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I-ACT With Check Yourself

Delivering Patient-Centered Adolescent Preventative Care With Training and Technology

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02764190
Enrollment
302
Registered
2016-05-06
Start date
2016-10-31
Completion date
2018-11-30
Last updated
2019-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent Behavior

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.

Interventions

BEHAVIORALI-ACT with Check Yourself

Sponsors

Patient-Centered Outcomes Research Institute
CollaboratorOTHER
Seattle Children's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
13 Years to 18 Years
Healthy volunteers
Yes

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 .

Design outcomes

Primary

MeasureTime frameDescription
Tobacco Use3 monthsAdolescent 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.
Number of Health Risk Behaviors3 monthThe 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 Consumption3 monthAdolescent 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 Consumption3 monthAdolescent 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 Activity3 monthAdolescent 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.
Sleep3 monthAdolescent 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)3 monthsAdolescent 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)3 monthsAdolescent 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 Consumption3 monthsAdolescent 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 Consumption3 monthsAdolescent 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.
Depression3 monthAdolescent 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 Use3 monthAdolescent 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 Use3 monthsAdolescent 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 Driving3 monthsAdolescent 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 Use3 monthsAdolescent 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 Impairment3 monthAdolescent 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 Care1-dayAdolescent 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 Care1-dayCaregiver 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-Centeredness1 dayThe 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.

Secondary

MeasureTime frameDescription
Seatbelt Use6 monthAdolescent self-reported frequency of seatbelt use in a car in past 3 months
Helmet Use6 monthAdolescent self-reported frequency of helmet use while bicycling in past 3 months
Number of Health Risk Behaviors6 monthAdolescent 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.
Sweetened Beverage Consumption6 monthAdolescent self-reported sweetened beverages consumed in a typical day in past 3 months
Fruit and Vegetable Consumption6 monthAdolescent self-reported fruits and vegetables consumed in a typical day in past 3 months
Physical Activity6 monthAdolescent self-reported days with \>60 minutes of physical activity in an average week in past 3 months
Sleep6 monthAdolescent self-reported hours of sleep on a typical night in past 3 months
Alcohol Consumption6 monthAdolescent self-reported number of days of alcohol consumption and drinks during typical drinking episode in the prior month
Marijuana and/or Other Drug Consumption6 monthAdolescent self-reported number of days using marijuana in the past month and/or other drugs used in past 3 months
Marijuana and/or Other Consumption12 monthAdolescent self-reported number of days using marijuana in the past month and/or other drugs used in past 3 months
Depression6 monthAdolescent self-reported depression as measured on the nine item Patient Health Questionnaire in past 2 weeks
Texting While Driving6 monthAdolescent self-reported endorsement of texting while driving in past 3 months
Condom Use and/or Birth Control Use6 monthAdolescent 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 Impairment6 monthAdolescent self-reported driving under the influence of a substance
Interval Receipt of Care Questionnaire3 monthDichotomous variable indicating receipt of any follow-up care to address risk behaviors identified at baseline adjusted for baseline number of health risk behaviors.
Readiness to Change Ruler Questionnaire1 dayAssessment of adolescent reported motivation to change overall health using a Readiness to Change Ruler.
Tobacco Use6 monthAdolescent self-reported tobacco use in past 3 months
Percent of Risk Behaviors Counseled on During Primary Care Appointment1 dayPercent 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Experimental: I-ACT With Check Yourself
Adolescents completed Check Yourself which delivered personalized, motivational feedback to them on their health behaviors prior to their primary care appointment. Primary care providers received training (I-ACT) and the Check Yourself summary report of health risk behaviors before the adolescent's appointment. I-ACT consisted of online, interactive training in adolescent-preferred communication methods and motivational interviewing, with booster sessions and feedback reports to reinforce new skills.
167
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.
135
Total302

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up1713

Baseline characteristics

CharacteristicNo Intervention: Usual CareExperimental: I-ACT With Check YourselfTotal
Age, Categorical
<=18 years
135 Participants167 Participants302 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Continuous14.70 years
STANDARD_DEVIATION 1.44
14.79 years
STANDARD_DEVIATION 1.41
14.75 years
STANDARD_DEVIATION 1.42
Race/Ethnicity, Customized
African American
4 Participants2 Participants6 Participants
Race/Ethnicity, Customized
Asian
17 Participants11 Participants28 Participants
Race/Ethnicity, Customized
Caucasian
90 Participants122 Participants212 Participants
Race/Ethnicity, Customized
Hispanic
6 Participants11 Participants17 Participants
Race/Ethnicity, Customized
Native American
1 Participants0 Participants1 Participants
Race/Ethnicity, Customized
Other/Multiple Races
17 Participants21 Participants38 Participants
Region of Enrollment
United States
135 participants167 participants302 participants
Sex: Female, Male
Female
69 Participants88 Participants157 Participants
Sex: Female, Male
Male
66 Participants79 Participants145 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1670 / 135
other
Total, other adverse events
0 / 1670 / 135
serious
Total, serious adverse events
0 / 1670 / 135

Outcome results

Primary

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.

Time frame: 1 day

ArmMeasureValue (MEAN)Dispersion
Experimental: I-ACT With Check YourselfAdolescent Perception of Patient-Centeredness45.63 score on a scaleStandard Deviation 5.6
No Intervention: Usual CareAdolescent Perception of Patient-Centeredness45.63 score on a scaleStandard Deviation 6.26
Primary

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.

Time frame: 1-day

ArmMeasureValue (MEAN)Dispersion
Experimental: I-ACT With Check YourselfAdolescent Satisfaction With Care9.18 score on a scaleStandard Deviation 1.11
No Intervention: Usual CareAdolescent Satisfaction With Care9.23 score on a scaleStandard Deviation 0.95
Primary

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.

Time frame: 3 months

ArmMeasureValue (MEAN)Dispersion
Experimental: I-ACT With Check YourselfAlcohol Consumption (Frequency)0.25 score on a scaleStandard Deviation 1.09
No Intervention: Usual CareAlcohol Consumption (Frequency)0.25 score on a scaleStandard Deviation 1.28
Primary

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.

Time frame: 3 months

ArmMeasureValue (MEAN)Dispersion
Experimental: I-ACT With Check YourselfAlcohol Consumption (Quantity)0.20 score on a scaleStandard Deviation 0.79
No Intervention: Usual CareAlcohol Consumption (Quantity)0.10 score on a scaleStandard Deviation 0.53
Primary

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.

Time frame: 1-day

ArmMeasureValue (MEAN)Dispersion
Experimental: I-ACT With Check YourselfCaregiver Satisfaction With Care21.54 score on a scaleStandard Deviation 0.76
No Intervention: Usual CareCaregiver Satisfaction With Care21.47 score on a scaleStandard Deviation 1.13
Primary

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.

Time frame: 3 months

ArmMeasureGroupValue (MEAN)Dispersion
Experimental: I-ACT With Check YourselfCondom and/or Birth Control UseCondom Use1.89 score on a scaleStandard Deviation 1.36
Experimental: I-ACT With Check YourselfCondom and/or Birth Control UseBirth Control Use1.0 score on a scaleStandard Deviation 0
No Intervention: Usual CareCondom and/or Birth Control UseCondom Use2.00 score on a scaleStandard Deviation 1
No Intervention: Usual CareCondom and/or Birth Control UseBirth Control Use1.0 score on a scaleStandard Deviation 0
Primary

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.

Time frame: 3 month

ArmMeasureValue (MEAN)Dispersion
Experimental: I-ACT With Check YourselfDepression3.02 score on a scaleStandard Deviation 4.14
No Intervention: Usual CareDepression3.41 score on a scaleStandard Deviation 4.16
Primary

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.

Time frame: 3 month

ArmMeasureValue (MEAN)Dispersion
Experimental: I-ACT With Check YourselfDriving With Impairment0.01 score on a scaleStandard Deviation 0.08
No Intervention: Usual CareDriving With Impairment0.02 score on a scaleStandard Deviation 0.13
Primary

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.

Time frame: 3 month

ArmMeasureValue (MEAN)Dispersion
Experimental: I-ACT With Check YourselfFruit and Vegetable Consumption2.84 score on a scaleStandard Deviation 1.29
No Intervention: Usual CareFruit and Vegetable Consumption2.53 score on a scaleStandard Deviation 1.17
Primary

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.

Time frame: 3 months

ArmMeasureValue (MEAN)Dispersion
Experimental: I-ACT With Check YourselfHelmet Use3.78 score on a scaleStandard Deviation 0.69
No Intervention: Usual CareHelmet Use3.52 score on a scaleStandard Deviation 1
Primary

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.

Time frame: 3 months

ArmMeasureValue (MEAN)Dispersion
Experimental: I-ACT With Check YourselfMarijuana Consumption0.53 score on a scaleStandard Deviation 3.05
No Intervention: Usual CareMarijuana Consumption0.14 score on a scaleStandard Deviation 0.97
Primary

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.

Time frame: 3 month

ArmMeasureValue (MEAN)Dispersion
Experimental: I-ACT With Check YourselfNumber of Health Risk Behaviors2.23 score on a scaleStandard Deviation 1.98
No Intervention: Usual CareNumber of Health Risk Behaviors2.62 score on a scaleStandard Deviation 2.02
Primary

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.

Time frame: 3 months

ArmMeasureValue (MEAN)Dispersion
Experimental: I-ACT With Check YourselfOther Drug Consumption0.02 score on a scaleStandard Deviation 0.14
No Intervention: Usual CareOther Drug Consumption0.00 score on a scaleStandard Deviation 0
Primary

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.

Time frame: 3 month

ArmMeasureValue (MEAN)Dispersion
Experimental: I-ACT With Check YourselfPhysical Activity4.81 score on a scaleStandard Deviation 1.72
No Intervention: Usual CarePhysical Activity4.26 score on a scaleStandard Deviation 1.66
Primary

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.

Time frame: 3 month

ArmMeasureValue (MEAN)Dispersion
Experimental: I-ACT With Check YourselfSeatbelt Use3.97 score on a scaleStandard Deviation 0.18
No Intervention: Usual CareSeatbelt Use3.94 score on a scaleStandard Deviation 0.24
Primary

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.

Time frame: 3 month

ArmMeasureValue (MEAN)Dispersion
Experimental: I-ACT With Check YourselfSleep7.75 score on a scaleStandard Deviation 1.26
No Intervention: Usual CareSleep7.73 score on a scaleStandard Deviation 1.39
Primary

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.

Time frame: 3 month

ArmMeasureValue (MEAN)Dispersion
Experimental: I-ACT With Check YourselfSweetened Beverage Consumption0.80 score on a scaleStandard Deviation 0.8
No Intervention: Usual CareSweetened Beverage Consumption0.95 score on a scaleStandard Deviation 1.05
Primary

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.

Time frame: 3 months

ArmMeasureValue (MEAN)Dispersion
Experimental: I-ACT With Check YourselfTexting While Driving1.06 score on a scaleStandard Deviation 0.24
No Intervention: Usual CareTexting While Driving1.07 score on a scaleStandard Deviation 0.26
Primary

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.

Time frame: 3 months

ArmMeasureValue (MEAN)Dispersion
Experimental: I-ACT With Check YourselfTobacco Use0.03 score on a scaleStandard Deviation 0.16
No Intervention: Usual CareTobacco Use0.02 score on a scaleStandard Deviation 0.13
Secondary

Alcohol Consumption

Adolescent self-reported number of days of alcohol consumption and drinks during typical drinking episode in the prior month

Time frame: 12 month

Secondary

Alcohol Consumption

Adolescent self-reported number of days of alcohol consumption and drinks during typical drinking episode in the prior month

Time frame: 6 month

Secondary

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

Time frame: 12 month

Secondary

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

Time frame: 6 month

Secondary

Depression

Adolescent self-reported depression as measured on the nine item Patient Health Questionnaire in past 2 weeks

Time frame: 12 month

Secondary

Depression

Adolescent self-reported depression as measured on the nine item Patient Health Questionnaire in past 2 weeks

Time frame: 6 month

Secondary

Driving With Alcohol Impairment

Adolescent self-reported driving under the influence of a substance

Time frame: 6 month

Secondary

Driving With Alcohol Impairment

Adolescent self-reported driving under the influence of a substance

Time frame: 12 month

Secondary

Fruit and Vegetable Consumption

Adolescent self-reported fruits and vegetables consumed in a typical day in past 3 months

Time frame: 6 month

Secondary

Fruit and Vegetable Consumption

Adolescent self-reported fruits and vegetables consumed in a typical day in past 3 months

Time frame: 12 month

Secondary

Helmet Use

Adolescent self-reported frequency of helmet use while bicycling in past 3 months

Time frame: 6 month

Secondary

Helmet Use

Adolescent self-reported frequency of helmet use while bicycling in past 3 months

Time frame: 12 month

Secondary

Interval Receipt of Care Questionnaire

Dichotomous variable indicating receipt of any follow-up care to address risk

Time frame: 12 month

Secondary

Interval Receipt of Care Questionnaire

Dichotomous variable indicating receipt of any follow-up care to address risk

Time frame: 6 month

Secondary

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.

Time frame: 3 month

Secondary

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

Time frame: 12 month

Secondary

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

Time frame: 6 month

Secondary

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.

Time frame: 6 month

Secondary

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.

Time frame: 12 month

Secondary

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.

Time frame: 1 day

ArmMeasureGroupValue (NUMBER)
Experimental: I-ACT With Check YourselfPercent of Risk Behaviors Counseled on During Primary Care AppointmentModerate risk behaviors43 percentage of risk behaviors counselled
Experimental: I-ACT With Check YourselfPercent of Risk Behaviors Counseled on During Primary Care AppointmentHigh risk behaviors36 percentage of risk behaviors counselled
No Intervention: Usual CarePercent of Risk Behaviors Counseled on During Primary Care AppointmentModerate risk behaviors35 percentage of risk behaviors counselled
No Intervention: Usual CarePercent of Risk Behaviors Counseled on During Primary Care AppointmentHigh risk behaviors23 percentage of risk behaviors counselled
Secondary

Physical Activity

Adolescent self-reported days with \>60 minutes of physical activity in an average week in past 3 months

Time frame: 12 month

Secondary

Physical Activity

Adolescent self-reported days with \>60 minutes of physical activity in an average week in past 3 months

Time frame: 6 month

Secondary

Readiness to Change Ruler Questionnaire

Assessment of adolescent reported motivation to change overall health using a Readiness to Change Ruler.

Time frame: 12 month

Secondary

Readiness to Change Ruler Questionnaire

Assessment of adolescent reported motivation to change overall health using a Readiness to Change Ruler.

Time frame: 1 day

Secondary

Readiness to Change Ruler Questionnaire

Assessment of adolescent reported motivation to change overall health using a Readiness to Change Ruler.

Time frame: 3 month

Secondary

Readiness to Change Ruler Questionnaire

Assessment of adolescent reported motivation to change overall health using a Readiness to Change Ruler.

Time frame: 6 month

Secondary

Seatbelt Use

Adolescent self-reported frequency of seatbelt use in a car in past 3 months

Time frame: 6 month

Secondary

Seatbelt Use

Adolescent self-reported frequency of seatbelt use in a car in past 3 months

Time frame: 12 month

Secondary

Sleep

Adolescent self-reported hours of sleep on a typical night in past 3 months

Time frame: 12 month

Secondary

Sleep

Adolescent self-reported hours of sleep on a typical night in past 3 months

Time frame: 6 month

Secondary

Sweetened Beverage Consumption

Adolescent self-reported sweetened beverages consumed in a typical day in past 3 months

Time frame: 6 month

Secondary

Sweetened Beverage Consumption

Adolescent self-reported sweetened beverages consumed in a typical day in past 3 months

Time frame: 12 month

Secondary

Texting While Driving

Adolescent self-reported endorsement of texting while driving in past 3 months

Time frame: 12 month

Secondary

Texting While Driving

Adolescent self-reported endorsement of texting while driving in past 3 months

Time frame: 6 month

Secondary

Tobacco Use

Adolescent self-reported tobacco use in past 3 months

Time frame: 12 month

Secondary

Tobacco Use

Adolescent self-reported tobacco use in past 3 months

Time frame: 6 month

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026