The Goodnight Screen Media Study

Study Overview
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Brief Summary
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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
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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).

Official Title
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Experimental Effects of Children's Evening Media Use on Circadian Phase, Sleep and Executive Functioning

Conditions
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Sleep, Sleep Hygiene

Intervention / Treatment
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* Behavioral: Timed evening technology and digital media use (tablet use)
* Behavioral: no technology and digital media use (screen media use)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 48 Months
Maximum Age: 59 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A: 1 hour of tablet use in the hour before bed<br>During week 1, children will maintain a sleep schedule within 30 minutes +/- of their habitual bedtime. This bedtime will be maintained throughout the 3 weeks of the study except on nights when dim light melatonin onset is assessed in the lab. During week 2, participants will be asked to reframe from screen use in the 3 hours before bed time for 6 evenings. During week 3, participants will be exposed to 1 hour of tablet use (Standard bright setting), 1 hour before bedtime for 6 evenings. | Behavioral: Timed evening technology and digital media use (tablet use)<br>* timing of children's evening tablet device use relative to bedtime<br>|
| Experimental: Group B: 1 hour of tablet use 2 hours before bed<br>During week 1, children will maintain a sleep schedule within 30 minutes +/- of their habitual bedtime. This bedtime will be maintained throughout the 3 weeks of the study except on nights when dim light melatonin onset is assessed in the lab. During week 2, participants will be asked to reframe from screen use in the 3 hours before bedtime for 6 evenings. During week 3, participants will be exposed to 1 hour of tablet use (Standard bright setting), 2 hours before bedtime (and no screen use in the hour before bed) for 6 evenings. | Behavioral: Timed evening technology and digital media use (tablet use)<br>* timing of children's evening tablet device use relative to bedtime<br>|
| Active Comparator: Control Condition<br>During week 1, children will maintain a sleep schedule within 30 minutes +/- of their habitual bedtime. This bedtime will be maintained throughout the 3 weeks of the study except on nights when dim light melatonin onset is assessed in the lab. During week 2, participants will engage no screen use for the 3 hours before bedtime for 6 evenings. During week 3, participants will be asked to engage in no screen use in the 3 hours before bedtime for 6 evenings. | Behavioral: no technology and digital media use (screen media use)<br>* no screen media use relative to bedtime (Tablets, computers, TV, moble devices, smart phone)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Dim light Melatonin Onset Phase | Circadian phase can be examined by measuring the circadian timing of melatonin onset under dim light conditions (dim light melatonin onset; DMLO). Compared to markers of endogenous circadian rhythms, melatonin is relatively robust. Salivary DLMO measures have demonstrated high intraclass correlations (.93) with plasma and sensitivity and specificity comparable to plasma assays. Following established procedures with children, salivary DLMO will be collected on a in the laboratory under dim light conditions (<5 lux), via a cheek swab every 30-60 minutes beginning 5 hours prior to and ending 1-hour following typical bedtime. Saliva samples will be centrifuged, frozen, and assayed using radioimmunoassay test kits by Solid Phase in Portland Me. DLMO phase will be determined using linear interpolation across the time points before and after melatonin concentration increased to and remained above 4pg/mL. | Day 7 to Day 14 | 
| Change in Dim light Melatonin Onset Phase | Circadian phase can be examined by measuring the circadian timing of melatonin onset under dim light conditions (dim light melatonin onset; DMLO). Compared to markers of endogenous circadian rhythms, melatonin is relatively robust. Salivary DLMO measures have demonstrated high intraclass correlations (.93) with plasma and sensitivity and specificity comparable to plasma assays. Following established procedures with children, salivary DLMO will be collected on a in the laboratory under dim light conditions (<5 lux), via a cheek swab every 30-60 minutes beginning 5 hours prior to and ending 1-hour following typical bedtime. Saliva samples will be centrifuged, frozen, and assayed using radioimmunoassay test kits by Solid Phase in Portland Me. DLMO phase will be determined using linear interpolation across the time points before and after melatonin concentration increased to and remained above 4pg/mL. | Day 14 to Day 21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Average Sleep Onset | Actigraphs (GT3X-BT, Pensacola, FL) worn on the wrist of the non dominant hand 24 hours a day for 4-5 days will measure sleep duration and timing of sleep onset and waking. Wrist placement reliably measures sleep duration. Sleep diaries will be completed. Monitor-wear logs will identify times the accelerometer is removed and the activity engaged in while the monitor is off. | Day 1 through 6 to Day 9 through Day 13 | 
| Change in the Average Sleep Onset | Actigraphs (GT3X-BT, Pensacola, FL) worn on the wrist of the non dominant hand 24 hours a day for 4-5 days will measure sleep duration and timing of sleep onset and waking. Wrist placement reliably measures sleep duration. Sleep diaries will be completed. Monitor-wear logs will identify times the accelerometer is removed and the activity engaged in while the monitor is off. | Day 9 through 13 and Day 16 through 20 | 
| Change in Average Sleep duration | Actigraphs (GT3X-BT, Pensacola, FL) worn on the wrist of the non dominant hand 24 hours a day for 4-5 days will measure sleep duration and timing of sleep onset and waking. Wrist placement reliably measures sleep duration. Sleep diaries will be completed. Monitor-wear logs will identify times the accelerometer is removed and the activity engaged in while the monitor is off. | Day 1 through 6 to Day 9 through Day 13 | 
| Change in Average Sleep duration | Actigraphs (GT3X-BT, Pensacola, FL) worn on the wrist of the non dominant hand 24 hours a day for 4-5 days will measure sleep duration and timing of sleep onset and waking. Wrist placement reliably measures sleep duration. Sleep diaries will be completed. Monitor-wear logs will identify times the accelerometer is removed and the activity engaged in while the monitor is off. | Day 9-13 and Day 16-20 | 
| Change in Inhibitory Control-Day/Night | Children's inhibitory control will be assessed using the Day/Night task. The order of this task will be counterbalanced across Day 14 and 21. This task can be used interchangeably with Grass/snow, so we will examine the difference in performance from the test administered on day 14 to the test administered on day 21. | Day 14 or Day 21 | 
| Change in Inhibitory Control-Grass/Snow | Children's inhibitory control will be assessed using the Grass/Snow. The order of this task will be counterbalanced across Day 14 and 21. This task can be used interchangeably with Grass/snow, so we will examine the difference in performance from the test administered on day 14 to the test administered on day 21. | Day 14 or Day 21 | 
| Change in Working memory | Children's Working Memory will be assessed using the Missing Scan assessment. This task will be administered at Day 14 and 21. | Day 14 to Day 21 | 
| Change in Working memory | Children's Working Memory will be assessed using the Spin the Pots assessment. This task will be administered at Day 14 and 21. | Day 14 to Day 21 | 
| Change in combined assessment of Executive Functioning working memory and inhibitory control | The Head-Toes-Knees-Shoulder Task assesses both working memory and inhibitory control and will be administered on Day 14 and Day 21. | Day 14 to Day 21 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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circadian phase, sleep, evening screen media use