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

The Development and Evaluation of a Web-based Childbirth and Parenting Intervention Program: A Randomized Controlled Trial

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04981730
Enrollment
600
Registered
2021-07-29
Start date
2023-12-14
Completion date
2025-10-14
Last updated
2025-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parenting, Psychological Distress, Self Efficacy

Keywords

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

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.

Interventions

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

Sponsors

Taipei Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Parenting self-efficacyBaselineParenting 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-efficacyBaselineBreastfeeding 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

MeasureTime frameDescription
Sleep qualityBaseline, the third trimester of pregnancy,1-month postpartum and 3-month postpartumSleep 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).
Social supportBaseline, the third trimester of pregnancy,1-month postpartum and 3-month postpartumSocial 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 methodsBaseline, the third trimester of pregnancy,1-month postpartum and 3-month postpartumInfant 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 symptomsBaseline, the third trimester of pregnancy,1-month postpartum and 3-month postpartumDepressive 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.
Infant development3-month postpartumInfant development will be measured using the Taipei City Developmental Checklist for the assessment of developmental delay.
Feasibility measured using a structured questionnaireimmediately after interventionThe feasibility of this trial will be measured using a structured questionnaire.
Satisfaction measured using a structured questionnaireimmediately after interventionParticipants' satisfaction will be measured using a structured questionnaire.
Infant sleep quality1-month postpartum and 3-month postpartumThe 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.
Anxiety symptomsBaseline, the third trimester of pregnancy,1-month postpartum and 3-month postpartumAnxiety 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.

Countries

Taiwan

Contacts

Primary ContactShu-Yu Kuo
sykuo@tmu.edu.tw+886-2-2736-1661

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026