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NCT Number: NCT06487650

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.

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Key information

Conditions

Sleep Anxiety Disorders Behavior Behavioral Symptoms Depression Dyssomnias Mental Disorders Nervous System Diseases Perinatal Problems Psychological Distress Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Sleep intervention

Behavioral

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.

Control Group

Behavioral

Participants in control group will follow standardized usual care and a perinatal health booklet

Primary outcomes

  1. Insomnia Severity Index

    Time frame: baseline, at 36-weeks' gestation, 2-week postpartum, 1-month, 3-month,6-month, and 12-month postpartum

    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.

Secondary outcomes

  1. Sleep quality

    Time frame: baseline, at 36-weeks' gestation, postpartum 1 month, 3 months, 6 months, and 12-months

    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

  2. Sleep duration using actigraphy

    Time frame: baseline, postpartum 1 month, 3 months, and 6 months.

    The Actiwatch will be used to collect objective data of sleep duration

  3. Sleep sleep onset latency using actigraphy

    Time frame: baseline, postpartum 1 month, 3 months, and 6 months.

    The Actiwatch will be used to collect objective data of sleep onset latency

  4. Sleep efficacy using actigraphy

    Time frame: baseline, postpartum 1 month, 3 months, and 6 months.

    The Actiwatch will be used to collect objective data of sleep efficacy

  5. Wake after sleep onset using actigraphy

    Time frame: baseline, postpartum 1 month, 3 months, and 6 months.

    The Actiwatch will be used to collect objective data of wake after sleep onset

  6. Infants sleep Questionnaire

    Time frame: postpartum 1 month, 3 months, 6 months, and 12-months

    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

  7. Depressive symptoms

    Time frame: baseline, at 36-weeks' gestation, postpartum 1 month, 3 months, 6 months, and 12-months

    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.

  8. Anxiety symptoms

    Time frame: baseline, at 36-weeks' gestation, postpartum 1 month, 3 months, 6 months, and 12-months

    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.

  9. Heart rate variability (HRV) measures

    Time frame: at baseline, postpartum 1 month, 3 months, and 6 months

    The resting interbeat interval will be recorded

  10. Infant weight

    Time frame: postpartum 3 months, 6 months, and 12-months

    Infants' body weight in gram will be measured by trained data collectors using an electronic scale specifically for infants

  11. Infant height

    Time frame: postpartum 3 months, 6 months, and 12-months

    Infants' height in cm will be measured by trained data collectors using an electronic scale specifically for infants

  12. Infant development

    Time frame: postpartum 3 months, 6 months, and 12-months

    Infant's social and emotional development will be assessed using the Taiwanese version of the Ages & Stages Questionnaires: Social-Emotional-2 (ASQ: SE-2).

  13. Infant feeding

    Time frame: postpartum 1 month, 3 months, and 6 months, and 12 months

    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.

  14. Satisfaction of sleep intervention

    Time frame: immediately after interventions

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Shu-Yu Kuo

CONTACT

[email protected]

+886-2-2736-1661 ext. 6301

Sponsors and collaborators

Lead sponsor

Taipei Medical University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 5, 2024
Registry last updated
Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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