Health Information Technology to Improve Bedtime Media Use in Children

NCT03177421 | Terminated

• 1 other identifier: chsr_bedtime-media-cdss_2017
• Study Type: interventional
• Target: 60,100
• Locations: 1 country
• Sites: 2

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.

Conditions

Sleep Hygiene, Inadequate

Outcome Measures

Primary Outcomes (1)

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

  Up to 3 years

Secondary Outcomes (3)

• Change in bedtime media use following clinician counseling

  Up to 3 years

• Change in inadequate sleep quantity following clinician counseling

  Up to 3 years

• Change in daytime sleepiness following clinician counseling

  Up to 3 years

Study Arms (2)

Bedtime media use and sleep problems

EXPERIMENTAL

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

Other: Problematic bedtime media use counseling

Sleep problems only

OTHER

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

Other: Sleep problem counseling

Interventions

Problematic bedtime media use counseling 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.

Also known as: Intervention

Bedtime media use and sleep problems

Sleep problem counseling OTHER

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

Also known as: Control

Sleep problems only

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Indiana University: lead

Study Sites (2)

Eskenazi Health

Indianapolis, Indiana, 46202, United States

Location

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Sleep Hygiene

Interventions

Methods

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Randall W. Grout, MD, MS

  Indiana University - Ped Health Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Visiting Assistant Professor of Clinical Pediatrics

Model Details: Midway through the study, participants from the control group will be folded into the intervention group.

Study Record Dates

• First Submitted: June 2, 2017
• First Posted: June 6, 2017
• Study Start: June 13, 2017
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: February 9, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)