This study aims to develop and test the intervention program to help manage parental thoughts in parents with child sleep problems.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
190
Structured online intervention consists of three weekly sessions of cognitive therapy and psychoeducation about child sleep
Psychoeducation about basic sleep structure and sleep hygiene
Sungshin Women's University
Seoul, South Korea
RECRUITINGParental 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.
Time frame: Changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention
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.
Time frame: Changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention
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.
Time frame: changes from baseline to 4 weeks
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.
Time frame: changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention
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.
Time frame: changes from baseline to 4 weeks
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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.
Time frame: changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention
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.
Time frame: changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention
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.
Time frame: changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention
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.
Time frame: changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention
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.
Time frame: changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention