ChangeGradients for Adolescent Health Behaviors

Recruiting at 1 trial location

Overseen By Alison S Giovanelli, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Non-English speakers

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new interactive system called ChangeGradients, designed to help adolescents make healthier choices, particularly concerning alcohol use. The system uses personalized stories and feedback to guide teens toward better health habits. Participants will use this system at home for four weeks following an initial introduction during their clinic visit. Teens who use alcohol and visit certain UCSF clinics for a well-visit might be suitable candidates. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative research that could shape future health interventions for adolescents.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this health behavior change system is safe for adolescents?

Research shows that specific safety information for the ChangeGradients treatment is not yet available. This project uses virtual, interactive stories and a type of computer learning to help change behaviors in teenagers, particularly regarding alcohol use. Since it is neither a drug nor a medical procedure, the safety risks are likely low.

The study's "Not Applicable" phase label indicates it is still in the early research stages, suggesting limited safety data. However, because it involves a computer program, the risks are generally lower compared to traditional medical treatments.

Prospective participants should ask the research team about any possible risks or concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for adolescent health behaviors, which often rely on direct counseling or medication, ChangeGradients takes a novel approach by using interactive narratives delivered through personal devices like laptops or tablets. This method allows for a personalized and engaging experience, accessible from home, which could increase engagement and adherence among teenagers. Researchers are excited about this digital, story-based intervention because it can seamlessly integrate into daily life, potentially leading to more lasting behavior changes without the need for frequent clinic visits.

What evidence suggests that the ChangeGradients system is effective for adolescent health behavior change?

Research shows that the ChangeGradients system, which participants in this trial may receive, is designed to help teenagers reduce risky behaviors, especially drinking alcohol. It uses a type of computer learning to create personalized stories that adapt based on user responses. This method helps teenagers understand the consequences of their actions and make better choices. Although specific results for ChangeGradients are not yet available, the technology relies on proven methods that help people change behaviors by providing personalized feedback and support. ^{2 3 4 6 7}

Who Is on the Research Team?

Elizabeth M Ozer, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for English-speaking adolescents aged 15-17 who visit UCSF Pediatric primary care clinics for a regular check-up and report current alcohol use. It's focused on those interested in changing risky behaviors, especially related to alcohol consumption.

Inclusion Criteria

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)

I am between 15 and 17 years old.

You need to tell us if you currently drink alcohol.

Exclusion Criteria

Non-English speakers

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Adolescents interact with the CHANGEGRADIENTS system to develop an experiential understanding of alcohol use decisions and behavior change

4 weeks

1 visit (in-person) for baseline, followed by virtual interactions

Follow-up

Participants are monitored for changes in self-efficacy and alcohol use behavior

4 weeks

1 visit (in-person) for assessment

Quality of Care Assessment

Assessment of the quality of care delivered to adolescents using the Adolescent Report of the Visit (AROV)

Immediately following baseline clinic visit

What Are the Treatments Tested in This Trial?

Interventions

• ChangeGradients

Trial Overview CHANGEGRADIENTS is being tested; it's an innovative system that uses interactive narratives and machine learning to help teens understand the consequences of their choices regarding alcohol use. The goal is to improve health behaviors through personalized virtual stories.

How Is the Trial Designed?

Group I: Treatment (ChangeGradients) Experimental Treatment 1 Intervention

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).

Group II: No Intervention (Usual Care) Active Control 1 Intervention

Participants will receive usual care at the clinic.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

North Carolina State University

Collaborator

Trials

38

Recruited

50,000+

Published Research Related to This Trial

A pilot study involving 336 students showed that a school-based health intervention effectively reduced extreme alcohol use, smoking, sedentary time, and bullying behaviors over a 3-year period.

The intervention had different impacts on boys and girls, with significant changes in behaviors like alcohol use and bullying victimization observed in girls, while boys showed changes in sedentary behaviors, highlighting the need for tailored approaches in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of a multibehavioral health-promoting school pilot intervention in a Dutch secondary school. Busch, V., De Leeuw, RJ., Schrijvers, AJ.[2018]

The ACTION program, a school-based health center weight management initiative, showed feasibility and effectiveness in improving BMI percentile and waist circumference among overweight/obese adolescents compared to standard care.

Out of 60 enrolled participants, 51 completed the study, and those in the ACTION group experienced significant improvements in body measurements, indicating that structured interventions can positively impact adolescent health behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

School-based health center intervention improves body mass index in overweight and obese adolescents. Kong, AS., Sussman, AL., Yahne, C., et al.[2022]

The study identified key questionnaires for assessing adolescent self-esteem, self-perception, physical exercise, and lifestyle, highlighting the Rosenberg Self-Esteem Scale as the most reliable tool for self-esteem assessment.

The Physical Activity Questionnaire for Adolescents was recognized as the best instrument for evaluating physical activity, while the Health Behavior in School-aged Children questionnaire effectively assesses lifestyle habits across different countries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Questionnaires Assessing Adolescents' Self-Concept, Self-Perception, Physical Activity and Lifestyle: A Systematic Review. Palenzuela-Luis, N., Duarte-Clíments, G., Gómez-Salgado, J., et al.[2022]

The pilot study involving 71 participants demonstrated that group obesity management visits in school-based health centers were feasible and well-received, particularly among Latinx and African American youth.

Quantitative results indicated significant improvements, including reduced soda consumption, increased exercise days, and enhanced social support, while qualitative feedback highlighted the value of cooking activities and family involvement in promoting healthier eating habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact on Healthy Behaviors of Group Obesity Management Visits in Middle School Health Centers. Schapiro, NA., Green, EK., Kaller, S., et al.[2021]

A team of healthcare professionals focused on improving asthma management by evaluating current practices and developing guidelines, which involved surveying primary care physicians and specialists to understand their methods.

The pilot of a patient outcomes survey tool showed it was effective for tracking asthma patient outcomes, leading to the creation of educational materials for both patients and providers to enhance asthma care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical practice improvement: management of the patient with chronic asthma. Weiss, M.[2019]

Out of 279 systematic reviews analyzed, only 70.61% considered the impact of interventions/controls on adverse events, while other important effect modifiers like treatment duration (21.15%) and dosage (24.73%) were rarely investigated.

The study highlights a significant gap in current systematic reviews regarding the assessment of effect modifiers on harmful effects, suggesting that methodological guidelines should include these factors to improve the evaluation of safety in healthcare interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of important modifiers on harmful effects in evidence synthesis practice of adverse events were insufficiently investigated: an empirical investigation. Zhou, X., Yang, X., Cai, F., et al.[2023]

In 2006, out of over 7.5 million pediatric hospital discharges, there were 84,510 adverse drug events (ADEs), representing 0.9% of total discharges, with the majority being adverse effects rather than accidental poisonings.

The study highlighted that the most common ADEs were associated with antineoplastic and immunosuppressive drugs, and the overall burden of pediatric ADEs was significant, leading to an estimated 104,230 excess hospital days and direct costs of $252.9 million.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The national burden of E-code-identified adverse drug events among hospitalized children using a national discharge database. Tundia, NL., Heaton, PC., Kelton, CM.[2022]

The RADARx software program effectively identified 34 actual adverse drug events (ADEs) and 48 potential ADEs, significantly outperforming traditional methods that only detected 23 ADEs during the evaluation period.

Despite generating 8-20 alerts daily, which required 10 to 30 minutes of pharmacist review, only 11% of RADARx alerts were confirmed as true positives, highlighting the need for efficient screening tools to manage ADEs in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

RADARx: Recognizing, Assessing, and Documenting Adverse Rx events. Brown, S., Black, K., Mrochek, S., et al.[2019]

The EACH-B intervention, designed for secondary school students, aims to improve dietary quality and physical activity through a combination of teacher training, in-school lessons, and a personalized digital platform, with a target recruitment of about 2300 students from 50 schools.

This cluster randomised controlled trial will assess the effectiveness of the EACH-B intervention over two academic years, highlighting the importance of engaging adolescents in healthy behavior changes for their long-term health and that of future generations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engaging adolescents in changing behaviour (EACH-B): a study protocol for a cluster randomised controlled trial to improve dietary quality and physical activity. Strömmer, S., Barrett, M., Woods-Townsend, K., et al.[2021]

Physicians need to actively participate in designing and improving health care delivery models, using scientific principles to enhance patient outcomes based on evidence.

Graduate medical education can effectively prepare future physicians to engage in continuous improvement by equipping them with skills to assess health needs, measure outcomes, and collaborate in interdisciplinary teams.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous improvement learning for residents. Headrick, LA., Richardson, A., Priebe, GP.[2000]

In 2001, there were approximately 4.3 million visits to healthcare facilities in the U.S. due to adverse drug events (VADEs), indicating a significant patient safety concern.

The study found that VADEs were more common in elderly patients aged 65-74 and in females, highlighting the need for targeted safety measures in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ambulatory care visits for treating adverse drug effects in the United States, 1995-2001. Zhan, C., Arispe, I., Kelley, E., et al.[2019]

A practice improvement initiative in a family medicine residency clinic successfully enhanced physician communication skills regarding childhood obesity, leading to better management of unhealthy pediatric weight.

The initiative resulted in increased rates of weight management counseling by physicians, indicating a positive impact on addressing childhood obesity in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting conversations between physicians and families about childhood obesity: evaluation of physician communication training within a clinical practice improvement initiative. Shue, CK., Whitt, JK., Daniel, L., et al.[2017]

A quality improvement project in a rural pediatric primary care office successfully integrated a toolkit for managing pediatric obesity, which included educational resources and management algorithms, into their electronic medical records.

After 8 weeks of implementation, providers reported improved patient interactions and increased effectiveness in evaluating families' readiness to change, indicating that the toolkit is a valuable resource for addressing pediatric obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved management of pediatric obesity in the primary care setting through implementation of the healthy care for healthy kids obesity toolkit. Thomas, LN., Donadio, A., Carnevale, T., et al.[2022]

The Childhood Healthy Behaviors Intervention (CHBI) significantly improved pediatric primary care providers' recognition of childhood overweight and obesity, with appropriate diagnostic coding increasing from 52% to 68% after the intervention.

The intervention also enhanced providers' assessment and counseling practices regarding healthy habits, with health habit assessments rising from 0% to 76% and goal setting for healthy behaviors increasing from 12% to 70%, demonstrating its efficacy in addressing childhood obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modifying Provider Practice To Improve Assessment of Unhealthy Weight and Lifestyle in Young Children: Translating Evidence in a Quality Improvement Initiative for At-Risk Children. Camp, NL., Robert, RC., Nash, JE., et al.[2018]

In a study analyzing 1,567,659 hospital discharges in Spain from 2005-2007, 96,607 adverse drug events (ADEs) were identified, representing 5.55% of all discharges, with a significant portion (82.86%) deemed not preventable.

The study found that adverse drug reactions (ADRs) were more common in women and led to longer hospital stays, highlighting the importance of monitoring and reporting ADEs for improving patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Adverse drug events in patients hospitalized in internal medicine]. Zapatero Gaviria, A., Barba, R., Ruiz Giardin, JM., et al.[2013]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04110756

ChangeGradients: Promoting Adolescent Health Behavior ... It is hypothesized that adolescents who interact with CHANGEGRADIENTS will reduce number of days of alcohol use, reduce binge drinking, and increase self- ...

2. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT04110756

Promoting Adolescent Health Behavior Change CHANGEGRADIENTS will iteratively improve its behavior change models using policy gradient methods for Reinforcement Learning (RL) designed to optimize ...

3. withpower.com withpower.com/trial/phase-alcohol-drinking-4-2022-14af1

ChangeGradients for Adolescent Health Behaviors The available research does not provide specific data on the effectiveness of ChangeGradients for Adolescent Health Behaviors. Instead, it focuses on other ...

4. ancora.ai ancora.ai/es/details/NCT04110756

ChangeGradients: Promoting Adolescent Health Behavior ... CHANGEGRADIENTS will introduce an innovative reinforcement learning-based feedback loop in which adolescent patients interact with personalized behavior change ...

5. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT04110756?keyword=%22Risk-Taking%22

ChangeGradients: Promoting Adolescent Health Behavior Change ChangeGradients: Promoting Adolescent Health Behavior Change ... The project will culminate with an investigation of the behavioral effects of the CHANGEGRADIENTS ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04110756

ChangeGradients: Promoting Adolescent Health Behavior ... CHANGEGRADIENTS will introduce an innovative reinforcement learning-based feedback loop in which adolescent patients interact with personalized behavior change ...

7. healthychild.ucla.edu healthychild.ucla.edu/programs/life-course-translational-research-network/resources/pilot-and-feasibility-studies

LCT-RN Pilot Studies | Center for Healthier Children, Families ... The overall goal of this study is to gather preliminary data for life course intervention research examining the impact of a virtual health behavior change ...