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临床试验/NCT03668912
NCT03668912已完成不适用

Feasibility of a Guided Participation Discharge Program for Very Preterm Infants

Chinese University of Hong Kong0 个研究点目标入组 30 人开始时间: 2016年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
主要终点
Parents' change in score of Parenting Sense of Competence Scale from baseline to up to 8 weeks

研究概览

简要总结

This study aimed at investigating the feasibility of a new guided participation (GP) discharge program for parents of very preterm infants. A randomized controlled trial was conducted in a neonatal intensive care unit. The intervention included three structured GP sessions and one follow-up phone call. The control group received usual care. Outcomes measured included parents' efficacy and satisfaction with parenting, and perceived stress. Data collection was conducted at baseline, on day of discharge, after the follow-up phone call, and 1 month after discharge. The outcomes were analyzed on the basis of intention-to-treat principles.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
— 至 32 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • A gestational age of ≤32 weeks at birth

排除标准

  • Have congenital malformation(s)
  • Need to undergo a major surgery
  • For Parents:
  • Inclusion Criteria:
  • Must be the infant's primary caregiver
  • Inclusion Criteria:
  • Diagnosed with a mental illness

研究组 & 干预措施

Guided participation group

Experimental

干预措施: Guided participation discharge programme (Behavioral)

Usual care group

No Intervention

结局指标

主要结局

Parents' change in score of Parenting Sense of Competence Scale from baseline to up to 8 weeks

时间窗: Baseline, and at 3-, 4-, and 8-weeks after baseline

The Chinese version of the Parenting Sense of Competence Scale is a self-reported instrument which includes 17 items in two subscales (efficacy and satisfaction). Each item is rated on a 6- point Likert scale ('Strongly disagree' = 1; 'Strongly agree' = 6). Nine items (items 2, 3, 4, 5, 8, 9, 12, 14 and 16) were reverse-coded. The total scores ranged from 17 to 102. A higher score indicates a higher sense of competence and satisfaction with parenting by parents.

次要结局

  • Parents' change in score of Perceived Stress Scale from baseline to up to 8 weeks(Baseline, and at 3-, 4-, and 8-weeks after baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lee Suk Yin

Principal Investigator

Chinese University of Hong Kong

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