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NCT Number: NCT04981730

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

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.

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Key information

Conditions

Parenting Psychological Distress Self Efficacy

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Medical University Hospital

Taipei, 110, Taiwan

Location status: Recruiting

Location contact

Shu-Yu Kuo, Phd

CONTACT

[email protected]

+886-2-2736-1661 ext. 6301

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for this study are first-time mothers and fathers who are

  • 20 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.

Exclusion criteria

are the first-time mothers and fathers who have

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Parenting self-efficacy

    Time frame: Baseline

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

  2. Breastfeeding self-efficacy

    Time frame: Baseline

    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. Parenting self-efficacy

    Time frame: the third trimester of pregnancy

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

  4. Breastfeeding self-efficacy

    Time frame: the third trimester of pregnancy

    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.

  5. Parenting self-efficacy

    Time frame: 1-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.

  6. Breastfeeding self-efficacy

    Time frame: 1-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.

  7. Parenting self-efficacy

    Time frame: 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.

  8. Breastfeeding self-efficacy

    Time frame: 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 outcomes

  1. Depressive symptoms

    Time frame: 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.

  2. Anxiety symptoms

    Time frame: 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.

  3. Sleep quality

    Time frame: 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).

  4. Social support

    Time frame: 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.

  5. Infant feeding methods

    Time frame: 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.

  6. Infant sleep quality

    Time frame: 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.

  7. Infant development

    Time frame: 3-month postpartum

    Infant development will be measured using the Taipei City Developmental Checklist for the assessment of developmental delay.

  8. Feasibility measured using a structured questionnaire

    Time frame: immediately after intervention

    The feasibility of this trial will be measured using a structured questionnaire.

  9. Satisfaction measured using a structured questionnaire

    Time frame: immediately after intervention

    Participants' satisfaction will be measured using a structured questionnaire.

Study contacts

Contact information is provided by the study sponsor or research team.

Shu-Yu Kuo

CONTACT

[email protected]

+886-2-2736-1661 ext. 6301

Sponsors and collaborators

Lead sponsor

Taipei Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 29, 2021
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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