Health Information Technology to Improve Bedtime Media Use in Children

NCT ID: NCT03177421

Last Updated: 2022-02-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 60100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-13
• Study Completion Date: 2019-05-31

Brief 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.

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.

Conditions

Sleep Hygiene, Inadequate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Bedtime media use and sleep problems

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

Group Type: EXPERIMENTAL

Problematic bedtime media use counseling

Intervention Type: OTHER

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.

Sleep problems only

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

Group Type: OTHER

Sleep problem counseling

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Sleep problem counseling

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

Intervention Type: OTHER

Other Intervention Names

Intervention; Control

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• None

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Randall Grout

Visiting Assistant Professor of Clinical Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Randall W. Grout, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Indiana University - Ped Health Services

Locations

Eskenazi Health

Indianapolis, Indiana, United States

Riley Hospital for Children

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

chsr_bedtime-media-cdss_2017

Identifier Type: -

Identifier Source: org_study_id