I-ACT With Check Yourself

Study Overview
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Brief Summary
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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.

Official Title
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Delivering Patient-Centered Adolescent Preventative Care With Training and Technology

Conditions
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Adolescent Behavior

Intervention / Treatment
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* Behavioral: I-ACT with Check Yourself


Participation Criteria
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Eligibility Criteria
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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 .

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I-ACT with Check Yourself<br>Adolescents complete Check Yourself which delivers personalized, motivational feedback on their health behaviors prior to their primary care appointment. Check Yourself includes the provision of age normative feedback, goal setting strategies, and strategies to highlight discrepancies. Primary care providers will receive I-ACT and the Check Yourself summary report of health risk behaviors before an adolescent patient's appointment. I-ACT will provide training in adolescent-preferred communication methods and use of Check Yourself as a framework for the provider to use motivational interviewing to consider the patients' change readiness and their personal health goals. I-ACT includes online interactive, case-based learning, with booster sessions and feedback reports to reinforce new skills. | Behavioral: I-ACT with Check Yourself<br> <br> |
| No Intervention: Usual care<br>In the usual care group, adolescents are asked to complete health risk screening on a computer. No personalized feedback is provided to adolescents and primary care providers do not receive I-ACT or the Check Yourself summary report of the adolescent's health risk behaviors. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Health Risk Behaviors | 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. | 3 month | 
| Sweetened Beverage Consumption | 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 month | 
| Fruit and Vegetable Consumption | 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. | 3 month | 
| Physical Activity | 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. | 3 month | 
| Sleep | 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. | 3 month | 
| Alcohol Consumption (Frequency) | 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. | 3 months | 
| Alcohol Consumption (Quantity) | 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. | 3 months | 
| Marijuana Consumption | 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. | 3 months | 
| Other Drug Consumption | 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. | 3 months | 
| Depression | 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. | 3 month | 
| Seatbelt Use | 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. | 3 month | 
| Helmet Use | 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. | 3 months | 
| Texting While Driving | 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. | 3 months | 
| Condom and/or Birth Control Use | 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. | 3 months | 
| Driving With Impairment | 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. | 3 month | 
| Adolescent Satisfaction With Care | 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. | 1-day | 
| Caregiver Satisfaction With Care | 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. | 1-day | 
| Adolescent Perception of Patient-Centeredness | 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. | 1 day | 
| Tobacco Use | 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. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Risk Behaviors Counseled on During Primary Care Appointment | 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. | 1 day | 
| Number of Health Risk Behaviors | 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. | 6 month | 
| Number of Health Risk Behaviors | 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. | 12 month | 
| Sweetened Beverage Consumption | Adolescent self-reported sweetened beverages consumed in a typical day in past 3 months | 6 month | 
| Sweetened Beverage Consumption | Adolescent self-reported sweetened beverages consumed in a typical day in past 3 months | 12 month | 
| Fruit and Vegetable Consumption | Adolescent self-reported fruits and vegetables consumed in a typical day in past 3 months | 6 month | 
| Fruit and Vegetable Consumption | Adolescent self-reported fruits and vegetables consumed in a typical day in past 3 months | 12 month | 
| Physical Activity | Adolescent self-reported days with >60 minutes of physical activity in an average week in past 3 months | 6 month | 
| Physical Activity | Adolescent self-reported days with >60 minutes of physical activity in an average week in past 3 months | 12 month | 
| Sleep | Adolescent self-reported hours of sleep on a typical night in past 3 months | 6 month | 
| Sleep | Adolescent self-reported hours of sleep on a typical night in past 3 months | 12 month | 
| Alcohol Consumption | Adolescent self-reported number of days of alcohol consumption and drinks during typical drinking episode in the prior month | 6 month | 
| Alcohol Consumption | Adolescent self-reported number of days of alcohol consumption and drinks during typical drinking episode in the prior month | 12 month | 
| Marijuana and/or Other Drug Consumption | Adolescent self-reported number of days using marijuana in the past month and/or other drugs used in past 3 months | 6 month | 
| Marijuana and/or Other Consumption | Adolescent self-reported number of days using marijuana in the past month and/or other drugs used in past 3 months | 12 month | 
| Depression | Adolescent self-reported depression as measured on the nine item Patient Health Questionnaire in past 2 weeks | 6 month | 
| Depression | Adolescent self-reported depression as measured on the nine item Patient Health Questionnaire in past 2 weeks | 12 month | 
| Seatbelt Use | Adolescent self-reported frequency of seatbelt use in a car in past 3 months | 6 month | 
| Seatbelt Use | Adolescent self-reported frequency of seatbelt use in a car in past 3 months | 12 month | 
| Helmet Use | Adolescent self-reported frequency of helmet use while bicycling in past 3 months | 6 month | 
| Helmet Use | Adolescent self-reported frequency of helmet use while bicycling in past 3 months | 12 month | 
| Texting While Driving | Adolescent self-reported endorsement of texting while driving in past 3 months | 6 month | 
| Texting While Driving | Adolescent self-reported endorsement of texting while driving in past 3 months | 12 month | 
| Condom Use and/or Birth Control Use | Adolescent self-reported condom use with sexual intercourse in the past 3 months and/or use of birth control at last sexual intercourse | 6 month | 
| Condom Use and/or Birth Control Use | Adolescent self-reported condom use with sexual intercourse in the past 3 months and/or use of birth control at last sexual intercourse | 12 month | 
| Driving With Alcohol Impairment | Adolescent self-reported driving under the influence of a substance | 6 month | 
| Driving With Alcohol Impairment | Adolescent self-reported driving under the influence of a substance | 12 month | 
| Interval Receipt of Care Questionnaire | 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 month | 
| Interval Receipt of Care Questionnaire | Dichotomous variable indicating receipt of any follow-up care to address risk | 6 month | 
| Interval Receipt of Care Questionnaire | Dichotomous variable indicating receipt of any follow-up care to address risk | 12 month | 
| Readiness to Change Ruler Questionnaire | Assessment of adolescent reported motivation to change overall health using a Readiness to Change Ruler. | 1 day | 
| Readiness to Change Ruler Questionnaire | Assessment of adolescent reported motivation to change overall health using a Readiness to Change Ruler. | 3 month | 
| Readiness to Change Ruler Questionnaire | Assessment of adolescent reported motivation to change overall health using a Readiness to Change Ruler. | 6 month | 
| Readiness to Change Ruler Questionnaire | Assessment of adolescent reported motivation to change overall health using a Readiness to Change Ruler. | 12 month | 
| Tobacco Use | Adolescent self-reported tobacco use in past 3 months | 6 month | 
| Tobacco Use | Adolescent self-reported tobacco use in past 3 months | 12 month |