Clinical trial NCT02764190: I-ACT With Check Yourself
Official title: Delivering Patient-Centered Adolescent Preventative Care With Training and Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Behavior
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2016-05-06
Enrollment: 302
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: 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 .

Primary outcomes:
measure: Number of Health Risk Behaviors
timeFrame: 3 month
measure: Sweetened Beverage Consumption
timeFrame: 3 month
measure: Fruit and Vegetable Consumption
timeFrame: 3 month
measure: Physical Activity
timeFrame: 3 month
measure: Sleep
timeFrame: 3 month
measure: Alcohol Consumption (Frequency)
timeFrame: 3 months
measure: Alcohol Consumption (Quantity)
timeFrame: 3 months
measure: Marijuana Consumption
timeFrame: 3 months
measure: Other Drug Consumption
timeFrame: 3 months
measure: Depression
timeFrame: 3 month
measure: Seatbelt Use
timeFrame: 3 month
measure: Helmet Use
timeFrame: 3 months
measure: Texting While Driving
timeFrame: 3 months
measure: Condom and/or Birth Control Use
timeFrame: 3 months
measure: Driving With Impairment
timeFrame: 3 month
measure: Adolescent Satisfaction With Care
timeFrame: 1-day
measure: Caregiver Satisfaction With Care
timeFrame: 1-day
measure: Adolescent Perception of Patient-Centeredness
timeFrame: 1 day
measure: Tobacco Use
timeFrame: 3 months
Secondary outcomes:
measure: Percent of Risk Behaviors Counseled on During Primary Care Appointment
timeFrame: 1 day
measure: Number of Health Risk Behaviors
timeFrame: 6 month
measure: Number of Health Risk Behaviors
timeFrame: 12 month
measure: Sweetened Beverage Consumption
timeFrame: 6 month
measure: Sweetened Beverage Consumption
timeFrame: 12 month
measure: Fruit and Vegetable Consumption
timeFrame: 6 month
measure: Fruit and Vegetable Consumption
timeFrame: 12 month
measure: Physical Activity
timeFrame: 6 month
measure: Physical Activity
timeFrame: 12 month
measure: Sleep
timeFrame: 6 month
measure: Sleep
timeFrame: 12 month
measure: Alcohol Consumption
timeFrame: 6 month
measure: Alcohol Consumption
timeFrame: 12 month
measure: Marijuana and/or Other Drug Consumption
timeFrame: 6 month
measure: Marijuana and/or Other Consumption
timeFrame: 12 month
measure: Depression
timeFrame: 6 month
measure: Depression
timeFrame: 12 month
measure: Seatbelt Use
timeFrame: 6 month
measure: Seatbelt Use
timeFrame: 12 month
measure: Helmet Use
timeFrame: 6 month
measure: Helmet Use
timeFrame: 12 month
measure: Texting While Driving
timeFrame: 6 month
measure: Texting While Driving
timeFrame: 12 month
measure: Condom Use and/or Birth Control Use
timeFrame: 6 month
measure: Condom Use and/or Birth Control Use
timeFrame: 12 month
measure: Driving With Alcohol Impairment
timeFrame: 6 month
measure: Driving With Alcohol Impairment
timeFrame: 12 month
measure: Interval Receipt of Care Questionnaire
timeFrame: 3 month
measure: Interval Receipt of Care Questionnaire
timeFrame: 6 month
measure: Interval Receipt of Care Questionnaire
timeFrame: 12 month
measure: Readiness to Change Ruler Questionnaire
timeFrame: 1 day
measure: Readiness to Change Ruler Questionnaire
timeFrame: 3 month
measure: Readiness to Change Ruler Questionnaire
timeFrame: 6 month
measure: Readiness to Change Ruler Questionnaire
timeFrame: 12 month
measure: Tobacco Use
timeFrame: 6 month
measure: Tobacco Use
timeFrame: 12 month
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
References:
citation: 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.