The Development and Evaluation of Sleep Intervention for Perinatal Family

Background: Sleep disruptions and disturbances are highly prevalent among new mothers and fathers and negatively affect their mental health and infant development outcomes. Effective sleep interventions are vital for family health. Objectives: To develop a sleep intervention for mother-father-infant triads, and to evaluate the effects on sleep improvement, emotional distress, and infant health outcomes. Methods: In this proposal, we plan to conduct a parallel-group two-arm randomized controlled trial on pregnant women and their partners. Mother-father-infant triads will be recruited and randomly allocated to the intervention group (receiving a sleep intervention) or the control group. Data will be collected with repeated measures, and the relationship between studied variables will be analyzed with descriptive and inferential statistics. Anticipatory results: The development and evaluation of an evidence-based sleep intervention will provide a scientific insight into sleep care for pregnant women and their families.

NCT Number	NCT06487650
Lead Sponsor	Taipei Medical University
Conditions	Sleep, Psychological Distress, Perinatal Problems
Enrollment	600 participants
Start Date	2025-12
Primary Completion	2026-09 (estimated)
Study Completion	2026-09 (estimated)
Updated on ClinicalTrials.gov	2025-01-14