Oppositional Defiant Disorder (ODD)

Researchers are investigating the effects of the PAX Good Behavior Game (GBG) in Swedish primary schools to address growing concerns of mental health issues among children and stress-related symptoms in teachers. This cluster-randomized controlled trial involves 28 schools and about 84 teachers, aiming to improve student well-being and reduce teacher stress. The study compares PAX GBG to active control interventions that also provide teacher training but with different content. The trial includes extensive measurements over two years, including self-assessments, classroom observations, sound level monitoring, sick leave data, and qualitative interviews. Teachers randomized to the PAX GBG group receive a two-day training on ten specific tools designed to promote prosocial and focused behaviors in classrooms, including a team-based game rewarding good behavior. Control schools choose between two alternatives: 'Count On Me!', a math fluency application for pupils, or a Collegial Learning Community intervention focused on professional development for teachers. Both groups receive similar amounts of training and supervision, including multiple sessions during the school year. The interventions are integrated into regular classroom activities starting in grade 1 through grade 3. Participants include approximately 2200 pupils and their teachers, with data collected through various methods such as questionnaires, standardized tests, observer ratings, and registry data. Measurements occur at multiple time points over two years, focusing on pupil well-being, teacher stress, classroom behavior, noise levels, and implementation fidelity. The study also evaluates cost-effectiveness by comparing health outcomes and related expenses. Safety and adverse events are monitored through teacher reports and interviews, ensuring comprehensive assessment of the interventions' impact.

Suicide is the second leading cause of death among youth, and rates in the US are rising despite prevention efforts. Researchers are evaluating a digital platform called Vira to improve how care is delivered to adolescents at high risk for suicide. This platform aims to use smartphone data and secure communication tools to better understand and manage risk factors like psychological distress, anhedonia, behavioral withdrawal, and sleep problems in young people receiving intensive outpatient treatment. The study compares two groups of adolescent patients aged 13 to 18 years old who are in an intensive outpatient Dialectical Behavior Therapy (DBT) program. One group uses the Vira platform, which collects data passively from smartphone sensors about activity, sleep, mobility, and mood-related language. Vira also prompts daily check-ins and supports practitioners with reminders to encourage behavior changes. The other group receives the usual treatment with the addition of a passive monitoring app called EARS. Participants will use their assigned app during their intensive outpatient treatment. Researchers will assess outcomes using tools like the Columbia Suicide Severity Rating Scale and Scale for Suicidal Ideation over six months. Other measures include anxiety, risky behaviors, sleep quality, mood, and pleasure scales at three and six months. The study monitors clinical outcomes to determine if the digital platform enhances care for youth at risk of suicide.

Researchers are evaluating a family-centred approach to prevent cardiovascular diseases (CVD) among adolescents and their families in Uganda. This 5-year study focuses on reducing risk factors like unhealthy diet and physical inactivity that contribute to CVD and other non-communicable diseases (NCDs). The study adapts a proven intervention from Asia to the Ugandan context, aiming to support healthier lifestyle behaviors during the critical adolescence period when habits form that affect adult health. The study includes two groups: one receiving the FaCe-D intervention, which involves home visits by Village Health Teams delivering diet, physical activity, and health messaging; and a control group receiving standard care with usual health promotion activities. The study is divided into three phases: adapting the intervention, implementing it, and evaluating its effectiveness and feasibility in 32 villages. Participants will be involved for at least 12 months, during which researchers will assess changes in cardiovascular health and sleep quality. Evaluations include monitoring behavior changes, health outcomes, and implementation costs. The study also considers adoption and feasibility to understand how well the intervention works in real community settings.

Researchers are evaluating the effectiveness and feasibility of Narrative Enhancement and Cognitive Therapy (NECT), a group-based treatment designed to reduce self-stigma in people with mental disorders. Self-stigma involves internalizing negative stereotypes which can harm treatment adherence, self-esteem, quality of life, and increase despair or suicide risk. This pragmatic, multicenter, randomized controlled trial includes 416 patients from 26 mental health centers in Northeast Italy, aiming to improve psychological outcomes like self-esteem, hope, empowerment, recovery perception, and mental well-being. Participants in the intervention group will attend 20 one-hour NECT group sessions divided into five parts: orientation, psychoeducation, cognitive restructuring, narrative enhancement, and conclusion. The therapy helps challenge stigmatizing beliefs and fosters a positive self-narrative. This group therapy is provided alongside participants' usual care, which may include medication and psychosocial treatments. The control group will continue their standard care without NECT. The study lasts about 12 months, with a 2-month recruitment phase, 5 months of intervention, and 5 months for data analysis and publication. Participants will undergo assessments at enrollment and after the 20-week intervention to measure changes in self-stigma, self-esteem, hope, empowerment, recovery perception, mental well-being, and stigma-related stress. Treatment fidelity will be monitored through session recordings. The study also tracks feasibility by evaluating participation rates and feedback. All participants remain under their usual care throughout the study, and data collection includes monitoring care received during the trial.

Researchers are evaluating the safety and effectiveness of a liposomal mitoxantrone combination regimen in treating relapsed and refractory solid tumors in children, adolescents, and young adults aged 6 to 24 years. This prospective, single-arm, multicenter clinical study aims to improve the objective response rate compared to historical data and to assess related side effects. The study focuses on specific tumor types including bone and soft tissue tumors and neuroblastoma among others. Participants will receive a treatment regimen combining mitoxantrone liposome, capecitabine, and anlotinib over 4 to 6 cycles, each lasting 21 days. Capecitabine is given twice daily on days 1 to 14, while anlotinib dosage is adjusted based on body weight and administered for 14 days per cycle. Those showing partial response or better may receive additional local treatments such as surgery or radiotherapy. During the study, participants will have regular checkups and tests to monitor tumor status, blood parameters, and other relevant health indicators. The main measurement is the objective response rate after up to 6 treatment cycles. Other outcomes include disease control rate, progression-free survival, overall survival, and safety monitoring for up to one year after treatment. The total observation period includes follow-up assessments to evaluate lasting effects and adverse events.

Researchers are evaluating the iDECIDE curriculum, a new drug education and diversion program, in about 300 middle and high school students who have recently broken school substance use rules. This randomized controlled trial aims to see if iDECIDE improves knowledge about drugs, attitudes toward substance use, and actual substance use behavior compared to a waitlist control group. The study focuses on adolescents' understanding of drug effects, brain development, and readiness to reduce or quit substance use. Participants will be randomly assigned to one of two groups: the iDECIDE group or a waitlist control group. The iDECIDE group will complete four weekly sessions of a drug education curriculum, delivered via videoconference or in-person, each lasting 60 to 75 minutes. This curriculum covers topics such as addiction neurobiology, brain development, industry tactics, and healthy alternatives. The control group will undergo symptom and substance use monitoring during the weekly visits and may choose to join the iDECIDE program after one month. The study involves nine visits over about one year, including baseline assessment, four weekly intervention or monitoring visits, and four follow-up visits at one week, one month, six months, and one year after the intervention. Participants will complete questionnaires, assessments, and urine tests at various visits, with raters blinded to group assignment. The study will measure knowledge of drug effects and brain development, frequency of substance use, readiness to quit, and perceptions of harm. Participants will receive compensation for attending sessions and providing urine samples.

Researchers are evaluating a brief and individually tailored behavioral parent training program for children aged 2 to 12 years who have behavioral difficulties such as oppositional, defiant, aggressive, hyperactive, impulsive, and inattentive behaviors. The study aims to compare this new short parent training with care as usual (CAU) in mental healthcare centers, focusing on both short- and long-term effectiveness and cost-effectiveness. The trial addresses current challenges like limited access to certified therapists and high dropout rates due to the length and rigidity of standard programs. Parents in the intervention group participate in three sessions over three to four weeks: two individually tailored sessions lasting two hours each, followed by a one-hour evaluation and maintenance session. Optional booster sessions are available once every four weeks for up to one year after the program to help maintain improvements. The control group receives usual care, which may include psychoeducation, counseling, longer parent training, medication, or family therapy. Both treatments are delivered within routine Dutch mental health care, and therapists receive specialized training and supervision to deliver the brief program. Participants provide information and complete various assessments at baseline, one week after treatment, six months, and twelve months later. These include parent questionnaires, audio recordings of mealtime routines, and daily phone calls to monitor child behavior, parenting stress, and parent-child relationships. Researchers also evaluate program feedback from parents and therapists, treatment costs, and health utilities. The total participation spans about one year, with careful monitoring to ensure treatment fidelity and ethical standards.

Researchers are studying ways to improve teaching self-control and communication skills to children and adolescents aged 6 to 17 with challenging behaviors. The goal is to find methods that make behavior-change treatments more effective and long-lasting, even when environments or reinforcement schedules change. The study looks at how cognitive and behavioral factors like memory, timing, and decision-making affect treatment success. Participants will receive a behavioral intervention that includes functional communication training to teach appropriate communication responses, extinction-correlated stimuli to signal reinforcement changes, schedule thinning to reduce reinforcement frequency, competing stimuli to reduce challenging behaviors during delays, and caregiver training to support skill use at home. These approaches will be personalized and applied in structured sessions. During the study, participants will complete assessments to identify preferred activities and understand causes of challenging behaviors. They will learn new communication skills to replace problem behaviors and practice transferring these skills to new situations and people. Researchers will monitor changes in challenging behavior from enrollment through 16 weeks of intervention to evaluate treatment durability and generalization.

Adolescents and young adults with HIV (AYWH) aged 15 to 24 years are the fastest-growing group living with HIV worldwide and face worse outcomes than adults, with HIV/AIDS being a leading cause of death and disability in this group. This research aims to develop and test a youth-friendly mobile health (mHealth) social media intervention to improve retention in HIV care, which may reduce AIDS-related deaths and new HIV transmissions. The study also supports the investigator's training in research and clinical trial skills focused on AYWH in low-resource settings. The study will use a social media-based intervention delivered through WhatsApp modules designed to encourage behaviors that improve retention in care for AYWH. Participants will be randomly assigned either to start receiving the intervention immediately or to a wait-list control group, which will begin the intervention after six months. The intervention targets new or re-engaging AYWH in HIV care and considers different infection routes to tailor support. Participants will take part for at least 12 months during which researchers will assess how feasible and acceptable the intervention is and measure retention in care. Data will be gathered from AYWH who are new or returning to care, including their HIV knowledge, experiences, and challenges. The study includes language fluency assessments and smartphone access for some parts. Safety and consent abilities are monitored, and the study is conducted without blinding, allowing direct observation of participation and outcomes.

Researchers are investigating treatments for children aged 1 to 18 years with chronic kidney disease (CKD) and proteinuria, conditions where the kidneys do not function properly and leak protein into the urine. CKD can cause complications like high blood pressure, and treatments currently include ACE inhibitors (ACEI) or angiotensin receptor blockers (ARB) that help control blood pressure and protein levels. This study focuses on evaluating the safety and effects of adding finerenone to these standard treatments, aiming to better manage the overactive kidney system involved in these conditions. Participants will receive finerenone orally, adjusted by age and body weight, alongside their existing ACEI or ARB treatment. The study lasts about 19 months, with up to 18 months of finerenone treatment and a one-month follow-up. During this time, children who are new to finerenone will have at least 12 visits, while those already on finerenone will have at least 8 visits. At these visits, various health checks and sample collections will occur to monitor safety and kidney function. Throughout the study, researchers will regularly measure blood pressure, heart rate, temperature, height, and weight, and collect blood and urine samples to assess kidney function and protein levels. They will also perform heart tests using electrocardiograms and echocardiography. Participants and their guardians will answer questions about medication use and any medical problems experienced. Safety will be closely monitored by tracking any adverse events during the study and a health check will be done about 30 days after treatment ends.