Early Behavioral and Transaction Interventions on Preterm Infants' and Parents' Biopsychosocial Well-being
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- Parent stress
研究概览
简要总结
This randomized controlled trial will use a longitudinal repeated-measures design to examine the effects of two interventions, behavioral support interventions and a parent-infant transactional program, on parents' stress, PPD and sleep quality, parent-infant interactions, and their preterm infants' stress (saliva cortisol levels), sleep patterns, emotional regulation, and neurobehavioral developmental outcomes from 7 days to 2 years corrected age.
详细描述
The proposed study has five specific aims:
- to develop behavioral-support interventions for preterm infants who receive painful, stressful procedures in the NICU,
- to develop a parent-infant transactional program (PITP) for parent-infant dyads with preterm infants in the NICU,
- to determine the short-term effects of the behavioral-support interventions and PITP on infant stress (salivary cortisol levels) and sleep patterns,
- to determine the short-term effects of the PITP on parental stress, depression, social support, and sleep quality during postpartum, and
- to determine the long-term effects of the behavioral-support interventions and PITP on parent-infant interactions and infants' long-term emotional regulation and neurobehavioral outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 28 Weeks 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Gestational age (GA) > 28 weeks and < 37 weeks
- •Postbirth age >2 days
- •Stable condition (score<20 on the Neonatal Therapeutic Intervention Scoring System [NTISS] for disease severity).
- •Parents are not diagnosed with mental illness or some other illness known to influence/confound the outcome variables
- •Parents are fluent in Chinese
- •Parents do not use drugs
- •Parents agree to participate in this study
排除标准
- •Congenital anomalies
- •Neurologic impairment including convulsion, intraventricular hemorrhage > grade II or periventricular leukomalacia
- •Documented congenital or nosocomial (infection acquired at hospital after birth) sepsis
- •Severe medical conditions requiring treatments such as cortisol supplementation, sedatives, muscle relaxants, antiepileptic, or analgesic drugs
结局指标
主要结局
Parent stress
时间窗: 7days to 12 months
Accessed by Parenting Stress Index-Short form (PSI-SF)
Parent depression
时间窗: 7days to 12 months
Accessed by the Edinburgh Postnatal Depression Scale (EPDS)
Parent sleep
时间窗: 7days to 12 months
Accessed by Pittsburgh Sleep Quality Index
Parent social support
时间窗: 7days to 12 months
Accessed by the Social Support Rating Scale (SSRS)
次要结局
- Preterm infant's stress(up to 3 months)
- Parent-infant interaction(1 month to 6 months)
- Preterm infant's sleep(up to 3 months)
研究者
Hsiang-Yun Lan
Investigator, National Defense Medical Center, Taiwan
National Defense Medical Center, Taiwan