The Development and Evaluation of a Web-based Childbirth and Parenting Intervention Program
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-60
SponsorTaipei Medical University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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;
Disqualifiers
chronic diseases;
obstetric complications;
an abnormal fetal screening;
unable or unwilling to comply with the requirements of the research protocol;
Trial design
Design model
Parallel
Treatments tested in this trial
Web-based intervention
BehavioralThe web-based intervention participants will follow the website's orientation, the curriculum of modules, and professional feedback to complete the intervention.
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: Web-based interventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline2
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.
Time frame
Baseline3
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.
Time frame
the third trimester of pregnancy4
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.
Time frame
the third trimester of pregnancySecondary outcomes
1
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.
Time frame
Baseline, the third trimester of pregnancy,1-month postpartum and 3-month postpartum2
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.
Time frame
Baseline, the third trimester of pregnancy,1-month postpartum and 3-month postpartum3
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).
Time frame
Baseline, the third trimester of pregnancy,1-month postpartum and 3-month postpartum4
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.
Time frame
Baseline, the third trimester of pregnancy,1-month postpartum and 3-month postpartumSponsors and contacts
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Source ClinicalTrials.gov