- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02584621
Web-Based Adolescent Motivational Enhancement Study (Web-AME)
October 4, 2017 updated by: Carolyn McCarty, Seattle Children's Hospital
Web-Supported Adolescent Motivational Enhancement to Reduce Alcohol Use
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 among moderate to high risk alcohol users.
The purpose of this study is to determine whether Check Yourself is more effective than usual care in reducing alcohol consumption and binge drinking and improving quality of care among adolescents receiving school-based health clinic services.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
148
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98118
- Interagency Teen Health Center
-
Seattle, Washington, United States, 98122
- Garfield Teen Health Center
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Seattle, Washington, United States, 98125
- Nathan Hale Teen Health Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Eligible individuals will be 13-18 years old who are able to read and comprehend English.
- Participants who indicate alcohol use consistent with moderate to high risk on the Check Yourself App.
Exclusion Criteria:
Individuals will be excluded from the study if:
- They do not meet age requirements
- Do not have a study visit at a participating school-based health clinic
- Lack the means to complete follow-up interviews (i.e. have neither telephone or internet access)
- Are not able to read or comprehend English
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Check Yourself App With Feedback
Participants complete Check Yourself, an electronic health screening app and receive personalized, motivational feedback on their health behaviors prior to their visit with their health provider.
Key components of Check Yourself include the provision of age normative feedback, goal setting strategies, and strategies to highlight discrepancies.
Health providers receive a summary report of health risk behaviors from Check Yourself prior to the visit.
|
|
No Intervention: Usual Care
Participants are asked to complete health risk screening questions on a tablet 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alcohol Use Frequency and Quantity
Time Frame: 2 months
|
Adolescent reported level for alcohol risk behaviors at 2 months adjusting for baseline level.
Specific alcohol behaviors include: 1) number of days in which alcohol was consumed in the past 30 days; 2) number of alcoholic drinks typically consumed per occasion; and 4) maximum number of alcoholic drinks consumed during one drinking episode.
|
2 months
|
Adolescent report of whether alcohol was counseled on during health provider visit
Time Frame: 1 day
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adolescent Satisfaction with Care
Time Frame: 1 day
|
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
|
Marijuana Use Frequency and Quantity
Time Frame: 2 months
|
Adolescent reported level for marijuana risk behaviors at 2 months adjusting for baseline level.
Specific marijuana behaviors include: 1) number of days in which marijuana was used in the past 30 days; and 2) number of hours high on a typical day of marijuana use.
|
2 months
|
Interval Receipt of Care for Substance Use
Time Frame: 2 months
|
Dichotomous variable indicating receipt of any follow-up care to address substance use identified at baseline.
|
2 months
|
Adolescent Substance Use Problem Recognition
Time Frame: 1 day & 2 months
|
Adolescent reported recognition of alcohol and/or marijuana use as a problem (5-point scale).
|
1 day & 2 months
|
Motivation for Substance Use Behavior Change
Time Frame: 1 day & 2 months
|
Adolescent reported motivation to change alcohol use and/or marijuana use using a readiness to change scale (4-point scale).
|
1 day & 2 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of non-substance use health risk behaviors
Time Frame: 2 months
|
Total count of non-substance use health risk behaviors at 2-month follow-up (score range=0-11) adjusted by total number of baseline health risk behaviors which include (with risk cut-off): during a typical day >2 sugar-sweetened beverages consumed or <3 servings of fruits/vegetables consumed; during a typical week <3 days with 60+ minutes of exercise; during a typical school day >3 hours of screen time; during a typical night <7 hours of sleep; not "always" using seatbelt; not "always" using helmet when bicycling; having driven/ridden in a car with a driver under the influence of substances; not using birth control during last sexual intercourse; not "always" using a condom; and a score of >10 on the Patient Health Questionnaire (PHQ-9).
|
2 months
|
Adolescent perceived support from their health care provider
Time Frame: 1 day
|
The total score on the Health Care Climate Questionnaire (HCCQ) will be used to assess adolescent self-report of perceived autonomy support from their health care provider.
|
1 day
|
Adolescent report of whether marijuana/other drug use was counseled on during health provider visit
Time Frame: 1 day
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2015
Primary Completion (Actual)
February 1, 2017
Study Completion (Actual)
April 1, 2017
Study Registration Dates
First Submitted
October 21, 2015
First Submitted That Met QC Criteria
October 21, 2015
First Posted (Estimate)
October 22, 2015
Study Record Updates
Last Update Posted (Actual)
October 5, 2017
Last Update Submitted That Met QC Criteria
October 4, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- 3679948
- 1R21AA023050-01A1 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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