Helping parents manage their child's sleep problems
Development of a Cognitive-Behavioral Intervention to Improve Infant and Parent Sleep Based on Big Data Analytics
This study is testing a new program to help parents better manage their child's sleep problems by changing any misunderstandings they might have about sleep.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 190 (estimated) |
| Ages | 6 Months to 24 Months |
| Sex | All |
| Sponsor | Sungshin Women's University Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05806450 on ClinicalTrials.gov |
What this trial studies
This study aims to develop and test an intervention program designed to assist parents in managing their child's sleep issues, specifically focusing on behavioral insomnia in children. The approach involves addressing parental thoughts and beliefs that may hinder the effective implementation of behavioral sleep interventions. By utilizing cognitive behavioral therapy techniques, the study will identify and target misperceptions parents have about their child's sleep. The efficacy of this intervention will be evaluated through a randomized controlled trial.
Who should consider this trial
Good fit: Ideal candidates include primary nighttime caregivers of healthy children aged 6 to 24 months who are native Korean speakers residing in South Korea.
Not a fit: Patients whose children have developmental disabilities or were born preterm or post-term may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve sleep quality for both children and their parents.
How similar studies have performed: Previous studies have shown that addressing parental beliefs can enhance the effectiveness of sleep interventions, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seoul
- Sungshin Women's University — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Sooyeon Suh, PhD — Sungshin Women's University
- Study coordinator: Sooyeon Suh, PhD
- Email: alysuh@sungshin.ac.kr
- Phone: +82-2-920-7215
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.