Recruiting

Observational Study

Sponsor:

Seattle Children's Hospital

Code:

NCT03304574

Conditions

Adolescent Behavior

Risk Behavior

Motivation

Eligibility Criteria

Sex: All

Age: 13 - 18

Healthy Volunteers: Accepted

Interventions

Integrated personalized feedback

Study Details

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

Study ID

NCT03304574

Start date

Mar 1, 2017

Status verified date

Sep, 2018

Completion date

Nov 30, 2018

Anticipated

Primary completion date

Oct 1, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 18

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 13-18 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

no intervention: Control

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

experimental: Intervention

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

Interventions

Integrated personalized feedback

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.

Primary outcome measure

  • Motivation to change [ Time Frame: We anticipate measuring this outcome by September 30, 2018, 6 months after recruitment has closed. ]
  • Decreased risk behaviors [ Time Frame: We anticipate measuring this outcome by September 30, 2018, 6 months after recruitment has closed. ]
  • Prevalence of risk behaviors [ Time Frame: We anticipate measuring this outcome by September 30, 2018, 6 months after recruitment has closed. ]

Central Contacts and Locations

Central contacts

Taraneh Shafii, MD, MPH

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

Eileen Klein, MD, MPH

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

Locations

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

Contacts

Lindsey Johnson

206-884-1075lindsey.johnson@seattlechildrens.org

Principal Investigator:

Taraneh Shafii, MD, MPH

More Information

Sponsor

Seattle Children's Hospital

Last update posted

Sep 6, 2018

Last verified

Sep, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Seattle Children's Hospital on 2018-09-06.