CheckED Yourself Study

NCT03304574 | Unknown

• 1 other identifier: 00000365
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

During adolescence, the most common causes of morbidity and mortality are related to risky behaviors. The American Academy of Pediatrics recommends that adolescents be screened for these behaviors during primary care visits, but many adolescents do not receive the recommended risk behavior screening and counseling, in part because they are infrequently seen in primary care. The objective of this study is to evaluate if the electronic health screening tool, which includes an electronic health assessment with integrated personalized feedback, reduces risk behaviors in adolescents seen in the Emergency Department (ED).

Conditions

Adolescent Behavior; Risk Behavior; Motivation

Outcome Measures

Primary Outcomes (3)

• Motivation to change

  To evaluate if adolescents who received integrated personalized feedback had higher levels of motivation to change their risk behaviors post-Emergency Department visit compared to adolescents who completed the electronic health assessment only and did not receive personalized feedback

  We anticipate measuring this outcome by September 30, 2018, 6 months after recruitment has closed.

• Decreased risk behaviors

  To evaluate if adolescents who received integrated personalized feedback reported decreased risk behaviors 3 months post-Emergency Department visit compared to adolescents who completed the electronic health assessment only and did not receive personalized feedback.

  We anticipate measuring this outcome by September 30, 2018, 6 months after recruitment has closed.

• Prevalence of risk behaviors

  To describe the prevalence of risk behaviors among adolescents who present to the Emergency Department for care.

  We anticipate measuring this outcome by September 30, 2018, 6 months after recruitment has closed.

Study Arms (2)

Control

NO INTERVENTION

Participants will complete the electronic health assessment only and will not receive integrated personalized feedback

Intervention

EXPERIMENTAL

Participants will complete the electronic health assessment and will receive integrated personalized feedback

Behavioral: Integrated personalized feedback

Interventions

Integrated personalized feedback BEHAVIORAL

Integrated personalized feedback about self-reported risk behaviors will be generated and shown to participants as they complete their baseline health risk assessment using the CheckED Yourself app. The integrated personalized feedback is based on motivational feedback strategies such as normative feedback (comparison to peer behaviors and age-based health guidelines), increasing knowledge regarding potential consequences of behaviors, and providing practical tips for changing behavior.

Intervention

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• years of age
• Ability of patient and parent of patient \<18 years old to fluently speak and read English
• Has email address and/or cell phone

You may not qualify if:

• Inability to independently complete the assessment due to intellectual disability
• Acute cognitive impairment due to injury and/or intoxication
• Administration of IV sedation or pain medications during Emergency Department visit
• Presenting to the Emergency Department due to a psychiatric or mental health complaint
• Emergency Department visit results in hospital admission

Sponsors & Collaborators

• Seattle Children's Hospital: lead

Study Sites (1)

Seattle Children's Hospital

Seattle, Washington, 98105, United States

RECRUITING

MeSH Terms

Conditions

Adolescent Behavior; Risk-Taking

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Taraneh Shafii, MD, MPH

CONTACT

206-987-2028; taraneh.shafii@seattlechildrens.org

Eileen Klein, MD, MPH

CONTACT

206-987-2708; eileen.klein@seattlechildrens.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded to their group assignment.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will be randomly assigned to one of two groups, a control or intervention group. Those assigned to the control group will complete the electronic health assessment only and will not receive integrated personalized feedback. Those assigned to the intervention group will complete the electronic health assessment and will receive integrated personalized feedback.

Study Record Dates

• First Submitted: October 3, 2017
• First Posted: October 9, 2017
• Study Start: March 1, 2017
• Primary Completion: October 1, 2018
• Study Completion: November 30, 2018
• Last Updated: September 6, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)