Clinical Research Directory

Single Session Support for Parents of Children With Neurodevelopmental Disabilities Struggling With Anxious Avoidance

This study will inform the development of a brief online program to help parents better understand and respond to anxiety-related behaviors in children with neurodevelopmental disorders (NDDs) such as autism spectrum disorder (ASD), attention-deficit/hyperactivity disorder (ADHD), intellectual disability, and learning disorders). Many neurodiverse children experience high levels of anxiety, which can appear as avoidance, emotional distress, or challenging behaviors that are difficult for parents to interpret and manage. The purpose of this research is to evaluate EMPOWER-ND with its digital, single-session intervention (SSI) that provides practical parenting strategies for addressing anxiety-related behaviors in neurodiverse children. Parents of eligible children aged 5-14 with neurodevelopmental conditions will be invited to enroll in the research study.

Phase 1: Thrive Together

During this first phase of the study, the investigators are conducting focus group to conduct a needs assessment. Specifically, the investigators will be holding focus groups with adolescents with ADHD as well as separate focus groups with the adolescents' parents to better understand the current needs of youth with ADHD and how to best support them.

Developing Virtual Reality Programs to Address Social Skills Deficits in Youth With ADHD

Researchers at OpenMindXR, in collaboration with Indiana University, are conducting a paid research study evaluating an innovative virtual reality (VR)-based intervention designed to support social and emotional skill development in children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD). Children with ADHD often experience challenges in social functioning, emotional regulation, and peer relationships. While behavioral therapies and school-based interventions can be effective, access, engagement, and real-world generalization of skills remain ongoing challenges. This study aims to evaluate the usability and preliminary effectiveness of VR programs for youth with ADHD.

Effects of HIIT and Dual-Task Training in Children With ADHD

This randomized controlled study evaluated the effects of an 8-week high-intensity interval training (HIIT)-based dual-task exercise program on attention, cognitive-motor performance, social adjustment, and quality of life in adolescents with attention-deficit/hyperactivity disorder (ADHD). Thirty adolescents aged 13-17 years were randomized to an intervention group (n=15) or a control group (n=15). The intervention group completed 24 exercise sessions, performed three times per week for eight weeks, while the control group received no structured exercise program. Outcomes were assessed before the intervention, after the intervention, and at 3-month follow-up using the D2 Test of Attention, Stroop Test, BOT-2 Short Form, Pediatric Quality of Life Inventory, and Social Adjustment Scale.

Clinical Trial to Investigate the Safety and Efficacy of Two Dexamfetamine Sulfate Formulations in Adults With ADHD and Moderate to Severe Depression

The indication of attention-deficit/hyperactivity disorder (ADHD) to be examined often occurs with other psychiatric disorders, and the majority of adults with ADHD have at least one psychiatric comorbidity in their lives. Depression is one of the most common comorbidities in patients with ADHD. The prevalence of comorbid depression in adults with ADHD is estimated to be as high as 50%. There is evidence that stimulants such as dexamfetamine and methylphenidate lead to an improvement in sustained focused attention, working memory, and a variety of cognitive processes in the prefrontal cortex (PFC). In combination with the pharmacological effects of stimulants, such as the inhibition of monoamine oxidase, the increase in the concentration of noradrenaline in the PFC and dopamine in the striatum, dexamfetamine and methylphenidate could improve the treatment of depression in patients with major depressive disorder and comorbid ADHD. This clinical trial will evaluate the safety and efficacy of DEX in two different formulations compared to placebo in adults with ADHD and moderate to severe depression. To ensure double blinding of the treatment, placebo will be administered in the form of tablets and capsules.

Binaural Beats Stimulation for Adults With Attention-Deficit/Hyperactivity Disorder

This study is conducted entirely in person at California State University, San Bernardino. Participation requires 12 campus visits over six weeks. Remote participation is not available, and travel expenses are not reimbursed. Participants who complete all study visits will receive a gift valued at $25. This study will evaluate the feasibility and potential effects of a six-week, music-based binaural beats stimulation program in adults with attention-deficit/hyperactivity disorder (ADHD). Forty adults with ADHD will be randomly assigned to either a binaural beat stimulation group or a control group. Both groups will attend 12 supervised listening sessions over six weeks and listen to similar music for 20 minutes per session; however, only the intervention group's music will contain embedded binaural beats. Cognitive assessments will be completed before and after the intervention to evaluate changes in attention and memory. Session attendance and participant retention will also be examined to assess the feasibility and acceptability of the program.

Treating Young Children With Attention Deficit Hyperactivity Disorder

This project will evaluate the effectiveness of Methylphenidate versus Guanfacine in treating Attention-Deficit/Hyperactivity Disorder (ADHD) in children aged 3 through 5 years (inclusive), as measured by clinician rating of global improvement.

Investigation of the Association of Multimodal Neuroimaging and Peripheral Biomarkers With Executive Functions and Emotional Regulation in Adolescents With Attention-Deficit/Hyperactivity Disorder

The purpose of this observational study is to investigate the relationships among resting-state brain connectivity, peripheral blood biomarkers, executive functions, and emotional regulation in adolescents with attention-deficit/hyperactivity disorder (ADHD). The study will include 40 adolescents aged 10 to 18 years with ADHD and 40 age- and sex-matched healthy controls. Participants will undergo clinical and psychological assessments, resting-state functional magnetic resonance imaging, and blood sampling. Serum levels of BDNF, cortisol, IL-1α, IFN-γ, TNF-α, and IL-6 will be measured. The study will examine whether differences in brain connectivity and biomarker levels are associated with executive functioning and emotional regulation.

The ADHD Kids´ Study for Children 9-12 Years of Age

The aim of the study is to compare the efficacy of The OutSMARTers program- an ADHD skills training group program for children aged 9-12 to customized individual counseling provided by a professional, The Kid Counseling Program. Approximately 100 children will be randomly assigned to either intervention or a small wait-list group who will after a five-week-waiting period receive either intervention. Following the intervention, parents, children, and teachers will evaluate the effects on communication skills, well-being, and emotional regulation.

Occupational Therapy-Based Dance Program for Children With ADHD

Attention-deficit/hyperactivity disorder (ADHD) is a common neurodevelopmental condition that can affect children's attention, movement, balance, sensory processing, and self-esteem. These difficulties may interfere with participation in daily activities, school performance, and social interactions. The purpose of this randomized controlled trial is to evaluate whether an occupational therapy-based dance program can improve cognitive-motor performance, self-esteem, functional balance, and sensory processing in children with ADHD. Participants will be randomly assigned to either an intervention group receiving a structured 5-week occupational therapy-based dance program or a control group receiving no intervention during the study period. Outcomes will be assessed before and after the intervention using standardized assessment tools. The study hypothesizes that children who participate in the occupational therapy-based dance program will demonstrate greater improvements in cognitive-motor performance, self-esteem, functional balance, and sensory processing than children in the control group.

Home Play-based Intervention for Parents and Infants

The goal of this clinical trial is to learn whether a 12-week home-based intervention (Sociometric Play-based Remediation of Individual Neurodevelopmental Trajectories (SPRINT)) helps support parenting and the development of infants aged 7 - 15 months (at the time they join the study) who were born preterm and/or have a higher family risk of developmental conditions, such as autism spectrum disorder (ASD), attention-deficit/hyperactivity disorder (ADHD), and/or global developmental delay (GDD). The main questions it aims to answer are: * Does taking part in the SPRINT intervention help parents develop parenting skills? * Does taking part in the SPRINT intervention improve infant's thinking skills and/or socio-emotional development? Researchers will compare families who receive the SPRINT intervention with families in a waitlist control group to see whether the intervention leads to greater improvements in parents and their children. Participants will: * Complete questionnaires and in-person assessments, before and after the 12-week period. * Be assigned to either the SPRINT intervention or a waitlist control group and complete the assigned activities for 12 weeks. * Use the SPRINT app, which provides information, guidance and activities for either the SPRINT intervention or waitlist control group.

Cannabigerol Oil for Adolescents With ADHD (CAN-ADHD)

This study aims to evaluate the potential effects of full-spectrum cannabigerol (CBG) oil on cognitive and behavioral symptoms in adolescents diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD). ADHD is a neurodevelopmental disorder characterized by inattention, hyperactivity, and impulsivity, often associated with impairments in academic, social, and emotional functioning. This is a randomized, double-blind, placebo-controlled clinical trial with a parallel design. A total of 60 adolescents aged 12 to 17 years, diagnosed with ADHD and with insufficient response to previous treatments, will be enrolled and randomly assigned to either the intervention group or the placebo group. Participants in the intervention group will receive full-spectrum CBG oil (30 mg/mL), administered sublingually, with individualized dosing determined by the study physician and adjusted through weekly monitoring. The placebo group will receive an inert oil matched in appearance and administration conditions. The intervention will last for 12 weeks, including in-person clinical assessments at baseline, week 6, and week 12, as well as weekly remote monitoring to assess adherence, safety, and dose adjustments. Primary outcomes will include changes in ADHD symptom severity measured by the SNAP-IV scale. Secondary outcomes will assess quality of life, emotional symptoms, sleep patterns, and safety profile. This study aims to contribute to the scientific understanding of cannabinoids as a potential therapeutic option for adolescents with ADHD, a population for which current evidence remains limited.

Finding Alternatives to Standard Treatment for Attention-Deficit Hyperactivity Disorder

Attention-Deficit/Hyperactivity Disorder (ADHD) is characterized by poor attention, impulsivity, hyperactivity and emotional-motivational dysregulation. Here, we will test if theta burst repetitive transcranial magnetic stimulation (rTMS) can reduce the symptoms of ADHD.