NCT07426536

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 25, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2023

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

February 14, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 23, 2026

Completed
Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

4 months

First QC Date

February 14, 2026

Last Update Submit

February 20, 2026

Conditions

Keywords

bed-sharingco-sleepingmaternal depressionmoderationsleep arrangementsleep parenting practicessleep routine consistency

Outcome Measures

Primary Outcomes (3)

  • Maternal depression is assessed by the Beck Depression Inventory-II (Beck et al., 1996)

    1-3 years postpartum

  • Toddler sleep is assessed by the Brief Infant Sleep Questionnaire-Revised (Mindell et al., 2019)

    1-3 years postpartum

  • Background data is collected by a self-designed questionnaire

    1-3 years postpartum

Interventions

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.

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Be of Taiwanese nationality.

You may qualify if:

  • 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

You may not qualify if:

  • ·none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chun Shan Medical University

Taichung, 40201, Taiwan

Location

MeSH Terms

Conditions

Consciousness Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 14, 2026

First Posted

February 23, 2026

Study Start

November 25, 2022

Primary Completion

March 25, 2023

Study Completion

January 31, 2024

Last Updated

February 23, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Because the consent of the participants was not obtained, we cannot share the data.

Locations