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

StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated January 28, 2025 (before its estimated October 14, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Notable Trial status: Not Yet Recruiting to Recruitingv7 Show 4 more changesShow less
    • Primary completion date: Jan 2024 to Oct 14, 2025
    • Study sites: 0 to 1
    • Study completion date: Apr 2024 to Oct 14, 2025
    • Start date changed from estimate of Dec 2023 to Dec 14, 2023
  2. Notable Start date: Aug 2023 to Dec 2023
    • Eligibility criteria expanded, about 1 word
    v6
  3. Notable Primary completion date: Dec 2022 to Jan 2024
    • Start date: Dec 2022 to Aug 2023
    • Study completion date: Jun 2023 to Apr 2024
    v5
  4. Notable Primary endpoints: 14 to 8v4 Show 4 more changesShow less
    • Interventions: Guided web-based intervention (Behavioral), Self-guided web-based intervention (Behavioral) to Web-based intervention (Behavioral)
    • Secondary endpoints: 10 to 9
    • Study arms: 3 to 2
    • Study description expanded, about 2 words
  5. Notable Start date: Jun 2022 to Dec 2022v3
  6. Notable Start date: Sep 2021 to Jun 2022
    • Primary completion date: Sep 2022 to Dec 2022
    • Study completion date: Jul 2023 to Jun 2023
    v2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04981730
Lead Sponsor Taipei Medical University
Conditions
(from sponsor)
Parenting, Self Efficacy, Psychological Distress
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov