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Completed

NCT Number: NCT02764190

I-ACT With Check Yourself

Adolescents have some of the highest rates of risk behaviors of all age groups and health behaviors developed in adolescence can persist into adulthood. These behaviors carry significant risks for subsequent disease, disability, and healthcare burden. Despite these risks, health risk screening in primary care is infrequently performed and results are rarely followed by targeted intervention. In response to the need for screening-linked interventions, our study team has developed a web-based, electronic Personalized Motivational Feedback tool which we refer to as "Check Yourself." 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 as well as to provide information to providers to promote discussions around health behaviors between providers and adolescents.

Building on electronic health interventions, primary care providers can play an essential role in helping adolescents to make healthy behavior choices. Emerging evidence suggests that the consistency of preventive counseling can be increased through provider training and the provision of screening tools; yet, we know very little about the quality of such counseling, and if it impacts outcomes that are important to adolescent patients themselves.

This study is a stepped-wedge, controlled trial comparing the effectiveness of an interactive adolescent-centered training for primary care providers (I-ACT) and Check Yourself to usual care. This study will take place in six pediatric practices. The purpose of this study is to determine whether this system of interventions (i.e., I-ACT, Check Yourself, and the summary report) is more effective than usual care in reducing health risk behaviors, improving adolescent motivation for health, and improving quality of care among adolescents receiving primary health care services.

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Key information

Conditions

Adolescent Behavior Behavior

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington

Seattle, Washington, 98105, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Eligible adolescent participants will be 13-18 years of age and caregiver participants will be 18 years of age or older and able to understand English. Eligible participants 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 if they 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, and/or are not able to understand English.
  • Caregivers will be excluded from the study if they do not speak English; or if their child is not eligible or declines to participate in the study .

Treatment and study plan

I-ACT with Check Yourself

Behavioral

Primary outcomes

  1. Number of Health Risk Behaviors

    Time frame: 3 month

    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 month

    Adolescent self-reported number of sweetened beverages consumed in a typical day in the 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. Fruit and Vegetable Consumption

    Time frame: 3 month

    Adolescent self-reported number of fruits and vegetables consumed in a typical day in the 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.

  4. Physical Activity

    Time frame: 3 month

    Adolescent self-reported number of days with >60 minutes of physical activity in an average week in the past 3 months. The physical activity scale includes 8 values: 0 (min) to 7 (max). Higher scores mean a better outcome.

  5. Sleep

    Time frame: 3 month

    Adolescent self-reported hours of sleep on a typical night in the 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.

  6. Alcohol Consumption (Frequency)

    Time frame: 3 months

    Adolescent self-reported number of days of alcohol consumption in the past month. Alcohol frequency scale includes 31 values: 0 (min) to 30 (max) days in the past month. Higher scores mean a worse outcome.

  7. Alcohol Consumption (Quantity)

    Time frame: 3 months

    Adolescent self-reported number of drinks during a typical drinking episode in the prior month. The alcohol quantity scale includes 16 values from 0 (min) to 15+ (max). Higher score means a worse outcome.

  8. Marijuana Consumption

    Time frame: 3 months

    Adolescent self-reported number of days using marijuana in the past month. The marijuana frequency scale includes 31 values: 0 (min) to 30 (max) days in the past month. Higher scores mean a worse outcome.

  9. Other Drug Consumption

    Time frame: 3 months

    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.

  10. Depression

    Time frame: 3 month

    Adolescent self-reported depression as measured on the nine item Patient Health Questionnaire (PHQ-9) in the past 2 weeks. The PHQ-9 depression scale includes 28 values: 0 (min) to 27 (max). Higher scores mean a worse outcome.

  11. Seatbelt Use

    Time frame: 3 month

    Adolescent self-reported frequency of seatbelt use in a car in the 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.

  12. Helmet Use

    Time frame: 3 months

    Adolescent self-reported frequency of helmet use while bicycling in the 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.

  13. Texting While Driving

    Time frame: 3 months

    Adolescent self-reported endorsement of texting while driving in the 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.

  14. Condom and/or Birth Control Use

    Time frame: 3 months

    Adolescent self-reported condom use with sexual intercourse in the past 3 months and/or use of birth control at 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.

  15. Driving With Impairment

    Time frame: 3 month

    Adolescent self-reported driving under the influence of a substance in the 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.

  16. Adolescent Satisfaction With Care

    Time frame: 1-day

    Adolescent satisfaction with care is assessed using one 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.

  17. Caregiver Satisfaction With Care

    Time frame: 1-day

    Caregiver satisfaction with care is assessed using the four items adapted from the Consumer Assessment of Healthcare Providers and Systems (CAHPS) measure at 1-day follow-up. Scores on this scale range from 3 (min) to 22 (max) with higher scores indicating higher satisfaction with care.

  18. Adolescent Perception of Patient-Centeredness

    Time frame: 1 day

    The total score on the Consultation and Relational Empathy measure (CARE) is used to assess adolescent self-report of perceived patient-centeredness from their primary care provider. Scores on the scale range from 10 (min) to 50 (max) with higher scores indicating a better outcome.

  19. Tobacco Use

    Time frame: 3 months

    Adolescent self-reported tobacco use in the 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. 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.

  2. Number of Health Risk Behaviors

    Time frame: 6 month

    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.

  3. Number of Health Risk Behaviors

    Time frame: 12 month

    Adolescent total count health-risk behaviors at 12 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.

  4. Sweetened Beverage Consumption

    Time frame: 6 month

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

  5. Sweetened Beverage Consumption

    Time frame: 12 month

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

  6. Fruit and Vegetable Consumption

    Time frame: 6 month

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

  7. Fruit and Vegetable Consumption

    Time frame: 12 month

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

  8. Physical Activity

    Time frame: 6 month

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

  9. Physical Activity

    Time frame: 12 month

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

  10. Sleep

    Time frame: 6 month

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

  11. Sleep

    Time frame: 12 month

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

  12. Alcohol Consumption

    Time frame: 6 month

    Adolescent self-reported number of days of alcohol consumption and drinks during typical drinking episode in the prior month

  13. Alcohol Consumption

    Time frame: 12 month

    Adolescent self-reported number of days of alcohol consumption and drinks during typical drinking episode in the prior month

  14. 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

  15. Marijuana and/or Other Consumption

    Time frame: 12 month

    Adolescent self-reported number of days using marijuana in the past month and/or other drugs used in past 3 months

  16. Depression

    Time frame: 6 month

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

  17. Depression

    Time frame: 12 month

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

  18. Seatbelt Use

    Time frame: 6 month

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

  19. Seatbelt Use

    Time frame: 12 month

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

  20. Helmet Use

    Time frame: 6 month

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

  21. Helmet Use

    Time frame: 12 month

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

  22. Texting While Driving

    Time frame: 6 month

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

  23. Texting While Driving

    Time frame: 12 month

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

  24. Condom Use and/or Birth Control Use

    Time frame: 6 month

    Adolescent self-reported condom use with sexual intercourse in the past 3 months and/or use of birth control at last sexual intercourse

  25. Condom Use and/or Birth Control Use

    Time frame: 12 month

    Adolescent self-reported condom use with sexual intercourse in the past 3 months and/or use of birth control at last sexual intercourse

  26. Driving With Alcohol Impairment

    Time frame: 6 month

    Adolescent self-reported driving under the influence of a substance

  27. Driving With Alcohol Impairment

    Time frame: 12 month

    Adolescent self-reported driving under the influence of a substance

  28. Interval Receipt of Care Questionnaire

    Time frame: 3 month

    Dichotomous variable indicating receipt of any follow-up care to address risk behaviors identified at baseline adjusted for baseline number of health risk behaviors.

  29. Interval Receipt of Care Questionnaire

    Time frame: 6 month

    Dichotomous variable indicating receipt of any follow-up care to address risk

  30. Interval Receipt of Care Questionnaire

    Time frame: 12 month

    Dichotomous variable indicating receipt of any follow-up care to address risk

  31. Readiness to Change Ruler Questionnaire

    Time frame: 1 day

    Assessment of adolescent reported motivation to change overall health using a Readiness to Change Ruler.

  32. Readiness to Change Ruler Questionnaire

    Time frame: 3 month

    Assessment of adolescent reported motivation to change overall health using a Readiness to Change Ruler.

  33. Readiness to Change Ruler Questionnaire

    Time frame: 6 month

    Assessment of adolescent reported motivation to change overall health using a Readiness to Change Ruler.

  34. Readiness to Change Ruler Questionnaire

    Time frame: 12 month

    Assessment of adolescent reported motivation to change overall health using a Readiness to Change Ruler.

  35. Tobacco Use

    Time frame: 6 month

    Adolescent self-reported tobacco use in past 3 months

  36. Tobacco Use

    Time frame: 12 month

    Adolescent self-reported tobacco use in past 3 months

Sponsors and collaborators

Lead sponsor

Seattle Children's Hospital

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

Delivering Patient-Centered Adolescent Preventative Care With Training and Technology

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 6, 2016
Registry last updated
Nov 19, 2019

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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