Improving Outcomes of LBW Premature Infants and Parents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 260
- 试验地点
- 4
- 主要终点
- Measures of emotional coping (mother/father/SO): State Anxiety Inventory: Phase I through VII Interventions and Observations (with exception of Phase II Observation)
研究概览
简要总结
The purpose of this study is to determine whether beginning an enriched educational/behavioral program for parents of premature infants, very early in the Neonatal Intensive Care Unit (NICU) stay, and lasting until the child is 3 years old, has beneficial results for both the parents and their infants.
The hospital phase of the program gives parents an understanding of what to expect in the NICU environment; physical characteristics and needs of their premature baby; and how and when to best support their infant's development during this time. The information given during the home phase of the program continues with information specific to the growth and development and the effective parenting of an infant/toddler who has been born prematurely.
It is believed that this information will help decrease parents' stress, anxiety and depression levels that can be related to giving birth to a premature infant. It is also expected that it will strengthen the mother's and father's ability to parent their premature child in a way that will help support their child's brain development and learning ability and to also decrease negative behaviors as the child grows.
详细描述
The incidence of premature and low birthweight (LBW) births continues to climb in the U.S. despite increased efforts to prevent it. Interventions to enhance coping in parents of infants in an attempt to improve both parent and child outcomes have not kept pace with the rapid technological advances to sustain survival for these medically compromised infants. Consequently, there is an urgent need to develop and evaluate coping interventions for parents of LBW premature infants in order to facilitate effective clinical practice strategies that are empirically based.
The primary objective for this study is to evaluate the short- and long-term effects of a theoretically-driven intervention program (COPE: Creating Opportunities for Parent Empowerment) on the process and outcomes of mothers and fathers/significant others' (SOs) coping with a LBW premature infant and infant developmental outcomes. The secondary objectives are to:
- Explore how the coping process and outcomes of mothers and fathers/significant others together contribute to the outcomes of LBW premature infants;
- Determine the cost-effectiveness of the COPE program; and
- Explore what factors moderate the effects of the intervention (e.g., family structure, SES, birthweight, disability, and infant temperament).
In this randomized clinical trial, the investigators are testing the following hypotheses separately for mothers and for fathers/significant others:
- Mothers/fathers who receive the COPE program will report less anxiety, depression, and stress related to the NICU environment than mothers/fathers who receive the comparison program;
- Mothers/fathers who receive the COPE program will demonstrate a higher quality of parenting during hospitalization than mothers/fathers who receive the comparison program;
- Mothers/fathers who receive the COPE program will report less anxiety and depression following hospitalization than mothers/fathers who receive the comparison program;
- Mothers/fathers who receive the COPE program will perceive their children as less vulnerable than mothers/fathers who receive the comparison program;
- Fathers who receive the COPE program will report greater involvement in their infants' lives (average time spent with infant per week) than fathers who receive the comparison program;
- Infants of mothers/fathers who receive the COPE program will have greater cognitive development than infants of mothers/fathers in the comparison program;
- Children of mothers/fathers in the COPE program will have less negative behaviors at 2 years corrected age than children of mothers/fathers in the comparison program;
- The proposed model to explain the effects of the COPE program on the process and outcomes of parental coping and infant outcomes will be supported for mothers and for fathers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age of 26 to 34 weeks inclusive
- •Birthweight of less than 2500 grams
- •Singleton birth
- •Anticipated survival
- •Not small for gestational age
- •No severe handicapping conditions
- •No Grade III or IV intraventricular hemorrhage
- •Speaks and reads English
排除标准
- •Parent/infant has positive drug testing
- •Live outside of a 60 mile radius
- •Had previous infants in a NICU
- •Significant mental health history
结局指标
主要结局
Measures of emotional coping (mother/father/SO): State Anxiety Inventory: Phase I through VII Interventions and Observations (with exception of Phase II Observation)
Beck Depression Inventory II: Phase I through VII Interventions and Observations (with exception of Phase II Observation)
Parental stress related to NICU: Phase II (Intervention), Post hospital stress: Phase V, VI and VII (Intervention)
Infant/child outcomes: Infant cognitive development assessment: 6, 12, 24 months corrected age (Observation), Child behavior questionnaire: Phase VII (Observation)
Functional coping (mother/father/SO): Quality of parenting in the NICU: Phase II (Observation)
Quality of parenting at home: Phase VI (Observation), Parental problem solving: Phase V (Intervention and Observation)
Perception of child vulnerability: Phase VI and VII (Observation)
Parental/SO beliefs (Proposed Mediator): Parental Beliefs Scale questionnaire: Phase II and III (Intervention)
次要结局
- Infant temperament (Proposed Moderator): Infant Temperament Questionnaires: Phase V, VI, VII (Intervention)
- Cost outcomes (direct and indirect health care costs): Resource Utilization Questionnaire: 6, 12, 24 months corrected age (Observations)