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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
148

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Washington
      • Seattle, Washington, United States, 98118
        • Interagency Teen Health Center
      • Seattle, Washington, United States, 98122
        • Garfield Teen Health Center
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Check Yourself App with Feedback
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seattle Children's Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 21, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 21, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 22, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 5, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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