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临床试验/NCT01385254
NCT01385254已完成不适用

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

Duke University2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2010年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
300
试验地点
2
主要终点
Differences in level of maternal worry in mothers of very low birthweight (VLBW) infants compared to mothers of full-term infants

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
— 至 4 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 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.

结局指标

主要结局

Differences in level of maternal worry in mothers of very low birthweight (VLBW) infants compared to mothers of full-term infants

时间窗: 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.

Differences in mother-sibling interaction between two groups

时间窗: 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.

Differences in internalizing and externalizing behaviors between two groups

时间窗: 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.

次要结局

  • Effects of maternal worry, anxiety, depression and Post-Traumatic Stress Disorder (PTSD) on two groups(one month and six months)
  • Change in mother-sibling interactions between groups(one month and six months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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