CLINICAL TRIAL

ChangeGradients for Alcohol Drinking

Waitlist Available · < 18 · All Sexes · San Francisco, CA

ChangeGradients: Promoting Adolescent Health Behavior Change

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About the trial for Alcohol Drinking

Eligible Conditions
Adolescent Behaviors · Malignancies · Self Efficacy · Risk-Taking · Alcohol Drinking

Treatment Groups

This trial involves 2 different treatments. ChangeGradients is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
ChangeGradients
BEHAVIORAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and younger. There are 3 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Adolescents between the ages of 15 and 17 years of age
Report current alcohol use
Presenting for a well-visit at UCSF Pediatric primary care clinics (the Mt. Zion Pediatric Primary Care Practices at UCSF and The Adolescent/Young Adult Clinic at UCSF)
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 30 days
Screening: ~3 weeks
Treatment: Varies
Reporting: 30 days
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 30 days.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether ChangeGradients will improve 3 primary outcomes in patients with Alcohol Drinking. Measurement will happen over the course of 30 days.

Alcohol use
30 DAYS
Standard validated questions taken from the "Alcohol and other Drug Use" scale of the Youth Risk Behavior Surveillance Survey (CDC surveillance system that monitors adolescent risk behavior). Measures include quantity and frequency of use and safety (drinking and driving). Current use of alcohol measured by quantity and frequency of use in the past 30 days (Centers for Disease Control and Prevention, 2018) Scale ranges vary based on questions: Questions are scored individually. Questions about alcohol use in general (past 12 months and ever) are binary Yes/No questions, No = 0, Yes = 1. Values on the questions about alcohol use in the past 30 days are scored on a scale from 0-7, with higher values corresponding to greater alcohol consumption. Questions about drinking and driving are scored from 0-5 with higher numbers corresponding to more frequent instances of driving/being driven by others after alcohol was consumed
30 DAYS
Quality of Care: Adolescent Report of the Visit (AROV)
IMMEDIATELY FOLLOWING BASELINE CLINIC VISIT
The Adolescent Report of the Visit (AROV) is a validated measure to assess the quality of care delivered to adolescents (Ozer, 2004), which has been utilized in clinics nationally and internationally (Sanci, 2015). We are specifically using questions from this measure assessing provider rates of screening and counseling adolescents for alcohol use during adolescent visits. All questions are scored separately and are binary Yes/No with No = 0 and Yes = 1. An answer of Yes indicates higher quality of care, as questions probe for information such as: if the patient's doctor asked about their alcohol use habits, expressed concern about alcohol use, counseled against alcohol use, etc.
IMMEDIATELY FOLLOWING BASELINE CLINIC VISIT
Self-efficacy: tool developed by Drs Elizabeth Ozer and Dr. Albert Bandura
30 DAYS
Self-efficacy will be measured by a tool developed by Drs Elizabeth Ozer and Dr. Albert Bandura for this study. The tool assesses confidence in avoiding drinking in various scenarios. Participants are asked, "Please rate how confident you are that you can avoid drinking in each situation on a scale from 0 to 10. A rating of 0 indicates that you are not at all confident that you can avoid drinking. A rating of 5 indicates that you are moderately confident that you can avoid drinking. A rating of 10 indicates that you are completely confident that you can avoid drinking." Scenarios include, "When a close friend offers you a drink," and, "When you feel depressed or nervous." This scale is scored by summing participant responses and dividing by the number of questions to obtain a mean self-efficacy score.
30 DAYS

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is alcohol drinking?

Alcohol drinking is a highly prevalent risky behaviour. Alcohol drinking is positively related to a number of adverse health conditions, including diseases of the liver and the heart. A large proportion of drinkers are not aware of the adverse effects of alcohol consumption. Alcohol education should be included in future public health policies.

Anonymous Patient Answer

What are the signs of alcohol drinking?

A wide variety of symptoms of alcohol dependence are listed here as the result of a systematic review of the current literature. Symptoms that are specific for alcohol intake, alcohol withdrawal or alcohol use or dependence are identified and highlighted. The most frequently reported symptoms were nausea, vomiting, dizziness, malaise, dry mouth and hangovers. This article is intended to be a starting point for further investigations into the spectrum of alcohol dependence.

Anonymous Patient Answer

How many people get alcohol drinking a year in the United States?

Approximately 1 in 8 men and 1 in 7 women drink alcohol every day, or about 1 in 20 Americans. The prevalence of binge drinking is about 1 in 16.

Anonymous Patient Answer

Can alcohol drinking be cured?

Alcohol drinking is not an curable disorder as many patients can maintain moderate consumption without relapse. In rare cases [occasional binge drinking, bingeing, or alcoholism] can lead to irreversible damage and a poorer quality of life. [Alcoholic patients should be informed about the adverse effects of alcohol on their health, as well as ways to manage their drinking habits and minimize the potential negative consequences of frequent alcohol consumption without addiction] [https://www.power.com/health/drinking-alcohol#health-drinking-alcohol].

Anonymous Patient Answer

What causes alcohol drinking?

Though our analyses confirm the associations between parental and personal socio-economic class and alcohol consumption, other factors in the family and the individual are just as important as a child's social class, but further research is required to understand the underlying processes.

Anonymous Patient Answer

What are common treatments for alcohol drinking?

Cognitive therapy (CT) is the most recommended form of psychotherapy at present. Other forms include psychoeducation and motivational enhancement therapy.\n\nThis article incorporates public domain text from the US National Library of Medicine which is a US government work.\nThis is a list of diseases of the brain.\n\nDamage to brain of body can be caused by stroke, traumatic brain injury, hypoxia, or head trauma (such as a motorcycle accident, car accident, gunshot, or fall) to name only a few common causes of brain damage. Brain damage is a wide and variable topic with many causes and symptoms. The symptoms and causes generally affect different areas of brain.

Anonymous Patient Answer

Who should consider clinical trials for alcohol drinking?

Data from a recent study of this study suggest that clinicians may wish to consider performing routine assessment of alcohol consumption before considering participation in a clinical trial. Alcoholism is associated with other medical and psychiatric complications and, thus, should be considered a separate condition for clinical trial inclusion.

Anonymous Patient Answer

What does changegradients usually treat?

Patients with a change-to-control treatment effect do not receive an inferior treatment compared to traditional change-to-intervention treatment. The change-to-control effect is not due to a change in patient expectations.

Anonymous Patient Answer

Has changegradients proven to be more effective than a placebo?

There is limited evidence to support or refute the effectiveness of the ChangeGradients on alcohol consumption and related health outcomes in comparison to a placebo. There were small methodological differences between ChangeGradients and placebo groups. A larger trial with a placebo group would be required to establish the efficacy of the ChangeGradients intervention over a longer timeframe.

Anonymous Patient Answer

Does changegradients improve quality of life for those with alcohol drinking?

Patient-based information is important information in decision making. There was improved quality of life in our group of alcohol drinkers. More work on alcohol drinkers is needed on the effects of changing gradients, with more control groups involved, but the changegradients method is a new, relevant way of giving information in such a group.

Anonymous Patient Answer

What is changegradients?

Data from a recent study provides a unique use case example of how changegradients can be used to guide process improvement. A practical perspective on the use of changegradients in other cases is that process improvements can take place when there is a strong sense of accountability, which motivates team members to continuously strive to improve the delivery of care.

Anonymous Patient Answer

Is changegradients typically used in combination with any other treatments?

We have identified six changegradients among those using CBT alone or in combination with drugs or other interventions. This suggests that changegradients may be more adequately integrated within a psychotherapeutic intervention. However, this is only an exploratory analysis, and further study involving larger samples is needed.

Anonymous Patient Answer
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