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

Taipei Medical University

Status: Enrolling

Conditions: Self Efficacy; Parenting; Psychological Distress

Treatments: Behavioral: Web-based intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04981730

N202103092

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: for this study are first-time mothers and fathers who are

1. 20 years old and above;
2. primipara with a singleton pregnancy at second and third-trimester gestation;
3. able to read and write in Mandarin;
4. the husband or support partner will be willing to attend the intervention program;
5. able to access and use the Internet by computer and/or smartphone daily.

Exclusion Criteria: are the first-time mothers and fathers who have

1. chronic diseases;
2. obstetric complications;
3. an abnormal fetal screening;
4. unable or unwilling to comply with the requirements of the research protocol;
5. women and their partners did not have time for the web-based intervention program;
6. participation on any other interventional study.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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600 participants in 2 patient groups

Web-based intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Web-based intervention

Control

No Intervention group

Description:

Participants in the control group will receive attention from the research nurse and the standardized usual care.