Clinical Research Directory

Neurobiological Markers of Non-suicidal Self-injury and Treatment Mechanisms of Adolescent Self-injury Intervention Skills Training

The goal of this clinical trial is to evaluate the effectiveness and safety of Adolescent Self-Injury Intervention Skills Training (ASIST), a treatment program developed by the research team, compared with treatment as usual (TAU) in adolescents who engage in non-suicidal self-injury (NSSI). The main questions it aims to answer are: 1. How do the effectiveness and safety of ASIST compare with those of treatment as usual in adolescents with NSSI? 2. How are treatment-related changes in psychological, clinical, behavioral, and biological measures associated with treatment response? 3. Can machine learning techniques be used to predict treatment responses in adolescents with NSSI? Researchers will compare adolescents receiving ASIST with those receiving TAU to examine changes in psychological, clinical, and behavioral characteristics before and after treatment. They will also examine changes in cortisol and beta-endorphin levels, as well as brain activity and functional connectivity during task performance, to explore potential mechanisms associated with treatment response. Participants will: 1. Receive either ASIST or TAU. 2. Complete psychological, clinical, and behavioral assessments before and after treatment. 3. Undergo measurements of cortisol and beta-endorphin levels. 4. Complete tasks during brain imaging assessments to measure brain activity and functional connectivity.

Evaluating Caregiver Involvement in Primary Care-Based Brief Interventions for Adolescent Alcohol Use Problems

Intervention for mild severity alcohol use among U.S. teens is crucial, as alcohol is the most commonly used substance in this age group, yet few receive the necessary interventions. Primary care, where over 90% of youth regularly visit, is an ideal setting for identifying and addressing mild alcohol use disorder (AUD) through brief interventions like motivational interviewing (MI) and cognitive-behavioral therapy (CBT). However, for teens with mild AUD, a single brief session may not be sufficient, raising questions about the role of caregiver involvement. This study seeks to determine the most effective level of caregiver involvement-no involvement, a single live session, or an online self-paced program-in reducing alcohol use or other substance use among adolescents with mild AUD/SUD in primary care/adolescent clinic settings. The study also explores the impact of these interventions on other outcomes such as substance use, psychosocial functioning, behavioral health services engagement, as well as the factors influencing treatment response. The results will guide the selection and implementation of effective, scalable interventions in primary care to address youth alcohol use and other substance use disorders.

Optimizing Care Transitions in CHD

Adolescents and young adults (AYA) with congenital heart disease (CHD) face psychosocial stresses as they transition to adult care. Parents of AYA with CHD also experience increased caregiver burden and psychosocial stresses. Peer support provided by a person with a similar experience has been found to improve disease self-management and psychosocial health outcomes in pediatric healthcare. However, many AYA with CHD still do not have access to formal social support resources. The aim of this study is to improve pediatric to adult transitions in healthcare by evaluating peer mentorship programs for AYA with CHD and their parents. Established, online mentorship programs, iPeer2Peer(iP2P)/iParent2Parent, will be employed through a pilot feasibility waitlist randomized controlled trial with repeated measures across four sites. Eighty mentees (AYA and parents of AYA) will be recruited and randomized into intervention and control groups. Forty mentees in the intervention group will be matched 1:1 with 30 trained mentors (young adults and parents of AYA). AYA mentees will be matched with young adult mentors and parents of AYA will be matched with other parent mentors. These pairings will connect over 12 weeks through video calls and text messaging to provide peer support to improve self-management and psychosocial health outcomes.

HD-tDCS for Adolescent Bipolar Depression Targeting S1

This randomized, double-blind, sham-controlled clinical trial aims to evaluate the efficacy and underlying biological mechanisms of HD-tDCS targeting the primary somatosensory cortex in adolescents with bipolar depression. Participants will be randomly assigned to receive either active HD-tDCS or sham stimulation, in addition to routine clinical care. Biological data, including neuroimaging, blood biomarkers, voice and facial features, Photoplethysmography (PPG), Electroencephalography (EEG), and behavioral data, will be collected to explore potential predictors of treatment response.

Engaging Adolescents in Decisions About Return of Genomic Research Results

Recent recommendations to return children's results for adult-onset conditions to parents anytime whole exome or genome sequencing is performed, as well as growing expectations to return research results to participants on a large-scale basis, mean adolescents will increasingly be engaged in assenting (\<age 18) and consenting (\>age 18) to return of genomic research results. There is an urgent need to understand adolescents' informational preferences and to create ethically informed, scalable processes that empower adolescents from diverse backgrounds to participate in the decision-making process about learning genomic results. This research will provide important insights into adolescents' choices, as well as the ethical, legal and societal implications of engaging adolescents in making choices about learning genomic results in genomic research and community-based research settings.

Dialectical Behavior Therapy for Adolescent With Repeated Suicidal and Self-harming Behavior in Tanta University Hospitals

The aim of the current study is to:-Evaluate the efficacy of dialectical behavior therapy compared with individual and group supportive therapy for reducing suicide attempts and ideation among adolescence. Evaluate role of dialectical behavior therapy in improving emotional regulation and distress tolerance among adolescence with suicidal ideation and attempts

Exercise as Medicine for Pediatric Chronic Pain

Youth with chronic pain struggle to go to school, play sports, or spend time with friends and family due to pain. Medications are often ineffective, and aerobic exercise may improve both pain sensitivity and participation in valued life activities. This study will be the first to examine the impact of a single session of intense aerobic exercise on pain sensitivity measures in youth with and without chronic pain syndromes to help determine if aerobic exercise can improve pain and functioning.

Quality of Life (HRQoL) of AIS Patients Who Require Bracing or Surgery Using SRS-22 Questionnaire

Adolescent Idiopathic Scoliosis (AIS) is an unexpected curvature of spine at teenage. AIS causes mainly unpleasant appearance, and sometime comes with pain and difficult to locate or move around. When the spinal curve, or "Cobb angle", increases with time, the investigators call it severe condition when the Cobb angle is 60 degrees or above. The severe suffering patients need to be operated to correct their spinal curve by using metallic rods and metallic screws (implants) to fix the spine. In order to avoid this surgery, the investigators use "brace", a hard fitting case, trying to control the spinal curve degree by using forces from outside. (bracing) to intervene the spinal curve progression is highly recommended for patients with particular clinical characteristics. However, bracing is not always a present experience apart from function restriction. Clinical recommendation requires the patients to brace over 20 hours everyday, which means the patients have to be "braced" around the clock. Patients' perception on being "braced" all day, apart from discomforts under bracing, self-image and mental health after bracing are also important psycho-social factors which have yet to be addressed. Based on our clinical experience, 1-2% of AIS patients, undergoing bracing or not (i.e. at observation stage), require surgical intervention due to rapid spinal progression in a short period of time. By definition, surgery will be arranged for patients with major spinal curve ≥50. The use of health-related-quality-of-life (HRQoL) questionnaires allow clinical professionals to explore many different kinds of interests on patients, including the patient's feeling on his/her medical condition and satisfaction with provided care. Scoliosis Research Society (SRS) patient outcome tool has been a well-accepted HRQoL questionnaire to look for the perception of patients with spinal problems of their status. The SRS-22 questionnaire that has been well accepted as its trustworthy on the score results and SRS-22 is good to be used in patients under different conditions across the disease. This is very important to obtain and compare the scores over time in order to look for any consistent changes. Apart from AIS patients requiring bracing, surgical cases are also very important group of patients to monitor their quality of life before and after surgery, and every follow-up visit after surgery.

Comprehensive Intervention to Promote Adjustment in Adolescents With Type 1 Diabetes and Their Parents During Transfer of Health Care Responsibility

Introduction: Type 1 diabetes mellitus is a health condition that produces physical and psychosocial alterations in both the person the person with diabetes mellitus and his or her family, that is why interventions should be designed that make a comprehensive approach to the physiological and psychological aspects of adolescents and parents in order to achieve adaptation to a new normality in the framework of this health condition. Objective: To establish the preliminary efficacy of a comprehensive intervention to promote adaptation in adolescents with type 1 diabetes mellitus and their parents during the transfer of health care responsibility in Bogota, Colombia 2023-2025. Materials and methods: we propose to conduct a pilot study that will develop and evaluate a comprehensive intervention to promote adaptation in adolescents with DM1 and their parents. In the qualitative phase, the needs of adolescents with type 1 diabetes mellitus and their parents will be explored through focus groups. In the quantitative phase, the intervention will be designed and its feasibility, acceptability and preliminary efficacy will be evaluated. A content analysis will be performed on the qualitative data and descriptive and inferential statistical tools will be used for the quantitative data, considering the behavior of the data. Expected results: It is expected to evaluate the preliminary efficacy of a comprehensive intervention to promote adaptation in adolescents with diabetes.

A Climate Change Education Program for 7th and 8th Grade Students in Istanbul Schools: Does It Improve Climate Knowledge and Health-Protective Behaviors?

Climate is the usual weather pattern of a place over a long time. Climate change means long-term shifts in climate, caused by natural processes and, above all, by human activity. Since the Industrial Revolution, factories and production have released more greenhouse gases into the air, and the planet has become warmer. These changes are a risk to public health. They harm some groups more than others: children, older adults, people with long-term illnesses, and people with fewer resources. This makes health inequalities worse, so fighting climate change is a public health issue as well as an environmental one. Young people today are more aware of climate change, which is a good chance to strengthen programs that protect and improve health. The few studies available show that climate change education for teenagers is mostly given in 7th and 8th grade. However, we do not know enough about whether this education changes behavior or improves health. This study aims to find out how a climate change education program affects teenagers' climate literacy (their understanding of climate change) and their health-protective behaviors. The study is quasi-experimental, with a control group and tests before and after the program. It will take place in two middle schools in Üsküdar, Istanbul, from September 2026 to January 2027. Participants will be 7th and 8th grade students from these schools. The sample size was calculated with the G\*Power 3.1.9.4 program. Allowing for dropouts, we plan to include 154 teenagers: 77 in the education group and 77 in the control group. Data will be collected with three tools: a Descriptive Information Form, the Climate Literacy Scale, and the Climate Change Health-Protective Behaviors Scale - Adolescent.

Sleep Quality in Adolescents With Idiopathic Scoliosis

This controlled cross-sectional observational study aims to compare sleep quality between adolescents with idiopathic scoliosis and age- and sex-similar healthy controls. Participants aged 10-18 years will complete online questionnaires assessing demographic characteristics and sleep quality. Adolescents with idiopathic scoliosis will also be evaluated for scoliosis-specific quality of life, body image, Cobb angle, curve type, pain, brace use, and daily brace-wearing duration. The study will additionally investigate factors associated with sleep quality in the scoliosis group. The planned enrollment is 100 participants, including 50 adolescents with idiopathic scoliosis and 50 healthy controls.

Effect of ACTIVE-Care on Cancer-Related Fatigue, Hope, and Psychological Resilience in Adolescents With Acute Lymphoblastic Leukemia

This study aimed to evaluate the effects of the ACTIVE-Care Integrated Physical Activity-Based Supportive Care Program on cancer-related fatigue, hope, and psychological resilience in adolescents with acute lymphoblastic leukemia (ALL). Seventy adolescents aged 13-16 years participated in a parallel-group randomized controlled trial. The intervention group received a six-week program integrating individualized physical activity with psychosocial support, while the control group received usual care. Outcomes were assessed at baseline and immediately after the six-week intervention.

A Pilot Study of a DBT-Informed Caregiver Risk Management Workshop

The goal of this pilot clinical trial is to explore the feasibility and acceptability of implementing an intervention for caregivers in our health care system. The intervention is intended to provide information and consultation to caregivers of youth ages 12-26 years old who are at risk of self-harm (i.e., suicidal behaviors and/or nonsuicidal self-injury). The intervention is based on principles of Dialectical Behavior Therapy, an evidence-based intervention for youth who engage in suicidal behaviors and nonsuicidal self-injury. Acceptability will be assessed through questionnaires and qualitative feedback. Feasibility will be assessed by tracking the amount of clinician resources needed and how long it takes to identify caregivers who want to participate. A group of caregivers who have lived experience of having a child at risk for self-harm will form an advisory board. The board will review the study methods and data; their advice will guide next steps.

Implementing Stepped Financial and Legal Navigation to Mitigate Financial Toxicity in Adolescent and Young Adult Cancer Patients Oncology Financial and Legal Navigation (OFLN)

The overall objective of this study is to test the effectiveness and implementability of stepped Oncology Financial and Legal Navigation (OFLN) in a noninferiority randomized controlled trial (RCT) using a hybrid type 1 (effectiveness-implementation) design.

Opioid Analgesia Impacts on Neurological Development

Background: Pain in childhood - whether from injuries like fractures or long-term conditions like scoliosis - is often treated with opioid medicines. These drugs are effective for pain relief. Recent research suggests that they may affect brain development if given during key stages of growth. This study will explore how different types of pain and opioid use impact brain activity in children using a child-friendly brain scan called OPM-MEG. Objectives: 1. To compare brain activity patterns in different regions of the brain in children with different pain and opioid exposure profiles. 2. To investigate the relationships between brain activity and clinical features, including subjective pain ratings, pain sensitivity, and psychological outcomes (e.g. trauma symptoms, distress). Participants will be asked to attend a single visit, which may coincide with their follow-up clinical appointment to orthopaedics or at an alternative convenient time. The visit will take approximately 1-1.5 hours and consist of recording brain activity using the child-friendly OPM-MEG (like a bicycle helmet) during rest and in response to a variety of sensory stimuli. Participants will also be asked to complete a small number of questionnaires.

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.

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.

Controlled Evaluation of an Exercise Program for Overweight Adolescents

Physical activity decreases as young people get older, especially during the shift from early to late adolescence. Unfortunately, around 81% of school-aged children worldwide between the ages of 11 and 17 do not meet the recommendation of at least one hour of physical activity per day - and this is also true in Switzerland. Not being active enough, whether normal weight or overweight, can lead to long-term health problems and is a major factor in becoming overweight over time. This results in healthcare costs and negatively affects quality of life. Supporting physical activity in overweight youth requires well-rounded, thoughtful programs. The investigators studying the impact of the movement programs now! and now!+ on the physical activity and health of young people. The goal is to look at both physical and mental changes equally. Taking part in this study involves minimal physical or mental risk for the participants. These small risks from the testing methods and activities are taken into account in how the program is explained and carried out. The benefits for the participants - feeling healthier and fitter physically, and more confident and capable mentally - clearly outweigh any potential risks, thanks to the additional, guided, and personalized exercise program. The participants take part in the now! and now!+ exercise programs run by the Basel-Stadt Sports Office and the DSBG. now! is a 90-minute group session with up to 14 young people, while now!+ is a 90-minute small-group session with 2 to 4 participants. Both programs take place once a week over a 12-month period and pause during school holidays (38 training weeks in total). Each session includes a warm-up, a strength or endurance training block, and a coordination phase. The program is modular and adapted to the physical and personal needs of each participant. This ensures that overweight adolescents are not overstrained and don't develop symptoms like pain, frustration, or lack of motivation (Behringer et al., 2011), while still allowing for a training stimulus that supports physical improvement. The results of the evaluations are directly used to improve and further develop the exercise program. The overall project includes three rounds, each consisting of one year of training and three test sessions, each lasting about two hours. The now! and now!+ programs are held weekly for a total of 38 weeks per year, with breaks during school holidays. Each of the three test sessions includes the same set of assessments (see "Study Intervention") and follows a set order: The process begins with measuring body size and blood pressure, followed by a static retinal vessel analysis. After these medical checks, participants do a 5-minute warm-up on a stationary bike at a set resistance level. Then, strength tests are performed: knee extension on the IsoMed 2000, handgrip strength, and jump power on the Leonardo force plate. The endurance test using spiroergometry marks the end of the physical assessments. Finally, impulse control is tested, and participants complete a set of questionnaires. At the end of the session, each participant is given an actigraph (a small motion sensor worn on the body) to track their physical activity over the following seven days.

Addressing Root Causes for Gun Violence Prevention (ARC-GVP)

The goal of this study is to help build the evidence base for a locally-relevant youth firearm violence prevention program in Washington D.C., a city experiencing disparities in youth firearm violence outcomes. The main question it aims to answer is: How is youth participation in the summer youth employment program, the True Reasons I Grabbed the Gun Evolved from Risk (The T.R.I.G.G.E.R Project), which is designed to address root causes of gun violence, associated with individual youth behavioral outcomes, including pro-social involvement, aggression, and firearm-related attitudes and behaviors?

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.

PRECEDE-PROCEED BASED FIRST AID TRAINING: SELF-EFFICACY, SKILL AND COST ANALYSIS IN HIGH SCHOLL STUDENTS

This research has two objectives. Firstly, to determine the effect of a first aid training program, developed based on the PRECEDE-PROCEED model, on the first aid knowledge, self-efficacy, and skill levels of high school students. Secondly, to conduct a cost analysis of the first aid training program. This study is a randomized controlled experimental follow-up study. The research is planned to be conducted in the Aliağa district of İzmir during the fall and spring semesters of the 2026-2027 academic year. The study population will consist of all 10th-grade students who will be studying at the selected high school during the fall semester of the 2026-2027 academic year. Ninth-grade students were excluded from the sample due to their school orientation process, and 11th and 12th-grade students were excluded due to academic intensity and exam anxiety related to their preparation for higher education entrance exams. A complete enumeration method was adopted for sample selection, and all 6 classes (n=187) were included in the study. The sample size calculation was performed based on the information that there are a total of 187 students in 6 different classes currently in 9th grade who will be entering 10th grade in the fall semester of the 2025-2026 academic year.Cluster Randomization was used to assign classes to experimental and control groups. A ranking system was created among the classes using the random.org digital random assignment tool. As a result of this assignment, classes 10-E, 10-D, and 10-F, which ranked first and third respectively, were designated as the Experimental Group, while classes 10-A, 10-C, and 10-B, which ranked third, were designated as the Control Group.To protect student identities and match pre-test and post-test data, a coding system will be used: \[Group Letter (D/K)\] + \[Class/Branch Code\] + \[Student Sequence/List Number\] (e.g., D10B12: The 12th student in the experimental group, class 10-B). To prevent intergroup interaction, the application is designed to be sequential. The experimental group will be applied after all training and data collection processes for the control group are completed. Experimental Group: Before the training, students in the experimental group will be administered a "Personal Information Form, First Aid Information Form, and First Aid Self-Efficacy Scale." Following this, a first aid training program developed based on PRECEDE-PROCEED will be implemented in the students' classrooms. As part of the training program, students will be individually given first aid interventions to assess their skills. Following the training, and then one month and three months after the training, the "First Aid Knowledge Form, First Aid Self-Efficacy Scale, and First Aid Application Skills Assessment Form" will be administered, respectively. Control Group: Students in the control group will be administered the "Personal Information Form, First Aid Knowledge Form, and First Aid Self-Efficacy Scale" before the training. Students will be given brochures based on traditional training methods. For application skills, video training will be conducted on the interactive whiteboard in the control group classrooms. If interactive whiteboards are not available, video training will be conducted for all students in the control group using a projector in the conference halls. After the video presentation, students will be given individual skill practice exercises. Following the brochure and video training, and then one month and three months after the training, the "First Aid Knowledge Form, First Aid Self-Efficacy Scale, and First Aid Application Skills Assessment Form" will be administered, respectively.

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

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