Depressed MoodNCT07426536
Sleep Parenting, Maternal Depression, and Toddler Sleep
An observational study of Depressed Mood and Toddler Sleep, run by Chung Shan Medical University at 1 site in Taiwan.
Trial summary
This study examined the relationship between maternal depression and toddler sleep. The moderating role of sleep parenting practices in the relationship was also explored. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depressed Mood, Toddler Sleep
- What is being tested?
- Beck Depression Inventory-II, Brief Infant Sleep Questionnaire-Revised, Background data sheet
- How many people
- 126 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Nov 2022to 31 Jan 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Be of Taiwanese nationality.
Who may be able to join
- Be 20 years of age or older
- Have a singleton child aged one to three years
- Be able to read and write Chinese
- Be of Taiwanese nationality
Who cannot join
- ·none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sleep Parenting Practices Moderate the Association Between Maternal Depression and Toddler Sleep
This study examined the relationship between maternal depression and toddler sleep. The moderating role of sleep parenting practices in the relationship was also explored.
- Conditions
- Depressed Mood, Toddler Sleep
- Being tested
- Beck Depression Inventory-II, Brief Infant Sleep Questionnaire-Revised, Background data sheet
- Keywords
- bed-sharing, co-sleeping, maternal depression, moderation, sleep arrangement, sleep parenting practices, sleep routine consistency
- Medical subject headings
- Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beck Depression Inventory-II, Brief Infant Sleep Questionnaire-Revised, Background data sheetDiagnostic test
Maternal depression was assessed using the Beck Depression Inventory, Second Edition (BDI-II; Beck, 1961/2000). Toddler sleep was assessed with the Brief Infant Sleep Questionnaire-Revised (BISQ-R, Sadeh, 2004). Four sleep indicators were used: severity of sleep problems, sleep latency, number of night awakenings, and nighttime sleep duration. Two sleep parenting practices were measured: sleep location and consistency of bedtime routines. Background information was collected using a self-designed questionnaire.
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal depression is assessed by the Beck Depression Inventory-II (Beck et al., 1996)
Measured: 1-3 years postpartum
Toddler sleep is assessed by the Brief Infant Sleep Questionnaire-Revised (Mindell et al., 2019)
Measured: 1-3 years postpartum
Background data is collected by a self-designed questionnaire
Measured: 1-3 years postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start25 Nov 2022
- Primary completion25 Mar 2023
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressed MoodStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 126 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peyling Shieh, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07426536
- Sponsor's protocol ID
- CS2-22136
- Status last verified
- Feb 2026
- First submitted
- 14 Feb 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Because the consent of the participants was not obtained, we cannot share the data.
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Parenting Practices Moderate the Association Between Maternal Depression and Toddler Sleep
- ClinicalTrials.gov ID
- NCT07426536
- Acronym / sponsor ID
- CS2-22136
- Conditions
- Depressed Mood, Toddler Sleep
- Keywords
- bed-sharing, co-sleeping, maternal depression, moderation, sleep arrangement, sleep parenting practices, sleep routine consistency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Study start
- 25 Nov 2022 (actual)
- Primary completion
- 25 Mar 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examined the relationship between maternal depression and toddler sleep. The moderating role of sleep parenting practices in the relationship was also explored.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Be of Taiwanese nationality.
Key inclusion criteria (4 listed)
- Be 20 years of age or older
- Have a singleton child aged one to three years
- Be able to read and write Chinese
- Be of Taiwanese nationality
Key exclusion criteria (1 listed)
- ·none
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 |
|---|---|---|
| Beck Depression Inventory-II, Brief Infant Sleep Questionnaire-Revised, Background data sheetMaternal depression was assessed using the Beck Depression Inventory, Second Edition (BDI-II; Beck, 1961/2000). Toddler sleep was assessed with the Brief Infant Sleep Questionnaire-Revised (BISQ-R, Sadeh, 2004). Four sleep indicators were used: severity of sleep problems, sleep latency, number of night awakenings, and nighttime sleep duration. Two sleep parenting practices were measured: sleep location and consistency of bedtime routines. Background information was collected using a self-designed questionnaire. | Diagnostic test | – |
Primary outcome
Maternal depression is assessed by the Beck Depression Inventory-II (Beck et al., 1996)
Time frame: 1-3 years postpartum
Toddler sleep is assessed by the Brief Infant Sleep Questionnaire-Revised (Mindell et al., 2019)
Time frame: 1-3 years postpartum
Background data is collected by a self-designed questionnaire
Time frame: 1-3 years postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Individual participant dataSharing planned: No. Because the consent of the participants was not obtained, we cannot share the data.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depressed Mood and Toddler Sleep, run by Chung Shan Medical University at 1 site in Taiwan.
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 4 inclusion and 1 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 23 Feb 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maternal depression is assessed by the Beck Depression Inventory-II (Beck et al., 1996) (time frame: 1-3 years postpartum). 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 23 Feb 2026.