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TerminatedNCT03177421Updated Feb 9, 2022

Health Information Technology to Improve Bedtime Media Use in Children

An interventional study of Problematic bedtime media use counseling and Sleep problem counseling in Sleep Hygiene, Inadequate, sponsored by Indiana University. Terminated at 2 sites in United States. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2022-02-09.

Sponsored by Indiana University · Not applicable, Interventional, and Health services research

Why this study was terminated
Study technology decommissioned at clinical site.
Phase
Not applicable
Study type
Interventional
Enrollment
60,100
Allocation
Randomized
Ages
2 Years to 18 Years
Sex
All
01

Study summary

The objective of this study is to use health information technology to implement and evaluate a counseling recommendation for children who suffer from problematic sleep associated with bedtime media use. Participants will be randomized by clinic to be screened for basic sleep concerns and receive appropriate counseling, or to be screened for sleep concerns and media use, and receive appropriate counseling.

Read the detailed description

Children and adolescents are increasingly integrating media and technology into daily life. A large body of research has shown poor sleep-related outcomes related to media exposure, especially in evening or bedtime hours - a trend that holds true from infancy to adolescence. Prior research has demonstrated clinic-based interventions can be effective in reducing general screen time. Yet, little work has been done to leverage existing health information technology to adapt bedtime media use guidelines into sustainable counseling interventions. This study will develop, implement, and evaluate a computerized, evidence-based decision support intervention for reducing inappropriate childhood bedtime media use and improving sleep measures.

02

Conditions studied

  • Sleep Hygiene, Inadequate
03

In context

Lead sponsor

Indiana University is the lead sponsor of 958 studies on the registry; 200 are open to participants now.

Of its 142 completed or terminated interventional studies of FDA-regulated products, 112 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Attend a participating clinic
  • Complete a prescreener form in the clinic

Exclusion criteria

Exclusion Criteria:

  • None
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
60,100 participants (actual)

Study arms

  • Experimental
    Bedtime media use and sleep problems

    This arm will receive screening for and associated clinical decision support on sleep problems and bedtime media use.

    Other: Problematic bedtime media use counseling

  • Other
    Sleep problems only

    This arm will receive screening for and associated clinical decision support on sleep problems only.

    Other: Sleep problem counseling

Interventions

  • OtherProblematic bedtime media use counseling

    Participants will be screened for bedtime media use and sleep problems, and the clinical decision support system will recommend counseling on the respective problems identified on screening.

    Also known as: Intervention

  • OtherSleep problem counseling

    Participants will be screened for sleep problems, and the clinical decision support system will recommend counseling if problems are identified.

    Also known as: Control

06

What researchers measure

Primary outcomes

  1. Rate of clinician counseling for problematic bedtime media use and sleep problems

    Time frame: Up to 3 years

Secondary outcomes

  1. Change in bedtime media use following clinician counseling

    Time frame: Up to 3 years

  2. Change in inadequate sleep quantity following clinician counseling

    Time frame: Up to 3 years

  3. Change in daytime sleepiness following clinician counseling

    Time frame: Up to 3 years

07

Study locations

2 sites
  • Eskenazi Health
    Indianapolis, Indiana 46202, United States
  • Riley Hospital for Children
    Indianapolis, Indiana 46202, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03177421
Lead sponsor
Indiana University
Responsible party
Randall Grout (Visiting Assistant Professor of Clinical Pediatrics, Indiana University) — Principal investigator
First posted
Jun 6, 2017
Start date
Jun 13, 2017
Primary completion
May 31, 2019
Completion
May 31, 2019
Last update
Feb 9, 2022

Study contacts

Randall W. Grout, MD, MS
principal investigator · Indiana University - Ped Health Services

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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