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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02360410
Other study ID # 6 R40MC26817-01-01
Secondary ID
Status Completed
Phase N/A
First received February 5, 2015
Last updated April 17, 2018
Start date February 2015
Est. completion date December 2016

Study information

Verified date April 2018
Source Seattle Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The proposed study is a randomized controlled trial that compares the effectiveness of an electronic personalized health screening app incorporating motivational feedback (i.e., "Check Yourself") to usual care. The purpose of this study is to determine whether Check Yourself is more effective than usual care in reducing health risk behaviors and improving quality of care among adolescents receiving primary health care services.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 13 Years to 18 Years
Eligibility Inclusion Criteria:

- Eligible individuals will be 13-18 years old who have an appointment to see a provider at a participating clinic and will be able to read and comprehend English.

Exclusion Criteria:

- Individuals will be excluded from the study if:

- they do not meet age requirements,

- do not have an appointment at a participating clinic,

- lack the means to complete follow-up interviews (i.e., has neither telephone not internet access),

- have a sibling who has/is being enrolled in the study and/or

- are not able to read or comprehend English.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Check Yourself App with Feedback


Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Laura Richardson

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Adolescent Perceived Support from their Primary Care Provider The total score on the Health Care Climate Questionnaire (HCCQ),) will be used to assess adolescent self-report of perceived autonomy support from their primary care provider. 1 day
Other Adolescent Health Self-Efficacy The total score on the Health Self Efficacy Scale will be used to assess adolescent self-report of perceived confidence in ability to execute health behaviors. 1 day
Primary Number of Health risk behaviors Total count health-risk behaviors at 3-month follow-up (Score range= 0-13) adjusted by total number of baseline risk behaviors (with risk cut-off): =2 sugar-sweetened beverages consumed/day; =3 servings fruits/vegetables consumed/day; =3 days with 60+ minutes exercise during typical week; =3 hours of screen time during typical school day; =7 hours of sleep during typical night; not "always" using seatbelt; not "always" using helmet when bicycling; having driven under the influence of substances; 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/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)); any tobacco use; any marijuana/other drugs use; not using birth control during last sexual intercourse and/or not "always" using a condom; and =10 score on PHQ-9. 3 months
Primary Number of risk behaviors counseled on during primary care appointment Number of adolescent-reported high risk health risk behaviors discussed with the healthcare provider during the primary care visit (Score range: 0-13) adjusted for the total number of health risk behaviors reported at baseline. Receipt of counseling/discussion assessed using an adapted version of the Adolescent Report of the Visit (AROV). The AROV includes counseling on the following behaviors: 1) sweetened beverage consumption; 2) fruit/vegetable consumption; 3) physical activity amount; 4) screen time (i.e., watching TV, playing video games, surfing the web, or texting); 5) sleep duration; 6) seat belt use; 7) helmet use while bicycling; 8) drinking/using drugs while driving; 9) alcohol use; 10) tobacco use; 11) marijuana and/or other drug use; 12) condom and/or birth control use; 13) depression and moods. 1 day
Secondary Adolescent Satisfaction with Care Adolescent satisfaction with care will be assessed using the total score on the 8-item Client Satisfaction Questionnaire (CSQ-8) at 1-day follow-up. 1 day
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 Motivation for Health Behavior Change Assessment of adolescent reported motivation to change overall health using a Readiness to Change Ruler. 1 day
Secondary Specific Health Risk Behavior Change Reported level for each specific health risk behavior at 3 months adjusting for baseline level of that specific behavior. Specific individual behaviors include: A.) number of: sweetened beverages consumed in a typical day; fruits and vegetables consumed in a typical day; days with >60 minutes of physical activity in an average week; hours of screen time on a typical day; hours of sleep on a typical night; days in which alcohol was consumed in the prior month; alcoholic drinks typically consumed per occasion; any tobacco use in the prior month (yes/no); days using marijuana in the past month; B) Score on the nine item Patient Health Questionnaire (27 point scale); C) Frequency of: seatbelt use in a car (4-point scale); helmet use while bicycling (4-point scale); condom use with sexual intercourse (4-point scale); D) Use of any form of birth control at last sexual intercourse (yes/no); and E) Driving under the influence of a substance (yes/no). 3 months
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