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

Sponsor

Taipei Medical University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04981730

Collaborator

(none)

600

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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 three-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 guided web-based intervention, a self-guided 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.

Condition or Disease	Intervention/Treatment	Phase
Parenting Self Efficacy Psychological Distress	Behavioral: Guided web-based intervention Behavioral: Self-guided web-based intervention	N/A

Detailed Description

The primary outcome of parenting self-efficacy and 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 Design

Study Type:

Interventional

Anticipated Enrollment :

600 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Health Services Research

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Guided 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 10 sessions completed in 10 weeks plus weekly email, message, or video-conference contact from their assigned nurse specialist.	Behavioral: Guided web-based intervention The guided web-based intervention participants will follow the website's orientation, the curriculum of modules, and professional feedback to complete the intervention during the 10 weeks.
Experimental: Self-guided web-based intervention Participants in the intervention will receive both the standardized usual care and self-guided web-based, individually-tailored childbirth and parenting intervention program, including 10 sessions completed in 10 weeks.	Behavioral: Self-guided web-based intervention The self-guided web-based intervention participants will follow the website's orientation and curriculum of modules to complete the intervention during the 10 weeks.
No Intervention: Attention control Participants in the control group will receive attention from the research nurse and the standardized usual care.

Arm

Intervention/Treatment

Experimental: Guided 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 10 sessions completed in 10 weeks plus weekly email, message, or video-conference contact from their assigned nurse specialist.

Behavioral: Guided web-based intervention

The guided web-based intervention participants will follow the website's orientation, the curriculum of modules, and professional feedback to complete the intervention during the 10 weeks.

Experimental: Self-guided web-based intervention

Participants in the intervention will receive both the standardized usual care and self-guided web-based, individually-tailored childbirth and parenting intervention program, including 10 sessions completed in 10 weeks.

Behavioral: Self-guided web-based intervention

The self-guided web-based intervention participants will follow the website's orientation and curriculum of modules to complete the intervention during the 10 weeks.

No Intervention: Attention control

Participants in the control group will receive attention from the research nurse and the standardized usual care.

Outcome Measures

Primary Outcome Measures

Parenting self-efficacy [Baseline]
Parenting self-efficacy will be measured and reported by Parenting Confidence Scale. The higher the total scores indicate greater perceived parental self-efficacy.
Breastfeeding self-efficacy [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.
Parenting self-efficacy [the third trimester of pregnancy]
Parenting self-efficacy will be measured and reported by Parenting Confidence Scale. The higher the total scores indicate greater perceived parental self-efficacy.
Breastfeeding self-efficacy [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.
Parenting self-efficacy [1-week after delivery]
Parenting self-efficacy will be measured and reported by Parenting Confidence Scale. The higher the total scores indicate greater perceived parental self-efficacy.
Breastfeeding self-efficacy [1-week after delivery]
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.
Parenting self-efficacy [1-month postpartum]
Parenting self-efficacy will be measured and reported by Parenting Confidence Scale. The higher the total scores indicate greater perceived parental self-efficacy.
Breastfeeding self-efficacy [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.
Parenting self-efficacy [3-month postpartum]
Parenting self-efficacy will be measured and reported by Parenting Confidence 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.
Parenting self-efficacy [6-month postpartum]
Parenting self-efficacy will be measured and reported by Parenting Confidence Scale. The higher the total scores indicate greater perceived parental self-efficacy.
Breastfeeding self-efficacy [6-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.
Parenting self-efficacy [12-month postpartum]
Parenting self-efficacy will be measured and reported by Parenting Confidence Scale. The higher the total scores indicate greater perceived parental self-efficacy.
Breastfeeding self-efficacy [12-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

Depressive symptoms [Baseline, the third trimester of pregnancy,1-week after delivery , 1-month postpartum, 3-month postpartum, 6-month postpartum and 12-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-week after delivery , 1-month postpartum, 3-month postpartum, 6-month postpartum and 12-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-week after delivery , 1-month postpartum, 3-month postpartum, 6-month postpartum and 12-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).
Social support [Baseline, the third trimester of pregnancy,1-week after delivery , 1-month postpartum, 3-month postpartum, 6-month postpartum and 12-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 attitude [Baseline, the third trimester of pregnancy,1-week after delivery , 1-month postpartum, 3-month postpartum, 6-month postpartum and 12-month postpartum]
The Infant feeding attitude will be measured using the Taiwanese version of the Iowa Infant Feeding Attitude Scale (IIFAS). The total score ranges from 17 to 85, with higher scores indicating a more positive attitude toward infant feeding.
Infant feeding methods [1-week after delivery , 1-month postpartum, 3-month postpartum, 6-month postpartum and 12-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.
Infant sleep quality [1-week after delivery , 1-month postpartum, 3-month postpartum, 6-month postpartum and 12-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 [1-week after delivery , 1-month postpartum, 3-month postpartum, 6-month postpartum and 12-month postpartum]
Infant development will be measured using the Chinese version DDST-IIF and the Taiwanese Ages &Stages Questionnaires: Social- Emotional-2 (ASQ: SE-2). DDST-IIF, which is valuable for screening personal, social, fine motor, gross motor, and language developmental areas. ASQ: SE-2 will be measured the seven keys behavioral related to social and emotional competence, such as self-regulation, compliance, communication, adaptive functioning, autonomy, affect, and interaction with people.
Feasibility measured using a structured questionnaire [immediately after intervention]
The feasibility of this trial will be measured using a structured questionnaire.
Satisfaction measured using a structured questionnaire [immediately after intervention]
Participants' satisfaction will be measured using a structured questionnaire.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria: for this study are first-time mothers and fathers who are

20 years old and above;
primipara with a singleton pregnancy at 24-28 weeks' 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.