Health Information Technology to Improve Bedtime Media Use in Children

January 26, 2022 updated by: Randall Grout, Indiana University

Improving Bedtime Media Use and Sleep Through Health Information Technology

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.
Other Names:
  • Intervention
Other: Sleep problems only
This arm will receive screening for and associated clinical decision support on sleep problems only.
Other: Sleep problem counseling
Participants will be screened for sleep problems, and the clinical decision support system will recommend counseling if problems are identified.
Other Names:
  • Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of clinician counseling for problematic bedtime media use and sleep problems
Time Frame: Up to 3 years
Up to 3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in bedtime media use following clinician counseling
Time Frame: Up to 3 years
Up to 3 years
Change in inadequate sleep quantity following clinician counseling
Time Frame: Up to 3 years
Up to 3 years
Change in daytime sleepiness following clinician counseling
Time Frame: Up to 3 years
Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Investigators

  • Principal Investigator: Randall W. Grout, MD, MS, Indiana University - Ped Health Services

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2017

Primary Completion (Actual)

May 31, 2019

Study Completion (Actual)

May 31, 2019

Study Registration Dates

First Submitted

June 2, 2017

First Submitted That Met QC Criteria

June 2, 2017

First Posted (Actual)

June 6, 2017

Study Record Updates

Last Update Posted (Actual)

February 9, 2022

Last Update Submitted That Met QC Criteria

January 26, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • chsr_bedtime-media-cdss_2017

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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