Alcohol Risk BehaviorsWeb-AMENCT02584621
Web-Based Adolescent Motivational Enhancement Study
A study testing Check Yourself App with Feedback in people with Alcohol Risk Behaviors and Health Care Services Quality of Care, run by Seattle Children's Hospital at 3 sites in United States.
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 among moderate to high risk alcohol users. Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Risk Behaviors, Health Care Services Quality of Care
- What is being tested?
- Check Yourself App with Feedback
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2015to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Interagency Teen Health Center
Seattle, Washington, 98118
Garfield Teen Health Center
Seattle, Washington, 98122
Nathan Hale Teen Health Center
Seattle, Washington, 98125
About this study
Official title: 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.
- Being tested
- Check Yourself App with Feedback
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Check Yourself App with FeedbackBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Check Yourself App With Feedback | Experimental | 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. Receives: Behavioral: Check Yourself App with Feedback |
| Usual Care | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Alcohol Use Frequency and Quantity
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.
Measured: 2 months
Adolescent report of whether alcohol was counseled on during health provider visit
Measured: 1 day
Secondary outcomes (5)
Marijuana Use Frequency and Quantity
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.
Measured: 2 months
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.
Measured: 1 day
Interval Receipt of Care for Substance Use
Dichotomous variable indicating receipt of any follow-up care to address substance use identified at baseline.
Measured: 2 months
Adolescent Substance Use Problem Recognition
Adolescent reported recognition of alcohol and/or marijuana use as a problem (5-point scale).
Measured: 1 day & 2 months
Motivation for Substance Use Behavior Change
Adolescent reported motivation to change alcohol use and/or marijuana use using a readiness to change scale (4-point scale).
Measured: 1 day & 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionFeb 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Risk BehaviorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Carolyn McCarty, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02584621
- Sponsor's protocol ID
- 3679948
- Other IDs
- 1R21AA023050-01A1
- Acronym
- Web-AME
- Status last verified
- Oct 2017
- First submitted
- 21 Oct 2015
- Last updated
- 5 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web-Supported Adolescent Motivational Enhancement to Reduce Alcohol Use
- ClinicalTrials.gov ID
- NCT02584621
- Acronym / sponsor ID
- Web-AME / 3679948
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Nov 2015
- Primary completion
- Feb 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 22 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Check Yourself App With Feedback | Experimental | Behavioral: Check Yourself App with FeedbackParticipants 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. |
| Usual Care | No intervention | –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. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Check Yourself App with Feedback | Behavioural | Check Yourself App With Feedback |
Primary outcome
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.
Adolescent report of whether alcohol was counseled on during health provider visit
Time frame: 1 day
5 secondary outcomes
Marijuana Use Frequency and Quantity
Time frame: 2 months
Adolescent Satisfaction with Care
Time frame: 1 day
Interval Receipt of Care for Substance Use
Time frame: 2 months
Adolescent Substance Use Problem Recognition
Time frame: 1 day & 2 months
Motivation for Substance Use Behavior Change
Time frame: 1 day & 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2017.
Related trials for Alcohol Risk Behaviors
Recruiting
ChangeGradients: Promoting Adolescent Health Behavior Change
Alcohol Drinking, Self Efficacy
Not yet recruiting
Implementing a Digital Alcohol Intervention to Raise Women's Awareness of Alcohol-related Breast Cancer Risk During Routine Screening Visits
Breast Cancer, Alcohol Drinking
Active, not recruiting
Development and Evaluation of a Virtual Reality Tool for At-Risk Trauma-Exposed Young People
Substance Use Disorders, HIV Infections
RecruitingObservational study
Prevalence and Associated Factors of High BMI and Periodontitis in Thai Adults Aged Under 60 Years
Diabete Mellitus, Dyslipidaemia
Not yet recruiting
Parent-Focused Alcohol Prevention Program for Hispanic Families in Faith-Based Settings
Alcohol Use, Underage Drinking
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Check Yourself App with Feedback in people with Alcohol Risk Behaviors and Health Care Services Quality of Care, run by Seattle Children's Hospital at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol Use Frequency and Quantity (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2017.