

2013年12月10日

最后验证

2013年12月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • Pro00019788
  • 1R03NR011196-01A1 (美国 NIH 拨款/合同)

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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