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NCT Number: NCT05806450

Development of Sleep Intervention for Parent and Child

This study aims to develop and test the intervention program to help manage parental thoughts in parents with child sleep problems.

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Key information

Conditions

Behavioral Insomnia of Childhood

Age range

6 month–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sungshin Women's University

Seoul, 02844, South Korea

Location status: Recruiting

About this study

Pediatric sleep problems are common and persistent, which result in negative outcomes without appropriate intervention. Behavioral sleep interventions (BSI) are evidence-based sleep training methods for improving pediatric sleep. However, parental factors (e.g., parental dysfunctional beliefs about child sleep) can interfere with the implementation of BSI. For example, being too worried or having misperceptions about infant sleep may interfere with the parent's ability to successfully and persistently implement BSIs. Therefore, parental thoughts and beliefs should be considered as an important target in the context of pediatric sleep interventions. This study aims to develop a cognitive intervention that identifies and targets parental misperceptions about child's sleep, and test the efficacy of the intervention through a randomized controlled trial.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Child's primary nighttime caregiver (mothers or fathers) of full-term, healthy, singleton, 6 to 24 months old
  • Caregiver participants aged between 19 to 65 years
  • The caregiver who is a native speaker of Korean (a person who is able to listen, speak, and write in Korean, and does not have any difficulties in understanding the Korean language)
  • Residents of South Korea
  • Sleep arrangements without restriction for using an auto-videosomnography device: (1) parent-child sleep separately (one should not change the sleep arrangement only for the participation in the study); (2) if parents and child share a bed, the child's own space should be large enough for the videosomnography camera to capture child body solely.
  • Be available on devices with the camera (e.g., tablets, personal computers) for the online intervention/session

Exclusion criteria

  • Child's gestational age before 37 weeks or after 42 weeks
  • Children with developmental disability
  • Caregiver participant (or partner) who is currently working the night shift or night duty
  • Caregiver participant who has a history of sleep disorders besides insomnia
  • Caregiver participant who has lifetime bipolar disorder, schizophrenia spectrum, and other psychotic disorders, alcohol, caffeine, or other substance substance-related disorders, neurocognitive disorders, thyroid-related disorders, or epilepsy
  • Caregiver participant who is currently experiencing a major depressive disorder, panic disorder (only if ≥ 4 nocturnal panic attacks in the past month), or post-traumatic stress-related problems
  • Caregiver participant who is using medications or substances that directly affect sleep
  • Caregiver participant who is currently getting cognitive behavioral therapy for insomnia (CBTi)
  • Pregnant women

Treatment and study plan

Intervention

Behavioral

Structured online intervention consists of three weekly sessions of cognitive therapy and psychoeducation about child sleep

Other names: Sleep Intervention for Mother and BAby (SIMBA)

Active control condition

Other

Psychoeducation about basic sleep structure and sleep hygiene

Primary outcomes

  1. Parental cognition about child sleep

    Time frame: Changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention

    Parental cognition about child's sleep will be measured by the Parental Understanding and Misperceptions about BAby Sleep-Questionnaire (PUMBA-Q). The score range is 0 to 92. Higher score represents higher levels of maladaptive cognition.

  2. Child sleep diary

    Time frame: Changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention

    Parent-report child's sleep diary will be collected. Sleep parameters include bedtime, wake time, total sleep time, sleep onset latency, wake time after sleep onset, and the number of awakenings. Total sleep time will be used as the main outcome.

  3. Child sleep (objective measurement)

    Time frame: changes from baseline to 4 weeks

    Child sleep will be objectively measured using the videosomnography. Sleep parameters such as bedtime, wake time, total sleep time, sleep onset latency, wake time after sleep onset, number of parental interventions, and number of awakenings are calculated by the algorithm. Total sleep time will be used as the main outcome.

Secondary outcomes

  1. Parental sleep diary

    Time frame: changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention

    Self-report parental sleep diary will be collected. Sleep parameters include bedtime, wake time, total sleep time, sleep onset latency, wake time after sleep onset, and number of awakenings.

  2. Parental sleep (objective measurement)

    Time frame: changes from baseline to 4 weeks

    Parental sleep will be objectively measured by the Fitbit wearable device. Sleep parameters such as bedtime, wake time, and total sleep time are calculated by the algorithm.

  3. Parental insomnia

    Time frame: changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention

    The ISI (Insomnia Severity Index) scale will be used to assess self-reported levels of insomnia severity. Scores range from 0 to 28. Higher scores reflect higher levels of insomnia symptom severity.

  4. Parental sleep disturbance

    Time frame: changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention

    The GSDS (General Sleep Disturbance Scale) scale will be used to assess self-reported levels of general sleep disturbance. Scores range from 0 to 147. Higher scores reflect higher levels of sleep disturbance.

  5. Child sleep environment and parental interaction

    Time frame: changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention

    The Brief Infant Sleep Questionnaire-Revised (BISQ-R) scale will assess child sleep environment such as bedroom environment, sleep routine, and parental behavior around infant sleep.

  6. Anxiety

    Time frame: changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention

    The PROMIS-anxiety scale will be used to assess self-reported levels of anxiety. Scores range from 8 to 40. Higher scores reflect higher levels of anxiety.

  7. Depression

    Time frame: changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention

    The PROMIS-depression scale will be used to assess self-reported levels of depression. Scores range from 8 to 40. Higher scores reflect higher levels of depression.

Other outcomes

  1. Parental cognition about sleep

    Time frame: changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention

    The DBAS-16 (Dysfunctional Beliefs and Attitudes about Sleep-16) scale will be used to assess parental cognition about own sleep. Scores range from 0 to 10. Higher scores reflect more maladaptive cognition.

  2. Marital satisfaction

    Time frame: changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention

    The MSI-B (Marital Satisfaction Index-Brief) scale will be used to assess marital satisfaction. Scores range from 0 to 10. Higher scores reflect worse marital satisfaction.

  3. Circadian rhythm

    Time frame: baseline assessment to identify circadian types that reflect an individual's preferred time of day for activity

    The MEQ (Morningness-Eveningness Questionnaire) scale will be used to assess one's circadian preference. Scores range from 16-86. Higher score means one's circadian preference is more close to morningness.

Study contacts

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

Sooyeon Suh, PhD

CONTACT

[email protected]

+82-2-920-7215

Sponsors and collaborators

Lead sponsor

Sungshin Women's University

Other

Collaborators

  • National Research Foundation of Korea

Registry information

Official study title

Development of a Cognitive-Behavioral Intervention to Improve Infant and Parent Sleep Based on Big Data Analytics

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 10, 2023
Registry last updated
May 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.