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

NCT ID: NCT04981730

Last Updated: 2025-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-14

Study Completion Date

2025-10-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Parenting Self Efficacy Psychological Distress

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Web-based intervention

Intervention Type BEHAVIORAL

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

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Taipei Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Shu Yu Kuo

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Shu-Yu Kuo

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Taipei Medical University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Shu-Yu Kuo

Role: CONTACT

+886-2-2736-1661 ext. 6301

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Shu-Yu Kuo, Phd

Role: primary

+886-2-2736-1661 ext. 6301

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

N202103092

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Childbirth Education Pilot Study
NCT04327557 SUSPENDED NA
Labor Education to Reduce Postpartum Traumatic Stress
NCT06992791 ENROLLING_BY_INVITATION NA