Check Yourself v2.0

Adolescent Behavior Clinical Trial

Official title:

Improving Teen Health With Health Information Technology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02882919
• Other study ID #: 1R01HS023383-01
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: August 2018

Study information

• Verified date: August 2020
• Source: Seattle Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Health risk screening in adolescent primary care is infrequently performed and results are rarely followed by targeted intervention. In response to the need for screening-linked interventions, the study team has developed and optimized a web-based, electronic Personalized Motivational Feedback tool referred to as "Check Yourself v2.0" 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.

Description:

The proposed study is a randomized controlled trial that compares the effectiveness of Check Yourself v2.0 to usual care. The purpose of this study is to determine the impact of Check Yourself on reducing health risk behaviors and improving quality of care among adolescents receiving primary health care services relative to usual care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: August 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

Inclusion Criteria:

• Eligible adolescent participants will be13-18 years of age

• Able to understand English.

• 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

• Participants 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

• Not able to understand English.

Related Conditions & MeSH terms

• Adolescent Behavior

Intervention

Behavioral:
• Check Yourself v2.0
In the intervention group, adolescents complete Check Yourself which delivers personalized, motivational feedback on their health behaviors prior to their primary care appointment. Key components of Check Yourself include the provision of age normative feedback, goal setting strategies, and strategies to increase motivation for healthy behaviors. Primary care providers will receive a summary report of health risk behaviors prior to their adolescent patient's primary care appointment.

Locations

Country	Name	City	State
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Carolyn McCarty

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 months
Primary	Sweetened Beverage Consumption	Adolescent self-reported sweetened beverages consumed in a typical day in 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 months
Primary	Physical Activity	Adolescent self-reported days with >60 minutes of physical activity in an average week in 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 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 and number of drinks during a typical drinking episode in the prior month	3 month
Primary	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. Two questions were used for this category. The marijuana frequency scale includes 31 values: 0 (min) to 30 (max) days in the past month. Higher scores mean a worse outcome. 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 month
Primary	Depression	Adolescent self-reported depression as measured on the nine item Patient Health Questionnaire in 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	Seat belt Use	Adolescent self-reported frequency of seat belt use in a car in 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 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 month
Primary	Texting while driving	Adolescent self-reported endorsement of texting while driving in 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 month
Primary	Condom Use and/or Birth Control Use	Adolescent self-reported condom use with sexual intercourse in past 3 months and/or use of birth control with 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 month
Primary	Driving with Impairment	Adolescent self-reported driving under the influence of a substance in 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	Fruit and Vegetable Consumption	Adolescent self-reported fruits and vegetables consumed in a typical day in 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	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
Primary	Adolescent Satisfaction with Care	Adolescent satisfaction with care will be assessed using 1 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	Tobacco Use	Adolescent self-reported endorsement of tobacco use in past 3 months. The tobacco use scale includes 2 values: 0=no (min) or 1=yes (max). Higher scores mean a worse outcome.	3 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.	6 months
Secondary	Sweetened Beverage Consumption	Adolescent self-reported sweetened beverages 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	6 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	Sleep	Adolescent self-reported hours of sleep on a typical night in past 3 months	6 month
Secondary	Alcohol Consumption	Adolescent self-reported number of days of alcohol consumption and number of drinks during a typical drinking episode in the prior month	6 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	Depression	Adolescent self-reported depression as measured on the nine item Patient Health Questionnaire in past 2 weeks	6 month
Secondary	Seat-belt Use	Adolescent self-reported frequency of seatbelt use in a car in past 3 months	6 month
Secondary	Helmet Use	Adolescent self-reported frequency of helmet use while bicycling in past 3 months	6 month
Secondary	Texting while driving	Adolescent self-reported endorsement of texting while driving in past 3 months	6 month
Secondary	Condom Use and or Birth Control Use	Adolescent self-reported condom use with sexual intercourse in past 3 months and/or use of birth control at last sexual intercourse	6 month
Secondary	Driving with Alcohol Impairment	Adolescent self-reported driving under the influence of a substance	6 month
Secondary	Interval Receipt of Care	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 months
Secondary	Interval Receipt of Care	Dichotomous variable indicating receipt of any follow-up care to address risk behaviors identified at baseline adjusted for baseline number of health risk behaviors	6 months
Secondary	Readiness to Change Ruler	Assessment of adolescent reported motivation to change overall health	1-day
Secondary	Readiness to Change Ruler	Assessment of adolescent reported motivation to change overall health	3 months
Secondary	Readiness to Change Ruler	Assessment of adolescent reported motivation to change overall health	6 months
Secondary	Adolescent Health Self -Efficacy	Self-report of adolescent health self efficacy	1 day
Secondary	Tobacco Use	Adolescent self-reported endorsement of tobacco use in past 3 months	6 month