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

NCT04981730 | Recruiting

• 1 other identifier: N202103092
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parenting; Self Efficacy; Psychological Distress

Keywords

parenting; parenthood; web-based intervention; self-efficacy; psychological distress; infant health

Outcome Measures

Primary Outcomes (8)

• Parenting self-efficacy

  Parenting self-efficacy will be measured and reported by Parenting Self-Efficacy Scale. The higher the total scores indicate greater perceived parental self-efficacy.

  Baseline

• Breastfeeding self-efficacy

  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.

  Baseline

• Parenting self-efficacy

  Parenting self-efficacy will be measured and reported by Parenting Self-Efficacy Scale. The higher the total scores indicate greater perceived parental self-efficacy.

  the third trimester of pregnancy

• Breastfeeding self-efficacy

  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.

  the third trimester of pregnancy

• Parenting self-efficacy

  Parenting self-efficacy will be measured and reported by Parenting Self-Efficacy Scale. The higher the total scores indicate greater perceived parental self-efficacy.

  1-month postpartum

• Breastfeeding self-efficacy

  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.

  1-month postpartum

• Parenting self-efficacy

  Parenting self-efficacy will be measured and reported by Parenting Self-Efficacy Scale. The higher the total scores indicate greater perceived parental self-efficacy.

  3-month postpartum

• Breastfeeding self-efficacy

  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.

  3-month postpartum

Secondary Outcomes (9)

• 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

• 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

Study Arms (2)

Web-based intervention

EXPERIMENTAL

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.

Behavioral: Web-based intervention

Control

NO INTERVENTION

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

Interventions

Web-based intervention BEHAVIORAL

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

Web-based intervention

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (1)

Taipei Medical University Hospital

Taipei, 110, Taiwan

RECRUITING

Study Officials

• Shu-Yu Kuo

  Taipei Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shu-Yu Kuo

CONTACT

+886-2-2736-1661; sykuo@tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 8, 2021
• First Posted: July 29, 2021
• Study Start: December 14, 2023
• Primary Completion: October 14, 2025
• Study Completion: October 14, 2025
• Last Updated: January 28, 2025

Record last verified: 2025-01

Locations

TW (1)