- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02882919
Check Yourself v2.0
August 27, 2020 updated by: Carolyn McCarty
Improving Teen Health With Health Information Technology
Health risk screening in adolescent primary care is infrequently performed and results are rarely followed by targeted intervention.
In response to the need for screening-linked interventions, the study team has developed and optimized a web-based, electronic Personalized Motivational Feedback tool referred to as "Check Yourself v2.0"
Based on motivational interviewing, a technique to mobilize personal change, Check Yourself is designed to promote healthy choices for the multiple behaviors relevant to adolescents.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The proposed study is a randomized controlled trial that compares the effectiveness of Check Yourself v2.0 to usual care.
The purpose of this study is to determine the impact of Check Yourself on reducing health risk behaviors and improving quality of care among adolescents receiving primary health care services relative to usual care.
Study Type
Interventional
Enrollment (Actual)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Washington
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Seattle, Washington, United States, 98105
- Seattle Children's Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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 adolescent participants will be13-18 years of age
- Able to understand English.
- Will have an appointment (or have a child with an appointment) with a participating medical practice.
Exclusion Criteria: Adolescents will be excluded from the study
- Participants do not meet age requirements
- Do not have an appointment with a participating provider at a PSPRN clinic,
- Lack the means to complete follow-up interviews (i.e., have neither telephone nor internet access)
- Have a sibling who has been/is being enrolled in the study or have previously participated in our previous trial comparing Check Yourself to usual care
- Not able to understand English.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Check Yourself v2.0
In the intervention group, adolescents complete Check Yourself which delivers 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 will receive a summary report of health risk behaviors prior to their adolescent patient's primary care appointment.
|
In the intervention group, adolescents complete Check Yourself which delivers 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 increase motivation for healthy behaviors.
Primary care providers will receive a summary report of health risk behaviors prior to their adolescent patient's primary care appointment.
|
|
No Intervention: Usual care
In the usual care group, patients are asked to complete health risk screening on a 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
Time Frame: 3 months
|
The risk behavior scale includes 22 values: 0 (min) to 21 (max).
Higher scores indicate a worse outcome.
Endorsement of any of the following counts as 1 (moderate risk) or 2 (high risk) on the scale depending on response and participant: ≥2 sugar-sweetened beverages consumed during typical day; ≤3 servings fruits/vegetables consumed during typical day; ≤3 days with 60+ minutes exercise during typical week; texting while driving in past 3 months; ≤7 hrs of sleep during typical night; not "always" using seatbelt; not "always" using helmet when bicycling; having driven under the influence of substances; tobacco use; days alcohol consumption in last 30 days (risk based on age) and/or number of drinks per drinking episode (risk based on age & sex); days marijuana consumption in last 30 days (risk based on age) and/or other drug use in past 3 months; not using birth control during last sexual intercourse and/or not "always" using a condom; & score of ≥10 on PHQ-9 depression.
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3 months
|
|
Sweetened Beverage Consumption
Time Frame: 3 months
|
Adolescent self-reported sweetened beverages consumed in a typical day in past 3 months.
The sweetened beverages scale includes 4 values: 0 (min), 1, 2, or 3+ (max) sweetened beverages per day.
Higher scores mean a worse outcome.
|
3 months
|
|
Physical Activity
Time Frame: 3 month
|
Adolescent self-reported days with >60 minutes of physical activity in an average week in past 3 months.
The physical activity scale includes 8 values: 0 (min) to 7 (max).
Higher scores mean a better outcome.
|
3 month
|
|
Sleep
Time Frame: 3 month
|
Adolescent self-reported hours of sleep on a typical night in past 3 months. .
The sleep scale includes 13 values: 0 (min) to 12+ (max) hours of sleep per night.
Higher scores mean a better outcome.
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3 month
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|
Alcohol Consumption (frequency)
Time Frame: 3 month
|
Adolescent self-reported number of days of alcohol consumption and number of drinks during a typical drinking episode in the prior month
|
3 month
|
|
Marijuana and/or Other Drug Consumption
Time Frame: 3 month
|
Adolescent self-reported number of days using marijuana in the past month and/or other drugs used in past 3 months.
Two questions were used for this category.
The marijuana frequency scale includes 31 values: 0 (min) to 30 (max) days in the past month.
Higher scores mean a worse outcome.
Adolescent self-reported use of other drugs in the past 3 months.
The other drug score includes 2 values: 0=no (min) and 1=yes (max).
Higher scores mean a worse outcome.
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3 month
|
|
Depression
Time Frame: 3 month
|
Adolescent self-reported depression as measured on the nine item Patient Health Questionnaire in past 2 weeks.
The PHQ-9 depression scale includes 28 values: 0 (min) to 27 (max).
Higher scores mean a worse outcome.
|
3 month
|
|
Seat belt Use
Time Frame: 3 month
|
Adolescent self-reported frequency of seat belt use in a car in past 3 months. .
The seatbelt use scale includes 4 values: 1=never (min), 2=sometimes, 3=usually, or 4=always (max).
Higher scores mean a better outcome.
|
3 month
|
|
Helmet Use
Time Frame: 3 month
|
Adolescent self-reported frequency of helmet use while bicycling in past 3 months.
The helmet use scale includes 4 values: 1=never (min), 2=sometimes, 3=usually, or 4=always (max).
Higher scores mean a better outcome.
|
3 month
|
|
Texting while driving
Time Frame: 3 month
|
Adolescent self-reported endorsement of texting while driving in past 3 months.
This question is only asked among adolescents who drive a car.
The texting while driving scale includes 4 values: 1=never (min), 2=sometimes, 3=usually, or 4=always (max).
Higher scores mean a worse outcome.
|
3 month
|
|
Condom Use and/or Birth Control Use
Time Frame: 3 month
|
Adolescent self-reported condom use with sexual intercourse in past 3 months and/or use of birth control with last sexual intercourse.
Two questions were used for this category.
These questions were asked only to sexually active youth.
The condom use scale includes 4 values: 1=always (min), 2=often, 3=sometimes, 4=never (max).
Higher scores mean a worse outcome.
The birth control scale includes 2 values: 0=no (min), 1=yes (max).
Higher scores mean a better outcome.
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3 month
|
|
Driving with Impairment
Time Frame: 3 month
|
Adolescent self-reported driving under the influence of a substance in past 3 months.
This question was asked only of adolescents who drive a car.
The driving with impairment scale includes 2 values: 0=no (min) and 1=yes (max).
Higher scores mean a worse outcome
|
3 month
|
|
Fruit and Vegetable Consumption
Time Frame: 3 month
|
Adolescent self-reported fruits and vegetables consumed in a typical day in past 3 months.
The fruits and vegetables scale includes 6 values: 0 (min), 1, 2, 3, 4, or 5+ (max).
Higher scores mean a better outcome.
|
3 month
|
|
Percent of risk behaviors counseled on during primary care appointment
Time Frame: 1 day
|
Percent of adolescent-reported health risk behaviors discussed with the healthcare provider during the primary care visit adjusted for the total number of health risk behaviors reported at baseline.
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1 day
|
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Adolescent Satisfaction with Care
Time Frame: 1 day
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Adolescent satisfaction with care will be assessed using 1 item adapted from the consumer Assessment Of healthcare Providers and Systems (CAHPS) measure at 1 day follow up.
The CAHPS scale includes 10 values: 1 (min) to 10 (max).
Higher scores mean a better outcome.
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1 day
|
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Tobacco Use
Time Frame: 3 month
|
Adolescent self-reported endorsement of tobacco use in past 3 months.
The tobacco use scale includes 2 values: 0=no (min) or 1=yes (max).
Higher scores mean a worse outcome.
|
3 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sweetened Beverage Consumption
Time Frame: 6 month
|
Adolescent self-reported sweetened beverages consumed in a typical day in past 3 months
|
6 month
|
|
Fruit and Vegetable Consumption
Time Frame: 6 month
|
Adolescent self-reported fruits and vegetables consumed in a typical day in past 3 months
|
6 month
|
|
Physical Activity
Time Frame: 6 month
|
Adolescent self-reported days with >60 minutes of physical activity in an average week in past 3 months
|
6 month
|
|
Sleep
Time Frame: 6 month
|
Adolescent self-reported hours of sleep on a typical night in past 3 months
|
6 month
|
|
Marijuana and/or Other Drug Consumption
Time Frame: 6 month
|
Adolescent self-reported number of days using marijuana in the past month and/or other drugs used in past 3 months
|
6 month
|
|
Depression
Time Frame: 6 month
|
Adolescent self-reported depression as measured on the nine item Patient Health Questionnaire in past 2 weeks
|
6 month
|
|
Helmet Use
Time Frame: 6 month
|
Adolescent self-reported frequency of helmet use while bicycling in past 3 months
|
6 month
|
|
Number of Health risk behaviors
Time Frame: 6 months
|
Adolescent total count health-risk behaviors at 6 month follow-up including: During typical day: ≥2 sugar-sweetened beverages consumed and ≤3 servings fruits/vegetables consumed; ≤3 days with 60+ minutes exercise during typical week; having texted while driving in past 3 months; ≤7 hours of sleep during typical night; not "always" using seatbelt; not "always" using helmet when bicycling; having driven under the influence of substances; tobacco use; 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 per 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)); days marijuana consumption in 30 day (risk based on age) and/or other drugs use in past 3 months; not using birth control during last sexual intercourse and/or not "always" using a condom; and score of ≥10 on PHQ-9.
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6 months
|
|
Alcohol Consumption
Time Frame: 6 month
|
Adolescent self-reported number of days of alcohol consumption and number of drinks during a typical drinking episode in the prior month
|
6 month
|
|
Seat-belt Use
Time Frame: 6 month
|
Adolescent self-reported frequency of seatbelt use in a car in past 3 months
|
6 month
|
|
Texting while driving
Time Frame: 6 month
|
Adolescent self-reported endorsement of texting while driving in past 3 months
|
6 month
|
|
Condom Use and or Birth Control Use
Time Frame: 6 month
|
Adolescent self-reported condom use with sexual intercourse in past 3 months and/or use of birth control at last sexual intercourse
|
6 month
|
|
Driving with Alcohol Impairment
Time Frame: 6 month
|
Adolescent self-reported driving under the influence of a substance
|
6 month
|
|
Interval Receipt of Care
Time Frame: 3 months
|
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
|
|
Interval Receipt of Care
Time Frame: 6 months
|
Dichotomous variable indicating receipt of any follow-up care to address risk behaviors identified at baseline adjusted for baseline number of health risk behaviors
|
6 months
|
|
Readiness to Change Ruler
Time Frame: 1-day
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Assessment of adolescent reported motivation to change overall health
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1-day
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Readiness to Change Ruler
Time Frame: 3 months
|
Assessment of adolescent reported motivation to change overall health
|
3 months
|
|
Readiness to Change Ruler
Time Frame: 6 months
|
Assessment of adolescent reported motivation to change overall health
|
6 months
|
|
Adolescent Health Self -Efficacy
Time Frame: 1 day
|
Self-report of adolescent health self efficacy
|
1 day
|
|
Tobacco Use
Time Frame: 6 month
|
Adolescent self-reported endorsement of tobacco use in past 3 months
|
6 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2016
Primary Completion (Actual)
June 1, 2018
Study Completion (Actual)
August 1, 2018
Study Registration Dates
First Submitted
August 25, 2016
First Submitted That Met QC Criteria
August 29, 2016
First Posted (Estimate)
August 30, 2016
Study Record Updates
Last Update Posted (Actual)
August 31, 2020
Last Update Submitted That Met QC Criteria
August 27, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 1R01HS023383-01 (U.S. AHRQ Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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