Development of Sleep Intervention for Parent and Child

NCT05806450 | Recruiting

• 1 other identifier: NRF-2021S1A5A2A03061721
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to develop and test the intervention program to help manage parental thoughts in parents with child sleep problems.

Conditions

Behavioral Insomnia of Childhood

Keywords

pediatric sleep problems; sleep intervention; cognitive behavioral therapy (CBT)

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (7)

• Parental sleep diary

  changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention

• Parental sleep (objective measurement)

  changes from baseline to 4 weeks

• Parental insomnia

  changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention

• Parental sleep disturbance

  changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention

• Child sleep environment and parental interaction

  changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention

Other Outcomes (3)

• Parental cognition about sleep

  changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention

• Marital satisfaction

  changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention

• Circadian rhythm

  baseline assessment to identify circadian types that reflect an individual's preferred time of day for activity

Study Arms (2)

Intervention condition

EXPERIMENTAL

Structured online intervention consists of three weekly sessions of cognitive therapy and psychoeducation about child sleep

Behavioral: Intervention

Active control condition

ACTIVE COMPARATOR

Psychoeducation about basic sleep structure and sleep hygiene

Other: Active control condition

Interventions

Intervention BEHAVIORAL

Structured online intervention consists of three weekly sessions of cognitive therapy and psychoeducation about child sleep

Also known as: Sleep Intervention for Mother and BAby (SIMBA)

Intervention condition

Active control condition OTHER

Psychoeducation about basic sleep structure and sleep hygiene

Active control condition

Eligibility Criteria

• Age: 6 Months - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sungshin Women's University: lead
• National Research Foundation of Korea: collaborator

Study Sites (1)

Sungshin Women's University

Seoul, 02844, South Korea

RECRUITING

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Sooyeon Suh, PhD

  Sungshin Women's University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sooyeon Suh, PhD

CONTACT

+82-2-920-7215; alysuh@sungshin.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: April 10, 2023
• Study Start: March 10, 2023
• Primary Completion: June 11, 2025
• Study Completion: June 30, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)