Adolescent BehaviorNCT02764190
I-ACT With Check Yourself
A study testing I-ACT with Check Yourself in people with Adolescent Behavior, run by Seattle Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Behavior
- What is being tested?
- I-ACT with Check Yourself
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to Nov 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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 .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Adolescent Behavior
- Being tested
- I-ACT with Check Yourself
- Medical subject headings
- Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-ACT with Check YourselfBehavioural
| Study group | Role | What they receive |
|---|---|---|
| I-ACT with Check Yourself | Experimental | 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. Receives: Behavioral: I-ACT with Check Yourself |
| Usual care | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months
Secondary outcomes (36)
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.
Measured: 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.
Measured: 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.
Measured: 12 month
Sweetened Beverage Consumption
Adolescent self-reported sweetened beverages consumed in a typical day in past 3 months
Measured: 6 month
Sweetened Beverage Consumption
Adolescent self-reported sweetened beverages consumed in a typical day in past 3 months
Measured: 12 month
Fruit and Vegetable Consumption
Adolescent self-reported fruits and vegetables consumed in a typical day in past 3 months
Measured: 6 month
Fruit and Vegetable Consumption
Adolescent self-reported fruits and vegetables consumed in a typical day in past 3 months
Measured: 12 month
Physical Activity
Adolescent self-reported days with >60 minutes of physical activity in an average week in past 3 months
Measured: 6 month
Physical Activity
Adolescent self-reported days with >60 minutes of physical activity in an average week in past 3 months
Measured: 12 month
Sleep
Adolescent self-reported hours of sleep on a typical night in past 3 months
Measured: 6 month
Sleep
Adolescent self-reported hours of sleep on a typical night in past 3 months
Measured: 12 month
Alcohol Consumption
Adolescent self-reported number of days of alcohol consumption and drinks during typical drinking episode in the prior month
Measured: 6 month
Alcohol Consumption
Adolescent self-reported number of days of alcohol consumption and drinks during typical drinking episode in the prior month
Measured: 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
Measured: 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
Measured: 12 month
Depression
Adolescent self-reported depression as measured on the nine item Patient Health Questionnaire in past 2 weeks
Measured: 6 month
Depression
Adolescent self-reported depression as measured on the nine item Patient Health Questionnaire in past 2 weeks
Measured: 12 month
Seatbelt Use
Adolescent self-reported frequency of seatbelt use in a car in past 3 months
Measured: 6 month
Seatbelt Use
Adolescent self-reported frequency of seatbelt use in a car in past 3 months
Measured: 12 month
Helmet Use
Adolescent self-reported frequency of helmet use while bicycling in past 3 months
Measured: 6 month
Helmet Use
Adolescent self-reported frequency of helmet use while bicycling in past 3 months
Measured: 12 month
Texting While Driving
Adolescent self-reported endorsement of texting while driving in past 3 months
Measured: 6 month
Texting While Driving
Adolescent self-reported endorsement of texting while driving in past 3 months
Measured: 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
Measured: 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
Measured: 12 month
Driving With Alcohol Impairment
Adolescent self-reported driving under the influence of a substance
Measured: 6 month
Driving With Alcohol Impairment
Adolescent self-reported driving under the influence of a substance
Measured: 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.
Measured: 3 month
Interval Receipt of Care Questionnaire
Dichotomous variable indicating receipt of any follow-up care to address risk
Measured: 6 month
Interval Receipt of Care Questionnaire
Dichotomous variable indicating receipt of any follow-up care to address risk
Measured: 12 month
Readiness to Change Ruler Questionnaire
Assessment of adolescent reported motivation to change overall health using a Readiness to Change Ruler.
Measured: 1 day
Readiness to Change Ruler Questionnaire
Assessment of adolescent reported motivation to change overall health using a Readiness to Change Ruler.
Measured: 3 month
Readiness to Change Ruler Questionnaire
Assessment of adolescent reported motivation to change overall health using a Readiness to Change Ruler.
Measured: 6 month
Readiness to Change Ruler Questionnaire
Assessment of adolescent reported motivation to change overall health using a Readiness to Change Ruler.
Measured: 12 month
Tobacco Use
Adolescent self-reported tobacco use in past 3 months
Measured: 6 month
Tobacco Use
Adolescent self-reported tobacco use in past 3 months
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study startOct 2016
- Primary completionFeb 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adolescent BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Carolyn McCarty, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02764190
- Sponsor's protocol ID
- IHS-1402-10592
- Status last verified
- Nov 2019
- First submitted
- 29 Apr 2016
- Last updated
- 19 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
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.
PubMed 34404610
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delivering Patient-Centered Adolescent Preventative Care With Training and Technology
- ClinicalTrials.gov ID
- NCT02764190
- Acronym / sponsor ID
- IHS-1402-10592
- Conditions
- Adolescent Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- Oct 2016
- Primary completion
- Feb 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 6 May 2016 (estimated)
- Results
- Posted 8 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I-ACT with Check Yourself | Experimental | Behavioral: I-ACT with Check YourselfAdolescents 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. |
| Usual care | No intervention | –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. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| I-ACT with Check Yourself | Behavioural | I-ACT with Check Yourself |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
36 secondary outcomes
Percent of Risk Behaviors Counseled on During Primary Care Appointment
Time frame: 1 day
Number of Health Risk Behaviors
Time frame: 6 month
Number of Health Risk Behaviors
Time frame: 12 month
Sweetened Beverage Consumption
Time frame: 6 month
Sweetened Beverage Consumption
Time frame: 12 month
Fruit and Vegetable Consumption
Time frame: 6 month
Fruit and Vegetable Consumption
Time frame: 12 month
Physical Activity
Time frame: 6 month
Physical Activity
Time frame: 12 month
Sleep
Time frame: 6 month
Sleep
Time frame: 12 month
Alcohol Consumption
Time frame: 6 month
Alcohol Consumption
Time frame: 12 month
Marijuana and/or Other Drug Consumption
Time frame: 6 month
Marijuana and/or Other Consumption
Time frame: 12 month
Depression
Time frame: 6 month
Depression
Time frame: 12 month
Seatbelt Use
Time frame: 6 month
Seatbelt Use
Time frame: 12 month
Helmet Use
Time frame: 6 month
Helmet Use
Time frame: 12 month
Texting While Driving
Time frame: 6 month
Texting While Driving
Time frame: 12 month
Condom Use and/or Birth Control Use
Time frame: 6 month
Condom Use and/or Birth Control Use
Time frame: 12 month
Driving With Alcohol Impairment
Time frame: 6 month
Driving With Alcohol Impairment
Time frame: 12 month
Interval Receipt of Care Questionnaire
Time frame: 3 month
Interval Receipt of Care Questionnaire
Time frame: 6 month
Interval Receipt of Care Questionnaire
Time frame: 12 month
Readiness to Change Ruler Questionnaire
Time frame: 1 day
Readiness to Change Ruler Questionnaire
Time frame: 3 month
Readiness to Change Ruler Questionnaire
Time frame: 6 month
Readiness to Change Ruler Questionnaire
Time frame: 12 month
Tobacco Use
Time frame: 6 month
Tobacco Use
Time frame: 12 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34404610McCarty 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing I-ACT with Check Yourself in people with Adolescent Behavior, run by Seattle Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Health Risk Behaviors (time frame: 3 month). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02764190, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2019.