I-ACT With Check Yourself

Adolescent Behavior Clinical Trial

Official title:

Delivering Patient-Centered Adolescent Preventative Care With Training and Technology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02764190
• Other study ID #: IHS-1402-10592
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: November 2018

Study information

• Verified date: November 2019
• Source: Seattle Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: November 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Adolescent Behavior

Intervention

Behavioral:
• I-ACT with Check Yourself

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Seattle Children's Hospital	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	3 month
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.	3 month
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.	3 month
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.	3 month
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.	3 month
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.	3 months
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.	3 months
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.	3 months
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.	3 months
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.	3 month
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.	3 month
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.	3 months
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.	3 months
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.	3 months
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.	3 month
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.	1-day
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.	1-day
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.	1 day
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.	3 months
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.	1 day
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.	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.	12 month
Secondary	Sweetened Beverage Consumption	Adolescent self-reported sweetened beverages consumed in a typical day in past 3 months	6 month
Secondary	Sweetened Beverage Consumption	Adolescent self-reported sweetened beverages consumed in a typical day in past 3 months	12 month
Secondary	Fruit and Vegetable Consumption	Adolescent self-reported fruits and vegetables consumed in a typical day in past 3 months	6 month
Secondary	Fruit and Vegetable Consumption	Adolescent self-reported fruits and vegetables consumed in a typical day in past 3 months	12 month
Secondary	Physical Activity	Adolescent self-reported days with >60 minutes of physical activity in an average week in past 3 months	6 month
Secondary	Physical Activity	Adolescent self-reported days with >60 minutes of physical activity in an average week in past 3 months	12 month
Secondary	Sleep	Adolescent self-reported hours of sleep on a typical night in past 3 months	6 month
Secondary	Sleep	Adolescent self-reported hours of sleep on a typical night in past 3 months	12 month
Secondary	Alcohol Consumption	Adolescent self-reported number of days of alcohol consumption and drinks during typical drinking episode in the prior month	6 month
Secondary	Alcohol Consumption	Adolescent self-reported number of days of alcohol consumption and drinks during typical drinking episode in the prior month	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	6 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	12 month
Secondary	Depression	Adolescent self-reported depression as measured on the nine item Patient Health Questionnaire in past 2 weeks	6 month
Secondary	Depression	Adolescent self-reported depression as measured on the nine item Patient Health Questionnaire in past 2 weeks	12 month
Secondary	Seatbelt Use	Adolescent self-reported frequency of seatbelt use in a car in past 3 months	6 month
Secondary	Seatbelt Use	Adolescent self-reported frequency of seatbelt use in a car in past 3 months	12 month
Secondary	Helmet Use	Adolescent self-reported frequency of helmet use while bicycling in past 3 months	6 month
Secondary	Helmet Use	Adolescent self-reported frequency of helmet use while bicycling in past 3 months	12 month
Secondary	Texting While Driving	Adolescent self-reported endorsement of texting while driving in past 3 months	6 month
Secondary	Texting While Driving	Adolescent self-reported endorsement of texting while driving in past 3 months	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	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	12 month
Secondary	Driving With Alcohol Impairment	Adolescent self-reported driving under the influence of a substance	6 month
Secondary	Driving With Alcohol Impairment	Adolescent self-reported driving under the influence of a substance	12 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.	3 month
Secondary	Interval Receipt of Care Questionnaire	Dichotomous variable indicating receipt of any follow-up care to address risk	6 month
Secondary	Interval Receipt of Care Questionnaire	Dichotomous variable indicating receipt of any follow-up care to address risk	12 month
Secondary	Readiness to Change Ruler Questionnaire	Assessment of adolescent reported motivation to change overall health using a Readiness to Change Ruler.	1 day
Secondary	Readiness to Change Ruler Questionnaire	Assessment of adolescent reported motivation to change overall health using a Readiness to Change Ruler.	3 month
Secondary	Readiness to Change Ruler Questionnaire	Assessment of adolescent reported motivation to change overall health using a Readiness to Change Ruler.	6 month
Secondary	Readiness to Change Ruler Questionnaire	Assessment of adolescent reported motivation to change overall health using a Readiness to Change Ruler.	12 month
Secondary	Tobacco Use	Adolescent self-reported tobacco use in past 3 months	6 month
Secondary	Tobacco Use	Adolescent self-reported tobacco use in past 3 months	12 month