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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03177421
Other study ID # chsr_bedtime-media-cdss_2017
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date June 13, 2017
Est. completion date May 31, 2019

Study information

Verified date January 2022
Source Indiana University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 60100
Est. completion date May 31, 2019
Est. primary completion date May 31, 2019
Accepts healthy volunteers No
Gender All
Age group 2 Years to 18 Years
Eligibility Inclusion Criteria: - Attend a participating clinic - Complete a prescreener form in the clinic Exclusion Criteria: - None

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Eskenazi Health Indianapolis Indiana
United States Riley Hospital for Children Indianapolis Indiana

Sponsors (1)

Lead Sponsor Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of clinician counseling for problematic bedtime media use and sleep problems Up to 3 years
Secondary Change in bedtime media use following clinician counseling Up to 3 years
Secondary Change in inadequate sleep quantity following clinician counseling Up to 3 years
Secondary Change in daytime sleepiness following clinician counseling Up to 3 years
See also
  Status Clinical Trial Phase
Completed NCT03717857 - A Sleep Hygiene Intervention to Improve Sleep Quality in Urban, Latino Middle School Children - Phase 1