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I-ACT With Check Yourself

This study is currently recruiting participants.
Verified May 2016 by Carolyn McCarty, Seattle Children's Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT02764190
First Posted: May 6, 2016
Last Update Posted: October 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Carolyn McCarty, Seattle Children's Hospital
  Purpose

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.


Condition Intervention
Adolescent Behavior Behavioral: I-ACT with Check Yourself

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Delivering Patient-Centered Adolescent Preventative Care With Training and Technology

Further study details as provided by Carolyn McCarty, Seattle Children's Hospital:

Primary Outcome Measures:
  • Number of Health risk behaviors [ Time Frame: 3 month ]
    Adolescent total count health-risk behaviors at 3 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.

  • Sweetened Beverage Consumption [ Time Frame: 3 month ]
    Adolescent self-reported sweetened beverages consumed in a typical day in past 3 months

  • Fruit and Vegetable Consumption [ Time Frame: 3 month ]
    Adolescent self-reported fruits and vegetables consumed in a typical day in past 3 months

  • Physical Activity [ Time Frame: 3 month ]
    Adolescent self-reported days with >60 minutes of physical activity in an average week in past 3 months

  • Sleep [ Time Frame: 3 month ]
    Adolescent self-reported hours of sleep on a typical night in past 3 months

  • Alcohol Consumption [ Time Frame: 3 month ]
    Adolescent self-reported number of days of alcohol consumption and drinks during typical drinking episode in the prior month

  • 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

  • Depression [ Time Frame: 3 month ]
    Adolescent self-reported depression as measured on the nine item Patient Health Questionnaire in past 2 weeks

  • Seatbelt Use [ Time Frame: 3 month ]
    Adolescent self-reported frequency of seatbelt use in a car in past 3 months

  • Helmet Use [ Time Frame: 3 month ]
    Adolescent self-reported frequency of helmet use while bicycling in past 3 months

  • Texting while driving [ Time Frame: 3 month ]
    Adolescent self-reported endorsement of texting while driving in the past 3 months

  • Condom and/or Birth Control Use [ Time Frame: 3 month ]
    Adolescent self-reported condom use with sexual intercourse in the past 3 months and/or use of birth control at last sexual intercourse

  • Driving with Alcohol Impairment [ Time Frame: 3 month ]
    Adolescent self-reported driving under the influence of a substance in the past 3 months

  • Adolescent Satisfaction with Care [ Time Frame: 1-day ]
    Adolescent satisfaction with care will be assessed using one item adapted from the Consumer Assessment of Healthcare Providers and Systems (CAHPS) measure at 1-day follow-up.

  • Caregiver Satisfaction with Care [ Time Frame: 1-day ]
    Caregiver satisfaction with care will be assessed using the four items adapted from the Consumer Assessment of Healthcare Providers and Systems (CAHPS) measure at 1-day follow-up.

  • Adolescent Perception of Patient-Centeredness [ Time Frame: 1 day ]
    The total score on the Consultation and Relational Empathy measure (CARE) will be used to assess adolescent self-report of perceived patient-centeredness from their primary care provider.

  • Tobacco Use [ Time Frame: 3 month ]
    Adolescent self-reported tobacco use in past 3 months


Secondary Outcome Measures:
  • Number of risk behaviors counseled on during primary care appointment [ Time Frame: 1 day ]
    Number 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.

  • 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.

  • 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.

  • Sweetened Beverage Consumption [ Time Frame: 6 month ]
    Adolescent self-reported sweetened beverages consumed in a typical day in past 3 months

  • Sweetened Beverage Consumption [ Time Frame: 12 month ]
    Adolescent self-reported sweetened beverages consumed in a typical day in past 3 months

  • Fruit and Vegetable Consumption [ Time Frame: 6 month ]
    Adolescent self-reported fruits and vegetables consumed in a typical day in past 3 months

  • Fruit and Vegetable Consumption [ Time Frame: 12 month ]
    Adolescent self-reported fruits and vegetables consumed in a typical day in past 3 months

  • Physical Activity [ Time Frame: 6 month ]
    Adolescent self-reported days with >60 minutes of physical activity in an average week in past 3 months

  • Physical Activity [ Time Frame: 12 month ]
    Adolescent self-reported days with >60 minutes of physical activity in an average week in past 3 months

  • Sleep [ Time Frame: 6 month ]
    Adolescent self-reported hours of sleep on a typical night in past 3 months

  • Sleep [ Time Frame: 12 month ]
    Adolescent self-reported hours of sleep on a typical night in past 3 months

  • 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

  • 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

  • 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

  • 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

  • Depression [ Time Frame: 6 month ]
    Adolescent self-reported depression as measured on the nine item Patient Health Questionnaire in past 2 weeks

  • Depression [ Time Frame: 12 month ]
    Adolescent self-reported depression as measured on the nine item Patient Health Questionnaire in past 2 weeks

  • Seatbelt Use [ Time Frame: 6 month ]
    Adolescent self-reported frequency of seatbelt use in a car in past 3 months

  • Seatbelt Use [ Time Frame: 12 month ]
    Adolescent self-reported frequency of seatbelt use in a car in past 3 months

  • Helmet Use [ Time Frame: 6 month ]
    Adolescent self-reported frequency of helmet use while bicycling in past 3 months

  • Helmut Use [ Time Frame: 12 month ]
    Adolescent self-reported frequency of helmet use while bicycling in past 3 months

  • Texting while driving [ Time Frame: 6 month ]
    Adolescent self-reported endorsement of texting while driving in past 3 months

  • Texting while driving [ Time Frame: 12 month ]
    Adolescent self-reported endorsement of texting while driving in past 3 months

  • 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

  • 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

  • Driving with Alcohol Impairment [ Time Frame: 6 month ]
    Adolescent self-reported driving under the influence of a substance

  • Driving with Alcohol Impairment [ Time Frame: 12 month ]
    Adolescent self-reported driving under the influence of a substance

  • 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.

  • Interval Receipt of Care Questionnaire [ Time Frame: 6 month ]
    Dichotomous variable indicating receipt of any follow-up care to address risk

  • Interval Receipt of Care Questionnaire [ Time Frame: 12 month ]
    Dichotomous variable indicating receipt of any follow-up care to address risk

  • Readiness to Change Ruler Questionnaire [ Time Frame: 1 day ]
    Assessment of adolescent reported motivation to change overall health using a Readiness to Change Ruler.

  • Readiness to Change Ruler Questionnaire [ Time Frame: 3 month ]
    Assessment of adolescent reported motivation to change overall health using a Readiness to Change Ruler.

  • Readiness to Change Ruler Questionnaire [ Time Frame: 6 month ]
    Assessment of adolescent reported motivation to change overall health using a Readiness to Change Ruler.

  • Readiness to Change Ruler Questionnaire [ Time Frame: 12 month ]
    Assessment of adolescent reported motivation to change overall health using a Readiness to Change Ruler.

  • Tobacco Use [ Time Frame: 6 month ]
    Adolescent self-reported tobacco use in past 3 months

  • Tobacco Use [ Time Frame: 12 month ]
    Adolescent self-reported tobacco use in past 3 months


Estimated Enrollment: 300
Study Start Date: October 2016
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 .
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02764190


Contacts
Contact: Heather Spielvogle, Ph.D. heather.spielvogle@seattlechildrens.org

Locations
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98105
Contact: Cari McCarty, Ph.D.    206-884-8243    cari.mccarty@seattlechildrens.org   
Sponsors and Collaborators
Seattle Children's Hospital
Patient-Centered Outcomes Research Institute
  More Information

Responsible Party: Carolyn McCarty, Principal Investigator, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT02764190     History of Changes
Other Study ID Numbers: IHS-1402-10592
First Submitted: April 29, 2016
First Posted: May 6, 2016
Last Update Posted: October 28, 2016
Last Verified: May 2016