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

Parenting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04981730
• Other study ID #: N202103092
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2023
• Est. completion date: April 2024

Study information

• Verified date: December 2023
• Source: Taipei Medical University
• Contact: Shu-Yu Kuo
• Phone: +886-2-2736-1661
• Email: sykuo[@]tmu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: April 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parenting
• Psychological Distress
• Self Efficacy

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Depressive symptoms	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.	Baseline, the third trimester of pregnancy,1-month postpartum and 3-month postpartum
Secondary	Anxiety symptoms	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.	Baseline, the third trimester of pregnancy,1-month postpartum and 3-month postpartum
Secondary	Sleep quality	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).	Baseline, the third trimester of pregnancy,1-month postpartum and 3-month postpartum
Secondary	Social support	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.	Baseline, the third trimester of pregnancy,1-month postpartum and 3-month postpartum
Secondary	Infant feeding methods	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.	Baseline, the third trimester of pregnancy,1-month postpartum and 3-month postpartum
Secondary	Infant sleep quality	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.	1-month postpartum and 3-month postpartum
Secondary	Infant development	Infant development will be measured using the Taipei City Developmental Checklist for the assessment of developmental delay.	3-month postpartum
Secondary	Feasibility measured using a structured questionnaire	The feasibility of this trial will be measured using a structured questionnaire.	immediately after intervention
Secondary	Satisfaction measured using a structured questionnaire	Participants' satisfaction will be measured using a structured questionnaire.	immediately after intervention