Development of Sleep Intervention for Parent and Child

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.

Study Overview

• Status: Recruiting
• Conditions: Behavioral Insomnia of Childhood
• Intervention / Treatment: Behavioral: Intervention; Other: Active control condition

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 Type: Interventional
• Enrollment (Estimated): 188
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sooyeon Suh, PhD; Phone Number: +82-2-920-7215; Email: alysuh@sungshin.ac.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 02844
    • Recruiting
    • Sungshin Women's University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 2 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention condition; Structured online intervention consists of three weekly sessions of cognitive therapy and psychoeducation about child sleep	Behavioral: Intervention; Structured online intervention consists of three weekly sessions of cognitive therapy and psychoeducation about child sleep; Other Names: Sleep Intervention for Mother and BAby (SIMBA)
Active Comparator: Active control condition; Psychoeducation about basic sleep structure and sleep hygiene	Other: Active control condition; Psychoeducation about basic sleep structure and sleep hygiene

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parental sleep diary	Self-report parental sleep diary will be collected. Sleep parameters include bedtime, wake time, total sleep time, sleep onset latency, wake time after sleep onset, and number of awakenings.	changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention
Parental sleep (objective measurement)	Parental sleep will be objectively measured by the Fitbit wearable device. Sleep parameters such as bedtime, wake time, and total sleep time are calculated by the algorithm.	changes from baseline to 4 weeks
Parental insomnia	The ISI (Insomnia Severity Index) scale will be used to assess self-reported levels of insomnia severity. Scores range from 0 to 28. Higher scores reflect higher levels of insomnia symptom severity.	changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention
Parental sleep disturbance	The GSDS (General Sleep Disturbance Scale) scale will be used to assess self-reported levels of general sleep disturbance. Scores range from 0 to 147. Higher scores reflect higher levels of sleep disturbance.	changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention
Child sleep environment and parental interaction	The Brief Infant Sleep Questionnaire-Revised (BISQ-R) scale will assess child sleep environment such as bedroom environment, sleep routine, and parental behavior around infant sleep.	changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention
Anxiety	The PROMIS-anxiety scale will be used to assess self-reported levels of anxiety. Scores range from 8 to 40. Higher scores reflect higher levels of anxiety.	changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention
Depression	The PROMIS-depression scale will be used to assess self-reported levels of depression. Scores range from 8 to 40. Higher scores reflect higher levels of depression.	changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parental cognition about sleep	The DBAS-16 (Dysfunctional Beliefs and Attitudes about Sleep-16) scale will be used to assess parental cognition about own sleep. Scores range from 0 to 10. Higher scores reflect more maladaptive cognition.	changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention
Marital satisfaction	The MSI-B (Marital Satisfaction Index-Brief) scale will be used to assess marital satisfaction. Scores range from 0 to 10. Higher scores reflect worse marital satisfaction.	changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention
Circadian rhythm	The MEQ (Morningness-Eveningness Questionnaire) scale will be used to assess one's circadian preference. Scores range from 16-86. Higher score means one's circadian preference is more close to morningness.	changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention

Collaborators and Investigators

• Sponsor: Sungshin Women's University
• Collaborators: National Research Foundation of Korea
• Investigators: Principal Investigator: Sooyeon Suh, PhD, Sungshin Women's University

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2023
• Primary Completion (Estimated): June 7, 2024
• Study Completion (Estimated): September 6, 2024

Study Registration Dates

• First Submitted: March 28, 2023
• First Submitted That Met QC Criteria: March 28, 2023
• First Posted (Actual): April 10, 2023

Study Record Updates

• Last Update Posted (Estimated): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: cognitive behavioral therapy (CBT); sleep intervention; pediatric sleep problems
• Other Study ID Numbers: NRF-2021S1A5A2A03061721

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No