NCT02882919

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 30, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

August 31, 2020

Status Verified

August 1, 2020

Enrollment Period

1.7 years

First QC Date

August 25, 2016

Last Update Submit

August 27, 2020

Conditions

Outcome Measures

Primary Outcomes (16)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (20)

  • Number of Health risk behaviors

    6 months

  • Sweetened Beverage Consumption

    6 month

  • Fruit and Vegetable Consumption

    6 month

  • Physical Activity

    6 month

  • Sleep

    6 month

  • +15 more secondary outcomes

Study Arms (2)

Check Yourself v2.0

EXPERIMENTAL

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

Usual care

NO INTERVENTION

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

Interventions

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.

Check Yourself v2.0

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Related Publications (1)

  • Richardson L, Parker EO, Zhou C, Kientz J, Ozer E, McCarty C. Electronic Health Risk Behavior Screening With Integrated Feedback Among Adolescents in Primary Care: Randomized Controlled Trial. J Med Internet Res. 2021 Mar 12;23(3):e24135. doi: 10.2196/24135.

MeSH Terms

Conditions

Adolescent Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Associate Professor of Pediatrics, University of Washington and Investigator, Seattle Children's Research Institute

Study Record Dates

First Submitted

August 25, 2016

First Posted

August 30, 2016

Study Start

October 1, 2016

Primary Completion

June 1, 2018

Study Completion

August 1, 2018

Last Updated

August 31, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations