Clinical Research Directory

Guardians Receiving Information Through Navigators

A multi-arm study, experimental and control groups, to explore the impact of an online training program to help community health workers conduct effective outreach to support the dental health of high-risk youth via their guardians.

The Effect of Health Education on Digital Game Addiction and Health Promotion Behavior in Adolescents

This study aimed to evaluate the effectiveness of a school nurse-led health education program in reducing digital game addiction and improving health-promoting behaviors among adolescents. Using a Solomon four-group randomized controlled trial design, the study examined whether the health education intervention affected digital game addiction and health-promoting behaviors and whether pretest measurement influenced the intervention outcomes.

Mobile Technology to Reduce Teen Substance Misuse

The goal of this study is to test the newly expanded WisePath for Teens (WPT) for substance use app, a direct-to-consumer paired mobile phone app for iOS and Android platforms that supports parents/guardians in delivering evidence-based techniques to reduce youth substance abuse and co-occurring mental health problems. This project will expand WPT for use with a general population of teens with problematic substance use and their parents to reduce substance abuse, its harmful effects, opioid overdoses, and progression to substance use disorders, as well as other behavioral health problems that are exacerbated by substance abuse and/or interfere with substance abuse treatment.

A Study of HTD1801 in Adolescents With Primary Sclerosing Cholangitis (PSC)

Randomized, double-blind, active-controlled, parallel-group study of HTD1801 in adolescents.

A Master Protocol (LY900023) That Includes Several Clinical Trials of Drugs for Children and Young Adults With Cancer

The main purpose of the master is to help the research sites and sponsor carry out several clinical trials more efficiently by providing a common research protocol. Individual clinical trials under this master protocol define drug/disease-specific research goals and activities to test them. New studies will be added as new drugs emerge against different cancers. Participation in the trial will depend on how long the benefit lasts.

Workforce and System Change to Treat Adolescent Opioid Use Disorder Within Integrated Pediatric Primary Care

This project seeks to address the increasing risk of overdose death, substance use disorder (SUD), and opioid use disorder (OUD) in adolescents. The investigators believe that pediatric primary care providers (PCP) could play an important role in helping youth with SUD because most adolescents see their PCPs for annual wellness visits. However, PCPs have many barriers to treating their young patients with SUD/OUD: lack of training, resources, and support to deliver SUD/OUD services, limited time with patients, and the only available referral options often come with long wait times for an appointment. Through this project, the investigators will build upon an existing Integrated Behavioral Health (IBH) system by offering stigma-reduction interventions and brief SUD interventions within primary care settings. The goal of this project is to learn if clinics participating in an Integrated Behavioral Healthcare Program with SUD resources will increase delivery of effective adolescent SUD care and ultimately lead to better health outcomes when compared to standard primary care treatment. During the first project phase, the research team will gather a Parent and Youth Advisory Board, Primary Care Provider Advisory Board, and Integrated Care Expert Panel (Aim 1) to inform the development and refinement of the primary care-based SUD interventions. The investigators will gather input from national experts, local stakeholders, and PCPs to refine our screening to treatment approach (Aim 2), coupled with stigma reduction activities, within pediatric primary care. During the second project phase, researchers will assess the impact of SUD IBH on PCP behaviors around adolescent SUD intervention. The investigators will interview and survey PCPs, clinic managers, and other clinical staff for willingness to engage in adolescent SUD treatment. The investigators will evaluate implementation outcomes (views toward SUD, stigma attitudes, IBH team dynamics; Aim 3) and effectiveness/reach outcomes (delivery of integrated primary care-based SUD services, the use of brief interventions for adolescents, number of consultation calls, and increased treatment engagement; Aim 4a), along with an exploratory test of local overdose rates for youth (Aim 4b), in order to examine local effects of the new intervention. This project is supported by the HEAL Initiative (https://heal.nih.gov/).

Tele Nursing Application For Type 1 Diabetes Mellitus Adolescents

Studies have shown that tele-nursing practice is effective in children with Type 1 Diabetes Mellitus, but the number of studies conducted is very few. No study examining the concepts of metabolic control, self-efficacy, quality of life and anxiety together was found in the literature review. With this study, it is aimed that diabetes education given by tele-nursing has an effect on metabolic control, self-efficacy, quality of life and anxiety level of adolescents with type 1 diabetes, and that diabetic adolescents can easily obtain the information they need about nursing care when they cannot come to the clinic.

The Effect of Education Provided to Adolescents Living in a Container Settlement on Their Genital Hygiene Behaviours and Menstrual Experiences

The aim of this study was to determine the effect of education provided to adolescents living in a container city, tailored to their needs regarding genital and menstrual hygiene, on their genital hygiene behaviours and menstrual experiences. The training is planned to consist of a total of two sessions (four hours), with each session lasting two hours, held twice a week (Saturdays and Sundays), with a maximum of 15 adolescent girls in each group. The training schedule will be determined based on the days and times suitable for the adolescents. In addition, a copy of the educational material prepared for the training will be provided to each adolescent girl. Appropriate interactive educational techniques (demonstration, role-play, question-and-answer, brainstorming, games, etc.) relevant to the topic will be used in each session of the educational program. Prior to the education, the adolescent girls will be asked to complete the Demographic Characteristics Form, the Genital Hygiene Behaviour Scale (GHDÖ) and the Menstrual Experiences Scale (MDÖ) based on self-reports. Following the final session of the education programme, these adolescent girls will be asked to complete these forms again. Finally, following the collection of the final test data, follow-up data will be collected from the adolescents at the end of the third month.

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.

Alternatives to Dental Opioid Prescribing After Tooth Extraction

The goal of this clinical trial is to test a three-item intervention in oral surgeons who remove teeth. The main questions it aims to answer are: * Can the intervention reduce opioid prescriptions to adolescents and young adults after tooth removal? * Do oral surgeons' beliefs about the intervention and opioid prescribing change? * Do patients that report using opioids after tooth removal have different experiences than patients that do not? Oral surgeon participants will: * Attend a 1-hour education session with a trained pharmacist * Receive patient instructions and blister packs of pain medicine to give to patients * Complete 2 surveys about feasibility and appropriateness Patient participants will complete a survey about pain and medication use after having a tooth removed. Researchers will compare the intervention to usual care to see if it reduces opioid prescribing.

Development of The Pediatric Physical Activity Tracking Platform (Pedi@Ctivity) and Smartwatch-based Big Data Analysis

Regular physical activity is extremely important for the protection and development of physical and psychosocial health. In addition, acquiring regular physical activity habits in the early years of life allows maintaining numerous gains related to physical fitness, functional capacity and psychoemotional health into adulthood. Guided by scientific and technological innovations, focusing on sustainable development goals, the vision of Society 5.0 is based on digital innovation with artificial intelligence, the internet of things, digital technologies and big data, and is to increase the awareness of individuals and encourage individuals to take a role in improving their health status with wearable technology and mobile health applications. In the literature, only one study has been found on the acquisition of big data with wearable technologies for the promotion of physical activity in adolescents. The general aim of our project is to obtain smartwatch-based big data for adolescents, which will be done for the first time in the field of health and sports in our country, and to analyze the obtained data using both statistical methods and big data analytics and artificial learning methods, to develop Pediatric Physical Activity Tracking Platform (Pedi@ktivite) through physical activity algorithms and to reveal the effect of the developed system on the physical fitness of adolescents and the usability of the system with scientific evidence. Within the scope of the project, adolescents with chronic rheumatic disease will also be included in the sample group, and the effects of the system to be developed in adolescents with the chronic rheumatic disease will be demonstrated. Due to the results obtained, we believe that this technology-supported approach will be an example of good practice for other chronic diseases. As the first technology-supported and big data-oriented project for health and sports in adolescents, our project will fill an important gap and provide pioneering results for future projects, paving the way for providing services in the fields of health and sports with big data analytics and addressing physical inactivity.

Nicotine and Cannabis Vape Labeling Experiment - Spring 2025

This study assesses how the ways in which nicotine and cannabis vaping devices are labeled impact use susceptibility, anticipated effects, and health harm.

Analysis of Factors Associated With Delayed Medical Consultation for Testicular Torsion Among Adolescents in the Haut-Rhin Department Between 2020 and 2025

The objective of this observational study is to identify the factors that influence whether or not an adolescent seeks immediate medical attention upon the onset of symptoms of testicular torsion. The main question it aims to answer is as follows: What factors are associated with a delay in seeking medical care-defined as a time interval of 6 hours or more between the onset of symptoms and the first visit to Colmar Hospital-among adolescents aged 10 to 18 who underwent surgery for testicular torsion? Participation in this study involves completing a questionnaire: the "Questionnaire for Assessing Factors Associated with Delay in Seeking Medical Care for Testicular Torsion in Adolescents."

Romiplostim N01 for Chemotherapy-Induced Thrombocytopenia in Pediatric Cancer Patients

The goal of this clinical trial is to evaluate the efficacy and safety of romiplostim N01 in treating chemotherapy-induced thrombocytopenia (CIT) in children and adolescents/young adults (CAYA; aged 6-24 years) with hematologic malignancies or solid tumors. The main questions it aims to answer are: * What proportion of participants achieve platelet count recovery (≥100×10⁹/L or an increase of ≥30×10⁹/L from baseline) within 3 weeks of romiplostim N01 treatment? * What is the safety profile of romiplostim N01 in this population, including the incidence and severity of adverse events (especially bleeding and thrombosis)? This is a single-arm study (no comparison group). Researchers will assess the outcomes against predefined efficacy thresholds and historical data (e.g., a 60.7% response rate reported for another TPO-RA, hetrombopag). Participants will: * Receive weekly subcutaneous injections of romiplostim N01 (starting dose: 2 µg/kg). * Have their romiplostim dose adjusted weekly based on platelet counts (increase by 1-2 µg/kg if platelets \<99×10⁹/L, maximum dose 10 µg/kg, stop when target recovery is met). * Undergo frequent monitoring, including blood tests (especially platelet counts), vital signs, physical exams, and assessment for adverse events and bleeding throughout the treatment and follow-up period.

Telpegfilgrastim vs Filgrastim for Secondary Prevention of Chemotherapy-Induced Neutropenia in Pediatric Solid Tumors

The goal of this clinical trial is to evaluate the efficacy and safety of Telpegfilgrastim (a PEGylated recombinant human granulocyte colony-stimulating factor, PEG-rhG-CSF) compared to Filgrastim (short-acting rhG-CSF) in preventing chemotherapy-induced neutropenia (CIN) in children and adolescents aged 6-24 years with malignant solid tumors receiving high-intensity chemotherapy regimens. The main questions it aims to answer are: * Does Tuopefilgrastim reduce the incidence of febrile neutropenia (FN) in the first chemotherapy cycle (Cx+1) compared to Filgrastim? * How do the two treatments compare in terms of duration and severity of neutropenia, chemotherapy delays/dose reductions, antibiotic use, and bone pain incidence? Researchers will compare the Telpegfilgrastim group (3:1 ratio, 99 participants) with the Filgrastim group (33 participants) to determine if Telpegfilgrastim demonstrates superior efficacy and safety. Participants will: * Receive subcutaneous injections of either Telpegfilgrastim (33 μg/kg, single dose) or Filgrastim (5 μg/kg/day, multiple doses) 24 hours after each chemotherapy cycle. * Undergo blood tests, physical exams, and temperature monitoring during follow-up visits. * Be assessed for bone pain severity using age-appropriate scales (FLACC or Wong-Baker). * Complete two chemotherapy cycles with close safety and efficacy monitoring.

Parent-Adolescent Relationships, Emotional Regulation, and HRV in Adolescents With Depression

This cross-sectional study examines associations among heart rate variability (HRV), emotional dysregulation, and parent-adolescent relationship quality in adolescents with Major Depressive Disorder (MDD). We hypothesize that lower HRV will be linked to greater emotional dysregulation and that more supportive parent-adolescent relationships will correlate with higher HRV. Participants will wear a Fitbit Charge 5 during nighttime sleep for 7 consecutive nights and complete validated measures of emotional regulation and relationship quality.

Screen Culture's Impact on Generation Z Adolescents' Physical Activity, Posture and Well-being in Egypt

Ubiquitous adoption of screen-based technologies has transformed the behavioral and physiological environment of Generation Z youth. In Egypt, where digital adoption speeds up with apace urbanisation, teens (13-18) have greater exposure to computers, mobile phones, and other screen-based devices. Growing evidence points towards excessive viewing of screens in compromised well-being, including sleep issues, inactive lifestyles, weight loss/gain, and musculoskeletal disturbances. Contextual evidence for the Egyptian teenager is scarce. This study fills the gap by investigating the multi-dimensional influence of screen culture on physical well-being, focusing on sleep quality, body mass index (BMI), posture, physical activity, and disability outcomes.

TECH App Marijuana Use Intervention for Court-Involved Adolescents

The study is about helping teens who are involved in the court system to cut down or quit using marijuana. Teens may be asked to test out an experimental smartphone app, called TECH, that will be used only by teens in this study. This app is a private online community where teens can work towards changing their substance use and other behavior with the help of other anonymous teens. We will use this information to learn how the app may help teens make a change and to improve the TECH app.

Efficacy and Safety of Sodium-Glucose Cotransporter-2 Inhibitors in Adolescents With Early Stages of Chronic Kidney Disease

Chronic kidney disease (CKD) is highly prevalent in the state of Aguascalientes, Mexico, particularly among adolescents and young adults. Epidemiologic and histologic studies suggest that this burden is largely driven by reduced nephron endowment of prenatal origin, leading to compensatory glomerular hyperfiltration, adaptive podocytopathy, and persistent albuminuria at early stages of disease. Sodium-glucose cotransporter-2 inhibitors (SGLT2i) have demonstrated nephroprotective effects in adult populations with CKD, including reductions in albuminuria and slowing of disease progression, independent of diabetes status. However, no randomized controlled trials have evaluated the efficacy and safety of SGLT2 inhibitors in adolescents with early-stage CKD and persistent albuminuria. This randomized, double-blind, placebo-controlled clinical trial aims to evaluate whether treatment with an SGLT2 inhibitor reduces albuminuria in adolescents aged 14 to 18 years with persistent microalbuminuria (albumin-to-creatinine ratio 30-300 mg/g) and preserved kidney function. Participants will be randomized in a 2:1 ratio to receive dapagliflozin 10 mg daily or placebo for six months. The primary outcome is the change in urinary albumin-to-creatinine ratio from baseline to six months. Secondary outcomes include changes in estimated glomerular filtration rate and safety outcomes.

An Evidence-based Family Support Program for Parents and Children in Palestine: A Theory-based Intervention

Few evidence-based programs exist to support children and families affected by sociopolitical conflict, despite documented evidence of their heightened risk for emotional and behavioral adjustment problems associated with exposure to conflict and violence at multiple levels of the social ecology (e.g., political, community, and family). Thus, a critical need exists for an evidence-based program to ameliorate the impact of political violence on the overall well-being of children and families. The current study will conduct a rigorous evaluation of a theoretically-driven, family-based intervention program in Palestine, including both the West Bank and Gaza. Firmly grounded in the cultural context of Palestine but with broad implications for individuals exposed to sociopolitical violence, the long-term goal of this project is to provide a family-focused intervention program (Promoting Positive Family Futures; PPFF) that may facilitate individuals' sense of safety and support in the context of chronic adversity. The objective is to evaluate this intervention program in the context of a randomized clinical trial (RCT) in the West Bank and Gaza (N=300). The central hypothesis is that the program will have direct positive effects on family conflict, parent psychopathology and parental security in the family as well as on adolescent emotional security in the family, with cascading effects on adolescent adjustment. Consistent with family systems theory, we further hypothesize that treatment effects on parents will mediate on the effects of the treatment on adolescent adjustment. The rationale is that bolstering resilience in family systems is a key approach to promoting positive functioning in families exposed to chronic violence. The hypothesis will be evaluated with three specific aims: 1) evaluate the efficacy of an evidence-based family support program; 2) examine process models of treatment change, and 3) examine interrelations between parent and child functioning. To achieve these aims, the study will be an RCT employing a longitudinal design (N=300) with multi-method assessments at baseline (T1), post-test (T2), 6-month follow-up (T3) and 12-month follow-up (T4). Families included in the study will be evenly divided between the West Bank (n=150) and Gaza Strip (n=150). Families will be randomized into the intervention condition (PPFF) or treatment as usual (TAU). Each territory will have an implementing partner, and implementing partners and investigators will work together to ensure the study procedures are implemented in parallel across sites. Data collection will be conducted by trained research staff from a third-party survey and policy research organization. The proposal seeks to shift current research and clinical paradigms in these contexts by employing novel theoretical concepts, approaches, and methodologies. The contribution will be significant by 1) further developing new directions for empirically-based interventions in these high-risk contexts, and 2) advancing a relatively brief, cost-effective program that can be readily implemented to help children and families exposed to continuing conflict in Palestine, with the potential to be brought to scale in other contexts.

The Effects of Thrower's Ten Exercises Performed With an External Focus

The aim of this study is to comprehensively investigate the effects of the Thrower's Ten exercise program-commonly recommended to enhance shoulder stability and strength in athletes-when applied using an external focus of attention approach (i.e., directing attention toward an object or movement outside the body), on functional performance, shoulder stability, balance, and throwing performance in adolescent basketball players. This study has been designed to examine the effects of performing the Thrower's Ten exercises with an external focus of attention on functional performance, shoulder stability, balance, and throwing performance in adolescent basketball players. Athletes will be randomly assigned to two groups: the experimental group will perform the exercises using an external focus of attention, whereas the control group will perform the same exercises without any specific attentional focus. The methods employed in this study are expected to effectively address the research objectives. The data collection tools and analytical techniques to be used are based on validated and widely accepted tests in the literature. Functional performance will be assessed using the Closed Kinetic Chain Upper Extremity Stability Test, balance will be evaluated using the Upper Extremity Y Balance Test, and throwing performance will be measured using the Medicine Ball Throw Test.

Time to Healing in Displaced Pediatric Diaphyseal Forearm Fractures Treated With Bioabsorbable Compared to Titanium Intramedullary Nails

This study looks at children with forearm fractures that need surgery. The standard treatment uses titanium nails, which usually need to be removed in a second operation later. This study compares titanium nails with bioabsorbable nails, which gradually dissolve in the body and may help some children avoid another operation. The study will compare how quickly the fractures heal on X-ray, and also look at complications, recovery, function, and the family's experience. Children who need surgery will be randomly assigned to one of the two treatments so the comparison is fair. Hypothesis: The researchers expect that fractures treated with bioabsorbable nails will heal almost as quickly as fractures treated with titanium nails, while reducing the need for later implant removal surgery.

A Scalable, Teacher-delivered, School-based Oral Health Intervention for Pakistani Lower Secondary Schoolchildren

This was a pragmatic, two-arm, and parallel-group, superiority cluster-randomized controlled trial with 1:1 allocation of clusters (schools) to either the Smile Smarts-PK intervention arm or the control arm. The trial settings were lower secondary schools (classes 5-8) in the Punjab, Pakistan. Punjab is the most populous province of Pakistan; it has many public and low-cost private schools that serve lower- and middle-income communities.

Implementation & Dissemination of a Digital Health Intervention for Adolescent Sleep

The goal of this study is to form a Teen Advisory Board (TAB), who will partner with our study team to co-design a beta-test a new prototype of the Firefly program, a mobile-native insomnia cognitive behavioral therapy intervention for teens. This new prototype will have addressed issues that adolescents who had used the first version of the program deemed to be barriers to engaging with the treatment.