Check Yourself Study

Promoting Adolescent Health Through Personalized Feedback

The proposed study is a randomized controlled trial that compares the effectiveness of an electronic personalized health screening app incorporating motivational feedback (i.e., "Check Yourself") to usual care. The purpose of this study is to determine whether Check Yourself is more effective than usual care in reducing health risk behaviors and improving quality of care among adolescents receiving primary health care services.

Study Overview

• Status: Completed
• Conditions: Health Risk Behaviors; Health Care Services Quality of Care
• Intervention / Treatment: Behavioral: Check Yourself App with Feedback

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Eligible individuals will be 13-18 years old who have an appointment to see a provider at a participating clinic and will be able to read and comprehend English.

Exclusion Criteria:

• Individuals will be excluded from the study if:

  • they do not meet age requirements,
  • do not have an appointment at a participating clinic,
  • lack the means to complete follow-up interviews (i.e., has neither telephone not internet access),
  • have a sibling who has/is being enrolled in the study and/or
  • are not able to read or comprehend English.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Check Yourself App With Feedback; Adolescents complete Check Yourself, an electronic health screening app and receive personalized, motivational feedback on their health behaviors prior to their primary care appointment. Key components of Check Yourself include the provision of age normative feedback, goal setting strategies, and strategies to highlight discrepancies. Primary care providers receive a summary report of health risk behaviors from Check Yourself prior to their adolescent patient's primary care appointment.	Behavioral: Check Yourself App with Feedback
No Intervention: Usual Care; Participants are asked to complete health risk screening on a tablet computer. No personalized feedback is provided to adolescents and primary care providers do not receive a summary report of the adolescent's health risk behaviors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Health risk behaviors	Total count health-risk behaviors at 3-month follow-up (Score range= 0-13) adjusted by total number of baseline risk behaviors (with risk cut-off): ≥2 sugar-sweetened beverages consumed/day; ≤3 servings fruits/vegetables consumed/day; ≤3 days with 60+ minutes exercise during typical week; ≥3 hours of screen time during typical school day; ≤7 hours of sleep during typical night; not "always" using seatbelt; not "always" using helmet when bicycling; having driven under the influence of substances; days of alcohol consumption in last 30 days (risk based on age: ≥1 day/30 days (ages 13-15), ≥2 days/30 days (ages 16-17), or ≥3 days/30 days (age 18)) and/or number of drinks/drinking episode (risk based on age and sex: ≥3 (Girls 13-17; Boys 13), ≥4 (Girls 18; Boys 14-15), or ≥5 (Boys 16-18)); any tobacco use; any marijuana/other drugs use; not using birth control during last sexual intercourse and/or not "always" using a condom; and ≥10 score on PHQ-9.	3 months
Number of risk behaviors counseled on during primary care appointment	Number of adolescent-reported high risk health risk behaviors discussed with the healthcare provider during the primary care visit (Score range: 0-13) adjusted for the total number of health risk behaviors reported at baseline. Receipt of counseling/discussion assessed using an adapted version of the Adolescent Report of the Visit (AROV). The AROV includes counseling on the following behaviors: 1) sweetened beverage consumption; 2) fruit/vegetable consumption; 3) physical activity amount; 4) screen time (i.e., watching TV, playing video games, surfing the web, or texting); 5) sleep duration; 6) seat belt use; 7) helmet use while bicycling; 8) drinking/using drugs while driving; 9) alcohol use; 10) tobacco use; 11) marijuana and/or other drug use; 12) condom and/or birth control use; 13) depression and moods.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adolescent Satisfaction with Care	Adolescent satisfaction with care will be assessed using the total score on the 8-item Client Satisfaction Questionnaire (CSQ-8) at 1-day follow-up.	1 day
Interval Receipt of Care	Dichotomous variable indicating receipt of any follow-up care to address risk behaviors identified at baseline adjusted for baseline number of health risk behaviors.	3 months
Motivation for Health Behavior Change	Assessment of adolescent reported motivation to change overall health using a Readiness to Change Ruler.	1 day
Specific Health Risk Behavior Change	Reported level for each specific health risk behavior at 3 months adjusting for baseline level of that specific behavior. Specific individual behaviors include: A.) number of: sweetened beverages consumed in a typical day; fruits and vegetables consumed in a typical day; days with >60 minutes of physical activity in an average week; hours of screen time on a typical day; hours of sleep on a typical night; days in which alcohol was consumed in the prior month; alcoholic drinks typically consumed per occasion; any tobacco use in the prior month (yes/no); days using marijuana in the past month; B) Score on the nine item Patient Health Questionnaire (27 point scale); C) Frequency of: seatbelt use in a car (4-point scale); helmet use while bicycling (4-point scale); condom use with sexual intercourse (4-point scale); D) Use of any form of birth control at last sexual intercourse (yes/no); and E) Driving under the influence of a substance (yes/no).	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adolescent Perceived Support from their Primary Care Provider	The total score on the Health Care Climate Questionnaire (HCCQ),) will be used to assess adolescent self-report of perceived autonomy support from their primary care provider.	1 day
Adolescent Health Self-Efficacy	The total score on the Health Self Efficacy Scale will be used to assess adolescent self-report of perceived confidence in ability to execute health behaviors.	1 day

Collaborators and Investigators

• Sponsor: Laura Richardson
• Investigators: Principal Investigator: Laura P Richardson, MD MPH, Seattle Children's Hospital

Publications and helpful links

General Publications

• Richardson LP, Zhou C, Gersh E, Spielvogle H, Taylor JA, McCarty CA. Effect of Electronic Screening With Personalized Feedback on Adolescent Health Risk Behaviors in a Primary Care Setting: A Randomized Clinical Trial. JAMA Netw Open. 2019 May 3;2(5):e193581. doi: 10.1001/jamanetworkopen.2019.3581.

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: February 5, 2015
• First Submitted That Met QC Criteria: February 9, 2015
• First Posted (Estimate): February 10, 2015

Study Record Updates

• Last Update Posted (Actual): April 18, 2018
• Last Update Submitted That Met QC Criteria: April 17, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 6 R40MC26817-01-01