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UCSF Alcohol Use Trial → ChangeGradients: Promoting Adolescent Health Behavior Change

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UCSF"> <input class="sr-only form-control-sm btn btn-sm btn-secondary" type="submit" value="Search trials"> </form></div></div> </nav></header><main id="content" class="mx-1 mx-md-0"> <div class="container-xl px-5"><div class="row"><div class="col-md-9 col-lg-8" role="main" id="main-column"><div id="summary" class="page-header show-jargon-definitions"><h1 id="summary--title"> ChangeGradients: Promoting Adolescent Health Behavior Change </h1><p class="h4 hide-long-content">a study on <span class="comma-list"><span class="comma-list-item"> <a href="../alcohol-use">Alcohol Use</a></span><span class="comma-list-item"> <a href="../self-efficacy">Self Efficacy</a></span><span class="comma-list-item"> <a href="../adolescent-behavior">Adolescent Behavior</a></span><span class="comma-list-item"> <a href="../risk-taking">Risk-Taking</a></span><span class="comma-list-item"> <a href="../cancer-general">Cancer, General</a></span></span></p></div><div id="trial-details-container"><div id="key-points" class="trial-details-block"><div class="row"> <div class="col"><h2 class="sr-only h3">Summary</h2><dl id="key-points-bullets" class="row"><dt class="d-none d-sm-block col-sm-1 col-lg-2"> <i class="fa fa-user fa-lg fa-fw" aria-hidden="true"></i> <span class="sr-only">Eligibility</span></dt><dd class="col-12 col-sm-11 col-lg-10"> <strong>for people ages 15-17</strong> (<a href="#eligibility">full criteria</a>) </dd><dt class="d-none d-sm-block col-sm-1 col-lg-2"> <i class="fa fa-check-circle fa-lg fa-fw" aria-hidden="true"></i> <span class="sr-only">Healthy Volunteers</span></dt><dd class="col-12 col-sm-11 col-lg-10"> <strong>healthy people welcome</strong> </dd><dt class="d-none d-sm-block col-sm-1 col-lg-2"> <i class="fa fa-map-marker fa-lg fa-fw" aria-hidden="true"></i> <span class="sr-only">Location</span></dt><dd class="col-12 col-sm-11 col-lg-10"> <a href="#location"> at San Francisco, California </a> </dd><dt class="d-none d-sm-block col-sm-1 col-lg-2"> <i class="fa fa-calendar fa-lg fa-fw" aria-hidden="true"></i> <span class="sr-only">Dates</span></dt><dd class="col-12 col-sm-11 col-lg-10"><div> study started <span itemscope itemtype="https://schema.org/WebPage"><time itemprop="dateCreated" datetime="2024-02-12">February 2024</time></span></div><div> completion around <time datetime="2025-02-28">February 2025</time></div><div itemscope itemtype="https://schema.org/WebPage" aria-hidden="true" class="d-none"><meta itemprop="datePublished" content="2019-10-01"></div></dd><dt class="d-none d-sm-block col-sm-1 col-lg-2"> <i class="fa fa-user-md fa-lg fa-fw" aria-hidden="true"></i> <span class="sr-only">Principal Investigator</span></dt><dd class="col-12 col-sm-11 col-lg-10 comma-list"> by <span class="pi-name comma-list-item"><span><a href="https://profiles.ucsf.edu/elizabeth.ozer" target="_blank" rel="noopener author" class="trial--link-to-pi-profile">Elizabeth Ozer, PhD</a></span></span></dd></dl></div> <div class="d-none d-md-block col-md-auto" id="pi-photos-block"><figure class="figure"><img class="pi-photo figure-img img-fluid rounded" src="https://researcherprofiles.org/profile/Modules/CustomViewPersonGeneralInfo/PhotoHandler.ashx?NodeID=188494" alt="Headshot of Elizabeth Ozer" loading="lazy"><figcaption class="figure-caption">Elizabeth Ozer</figcaption></figure></div></div></div><div id="description" class="trial-details-block"><h2 class="h3">Description</h2><div class="show-jargon-definitions"><h3 class="h4">Summary</h3><div class="hide-long-content"><p>As most adolescents visit a healthcare provider once a year, <a href="../health-behavior" class="trial--link-to-condition-in-text">health behavior</a> change interventions linked to clinic-based health information technologies hold significant promise for improving healthcare quality and subsequent behavioral health outcomes for adolescents (Baird, 2014, Harris, 2017). Recognizing the potential to leverage recent advances in machine learning and interactive narrative environments, the investigators are now well positioned to design health behavior change systems that extend the reach of clinicians to realize significant impacts on behavior change for adolescent preventive health.</p><p>The proposed project centers on the design, development, and evaluation of a clinically-integrated health behavior change system for adolescents. CHANGEGRADIENTS will introduce an innovative reinforcement learning-based feedback loop in which adolescent patients interact with personalized behavior change interactive narratives that are dynamically personalized and realized in a rich narrative-centered virtual environment. CHANGEGRADIENTS will iteratively improve its behavior change models using policy gradient methods for Reinforcement Learning (RL) designed to optimize adolescents' achieved behavior change outcomes. This in turn will enable CHANGEGRADIENTS to generate more effective behavior change narratives, which will then lead to further improved behavior change outcomes. With a focus on risky behaviors and an emphasis on <a href="../alcohol-use" class="trial--link-to-condition-in-text">alcohol use</a>, adolescents will interact with CHANGEGRADIENTS to develop an experiential understanding of the dynamics and consequences of their alcohol use decisions. The proposed project holds significant transformative potential for (1) producing theoretical and practical advances in how to realize significant impacts on adolescent health behavior change through novel interactive narrative technologies integrated with policy-based reinforcement learning, (2) devising sample-efficient policy gradient methods for RL that produce personalized behavior change experiences by integrating theoretically based models of health behavior change with data-driven models of interactive narrative generation, and (3) promoting new models for integrating personalized health behavior change technologies into clinical care that extend the effective reach of clinicians.</p></div><h3 class="h4">Official Title</h3><p class="hide-long-content">Promoting Adolescent Health Behavior Change With Clinically Integrated Sample-Efficient Policy Gradient Methods</p><h3 class="h4">Details</h3><div class="hide-long-content"><p>Because the majority of adolescent health problems are amenable to behavioral intervention and most adolescents visit a healthcare provider once a year, <a href="../health-behavior" class="trial--link-to-condition-in-text">health behavior</a> change interventions linked to clinic- based health information technologies hold significant promise for improving healthcare quality and subsequent behavioral health outcomes for adolescents. Recognizing the potential to leverage advances in machine learning and virtual narrative environments, the field of health behavior change is now well-positioned to design health behavior change systems that extend the reach of clinicians to realize significant impacts on behavior change for adolescent preventive health.</p><p>With a focus on risky behaviors and an emphasis on alcohol use, the project has two specific aims: (1) design, develop, and iteratively refine a policy-based reinforcement learning behavior change system for preventive adolescent health, and (2) investigate the impact of a clinically integrated sample-efficient policy gradient-based behavior change system on <a href="../adolescent-behavior" class="trial--link-to-condition-in-text">adolescent behavior</a>. The project will culminate with an investigation of the behavioral effects of the CHANGEGRADIENTS system using adolescent patients recruited from two outpatient primary care clinics within the UCSF Department of Pediatrics: Mt. Zion Pediatrics and the Adolescent/Young Adult Clinic. It is hypothesized that adolescents who interact with CHANGEGRADIENTS will reduce number of days of alcohol use, reduce <a href="../alcohol-use" class="trial--link-to-condition-in-text">binge drinking</a>, and increase <a href="../self-efficacy" class="trial--link-to-condition-in-text">self-efficacy</a> to engage in healthy behavior and avoid risky <a href="../substance-abuse" class="trial--link-to-condition-in-text">substance use</a>.</p><p>It is anticipated that CHANGEGRADIENTS will provide a testbed for a broad range of health behavior change research and serve as the foundation for next-generation personalized preventive healthcare through computationally-enabled behavior change that is designed to be tightly integrated into clinical practice workflow. By taking advantage of the high degree of adaptive interactivity offered by its personalized behavior change environment, CHANGEGRADIENTS holds significant potential for creating compelling interactions that promote self-efficacy and engagement in healthy lifestyle behaviors to prevent cancer through improving cancer-related behaviors and risk factors.</p></div><h3 class="h4">Keywords</h3><p class=" hide-long-content"><span> <a href="../alcohol-use" class="trial--link-to-condition-in-text">Alcohol Drinking</a></span>, <span> <a href="../self-efficacy" class="trial--link-to-condition-in-text">Self Efficacy</a></span>, <span> <a href="../adolescent-behavior" class="trial--link-to-condition-in-text">Adolescent Behavior</a></span>, <span> Risk-Taking</span>, <span> Cancer</span>, <span> Alcohol- Prevention/Control</span>, <span> Video games- psychology</span>, <span> ChangeGradients</span></p></div></div><div id="eligibility" class="trial-details-block show-jargon-definitions"><h2 class="h3">Eligibility</h2><div class="hide-long-content"><div class="row"><div class="col-12 col-lg-6"><h3 class="h4 mt-0"> <i class="fa fa-check-square-o" aria-hidden="true"></i> You can join if… </h3><div><p><strong>Open to people ages 15-17</strong></p><ul><li>Adolescents between the ages of 15 and 17 years of age</li><li>Report current <a href="../alcohol-use" class="trial--link-to-condition-in-text">alcohol use</a></li><li>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)</li></ul></div></div><div class="col-12 col-lg-6"><h3 class="h4 mt-0"> <i class="fa fa-ban" aria-hidden="true"></i> You CAN'T join if... </h3><div><ul><li> Non-English speakers</li></ul></div></div></div></div></div><div id="location" class="trial-details-block"><h2 class="h3">Location</h2><ul id="locations-list" class="hide-long-content locations-list--only-one-location"><li class="location location-is-institutional" itemprop="address" itemscope itemtype="https://schema.org/PostalAddress"><span class="location-name" itemprop="name">UCSF Adolescent and Young Adult Medicine Clinic</span><wbr> <span class="badge badge-secondary">accepting new patients</span><br><span class="location-address comma-list comma-list--without-and"><span class="comma-list-item" itemprop="addressLocality"> San Francisco</span><span class="comma-list-item" itemprop="addressRegion"> California</span><span class="comma-list-item" itemprop="postalCode"> 94107</span><span class="comma-list-item" itemprop="addressCountry"> United States</span></span></li></ul></div><div id="pis" class="trial-details-block"><h2 class="h3">Lead Scientist <span class="d-none d-sm-inline">at UCSF</span></h2><ul class="pis-list--only-one-pi"><li class="pi"><span class="pi-name"> <strong> <a href="https://profiles.ucsf.edu/elizabeth.ozer" target="_blank" rel="noopener author" class="trial--link-to-pi-profile">Elizabeth Ozer, PhD</a> </strong> </span><br> Elizabeth Ozer is Professor of Pediatrics &amp; Associate Vice Provost, Faculty Equity, Office of Diversity and Outreach, at the University of California, SF (UCSF). She also serves as Director of Fellows Research Training in Adolescent &amp; Young Adult Medicine. Dr. Ozer is a psychologist whose research has focused primarily on the health of adolescents, young adults, and women. </li></ul></div><div id="details" class="trial-details-block"><h2 class="h3">Details</h2><dl class="row"><dt class="col-sm-3 text-sm-right">Status</dt><dd class="col-sm-9"> accepting new patients </dd><dt class="col-sm-3 text-sm-right">Start Date</dt><dd class="col-sm-9"><time datetime="2024-02-12">February 2024</time></dd><dt class="col-sm-3 text-sm-right">Completion Date</dt><dd class="col-sm-9"><time datetime="2025-02-28">February 2025</time> (estimated)</dd><dt class="col-sm-3 text-sm-right">Sponsor</dt><dd class="col-sm-9">University of California, San Francisco</dd><dt class="col-sm-3 text-sm-right">ID</dt><dd class="col-sm-9"> <a href="https://clinicaltrials.gov/ct2/show/NCT04110756" class="trial--link-to-clinicaltrials-gov" target="_blank" rel="noopener nofollow" title="ClinicalTrials.gov identifier">NCT04110756</a> </dd><dt class="col-sm-3 text-sm-right">Study Type</dt><dd class="col-sm-9">Interventional</dd><dt class="col-sm-3 text-sm-right">Participants</dt><dd class="col-sm-9">Expecting 200 study participants</dd><dt class="col-sm-3 text-sm-right">Last Updated</dt><dd class="col-sm-9"><span itemscope itemtype="https://schema.org/WebPage"><time itemprop="dateModified" datetime="2024-10-23">October 23, 2024</time></span></dd></dl></div><div id="faq" class="trial-details-block d-print-none" role="complementary"><h2 class="h3">Frequently Asked Questions</h2><ul><li><a href="../about/how-clinical-trials-work">How Do Clinical Trials Work?</a></li><li><a href="../about/what-to-expect">What to Expect</a></li><li><a href="../about/who-can-join">Who Can Join</a></li><li><a href="../about/our-researchers">Our Researchers</a></li></ul></div><div class="text-center my-3"> <a href="#" id="contact-button-end" class="btn btn-primary btn-lg d-none d-md-inline" data-toggle="modal" data-target="#contact-modal" aria-description="Are you interested? 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Contact us to learn more about joining this clinical trial"> I’m interested in this study! </a> </div> <div class="modal fade" id="contact-modal" tabindex="-1" role="dialog" aria-labelledby="contact-modal-label" aria-hidden="true"><div class="modal-dialog modal-dialog-scrollable" role="document"><div class="modal-content"><div class="modal-header"><h4 class="modal-title h5" id="contact-modal-label">Please contact me about this study</h4> <button type="button" class="close" data-dismiss="modal" aria-label="Close"> <span aria-hidden="true">&times;</span> </button> </div><div class="modal-body"> <form id="contact-form" class="form-horizontal" action="https://clinicaltrials.ucsf.edu/action/trial-contact/" method="POST"> <input type="hidden" name="Trial_NCT" value="NCT04110756"> <input type="hidden" name="Trial_Title" value="ChangeGradients: Promoting Adolescent Health Behavior Change"> <input type="hidden" name="Trial_Contact" value="53616c7465645f5f0a141e28323c465046886400c52e93939482a997be5f45d35de5947f6bcea5d7618e94a2a2feae2c"> <div class="form-group row"> <label class="col-sm-3 col-form-label col-form-label-lg text-sm-right" for="contact-name">Name</label> <div class="col-sm-8 form-group--input-container"> <input name="Name" type="text" class="form-control form-control-lg" id="contact-name" placeholder="Your name" required pattern=".*\w\w.*" minlength="2" autocomplete="name"> </div></div><div class="form-group row"> <label class="col-sm-3 col-form-label col-form-label-lg text-sm-right" for="contact-email">Email</label> <div class="col-sm-8 form-group--input-container"> <input name="Email" type="email" class="form-control form-control-lg" id="contact-email" placeholder="Your email" required data-error="Invalid email address" autocomplete="email"> <div id="contact-email--suggestion" class="d-none small"> You typed <span id="contact-email--suggestion-original" class="text-monospace text-info font-weight-bold"></span>. 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Submitting your contact information does not obligate you to participate in research.</p></div> </div></div></div><div class="modal fade" id="contact-thank-you-modal" tabindex="-1" role="dialog" aria-hidden="true" aria-labelledby="contact-modal-label"><div class="modal-dialog" role="document"><div class="modal-content"><div class="modal-header"> <button type="button" class="close" data-dismiss="modal"><span aria-hidden="true">&times;</span><span class="sr-only">Close</span></button> <h4 class="modal-title h5" id="contact-thank-you-modal-label">Thank you!</h4></div><div class="modal-body"><p>The study team should get back to you in a few business days.</p><p>You will also receive an email with next steps. Check your junk/spam folder if needed.</p><p>If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT04110756.</p></div><div class="modal-footer"> <button type="button" class="btn btn-primary" data-dismiss="modal">OK</button> </div></div></div></div> <script type="application/ld+json"> [{"@context":"https://schema.org/","@type":"MedicalTrial","additionalType":"Product","alternateName":"Promoting Adolescent Health Behavior Change With Clinically Integrated Sample-Efficient Policy Gradient Methods","code":{"@type":"MedicalCode","codeValue":"NCT04110756","codingSystem":"ClinicalTrials.gov"},"description":"As most adolescents visit a healthcare provider once a year, health behavior change interventions linked to clinic-based health information technologies hold significant promise for improving healthcare quality and subsequent behavioral health outcomes for adolescents (Baird, 2014, Harris, 2017). 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This in turn will enable CHANGEGRADIENTS to generate more effective behavior change narratives, which will then lead to further improved behavior change outcomes. With a focus on risky behaviors and an emphasis on alcohol use, adolescents will interact with CHANGEGRADIENTS to develop an experiential understanding of the dynamics and consequences of their alcohol use decisions. 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