The Goodnight Screen Media Study

NCT ID: NCT05820555

Last Updated: 2025-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-24

Study Completion Date

2026-08-31

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).

Conditions

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Sleep Sleep Hygiene

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators
Blinding of the study biostatistician and PI during the analysis will be ensured. Groups will be denoted by a variable that does not reveal its identity. The blinding will be broken after the data set is closed and analyses completed.

Study Groups

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Group A: 1 hour of tablet use in the hour before bed

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.

Group Type EXPERIMENTAL

Timed evening technology and digital media use (tablet use)

Intervention Type BEHAVIORAL

timing of children's evening tablet device use relative to bedtime

Group B: 1 hour of tablet use 2 hours before bed

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.

Group Type EXPERIMENTAL

Timed evening technology and digital media use (tablet use)

Intervention Type BEHAVIORAL

timing of children's evening tablet device use relative to bedtime

Control Condition

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.

Group Type ACTIVE_COMPARATOR

no technology and digital media use (screen media use)

Intervention Type BEHAVIORAL

no screen media use relative to bedtime (Tablets, computers, TV, moble devices, smart phone)

Interventions

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Timed evening technology and digital media use (tablet use)

timing of children's evening tablet device use relative to bedtime

Intervention Type BEHAVIORAL

no technology and digital media use (screen media use)

no screen media use relative to bedtime (Tablets, computers, TV, moble devices, smart phone)

Intervention Type BEHAVIORAL

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.
Minimum Eligible Age

48 Months

Maximum Eligible Age

59 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

William Marsh Rice University

OTHER

Sponsor Role collaborator

University of Nevada, Reno

OTHER

Sponsor Role collaborator

Baylor College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Jennette P. Moreno, PhD

Assistant Professor, Pediatrics - Nutrition

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Children's Nutrition Research Center

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jennifer Coon

Role: CONTACT

713-798-7143

Facility Contacts

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Hafza Dadabhoy

Role: primary

713-798-0557

Jennette Moreno, PhD

Role: backup

7137987069

Other Identifiers

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P01 HD109876-01 5256

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

P01HD109876-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-52269

Identifier Type: -

Identifier Source: org_study_id

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