Development of Sleep Intervention for Parent and Child

Behavioral Insomnia of Childhood Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05806450
• Other study ID #: NRF-2021S1A5A2A03061721
• Status: Recruiting
• Phase: N/A
• Start date: March 10, 2023
• Est. completion date: February 28, 2025

Study information

• Verified date: June 2024
• Source: Sungshin Women's University
• Contact: Sooyeon Suh, PhD
• Phone: +82-2-920-7215
• Email: alysuh[@]sungshin.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 188
• Est. completion date: February 28, 2025
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 24 Months

Eligibility

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

Related Conditions & MeSH terms

• Behavioral Insomnia of Childhood

Intervention

Behavioral:
• Intervention
Structured online intervention consists of three weekly sessions of cognitive therapy and psychoeducation about child sleep

Other:
• Active control condition
Psychoeducation about basic sleep structure and sleep hygiene

Locations

Country	Name	City	State
Korea, Republic of	Sungshin Women's University	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Sungshin Women's University	National Research Foundation of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Parental cognition about sleep	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.	changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention
Other	Marital satisfaction	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.	changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention
Other	Circadian rhythm	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.	baseline assessment to identify circadian types that reflect an individual's preferred time of day for activity
Primary	Parental cognition about child sleep	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.	Changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention
Primary	Child sleep diary	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.	Changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention
Primary	Child sleep (objective measurement)	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.	changes from baseline to 4 weeks
Secondary	Parental sleep diary	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.	changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention
Secondary	Parental sleep (objective measurement)	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.	changes from baseline to 4 weeks
Secondary	Parental insomnia	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.	changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention
Secondary	Parental sleep disturbance	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.	changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention
Secondary	Child sleep environment and parental interaction	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.	changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention
Secondary	Anxiety	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.	changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention
Secondary	Depression	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.	changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention