Clinical trial NCT05820555: The Goodnight Screen Media Study
Official title: Experimental Effects of Children's Evening Media Use on Circadian Phase, Sleep and Executive Functioning
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep
Sleep Hygiene
Keywords: circadian phase
sleep
evening screen media use
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: William Marsh Rice University
name: University of Nevada, Reno
First posted: 2023-04-19
Enrollment: 180
Sex: ALL
Minimum age (years): 48
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A 3-group randomized controlled trial design will be used in which children are assigned to receive one of 2 experimental conditions or a control condition
Primary purpose: PREVENTION

Brief summary: To test the timing of evening tablet use on children's circadian phase and sleep (i.e., sleep onset and sleep duration) compared to no screen media use. To explore the effect of evening tablet use on children's inhibitory control and executive function.

Detailed description: The goal of the study is to test the effect of tablet use before bed on the sleep, circadian phase, and executive functioning (EF) of 4-year-olds using a 3-group randomized controlled trial in which children are assigned to receive one of 2 experimental conditions (Group A:1 hour of tablet use in the hour before bed; Group B:1 hour of tablet use 2 hours before bed) or a control condition (no evening screen media use). It is hypothesized that in comparison to no tablet use, daily exposure to tablet use before bed will be associated with a delay in children's circadian phase (e.g., occurring later in the evening/night), a longer sleep latency (i.e., later sleep onset), and shorter sleep duration. It is anticipated that tablet use in the hour before bed will have a greater impact on children's circadian phase and sleep than tablet use 2 hours before bed, or no tablet use before bed. We will explore whether changes in circadian phase and sleep result in poorer performance on measures of EF (i.e., inhibitory control and working memory).

Eligibility criteria: Inclusion Criteria:

* preschool-aged children (4.0 to \<5.0 years old) and their parent
* living in the Greater Houston area.
* parent must be a biological parent or legal guardian who lives with the child ≥50% of the time and has a primary role of caring for the child
* parent is comfortable participating in the study and responding to questionnaires in English.
* The child does not have to have access to mobile device, but if they do, the primary device they use has to be an Android OS ≥5.0 either used only by the study child or shared with others, or an Apple iOS ≥14.0 that only the child uses.
* Parent and child must be fluent in English.

Exclusion Criteria:

* The child has a chronic medical condition or takes a medication affecting sleep, or circadian rhythms (e.g., melatonin supplementation, diagnosed sleep disorder, steroid use, etc.) or a diagnosed cognitive or learning impairment affecting EF (e.g., attention deficit hyperactivity disorder).
* Child with blindness or significant vision problems that impacts both screen media use and sleep.

Primary outcomes:
measure: Change in Dim light Melatonin Onset Phase
timeFrame: Day 7 to Day 14
measure: Change in Dim light Melatonin Onset Phase
timeFrame: Day 14 to Day 21
Secondary outcomes:
measure: Change in the Average Sleep Onset
timeFrame: Day 1 through 6 to Day 9 through Day 13
measure: Change in the Average Sleep Onset
timeFrame: Day 9 through 13 and Day 16 through 20
measure: Change in Average Sleep duration
timeFrame: Day 1 through 6 to Day 9 through Day 13
measure: Change in Average Sleep duration
timeFrame: Day 9-13 and Day 16-20
measure: Change in Inhibitory Control-Day/Night
timeFrame: Day 14 or Day 21
measure: Change in Inhibitory Control-Grass/Snow
timeFrame: Day 14 or Day 21
measure: Change in Working memory
timeFrame: Day 14 to Day 21
measure: Change in Working memory
timeFrame: Day 14 to Day 21
measure: Change in combined assessment of Executive Functioning working memory and inhibitory control
timeFrame: Day 14 to Day 21
Other outcomes:
measure: Ambient Light Exposure
timeFrame: Days 1-21
measure: Average daily duration of Tablet use (excluding the experimental exposures)
timeFrame: Days 1-21
measure: Percentage of time that children followed the screen media use guidelines for their condition during week 2
timeFrame: Days 8-13
measure: Percentage of time that children followed the screen media use guidelines for their condition during week 3
timeFrame: Days 15-20
measure: Children's Sleep Hygiene Scale (total score)
timeFrame: Day 7
measure: The Children's Chronotype Questionnaire
timeFrame: Day 7
measure: Children's Sleep Habits Questionnaire
timeFrame: Day 7
Locations:
city: Houston
country: United States
facility: Children's Nutrition Research Center
state: Texas
Study officials:
References: