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Completed

NCT Number: NCT02882919

Check Yourself v2.0

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.

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Key information

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Check Yourself v2.0

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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. 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.

  4. 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.

  5. 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

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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

  13. 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.

  14. 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.

  15. Adolescent Satisfaction with Care

    Time frame: 1 day

    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.

  16. 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.

Secondary outcomes

  1. 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.

  2. Sweetened Beverage Consumption

    Time frame: 6 month

    Adolescent self-reported sweetened beverages consumed in a typical day in past 3 months

  3. Fruit and Vegetable Consumption

    Time frame: 6 month

    Adolescent self-reported fruits and vegetables consumed in a typical day in past 3 months

  4. Physical Activity

    Time frame: 6 month

    Adolescent self-reported days with >60 minutes of physical activity in an average week in past 3 months

  5. Sleep

    Time frame: 6 month

    Adolescent self-reported hours of sleep on a typical night in past 3 months

  6. 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

  7. 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

  8. Depression

    Time frame: 6 month

    Adolescent self-reported depression as measured on the nine item Patient Health Questionnaire in past 2 weeks

  9. Seat-belt Use

    Time frame: 6 month

    Adolescent self-reported frequency of seatbelt use in a car in past 3 months

  10. Helmet Use

    Time frame: 6 month

    Adolescent self-reported frequency of helmet use while bicycling in past 3 months

  11. Texting while driving

    Time frame: 6 month

    Adolescent self-reported endorsement of texting while driving in past 3 months

  12. 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

  13. Driving with Alcohol Impairment

    Time frame: 6 month

    Adolescent self-reported driving under the influence of a substance

  14. 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

  15. 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

  16. Readiness to Change Ruler

    Time frame: 1-day

    Assessment of adolescent reported motivation to change overall health

  17. Readiness to Change Ruler

    Time frame: 3 months

    Assessment of adolescent reported motivation to change overall health

  18. Readiness to Change Ruler

    Time frame: 6 months

    Assessment of adolescent reported motivation to change overall health

  19. Adolescent Health Self -Efficacy

    Time frame: 1 day

    Self-report of adolescent health self efficacy

  20. Tobacco Use

    Time frame: 6 month

    Adolescent self-reported endorsement of tobacco use in past 3 months

Sponsors and collaborators

Lead sponsor

Carolyn McCarty

Other

Registry information

Official study title

Improving Teen Health With Health Information Technology

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 30, 2016
Registry last updated
Aug 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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