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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sleep; Psychological Distress; Perinatal Problems
• Intervention / Treatment: Behavioral: sleep intervention; Behavioral: Control group

Detailed Description

The primary outcome is the severity of insomnia symptoms. The secondary outcomes of parents' sleep quality, objective sleep indicators, symptoms of depression and anxiety, and heart rate variability will be collected. Infant sleep quality, infant feeding, and infant health outcomes will also be assessed. Data will be analyzed using descriptive and inferential statistics.

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shu-Yu Kuo; Phone Number: 6301 +886-2-2736-1661; Email: sykuo@tmu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. First-time mothers and their partners aged 20 and older;
2. Currently 30 weeks gestation or more, singleton;
3. insomnia severity index score greater than 10;
4. living with a husband or partner;
5. Both women and their partners are willing to participate in and adhere to the research protocol;
6. be able to read and speak the Mandarin language

Exclusion Criteria:

1. sleep disorders, depression or anxiety disorders;
2. medical diseases with abnormal heart rate variability, or arrhythmia;
3. taking medicines that may affect the autonomic nervous system or
4. night shift workers;
5. obstetric complications, including gestational hypertension, preterm labor, labor complications, or postpartum complications;
6. infants with fetal deformity, or neonatal complications;
7. no access to Internet resources

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: sleep intervention; Participants in the intervention group will receive both the standardized usual care and the sleep intervention. The intervention consists of sleep education, health professional support, and counseling. The intervention will be delivered from pregnancy to postpartum for mothers and fathers.	Behavioral: sleep intervention; At the beginning of the intervention, participants will have an orientation and overview of the program. Then, participants will follow the curriculum of modules, and professional feedback to complete the intervention.
Active Comparator: Control; Participants in the control group will receive a perinatal health booklet in addition to the standardized usual care.	Behavioral: Control group; Participants in control group will follow standardized usual care and a perinatal health booklet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Taipei Medical University
• Investigators: Principal Investigator: Shu-Yu Kuo, Phd, Taipei Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: June 13, 2024
• First Submitted That Met QC Criteria: June 27, 2024
• First Posted (Actual): July 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 12, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: depression; anxiety; sleep quality; perinatal; infant health; infant sleep
• Other Study ID Numbers: N202204079

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No