Verified August 2016 by Seattle Children’s Hospital
Sponsor:
Information provided by (Responsible Party):
Carolyn McCarty, Seattle Children’s Hospital
ClinicalTrials.gov Identifier:
NCT02882919
First received: August 25, 2016
Last updated: August 29, 2016
Last verified: August 2016
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.
| Adolescent Behavior | Behavioral: Check Yourself v2.0 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Health Services Research |
| Official Title: | Improving Teen Health With Health Information Technology |
- Number of Health risk behaviors [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Total count adolescent health-risk behaviors at 3 month follow-up. Risk behaviors include: during typical day: ≥2 sugar-sweetened beverages consumed and ≤3 servings fruits/vegetables consumed; ≤3 days with 60+ minutes exercise during typical week; ≤7 hours of sleep during typical night; not “always” using seatbelt; not “always” using helmet when bicycling; having driven/ridden in a car with a driver under the influence of substances; days of alcohol consumption in last 30 days and/or 1 year (risk based on age); number of drinks per drinking episode (risk based on age and gender); days of marijuana consumption in 30 days and/or last year (risk based on age); not using birth control during last sexual intercourse; not “always” using a condom; and score of ≥10 on PHQ-9.
- Sweetened Beverage Consumption [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Adolescent self-reported sweetened beverages consumed in a typical day
- Physical Activity [ Time Frame: 3 month ] [ Designated as safety issue: No ]
Adolescent self-reported days with >60 minutes of physical activity in an average week
- Sleep [ Time Frame: 3 month ] [ Designated as safety issue: No ]
Adolescent self-reported hours of sleep on a typical night
- Alcohol Consumption [ Time Frame: 3 month ] [ Designated as safety issue: No ]
Adolescent self-reported days in which alcohol was consumed in the prior month
- Marijuana Consumption [ Time Frame: 3 month ] [ Designated as safety issue: No ]
Adolescent self-reported number of days using marijuana in the past month
- Depression [ Time Frame: 3 month ] [ Designated as safety issue: No ]
Adolescent self-reported depression as measured on the nine item Patient Health Questionnaire
- Seat belt Use [ Time Frame: 3 month ] [ Designated as safety issue: No ]
Adolescent self-reported frequency of seat belt use in a car
- Helmet Use [ Time Frame: 3 month ] [ Designated as safety issue: No ]
Adolescent self-reported frequency of helmet use while bicycling
- Texting while driving [ Time Frame: 3 month ] [ Designated as safety issue: No ]
Adolescent self-reported endorsement of texting while driving
- Condom Use [ Time Frame: 3 month ] [ Designated as safety issue: No ]
Adolescent self-reported condom use with sexual intercourse
- Use of Birth control [ Time Frame: 3 month ] [ Designated as safety issue: No ]
Adolescent self-reported use of any form of birth control at last sexual intercourse
- Driving or Riding with Alcohol Impairment [ Time Frame: 3 month ] [ Designated as safety issue: No ]
Adolescent self-reported driving or riding in a car with someone under the influence of a substance
- Fruit and Vegetable Consumption [ Time Frame: 3 month ] [ Designated as safety issue: No ]
Adolescent self-reported fruits and vegetables consumed in a typical day
- Number of risk behaviors counseled on during primary care appointment [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Number 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
- Adolescent Satisfaction with Care [ Time Frame: 1 day ] [ Designated as safety issue: No ]
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
- Number of Health risk behaviors [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Total count adolescent health-risk behaviors at 3 month follow-up. Risk behaviors include: during typical day: ≥2 sugar-sweetened beverages consumed and ≤3 servings fruits/vegetables consumed; ≤3 days with 60+ minutes exercise during typical week; ≤7 hours of sleep during typical night; not “always” using seatbelt; not “always” using helmet when bicycling; having driven/ridden in a car with a driver under the influence of substances; days of alcohol consumption in last 30 days and/or 1 year (risk based on age); number of drinks per drinking episode (risk based on age and gender); days of marijuana consumption in 30 days and/or last year (risk based on age); not using birth control during last sexual intercourse; not “always” using a condom; and score of ≥10 on PHQ-9.
- Sweetened Beverage Consumption [ Time Frame: 6 month ] [ Designated as safety issue: No ]
Adolescent self-reported sweetened beverages consumed in a typical day
- Fruit and Vegetable Consumption [ Time Frame: 6 month ] [ Designated as safety issue: No ]
Adolescent self-reported fruits and vegetables consumed in a typical day
- Physical Activity [ Time Frame: 6 month ] [ Designated as safety issue: No ]
Adolescent self-reported days with >60 minutes of physical activity in an average week
- Sleep [ Time Frame: 6 month ] [ Designated as safety issue: No ]
Adolescent self-reported hours of sleep on a typical night
- Alcohol Consumption [ Time Frame: 6 month ] [ Designated as safety issue: No ]
Adolescent self-reported days in which alcohol was consumed in the prior month
- Marijuana Consumption [ Time Frame: 6 month ] [ Designated as safety issue: No ]
Adolescent self-reported number of days using marijuana in the past month
- Depression [ Time Frame: 6 month ] [ Designated as safety issue: No ]
Adolescent self-reported depression as measured on the nine item Patient Health Questionnaire
- Seat-belt Use [ Time Frame: 6 month ] [ Designated as safety issue: No ]
Adolescent self-reported frequency of seatbelt use in a car
- Helmet Use [ Time Frame: 6 month ] [ Designated as safety issue: No ]
Adolescent self-reported frequency of helmet use while bicycling
- Texting while driving [ Time Frame: 6 month ] [ Designated as safety issue: No ]
Adolescent self-reported endorsement of texting while driving
- Condom Use [ Time Frame: 6 month ] [ Designated as safety issue: No ]
Adolescent self-reported condom use with sexual intercourse
- Use of Birth control [ Time Frame: 6 month ] [ Designated as safety issue: No ]
Adolescent self-reported use of any form of birth control at last sexual intercourse
- Driving or Riding with Alcohol Impairment [ Time Frame: 6 month ] [ Designated as safety issue: No ]
Adolescent self-reported driving or riding in a car with someone under the influence of a substance
- Interval Receipt of Care [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Dichotomous variable indicating receipt of any follow-up care to address risk behaviors identified at baseline adjusted for baseline number of health risk behaviors
- Interval Receipt of Care [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Dichotomous 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 [ Time Frame: 1-day ] [ Designated as safety issue: No ]
Assessment of adolescent reported motivation to change overall health
- Readiness to Change Ruler [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Assessment of adolescent reported motivation to change overall health
- Readiness to Change Ruler [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Assessment of adolescent reported motivation to change overall health
- Adolescent Health Self -Efficacy [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Self-report of adolescent health self efficacy
| Estimated Enrollment: | 300 |
| Study Start Date: | September 2016 |
| Estimated Study Completion Date: | August 2018 |
| Estimated Primary Completion Date: | May 2018 (Final data collection date for primary outcome measure) |
| Experimental: 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 highlight discrepancies. Primary care providers will receive a summary report of health risk behaviors prior to their adolescent patient’s primary care appointment. |
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. |
| No Intervention: Usual care
In the usual care group, patients are asked to complete health risk screening on a computer. No personalized feedback is provided to adolescents and primary care providers do not receive a summary report of the adolescent’s health risk behaviors |
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.
| Ages Eligible for Study: | 13 Years to 18 Years (Child, Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Eligible adolescent participants will be13-18 years of age
- Caregiver participants will be 18 years of age or older
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02882919
Carolyn McCarty
| Responsible Party: | Carolyn McCarty, Research Associate Professor of Pediatrics, University of Washington and Investigator, Seattle Children’s Research Institute, Seattle Children’s Hospital |
| ClinicalTrials.gov Identifier: | NCT02882919 History of Changes |
| Other Study ID Numbers: | 1R01HS023383-01 |
| Study First Received: | August 25, 2016 |
| Last Updated: | August 29, 2016 |
| Health Authority: | United States: Institutional Review Board |
| Individual Participant Data | |
| Plan to Share IPD: | No |
ClinicalTrials.gov processed this record on September 01, 2016