I-ACT With Check Yourself

Delivering Patient-Centered Adolescent Preventative Care With Training and Technology

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.

Study Overview

• Status: Completed
• Conditions: Adolescent Behavior
• Intervention / Treatment: Behavioral: I-ACT with Check Yourself

• Study Type: Interventional
• Enrollment (Actual): 302
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98105
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 .

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: I-ACT with Check Yourself; 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
No Intervention: Usual care; 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?

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

Collaborators and Investigators

• Sponsor: Seattle Children's Hospital
• Collaborators: Patient-Centered Outcomes Research Institute

Publications and helpful links

General Publications

• McCarty CA, Parker E, Zhou C, Katzman K, Stout J, Richardson LP. Electronic Screening, Feedback, and Clinician Training in Adolescent Primary Care: A Stepped-Wedge Cluster Randomized Trial. J Adolesc Health. 2022 Feb;70(2):234-240. doi: 10.1016/j.jadohealth.2021.07.019. Epub 2021 Aug 14.

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): November 1, 2018

Study Registration Dates

• First Submitted: April 29, 2016
• First Submitted That Met QC Criteria: May 3, 2016
• First Posted (Estimate): May 6, 2016

Study Record Updates

• Last Update Posted (Actual): November 19, 2019
• Last Update Submitted That Met QC Criteria: November 7, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: IHS-1402-10592