Clinical Research Directory

Clinical Trial for Integrated Care to Help At Risk Teens (iCHART) Intervention

This protocol will test the effectiveness of an intervention, iCHART (integrated Care to Help At-Risk Teens) and facilitate recruitment for other studies in the larger ETUDES Center grant, which are focused on treatment development for target risk factors for suicidal behavior, specifically, sleep, anhedonia, and stress related to cyber-victimization. This study will recruit 900 adolescents which will be enrolled in a randomized controlled trial to test iCHART and will be randomized to iCHART or treatment as usual (TAU). Based on previous work, the investigators hypothesize that iCHART, compared to TAU, will decrease suicide-related events by 50%. The investigators will use implementation science methods to assess contextual factors (i.e., barriers and facilitators) and implementation outcomes specifically, acceptability, feasibility, appropriateness, and cost for our predictive algorithm and iCHART to inform future implementation efforts and promote health equity.

ChangeGradients: Promoting Adolescent Health Behavior Change

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.

Adolescents and Young Adults With Cancer: Their Preferred Involvement in Decision Making

The purpose of this mixed-methods study is to determine Adolescent and Young Adult (AYAs) decision making preferences post cancer diagnosis using vignettes designed to assess their preferred involvement in decisions about their cancer treatment and variables associated with these treatment decision-making (TDM) preferences.

Wearable Suicidal Early Warning System for Adolescents

This study is prospectively enrolling a cohort of adolescent patients who present to the Emergency Department and an inpatient psychiatric adolescent unit with acute suicidality.

Evaluation of Violence Prevention Strategies to Prevent and Reduce Community Levels of Youth Violence

The goal of this research study is to implement and evaluate a comprehensive community-level approach, Healthy Communities for Youth, that includes both a selective hospital-based prevention strategy, Emerging Leaders, and universal prevention strategies that increase Positive Youth Development opportunities through participatory action research, stakeholder education, community mobilization, and an overall focus on increasing community capacity for prevention. Key project aims are to evaluate the impact of Healthy Communities for Youth on community rates of youth violence using surveillance data and evaluate the impact of each violence prevention strategy on proximal outcomes including their impact on risk factors and protective processes related to multiple forms of youth violence.

An Interactive Education Program to Reduce High Risk Behavior in Adolescents Ph II (iTRAC HERO)

Using the efficacious iTRAC intervention to enhance emotion regulation competencies as a foundation, this study will create and test iTRAC-HERO to teach emotion regulation skills in the context of sexual health education.

HIV Engagement and Adolescent Depression Support (HEADS-UP)

This pilot study will individually randomize 105 adolescents living with HIV 1:1:1 to standard of care, adapted intervention, or enhanced intervention. The intervention is called the Friendship Bench Intervention is a counseling intervention for depression and engagement in HIV care.

Shifting Sleep Timing in Teens

The goal of this clinical trial is to determine whether a combination of a novel lighting intervention and a behavioral intervention are able to increase total sleep time in adolescents. The main questions this trial aims to answer are whether this combination therapy is able to meaningfully increase total sleep time in adolescents, and do so over a sustained period of time, and whether such a changes is associated with concomitant changes in mood and cognitive performance.

A Trial of Two Universal Programs for Parents of Teenagers

Group-based and internet-delivered parenting programs may help parents improve their communication and relationships with their children. However, relatively little is known about how well such programs work for parents of adolescents, because most previous studies have focused on younger children or on families selected because of elevated risk. This study evaluated two universal preventive parenting programs for parents of adolescents: the group-based ABC-Teen program and the internet-delivered ParentWeb program. Both programs were developed in Sweden and aim to promote adolescent well-being by strengthening parenting practices and parent-adolescent relationships and reducing negative communication. Families were randomized to ABC-Teen, ParentWeb, or a waitlist control condition. The sole primary outcome was parent-reported adolescent mental health problems, measured using the Strengths and Difficulties Questionnaire Total Difficulties score. Secondary outcomes included parental mental health and stress, parenting behaviors and parental self-efficacy, parent-adolescent and family relationships, adolescent school adjustment and substance use, and outcomes reported by participants in an optional adolescent survey. Parent and adolescent assessments were conducted at baseline, 4 months, and 12 months. After completion of the 4-month assessment, families assigned to the waitlist were offered their choice of ABC-Teen or ParentWeb. Consequently, comparisons with the waitlist were restricted to the period from baseline to 4 months, whereas longer-term analyses compared ABC-Teen with ParentWeb.

Adolescent Mental Health Parenting Program for Child-Adult Relationship Enhancement

The purpose of this research study is to learn if a parenting program called Adolescent Mental Health Parenting Program for Child Adult Relationship Enhancement (AMP-CARE) can help parents have more confidence in parenting their teen and improve their knowledge about normal teen development and teen mental health. The main questions it aims to answer are: * Does the AMP-CARE parenting program improve confidence in teen parenting and positive parenting? * Does the AMP-CARE parenting program improve parent knowledge about mental health? Researchers will compare participants who complete the parenting program to those who do not. Participants will: * Complete 2 surveys, one at the start of the study and one 6 -12 weeks later * Half of the participants will be randomly picked to attend the 6 virtual AMP-CARE sessions right away. * The other half will have the opportunity to attend AMP-CARE after they complete the second survey.

Testing and Evaluating an Interactive Media Use Journal for Adolescents

The goal of this study is to test the feasibility and acceptability of an Interactive Media Use Journal (IMUJ) co-developed with youth. This study is part of a larger effort using Intervention Mapping to co-develop this resource, test it for feasibility and acceptability via this proposed protocol, and then eventually disseminate the resource in partnership with the American Academy of Pediatrics. 50 participants between the ages of 13-18 will be recruited for this study

Forging Hopeful Futures to Reduce Youth Violence

This cluster-randomized community-partnered study will examine the effectiveness of a racial-, gender-, and economic-justice focused youth violence prevention program called Forging Hopeful Futures with youth ages 13-19.

ALHIV Smartphone Game Study

This is a cluster-randomized controlled trial that aims to conduct comprehensive feasibility testing of a smartphone game in a sample of 120 adolescents living with HIV (ALHIV) ages 15-21 in Kisumu, Kenya, to determine whether the game influences behavioral mediators of engagement in care and sexual risk avoidance and reduction (including knowledge, attitudes, behavioral intentions, and self-efficacy).

Effectiveness of an Audiovisual Disaster-Education Intervention on Disaster Risk Perception and Preparedness Belief Among Senior High-School Adolescents

This cluster-randomized controlled trial tests whether a short, standardized disaster-education video improves two psychological precursors of disaster preparedness among senior high-school students in a hazard-prone district of West Kalimantan, Indonesia. Twelve intact classes at one senior high school will be randomized 1:1, stratified by grade level, either to view a purpose-built audiovisual disaster-education module (approximately 20 minutes, shown twice in a single classroom session) or to view an attention-matched general adolescent-health video of similar length on an unrelated topic. Randomization is at the class level to reduce contamination between students, and the individual student is the unit of analysis. All students in a participating class view the video allocated to that class; a randomly drawn subsample of twelve students per class, 144 in total, completes the study questionnaires. Two co-primary outcomes are measured in every participant. The first is disaster preparedness belief, measured by the General Disaster Preparedness Belief (GDPB) scale. The second is disaster risk perception, measured by the Disaster Risk Perception Scale (DRPS). Both are collected at baseline before allocation, immediately after the session, and again four weeks later. The intervention and both instruments are grounded in the Health Belief Model, which predicts that raising perceived threat contributes to readiness to act. An exploratory mediation analysis will test whether change in risk perception explains part of any effect on preparedness belief. After the four-week assessment, control classes are offered the full disaster-education intervention.

Evaluation of the Close to Home Program in California

Investigators propose to rigorously evaluate the Close to Home (C2H) model via a cluster-matched control trial across 18 diverse communities (9 C2H, 9 control) in California via collection and analyses of social network, school-based and social media data. Close to Home is a primary prevention community mobilization model implemented in 10 communities across California that engages community members across multiple sectors and social networks to strengthen community connections and shift social norms regarding sexual violence (SV), but has never been rigorously evaluated. C2H moves beyond criminal justice, lobbying, or school-based curricular approaches, taking a true community-level and community-led approach. This is a five-year project, funded by the Centers for Disease Control and Prevention (CDC) for 3 years with competitive awards for years 4 and 5, and is conducted in partnership with the California Department of Public Health (CDPH) and ValorUs (formerly CALCASA). The University of California, San Diego (UCSD) and CDPH partnership is uniquely poised to conduct the first rigorous evaluation of C2H in California at this time.

Rigorous Evaluation of Yes and Know, a Fully Virtual Sexual Health and Well-Being Intervention for Youth

This study is a 2-arm cluster randomized controlled trial with approximately 1,200 youth aged 14-19 years to assess the effectiveness of Yes and Know, a sexual health education program. To be eligible, participants must be 14-19 years old and English-speaking. Those in the treatment arm will receive Yes and Know, a synchronous virtual program delivered over multiple sessions totaling nine hours, along with asynchronous online activities and resources. Those in the control arm will receive a similarly structured program focused on nutrition education. Participants will complete brief online surveys at baseline and at 3 and 12 months after the synchronous sessions. The study will assess the program's effectiveness in reducing the prevalence of unprotected sex among youth and improving short-term outcomes, such as knowledge of reproductive health and healthy relationships, self-efficacy, and the use of reproductive health services.

CEDARS Intervention: A Coping, Emotional Development, & Stress Reduction Intervention

Using an adapted stress-reduction intervention called the CEDARS, the investigators will pilot the intervention in adolescents (N=40) to determine the feasibility and acceptability of CEDARS implementation and to investigate adolescent stress reduction. As an exploratory aim, the investigators will explore the influence of the CEDARS on CMH-related behaviors and CMH. The investigators expect that those adolescents who undergo the intervention will have the greatest improvement in mental health symptoms than their waitlisted counterparts. Our secondary hypothesis is that those who report more adversity will also report greater improvement in mental health symptoms than their peers.

Social Media Anti-Vaping Messages to Reduce ENDS Use Among Sexual and Gender Minority Teens

The investigators long-term goal is to reduce tobacco use and tobacco-related health disparities among SGM populations. The objective of Project SMART (Social Media Anti-Vaping Messages to Reduce ENDS Use Among Sexual and Gender Minority Teens) is to evaluate the effectiveness of an sexual gender minority (SGM) -tailored social media intervention to prevent vaping initiation among SGM youth ages 13-20 years. The investigators central hypothesis is that SGM-tailored anti-vaping social media messages will be more effective than existing non-tailored messages to prevent vaping initiation among SGM youth. The scientific premise for this work is based on principles of cultural tailoring in health communication for vulnerable populations, the Health Equity Promotion Model, and the Message Impact Framework. The investigators are developing and evaluating a social media intervention because SGM youth have a high rate of social media use and are more likely to go online for health information than non-SGM youth. Social media, moreover, are increasingly used for health promotion to address health disparities and well-being of SGM populations. The investigators will conduct rapid-cycle feedback with stakeholders including SGM organization leaders to provide input on the message design, testing, and intervention implementation to ensure feasibility and acceptability of the intervention.

Feasibility Usability & Acceptability Study: Symptom Reporting by Children Adolescents & Young Adults w/Cancer

The purpose of this project is to pilot test an electronically delivered symptom assessment tool Pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (Ped-PRO-CTCAE), completed by children/adolescents and young adults (AYAs) and caregivers and shared with their clinicians during an outpatient clinic visit, in preparation for a future test of intervention efficacy.

Respiration and Balance in Adolescent Volleyball Players

A volleyball player with high respiratory muscle endurance can perform at a high level of efficiency during competitions without experiencing fatigue. However, no study has been found in the literature examining respiratory muscle strength, respiratory muscle endurance, cough strength and balance parameters in adolescent volleyball players which was therefore aimed to investigate the potential relationship between these parameters in this study.

Agile Development of a Digital Exposure Treatment for Youth With Chronic Musculoskeletal Pain

This project proposes to systematically develop and evaluate the feasibility and preliminary effectiveness of a digitally delivered, graded exposure treatment for youth with chronic musculoskeletal pain, utilizing a sequential replicated and randomized single-case experimental design (SCED). SCED provides the opportunity to rigorously evaluate treatment effectiveness at the individual level. Development of iGET Living will be based on a series of short iterations, with alpha testing (Aim 1) on a small sample of adolescents with chronic pain (N = 15). For Aim 1, participants will participate in one session (lasting 2 hours). In Aim 2, Participants will be enrolled in a baseline period ranging from 7-25 days (done to support SCED methodology) after which they will be enrolled in the online intervention program, lasting 6-weeks. Patients will be contacted 3-months post-discharge from treatment (week 22 of enrollment) and will complete self-report outcome measures at this time.

Intervention to Enhance Coping and Help-seeking Among Youth in Foster Care

This study will deploy a scalable secondary prevention program that leverages existing foster youth transition services to improve mental health functioning and service use before and after exiting foster care. Our short-term objective is to remotely test a group intervention called Stronger Youth Networks and Coping (SYNC) that targets cognitive schemas influencing stress responses, including mental health help-seeking and service engagement, among foster youth with behavioral health risk. SYNC aims to increase youth capacity to appraise stress and regulate emotional responses, to flexibly select adaptive coping strategies, and to promote informal and formal help-seeking as an effective coping strategy. The proposed aims will establish whether the 10-module program engages the targeted proximal mechanisms with a signal of efficacy on clinically-relevant outcomes, and whether a fully-powered randomized control trial (RCT) of SYNC is feasible in the intended service context. Our first aim is to refine our SYNC curriculum and training materials, prior to testing SYNC in a remote single-arm trial with two cohorts of 8-10 Oregon foster youth aged 16-20 (N=26). Our second aim is to conduct a remote two-arm individually-randomized group treatment trial with Oregon foster youth aged 16-20 with indicated behavioral health risk (N=80) to examine: (a) intervention group change on proximal mechanisms of coping self-efficacy and help-seeking attitudes, compared to services-as-usual at post-intervention and 6-month follow-up: and (b) association between the mechanisms and targeted outcomes, including emotional regulation, coping behaviors, mental health service use, and symptoms of depression, anxiety, and PTSD. Our third aim is to refine and standardize the intervention and research protocol for an effectiveness trial, including confirming transferability with national stakeholders.

Virtual-reality and Emotion Regulation in Violence-Exposed Youth

The current proposal aims to evaluate a novel virtual-reality-based (VR-B) video game treatment for emotional dysregulation for youth currently under the supervision of the juvenile justice system. 135 participants under the age of 17 will be enrolled and will be asked to complete up to 6 VR-B sessions.

Laughter Yoga Integrated PRECEDE-PROCEED Health Education Program in Adolescents

Adolescence is a critical developmental period in which lifelong health behaviors are shaped, and behaviors acquired during this stage significantly influence health outcomes in adulthood. Physical activity, healthy nutrition, adequate sleep, stress management, and positive social relationships are among the key determinants of adolescent health. However, current evidence indicates that physical inactivity, unhealthy dietary habits, sedentary lifestyles, and psychosocial problems remain highly prevalent among adolescents globally. In addition, insufficient access to health information and inadequate health information-seeking behaviors among adolescents have been reported to be associated with risky health behaviors. Therefore, the development of healthy lifestyle behaviors in adolescents is considered a public health priority. Schools are recognized as strategic settings for health-promoting interventions targeting adolescents due to their significant social and educational influence on health behaviors. Recent systematic reviews and meta-analyses report that school-based and multi-component interventions have positive effects on adolescents' health behaviors and psychosocial well-being. The integration of behavioral and psychosocial components in school-based health education programs has been associated with more effective and sustainable improvements in adolescent health outcomes . In this process, school health nurses play a critical role in planning and implementing preventive and health-promoting interventions for adolescents . Moreover, it has been reported that healthy behaviors gained through school health nursing interventions may persist into adulthood . Additionally, a systematic review of health education interventions has shown that multi-component approaches-such as classroom education combined with school policies, parental involvement, and school-community collaboration-produce more significant effects on adolescent health outcomes. In recent years, there has been increasing interest in complementary approaches supporting stress management and emotional well-being in school-based interventions. In this context, laughter yoga is described as a low-cost, feasible, and group-based method associated with reduced stress, improved psychological well-being, and enhanced social interaction. Experimental studies conducted with adolescents have also demonstrated that laughter yoga has positive effects on school burnout, hope, and educational stress. However, the literature indicates a limited number of studies examining the integration of laughter yoga into structured school-based health education programs and its effects on healthy lifestyle behaviors. In line with the life-course health perspective, school-based interventions aimed at health promotion during childhood and adolescence are reported to be critical for the sustainability of healthy lifestyle behaviors. In this context, the PRECEDE-PROCEED Model is a theoretical framework widely used in the planning and implementation of health promotion programs, systematically assessing behavioral, environmental, and psychosocial factors influencing health behaviors. Studies based on the PRECEDE-PROCEED Model have demonstrated its effectiveness in improving health behaviors among adolescents. Furthermore, current evidence emphasizes that parental involvement in school-based health interventions strengthens the sustainability of behavior change, highlighting the need for further research in this area. The literature indicates that no studies have examined the effects of a health education program based on the PRECEDE-PROCEED Model integrated with laughter yoga on adolescents' healthy lifestyle behaviors. This gap highlights an important research need for interventions that combine a theoretical behavior change framework with complementary practices that may enhance psychosocial well-being. Study aim Accordingly, the aim of this study is to evaluate the effect of a health education program based on the PRECEDE-PROCEED Model and integrated with laughter yoga on healthy lifestyle behaviors of secondary school students. Study hypotheses H1: Students who receive a health education program based on the PRECEDE-PROCEED Model and integrated with laughter yoga will have significantly higher healthy lifestyle behavior scores compared to the control group.