ChangeGradients: Promoting Adolescent Health Behavior Change

October 29, 2025 updated by: University of California, San Francisco

Promoting Adolescent Health Behavior Change With Clinically Integrated Sample-Efficient Policy Gradient Methods

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). 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.

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 alcohol use, 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

STUDY AIMS:

I. Design, develop, and iteratively refine a policy-based reinforcement learning behavior change system for preventive adolescent health (Part 1).

II. Investigate the impact of a clinically integrated sample-efficient policy gradient-based behavior change system on adolescent behavior (Part 2).

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 binge drinking, and increase self-efficacy to engage in healthy behavior and avoid risky substance use.

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.

PART 1 of the study (Focus Group) has closed to enrollment.

PART 2 of the study (Randomized Clinical Trial) is planned for enrollment upon finalization of data collected in Part 1.

Study Type

Interventional

Enrollment (Estimated)

200

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 Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94107
        • Recruiting
        • University of California San Francisco Adolescent and Young Adult Medicine Clinic
        • Principal Investigator:
          • Elizabeth M Ozer, PhD
        • Contact:
        • Contact:

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

15 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Non-English speakers

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment (ChangeGradients)
Adolescent participants will be introduced to the intervention through a brief introductory video trailer during their clinic visit and receive a link that enables them to engage with CHANGEGRADIENTS interactive narratives at home over a course of four weeks (i.e., one per week) on a personal computing device (e.g., laptop or tablet).
Behavioral: ChangeGradients
CHANGEGRADIENTS is an interactive web-based tool which includes narrative-centered behavior change experiences that are dynamically generated.
Other Names:
  • CHANGEGRADIENTS system
No Intervention: No Intervention (Usual Care)
Participants will receive usual care at the clinic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean scores on assessment of Alcohol Use
Time Frame: 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) will be administered. 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 and questions are scored individually. Responses to questions about alcohol use in general (past 12 months and ever) are scored as No = 0 and Yes = 1. Values on 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 on a scale from 0-5 with higher numbers corresponding to more frequent instances of driving/being driven by others after alcohol was consumed.
30 days
Mean score on a Self-efficacy tool developed by Drs Elizabeth Ozer and Dr. Albert Bandura
Time Frame: 30 days
Self-efficacy will be measured using a tool developed by Drs Elizabeth Ozer and Dr. Albert Bandura designed for this study. The tool assesses confidence in avoiding drinking in various scenarios. Participants are asked to rate level of confidence in drinking avoidance across various situations. Responses are rated on a scale of 0 to 10, with a rating of 0 indicating 'not at all confident', a rating of 5 indicating 'moderately confident', and rating of 10 indicating t 'completely confident'. Scenarios include: "When a close friend offers you a drink," and, "When you feel depressed or nervous." Scores on this assessment are calculated by summing participant responses and dividing by the number of questions to obtain a mean self-efficacy score.
30 days
Quality of Care: Adolescent Report of the Visit (AROV)
Time Frame: 1 day, 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). The investigators 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 on a binary scale, with response scoring as No = 0 and Yes = 1. An answer of Yes to any item indicates higher quality of care.
1 day, immediately following baseline clinic visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

National Cancer Institute (NCI)
North Carolina State University

Investigators

  • Principal Investigator: Elizabeth Ozer, PhD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 (Actual)

February 12, 2024

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

September 10, 2019

First Submitted That Met QC Criteria

September 30, 2019

First Posted (Actual)

October 1, 2019

Study Record Updates

Last Update Posted (Estimated)

October 31, 2025

Last Update Submitted That Met QC Criteria

October 29, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-28893
  • R01CA247705 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data may be shared with research collaborators during the course of the study

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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