The Development and Evaluation of a Web-based Childbirth and Parenting Intervention Program: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Parenting self-efficacy
研究概览
简要总结
Background: The transition to parenthood is stressful for first-time mothers and fathers and links to adverse health outcomes. Despite Internet use's popularity, an effective web-based, individually-tailored intervention to enhance parental self-efficacy and infant health for first-time parents remains lacking.
Objectives: This study aims to develop and evaluate the effectiveness of a web-based, individually-tailored childbirth and parenting intervention program on parenting self-efficacy and infant health outcomes. The feasibility and acceptability of a theory-driven intervention will be examined in first-time mothers and fathers.
Methods: A two-arm, single-blind randomized controlled trial will be conducted to investigate the effects of web-based intervention in the first-time mother and father. Participants will be randomly allocated to a web-based intervention or a control condition. A repeated measurement will be performed.
Anticipatory results: The efficacy of a theory-driven web-based, individually tailored intervention program will provide a valuable contribution to perinatal health care for first-time mothers and fathers.
详细描述
The primary outcome of parenting self-efficacy and breastfeeding self-efficacy. The secondary outcomes of anxiety, depression, sleep quality, social support, infant health outcomes will be assessed. Data will be analyzed with the intention-to-treat analysis using linear mixed-effects modeling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for this study are first-time mothers and fathers who are
- •20 years old and above;
- •primipara with a singleton pregnancy at second and third-trimester gestation;
- •able to read and write in Mandarin;
- •the husband or support partner will be willing to attend the intervention program;
- •able to access and use the Internet by computer and/or smartphone daily.
排除标准
- •are the first-time mothers and fathers who have
- •chronic diseases;
- •obstetric complications;
- •an abnormal fetal screening;
- •unable or unwilling to comply with the requirements of the research protocol;
- •women and their partners did not have time for the web-based intervention program;
- •participation on any other interventional study.
研究组 & 干预措施
Web-based intervention
Participants in the intervention will receive both the standardized usual care and guided web-based, individually-tailored childbirth and parenting intervention program, consisting of training sessions plus weekly email, message, or video-conference contact from their assigned nurse specialist.
干预措施: Web-based intervention (Behavioral)
Control
Participants in the control group will receive attention from the research nurse and the standardized usual care.
结局指标
主要结局
Parenting self-efficacy
时间窗: 3-month postpartum
Parenting self-efficacy will be measured and reported by Parenting Self-Efficacy Scale. The higher the total scores indicate greater perceived parental self-efficacy.
Breastfeeding self-efficacy
时间窗: 3-month postpartum
Breastfeeding self-efficacy was measured using the Taiwanese version of the Maternal Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) and Breastfeeding self-efficacy Scale-Short Form among fathers (BSES-SFF). Total scores range from 14 to 70, with higher scores representing a higher level of self-efficacy.
Parenting self-efficacy
时间窗: Baseline
Parenting self-efficacy will be measured and reported by Parenting Self-Efficacy Scale. The higher the total scores indicate greater perceived parental self-efficacy.
Breastfeeding self-efficacy
时间窗: Baseline
Breastfeeding self-efficacy was measured using the Taiwanese version of the Maternal Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) and Breastfeeding self-efficacy Scale-Short Form among fathers (BSES-SFF). Total scores range from 14 to 70, with higher scores representing a higher level of self-efficacy.
Parenting self-efficacy
时间窗: the third trimester of pregnancy
Parenting self-efficacy will be measured and reported by Parenting Self-Efficacy Scale. The higher the total scores indicate greater perceived parental self-efficacy.
Breastfeeding self-efficacy
时间窗: the third trimester of pregnancy
Breastfeeding self-efficacy was measured using the Taiwanese version of the Maternal Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) and Breastfeeding self-efficacy Scale-Short Form among fathers (BSES-SFF). Total scores range from 14 to 70, with higher scores representing a higher level of self-efficacy.
Parenting self-efficacy
时间窗: 1-month postpartum
Parenting self-efficacy will be measured and reported by Parenting Self-Efficacy Scale. The higher the total scores indicate greater perceived parental self-efficacy.
Breastfeeding self-efficacy
时间窗: 1-month postpartum
Breastfeeding self-efficacy was measured using the Taiwanese version of the Maternal Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) and Breastfeeding self-efficacy Scale-Short Form among fathers (BSES-SFF). Total scores range from 14 to 70, with higher scores representing a higher level of self-efficacy.
次要结局
- Feasibility measured using a structured questionnaire(immediately after intervention)
- Social support(Baseline, the third trimester of pregnancy,1-month postpartum and 3-month postpartum)
- Infant feeding methods(Baseline, the third trimester of pregnancy,1-month postpartum and 3-month postpartum)
- Depressive symptoms(Baseline, the third trimester of pregnancy,1-month postpartum and 3-month postpartum)
- Anxiety symptoms(Baseline, the third trimester of pregnancy,1-month postpartum and 3-month postpartum)
- Sleep quality(Baseline, the third trimester of pregnancy,1-month postpartum and 3-month postpartum)
- Infant sleep quality(1-month postpartum and 3-month postpartum)
- Infant development(3-month postpartum)
- Satisfaction measured using a structured questionnaire(immediately after intervention)
研究者
Shu Yu Kuo
Principal investigator
Taipei Medical University