Behavioral Insomnia of ChildhoodNCT05806450
Development of Sleep Intervention for Parent and Child
A study testing Intervention in people with Behavioral Insomnia of Childhood, run by Sungshin Women's University at 1 site in South Korea.
Trial summary
This study aims to develop and test the intervention program to help manage parental thoughts in parents with child sleep problems. Read more about this study
- Who is it for?
- Ages 6 to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Behavioral Insomnia of Childhood
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Mar 2023to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of a Cognitive-Behavioral Intervention to Improve Infant and Parent Sleep Based on Big Data Analytics
This study aims to develop and test the intervention program to help manage parental thoughts in parents with child sleep problems.
Read the detailed 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.
- Conditions
- Behavioral Insomnia of Childhood
- Being tested
- Intervention, Active control condition
- Keywords
- pediatric sleep problems, sleep intervention, cognitive behavioral therapy (CBT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
Also called Sleep Intervention for Mother and BAby (SIMBA)
Structured online intervention consists of three weekly sessions of cognitive therapy and psychoeducation about child sleep
Active control conditionOther
Psychoeducation about basic sleep structure and sleep hygiene
| Study group | Role | What they receive |
|---|---|---|
| Intervention condition | Experimental | Structured online intervention consists of three weekly sessions of cognitive therapy and psychoeducation about child sleep Receives: Behavioral: Intervention |
| Active control condition | Active comparator | Psychoeducation about basic sleep structure and sleep hygiene Receives: Other: Active control condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental Cognition About Child Sleep
Parental cognitions about infant sleep were assessed using the Parental Understanding and Misperceptions about BAby's Sleep Questionnaire (PUMBA-Q). Total scores range from 0 to 92, with higher scores indicating more maladaptive sleep-related cognitions.
Measured: T1: Baseline, T2: Post-intervention (Week 4), T3: 4-Week Follow-Up (Week 8), T4: 12-Week Follow-Up (Week 16)
Child Sleep Diary
Parent-reported daily sleep diaries were used to assess infant sleep parameters, including bedtime (BT), wake time (WT), sleep onset latency (SOL), number of night awakenings (NWAK), wake after sleep onset (WASO), total sleep time (TST), parental nighttime involvement (frequency and duration), and daytime sleep (nap frequency and duration). Total sleep time (TST) is reported here as the primary summary measure.
Measured: T1: Baseline, T2: Post-intervention (Week 4), T3: 4-Week Follow-Up (Week 8), T4: 12-Week Follow-Up (Week 16)
Child Sleep (Objective Measurement)
Infant sleep was objectively measured using home-based auto-videosomnography (Nanit), which derives sleep-wake metrics from computer-vision algorithms, including total sleep time (TST), sleep onset latency (SOL), number of night awakenings (NWAK), and wake after sleep onset (WASO), and parental nighttime involvement frequency. Total sleep time (TST) is reported here as the primary summary measure.
Measured: T1: Baseline, T2: Post-intervention (Week 4)
Secondary outcomes (7)
Parental Sleep Diary
Parents' sleep was assessed using daily sleep diaries reporting scheduled bedtime (SBT), bedtime (BT), lights-off time (LO), sleep onset latency (SOL), number of night awakenings (NWAK), wake after sleep onset (WASO), wake time (WT), time out of bed (TOB), total sleep time (TST), time in bed (TIB), sleep efficiency (SE), and daytime sleep (nap frequency and duration). Total sleep time (TST) is reported here as the primary summary measure.
Measured: T1: Baseline, T2: Post-intervention (Week 4), T3: 4-Week Follow-Up (Week 8), T4: 12-Week Follow-Up (Week 16)
Parental Sleep (Objective Measurement)
Objective parental sleep was measured using wrist-worn actigraphy (Fitbit Inspire 3), providing estimates of sleep onset time, wake time, total sleep time (TST), wake after sleep onset (WASO), and sleep stage parameters based on accelerometry. Total sleep time (TST) is reported here as the primary summary measure.
Measured: T1: Baseline, T2: Post-intervention (Week 4)
Parental Insomnia
Insomnia severity was measured using the Insomnia Severity Index (ISI), a 7-item scale (range 0-28) where higher scores indicate more severe insomnia symptoms.
Measured: T1: Baseline, T2: Post-intervention (Week 4), T3: 4-Week Follow-Up (Week 8), T4: 12-Week Follow-Up (Week 16)
Parental Sleep Disturbance
General sleep disturbance was assessed using the General Sleep Disturbance Scale (GSDS), a 21-item measure evaluating sleep quality, sleep initiation, sleep maintenance, and daytime fatigue. Each item is rated on an 8-point scale (0-7) based on the number of days the symptom was experienced during the past week. Total scores are calculated by summing all items and range from 0 to 147, with higher scores indicating greater overall sleep disturbance.
Measured: T1: Baseline, T2: Post-intervention (Week 4), T3: 4-Week Follow-Up (Week 8), T4: 12-Week Follow-Up (Week 16)
Child Sleep Environment and Parental Interaction
Infant sleep environment and parental nighttime behaviors were assessed using the Brief Infant Sleep Questionnaire-Revised (BISQ-R). Subscale and total scores are scaled from 0 to 100, with higher scores indicating better sleep quality, more positive perception of infant sleep, and parent behaviors that promote healthy and independent sleep. The BISQ-R includes three subscales: Infant Sleep (IS), Parent Perception (PP), and Parent Behavior (PB). The total score is the average of the three subscale scores and is reported here.
Measured: T1: Baseline, T2: Post-intervention (Week 4), T3: 4-Week Follow-Up (Week 8), T4: 12-Week Follow-Up (Week 16)
Anxiety
Parental anxiety symptoms were measured using the PROMIS-Anxiety scale. Scores range from 8 to 40, with higher scores indicating greater anxiety.
Measured: T1: Baseline, T2: Post-intervention (Week 4), T3: 4-Week Follow-Up (Week 8), T4: 12-Week Follow-Up (Week 16)
Depression
Parental depressive symptoms were measured using the PROMIS-Depression scale. Scores range from 8 to 40, with higher scores indicating greater depressive symptoms.
Measured: T1: Baseline, T2: Post-intervention (Week 4), T3: 4-Week Follow-Up (Week 8), T4: 12-Week Follow-Up (Week 16)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start10 Mar 2023
- Primary completion11 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Behavioral Insomnia of ChildhoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sungshin Women's University
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Foundation of Korea
- Responsible party
- Principal investigator, Sooyeon Suh, Sungshin Women's University
- Investigators
- Sooyeon Suh, PhD, Principal investigator, Sungshin Women's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05806450
- Sponsor's protocol ID
- NRF-2021S1A5A2A03061721
- Status last verified
- Aug 2026
- First submitted
- 28 Mar 2023
- Last updated
- 30 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Cognitive-Behavioral Intervention to Improve Infant and Parent Sleep Based on Big Data Analytics
- ClinicalTrials.gov ID
- NCT05806450
- Acronym / sponsor ID
- NRF-2021S1A5A2A03061721
- Conditions
- Behavioral Insomnia of Childhood
- Keywords
- pediatric sleep problems, sleep intervention, cognitive behavioral therapy (CBT)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Sungshin Women's UniversityUniversity, hospital or other
- Collaborators
- National Research Foundation of Korea
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- 11 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 10 Apr 2023 (actual)
- Results
- Posted 30 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to develop and test the intervention program to help manage parental thoughts in parents with child sleep problems.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention condition | Experimental | Behavioral: InterventionStructured online intervention consists of three weekly sessions of cognitive therapy and psychoeducation about child sleep |
| Active control condition | Active comparator | Other: Active control conditionPsychoeducation about basic sleep structure and sleep hygiene |
Who may qualify
- Ages
- 6 to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionAlso: Sleep Intervention for Mother and BAby (SIMBA)Structured online intervention consists of three weekly sessions of cognitive therapy and psychoeducation about child sleep | Behavioural | Intervention condition |
| Active control conditionPsychoeducation about basic sleep structure and sleep hygiene | Other | Active control condition |
Primary outcome
Parental Cognition About Child Sleep
Time frame: T1: Baseline, T2: Post-intervention (Week 4), T3: 4-Week Follow-Up (Week 8), T4: 12-Week Follow-Up (Week 16)
Parental cognitions about infant sleep were assessed using the Parental Understanding and Misperceptions about BAby's Sleep Questionnaire (PUMBA-Q). Total scores range from 0 to 92, with higher scores indicating more maladaptive sleep-related cognitions.
Child Sleep Diary
Time frame: T1: Baseline, T2: Post-intervention (Week 4), T3: 4-Week Follow-Up (Week 8), T4: 12-Week Follow-Up (Week 16)
Parent-reported daily sleep diaries were used to assess infant sleep parameters, including bedtime (BT), wake time (WT), sleep onset latency (SOL), number of night awakenings (NWAK), wake after sleep onset (WASO), total sleep time (TST), parental nighttime involvement (frequency and duration), and daytime sleep (nap frequency and duration). Total sleep time (TST) is reported here as the primary summary measure.
Child Sleep (Objective Measurement)
Time frame: T1: Baseline, T2: Post-intervention (Week 4)
Infant sleep was objectively measured using home-based auto-videosomnography (Nanit), which derives sleep-wake metrics from computer-vision algorithms, including total sleep time (TST), sleep onset latency (SOL), number of night awakenings (NWAK), and wake after sleep onset (WASO), and parental nighttime involvement frequency. Total sleep time (TST) is reported here as the primary summary measure.
7 secondary outcomes
Parental Sleep Diary
Time frame: T1: Baseline, T2: Post-intervention (Week 4), T3: 4-Week Follow-Up (Week 8), T4: 12-Week Follow-Up (Week 16)
Parental Sleep (Objective Measurement)
Time frame: T1: Baseline, T2: Post-intervention (Week 4)
Parental Insomnia
Time frame: T1: Baseline, T2: Post-intervention (Week 4), T3: 4-Week Follow-Up (Week 8), T4: 12-Week Follow-Up (Week 16)
Parental Sleep Disturbance
Time frame: T1: Baseline, T2: Post-intervention (Week 4), T3: 4-Week Follow-Up (Week 8), T4: 12-Week Follow-Up (Week 16)
Child Sleep Environment and Parental Interaction
Time frame: T1: Baseline, T2: Post-intervention (Week 4), T3: 4-Week Follow-Up (Week 8), T4: 12-Week Follow-Up (Week 16)
Anxiety
Time frame: T1: Baseline, T2: Post-intervention (Week 4), T3: 4-Week Follow-Up (Week 8), T4: 12-Week Follow-Up (Week 16)
Depression
Time frame: T1: Baseline, T2: Post-intervention (Week 4), T3: 4-Week Follow-Up (Week 8), T4: 12-Week Follow-Up (Week 16)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sooyeon Suh, PhD principal investigator
Sungshin Women's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Behavioral Insomnia of Childhood, run by Sungshin Women's University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental Cognition About Child Sleep (time frame: T1: Baseline, T2: Post-intervention (Week 4), T3: 4-Week Follow-Up (Week 8), T4: 12-Week Follow-Up (Week 16)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.