The Development and Evaluation of Sleep Intervention for Perinatal Family
NCT Number: NCT06487650
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Sleep|Psychological Distress|Perinatal Problems
Interventions: BEHAVIORAL: sleep intervention|BEHAVIORAL: Control group
Sponsor: Taipei Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 600
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-09
Completion Date: 2026-09

Summary:
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.

Primary Outcome Measures: Insomnia Severity Index, The Chinese version of the Insomnia Severity Index (ISI) is used to measure the severity of insomnia symptoms, a higher score indicates more severe insomnia symptoms., baseline, at 36-weeks' gestation, 2-week postpartum, 1-month, 3-month,6-month, and 12-month postpartum
Secondary Outcome Measures: Sleep quality, The 19-item Chinese version of the Pittsburgh Sleep Quality Index (PSQI), will be used to measure sleep quality and sleep disturbance, higher score indicates worse sleep quality, baseline, at 36-weeks' gestation, postpartum 1 month, 3 months, 6 months, and 12-months|Sleep duration using actigraphy, The Actiwatch will be used to collect objective data of sleep duration, baseline, postpartum 1 month, 3 months, and 6 months.|Sleep sleep onset latency using actigraphy, The Actiwatch will be used to collect objective data of sleep onset latency, baseline, postpartum 1 month, 3 months, and 6 months.|Sleep efficacy using actigraphy, The Actiwatch will be used to collect objective data of sleep efficacy, baseline, postpartum 1 month, 3 months, and 6 months.|Wake after sleep onset using actigraphy, The Actiwatch will be used to collect objective data of wake after sleep onset, baseline, postpartum 1 month, 3 months, and 6 months.|Infants sleep Questionnaire, Parents will be asked to rate their infant's sleep quality using the 19-item Brief Infant Sleep Questionnaire-Revised (BISQ-R). The BISQ will be used to assess sleep duration, duration of sleep by circadian rhythm, and night-time awakenings, postpartum 1 month, 3 months, 6 months, and 12-months|Depressive symptoms, Maternal and paternal depressive symptoms will be assessed using the Taiwanese version of the 10-item Edinburgh Postnatal Depression Scale (EPDS), a higher score indicated more severe symptoms., baseline, at 36-weeks' gestation, postpartum 1 month, 3 months, 6 months, and 12-months|Anxiety symptoms, The 20-item State Anxiety subscale of the State-Trait Anxiety Inventory (STAI) will be used to measure levels of anxiety symptoms in mothers and fathers, higher score presents more severe symptoms., baseline, at 36-weeks' gestation, postpartum 1 month, 3 months, 6 months, and 12-months|Heart rate variability (HRV) measures, The resting interbeat interval will be recorded, at baseline, postpartum 1 month, 3 months, and 6 months|Infant weight, Infants' body weight in gram will be measured by trained data collectors using an electronic scale specifically for infants, postpartum 3 months, 6 months, and 12-months|Infant height, Infants' height in cm will be measured by trained data collectors using an electronic scale specifically for infants, postpartum 3 months, 6 months, and 12-months|Infant development, Infant's social and emotional development will be assessed using the Taiwanese version of the Ages \& Stages Questionnaires: Social-Emotional-2 (ASQ: SE-2)., postpartum 3 months, 6 months, and 12-months|Infant feeding, Infant feeding methods will be measured using a self-report questionnaire. The feeding methods, including initiated breastfeeding within 24 hours after birth, and type of breastfeeding., postpartum 1 month, 3 months, and 6 months, and 12 months|Satisfaction of sleep intervention, A structured questionnaire with a 5-point Likert scale will be used to collect the level of satisfaction of the sleep intervention upon completion of programs., immediately after interventions