Trial Outcomes & Findings for I-ACT With Check Yourself (NCT NCT02764190)

NCT ID: NCT02764190

Last Updated: 2019-11-19

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 302 participants
• Primary outcome timeframe: 3 month
• Results posted on: 2019-11-19

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	167	135
Overall Study 1 Day Follow-up	161	131
Overall Study 3 Month Follow-up	156	128
Overall Study 6 Month Follow-up	155	128
Overall Study 12 Month Follow-up	150	122
Overall Study COMPLETED	150	122
Overall Study NOT COMPLETED	17	13

Reasons for withdrawal

Measure	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.	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.
Overall Study Lost to Follow-up	17	13

Baseline Characteristics

I-ACT With Check Yourself

Baseline characteristics by cohort

Measure	Experimental: I-ACT With Check Yourself n=167 Participants 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.	No Intervention: Usual Care n=135 Participants 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.	Total n=302 Participants Total of all reporting groups
Age, Categorical <=18 years	167 Participants n=5 Participants	135 Participants n=7 Participants	302 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	14.79 years STANDARD_DEVIATION 1.41 • n=5 Participants	14.70 years STANDARD_DEVIATION 1.44 • n=7 Participants	14.75 years STANDARD_DEVIATION 1.42 • n=5 Participants
Sex: Female, Male Female	88 Participants n=5 Participants	69 Participants n=7 Participants	157 Participants n=5 Participants
Sex: Female, Male Male	79 Participants n=5 Participants	66 Participants n=7 Participants	145 Participants n=5 Participants
Race/Ethnicity, Customized African American	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Native American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian	11 Participants n=5 Participants	17 Participants n=7 Participants	28 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	122 Participants n=5 Participants	90 Participants n=7 Participants	212 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	11 Participants n=5 Participants	6 Participants n=7 Participants	17 Participants n=5 Participants
Race/Ethnicity, Customized Other/Multiple Races	21 Participants n=5 Participants	17 Participants n=7 Participants	38 Participants n=5 Participants
Region of Enrollment United States	167 participants n=5 Participants	135 participants n=7 Participants	302 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Experimental: I-ACT With Check Yourself n=150 Participants 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.	No Intervention: Usual Care n=120 Participants 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.
Number of Health Risk Behaviors	2.23 score on a scale Standard Deviation 1.98	2.62 score on a scale Standard Deviation 2.02

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Experimental: I-ACT With Check Yourself n=154 Participants 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.	No Intervention: Usual Care n=128 Participants 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.
Sweetened Beverage Consumption	0.80 score on a scale Standard Deviation 0.80	0.95 score on a scale Standard Deviation 1.05

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Experimental: I-ACT With Check Yourself n=154 Participants 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.	No Intervention: Usual Care n=127 Participants 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.
Fruit and Vegetable Consumption	2.84 score on a scale Standard Deviation 1.29	2.53 score on a scale Standard Deviation 1.17

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Experimental: I-ACT With Check Yourself n=154 Participants 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.	No Intervention: Usual Care n=126 Participants 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.
Physical Activity	4.81 score on a scale Standard Deviation 1.72	4.26 score on a scale Standard Deviation 1.66

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Experimental: I-ACT With Check Yourself n=152 Participants 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.	No Intervention: Usual Care n=124 Participants 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.
Sleep	7.75 score on a scale Standard Deviation 1.26	7.73 score on a scale Standard Deviation 1.39

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Experimental: I-ACT With Check Yourself n=154 Participants 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.	No Intervention: Usual Care n=128 Participants 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.
Alcohol Consumption (Frequency)	0.25 score on a scale Standard Deviation 1.09	0.25 score on a scale Standard Deviation 1.28

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Experimental: I-ACT With Check Yourself n=154 Participants 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.	No Intervention: Usual Care n=128 Participants 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.
Alcohol Consumption (Quantity)	0.20 score on a scale Standard Deviation 0.79	0.10 score on a scale Standard Deviation 0.53

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Experimental: I-ACT With Check Yourself n=154 Participants 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.	No Intervention: Usual Care n=128 Participants 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.
Marijuana Consumption	0.53 score on a scale Standard Deviation 3.05	0.14 score on a scale Standard Deviation 0.97

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Experimental: I-ACT With Check Yourself n=154 Participants 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.	No Intervention: Usual Care n=128 Participants 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.
Other Drug Consumption	0.02 score on a scale Standard Deviation 0.14	0.00 score on a scale Standard Deviation 0.00

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Experimental: I-ACT With Check Yourself n=154 Participants 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.	No Intervention: Usual Care n=128 Participants 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.
Depression	3.02 score on a scale Standard Deviation 4.14	3.41 score on a scale Standard Deviation 4.16

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Experimental: I-ACT With Check Yourself n=154 Participants 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.	No Intervention: Usual Care n=128 Participants 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.
Seatbelt Use	3.97 score on a scale Standard Deviation 0.18	3.94 score on a scale Standard Deviation 0.24

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Experimental: I-ACT With Check Yourself n=153 Participants 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.	No Intervention: Usual Care n=128 Participants 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.
Helmet Use	3.78 score on a scale Standard Deviation 0.69	3.52 score on a scale Standard Deviation 1.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Experimental: I-ACT With Check Yourself n=154 Participants 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.	No Intervention: Usual Care n=128 Participants 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.
Texting While Driving	1.06 score on a scale Standard Deviation 0.24	1.07 score on a scale Standard Deviation 0.26

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Experimental: I-ACT With Check Yourself n=9 Participants 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.	No Intervention: Usual Care n=3 Participants 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.
Condom and/or Birth Control Use Condom Use	1.89 score on a scale Standard Deviation 1.36	2.00 score on a scale Standard Deviation 1.0
Condom and/or Birth Control Use Birth Control Use	1.0 score on a scale Standard Deviation 0.00	1.0 score on a scale Standard Deviation 0.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Experimental: I-ACT With Check Yourself n=154 Participants 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.	No Intervention: Usual Care n=128 Participants 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.
Driving With Impairment	0.01 score on a scale Standard Deviation 0.08	0.02 score on a scale Standard Deviation 0.13

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Experimental: I-ACT With Check Yourself n=148 Participants 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.	No Intervention: Usual Care n=119 Participants 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.
Adolescent Satisfaction With Care	9.18 score on a scale Standard Deviation 1.11	9.23 score on a scale Standard Deviation 0.95

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Experimental: I-ACT With Check Yourself n=115 Participants 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.	No Intervention: Usual Care n=100 Participants 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.
Caregiver Satisfaction With Care	21.54 score on a scale Standard Deviation 0.76	21.47 score on a scale Standard Deviation 1.13

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Experimental: I-ACT With Check Yourself n=150 Participants 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.	No Intervention: Usual Care n=123 Participants 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.
Adolescent Perception of Patient-Centeredness	45.63 score on a scale Standard Deviation 5.60	45.63 score on a scale Standard Deviation 6.26

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Experimental: I-ACT With Check Yourself n=154 Participants 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.	No Intervention: Usual Care n=128 Participants 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.
Tobacco Use	0.03 score on a scale Standard Deviation 0.16	0.02 score on a scale Standard Deviation 0.13

SECONDARY outcome

Timeframe: 1 day

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.

Outcome measures

Measure	Experimental: I-ACT With Check Yourself n=152 Participants 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.	No Intervention: Usual Care n=123 Participants 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.
Percent of Risk Behaviors Counseled on During Primary Care Appointment Moderate risk behaviors	43 percentage of risk behaviors counselled	35 percentage of risk behaviors counselled
Percent of Risk Behaviors Counseled on During Primary Care Appointment High risk behaviors	36 percentage of risk behaviors counselled	23 percentage of risk behaviors counselled

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 month

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 month

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 month

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 month

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 month

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 month

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 month

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 month

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 month

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 month

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 month

Adolescent self-reported number of days using marijuana in the past month and/or other drugs used in past 3 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 month

Adolescent self-reported number of days using marijuana in the past month and/or other drugs used in past 3 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 month

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 month

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 month

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 month

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 month

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 month

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 month

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 month

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 month

Adolescent self-reported driving under the influence of a substance

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 month

Adolescent self-reported driving under the influence of a substance

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 month

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 month

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 day

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 month

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 month

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 month

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 month

Adolescent self-reported tobacco use in past 3 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 month

Adolescent self-reported tobacco use in past 3 months

Outcome measures

Outcome data not reported

Adverse Events

Experimental: I-ACT With Check Yourself

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Intervention: Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Cari McCarty

Seattle Children's Research Institute

Phone: 206-884-8243

Email: Carolyn.McCarty@seattlechildrens.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place