Clinical trial NCT04981730: The Development and Evaluation of a Web-based Childbirth and Parenting Intervention Program
Official title: The Development and Evaluation of a Web-based Childbirth and Parenting Intervention Program: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parenting
Self Efficacy
Psychological Distress
Keywords: parenting
parenthood
web-based intervention
self-efficacy
psychological distress
infant health
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2021-07-29
Enrollment: 600
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Parenting self-efficacy
timeFrame: Baseline
measure: Breastfeeding self-efficacy
timeFrame: Baseline
measure: Parenting self-efficacy
timeFrame: the third trimester of pregnancy
measure: Breastfeeding self-efficacy
timeFrame: the third trimester of pregnancy
measure: Parenting self-efficacy
timeFrame: 1-month postpartum
measure: Breastfeeding self-efficacy
timeFrame: 1-month postpartum
measure: Parenting self-efficacy
timeFrame: 3-month postpartum
measure: Breastfeeding self-efficacy
timeFrame: 3-month postpartum
Secondary outcomes:
measure: Depressive symptoms
timeFrame: Baseline, the third trimester of pregnancy,1-month postpartum and 3-month postpartum
measure: Anxiety symptoms
timeFrame: Baseline, the third trimester of pregnancy,1-month postpartum and 3-month postpartum
measure: Sleep quality
timeFrame: Baseline, the third trimester of pregnancy,1-month postpartum and 3-month postpartum
measure: Social support
timeFrame: Baseline, the third trimester of pregnancy,1-month postpartum and 3-month postpartum
measure: Infant feeding methods
timeFrame: Baseline, the third trimester of pregnancy,1-month postpartum and 3-month postpartum
measure: Infant sleep quality
timeFrame: 1-month postpartum and 3-month postpartum
measure: Infant development
timeFrame: 3-month postpartum
measure: Feasibility measured using a structured questionnaire
timeFrame: immediately after intervention
measure: Satisfaction measured using a structured questionnaire
timeFrame: immediately after intervention
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital
Study officials:
affiliation: Taipei Medical University
name: Shu-Yu Kuo
role: PRINCIPAL_INVESTIGATOR
References: