The Development and Evaluation of a Web-based Childbirth and Parenting Intervention Program
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Web-based intervention.
- Who it may be relevant to
- Registry conditions: Parenting, Self Efficacy, Psychological Distress. Basic parameters: 20 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Development and Evaluation of a Web-based Childbirth and Parenting Intervention Program: A Randomized Controlled Trial
Overview
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.
Detailed description
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.
Interventions
- Behavioral 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.
Primary outcome measures
- Parenting self-efficacy [Time frame: Baseline]
- Breastfeeding self-efficacy [Time frame: Baseline]
- Parenting self-efficacy [Time frame: the third trimester of pregnancy]
- Breastfeeding self-efficacy [Time frame: the third trimester of pregnancy]
- Parenting self-efficacy [Time frame: 1-month postpartum]
- Breastfeeding self-efficacy [Time frame: 1-month postpartum]
- Parenting self-efficacy [Time frame: 3-month postpartum]
- Breastfeeding self-efficacy [Time frame: 3-month postpartum]
Secondary outcome measures (9)
- Depressive symptoms [Time frame: Baseline, the third trimester of pregnancy,1-month postpartum and 3-month postpartum]
- Anxiety symptoms [Time frame: Baseline, the third trimester of pregnancy,1-month postpartum and 3-month postpartum]
- Sleep quality [Time frame: Baseline, the third trimester of pregnancy,1-month postpartum and 3-month postpartum]
- Social support [Time frame: Baseline, the third trimester of pregnancy,1-month postpartum and 3-month postpartum]
- Infant feeding methods [Time frame: Baseline, the third trimester of pregnancy,1-month postpartum and 3-month postpartum]
- Infant sleep quality [Time frame: 1-month postpartum and 3-month postpartum]
- Infant development [Time frame: 3-month postpartum]
- Feasibility measured using a structured questionnaire [Time frame: immediately after intervention]
- Satisfaction measured using a structured questionnaire [Time frame: immediately after intervention]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Health services research
Study locations
Taiwan · 1 center
- Taipei Medical University Hospital — Taipei
Identifiers
NCT: NCT04981730 · N202103092