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

Not Applicable

Recruiting

• Conditions: Parenting; Self Efficacy; Psychological Distress
• Interventions: Behavioral: Web-based intervention

• Registration Number: NCT04981730
• Lead Sponsor: Taipei Medical University

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.

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.

Study Timeline

• Study First Submitted: 2021-07-08
• Study First Submitted QC: 2021-07-26
• Study First Posted: 2021-07-29
• Study Start: 2023-12-14
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-24
• Last Update Posted: 2025-01-28
• Primary Completion: 2025-10-14
• Study Completion: 2025-10-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Web-based intervention	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.

Primary Outcome Measures

Name	Time	Method
Parenting self-efficacy	3-month postpartum	Parenting self-efficacy will be measured and reported by Parenting Self-Efficacy Scale. The higher the total scores indicate greater perceived parental self-efficacy.
Breastfeeding self-efficacy	3-month postpartum	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.

Secondary Outcome Measures

Name	Time	Method
Feasibility measured using a structured questionnaire	immediately after intervention	The feasibility of this trial will be measured using a structured questionnaire.
Social support	Baseline, the third trimester of pregnancy,1-month postpartum and 3-month postpartum	Social support will be measured using the Chinese version of the multidimensional scale of perceived social support (MSPSS). The higher the score, the higher the degree of support; total score ranging from 12 to 84.
Infant feeding methods	Baseline, the third trimester of pregnancy,1-month postpartum and 3-month postpartum	Infant feeding methods will be measured using a self-report questionnaire. The feeding methods, including initiated breastfeeding within 24h after birth, and type of breastfeeding.
Depressive symptoms	Baseline, the third trimester of pregnancy,1-month postpartum and 3-month postpartum	Depressive symptoms will be measured using the Taiwanese version of the Edinburgh Postnatal Depression Scale (T-EPDS). Total scores range from 0 to 30, A higher score indicated a higher levels of depression, with a total score of 30.
Anxiety symptoms	Baseline, the third trimester of pregnancy,1-month postpartum and 3-month postpartum	Anxiety symptoms will be measured using the Taiwanese version of the State-Trait Anxiety Inventory (TSTAI). Total scores range from 20 to 80, with a high score indicating a high level of anxiety.
Sleep quality	Baseline, the third trimester of pregnancy,1-month postpartum and 3-month postpartum	Sleep quality and disturbance will be measured using the Chinese version Pittsburgh Sleep Quality Index (CPSQI). CPSQI is a self-reported questionnaire and assesses seven sleep quality components from 0 to 3, with a total score ranging from 0 (good sleep) to 21 (very poor sleep).
Infant sleep quality	1-month postpartum and 3-month postpartum	The infant sleep quality will be measured using the Taiwanese version of the Brief Infant Sleep Questionnaire (BISQ). The BISQ will be used to assess sleep duration, duration of sleep by circadian rhythm, and night-time awakenings.
Infant development	3-month postpartum	Infant development will be measured using the Taipei City Developmental Checklist for the assessment of developmental delay.
Satisfaction measured using a structured questionnaire	immediately after intervention	Participants' satisfaction will be measured using a structured questionnaire.

Trial Locations

Locations (1)

Taipei Medical University Hospital; 🇨🇳 Taipei, Taiwan