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| Name | Class |
|---|---|
| National Research Foundation of Korea | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention condition | Experimental | Structured online intervention consists of three weekly sessions of cognitive therapy and psychoeducation about child sleep |
|
| Active control condition | Active Comparator | Psychoeducation about basic sleep structure and sleep hygiene |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention | Behavioral | Structured online intervention consists of three weekly sessions of cognitive therapy and psychoeducation about child sleep |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Parental sleep (objective measurement) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sooyeon Suh, PhD | Contact | +82-2-920-7215 | alysuh@sungshin.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Sooyeon Suh, PhD | Sungshin Women's University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sungshin Women's University | Recruiting | Seoul | 02844 | South Korea |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 11, 2026 | |
| Reset | Jul 8, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 11, 2026 | Jul 8, 2026 |
| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| Active control condition | Other | Psychoeducation about basic sleep structure and sleep hygiene |
|
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |