The Development and Evaluation of a Web-based Childbirth and Parenting Intervention Program

Официальное название

The Development and Evaluation of a Web-based Childbirth and Parenting Intervention Program: A Randomized Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Web-based intervention
  The web-based intervention participants will follow the website's orientation, the curriculum of modules, and professional feedback to complete the intervention.

Первичные конечные точки

• Parenting self-efficacy [Срок оценки: Baseline]
• Breastfeeding self-efficacy [Срок оценки: Baseline]
• Parenting self-efficacy [Срок оценки: the third trimester of pregnancy]
• Breastfeeding self-efficacy [Срок оценки: the third trimester of pregnancy]
• Parenting self-efficacy [Срок оценки: 1-month postpartum]
• Breastfeeding self-efficacy [Срок оценки: 1-month postpartum]
• Parenting self-efficacy [Срок оценки: 3-month postpartum]
• Breastfeeding self-efficacy [Срок оценки: 3-month postpartum]

Вторичные конечные точки (9)

• Depressive symptoms [Срок оценки: Baseline, the third trimester of pregnancy,1-month postpartum and 3-month postpartum]
• Anxiety symptoms [Срок оценки: Baseline, the third trimester of pregnancy,1-month postpartum and 3-month postpartum]
• Sleep quality [Срок оценки: Baseline, the third trimester of pregnancy,1-month postpartum and 3-month postpartum]
• Social support [Срок оценки: Baseline, the third trimester of pregnancy,1-month postpartum and 3-month postpartum]
• Infant feeding methods [Срок оценки: Baseline, the third trimester of pregnancy,1-month postpartum and 3-month postpartum]
• Infant sleep quality [Срок оценки: 1-month postpartum and 3-month postpartum]
• Infant development [Срок оценки: 3-month postpartum]
• Feasibility measured using a structured questionnaire [Срок оценки: immediately after intervention]
• Satisfaction measured using a structured questionnaire [Срок оценки: immediately after intervention]

Критерии участия

Inclusion Criteria: 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.

Exclusion Criteria: 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

Тайвань · 1 центр

• Taipei Medical University Hospital — Taipei

Идентификаторы

NCT: NCT04981730 · N202103092

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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