Attention Deficit Disorder With Hyperactivity (ADHD)

The purpose of this study is to measure safety and the improvement in symptoms in subjects with ADHD when taking ALKS 7290 tablets compared with placebo tablets.

Interventions for parents of children with NDD face two pivotal challenges. Firstly, many overlook the consequential influence of parenting stress, symptoms of parental anxiety and depression on the well-being of parent-child dyads. Though some address parenting stress, they fall short of considering comprehensive health outcomes. Secondly, current evidence has supported ACT as an empirically validated, transdiagnostic psychotherapeutic intervention for parents with dual benefits for the parent-child dyads, but the treatment delivery (e.g., group-based and guided online approaches) is primarily in-person, demanding the presence of expert personnel in every session, limiting its scalability and accessibility. Unlike other psychotherapies like CBT and mindfulness, conventional ACT sessions often adopt a 'one-size-fits-all' strategy, using standardised and pre-packed exercises lacking the personalisation necessary to address individual variations in psychological inflexibility. Leveraging our available innovation, Pai.ACT, an AI-driven chatbot adopting the Focused ACT approach, seeks to offer personalised and scalable mental health solutions for Chinese-speaking parents of NDD children. With our encouraging preliminary data supporting our pre-trained NLP model's accuracy and Pai.ACT's feasibility, the investigators propose to examine Pai.ACT in a full-scale clinical trial. The study will examine the following research questions: 1. Is Pai.ACT more effective than positive parenting advice for reducing parenting stress (primary outcome for parents) of parents and the emotional and behavioural symptoms of their young children with NDD (primary outcome for children) over the 12-month post-intervention follow-up? 2. Is Pai.ACT more effective than positive parenting advice for reducing symptoms of depression and anxiety, improving parental psychological flexibility and parenting behaviour over the 12-month post-intervention follow-up? 3. Is Pai.ACT more effective than positive parenting advice for reducing the use of healthcare and rehabilitation services in children with NDD over the 12-month post-intervention follow-up? 4. What are the perceived benefits, satisfaction, strengths, and limitations of Pai.ACT from the parents' perspectives?

Substance use disorders (SUD) and attention deficit disorder with or without hyperactivity (ADHD) are frequently co-morbid, particularly among people under court supervision. The coexistence of these disorders increases the social and legal vulnerability of individuals. Better identification of ADHD in vulnerable people with SUD is essential to improving their care. This project aims to provide appropriate support for this at-risk population.

The goal of this clinical trial is to learn if adding an artificial intelligence (AI) application called to standard Behavioral Parent Training (BPT) helps families with children who have disruptive behavior problems. It will also help researchers understand if the app is easy to use and helpful for parents. The main question it aims to answer is: \- Is it feasible and acceptable for parents to use the AI app alongside their therapy sessions? The secondary questions it aims to answer are: * Does the app help reduce children's disruptive behaviors and irritability more than therapy alone? * Does using the app help lower stress, anxiety, and depression levels for the parents? Researchers will compare: 1. Standard BPT: Parents receive 8 weekly group training sessions (online). 2. BPT plus ParenteAI: Parents receive the same 8 weekly sessions plus 24/7 access to an AI virtual assistant for personalized support. Participants will: * Attend 8 weekly group training sessions. * Complete surveys about their child's behavior and their own well-being at baseline, after group training sessions 4 and 8, and 3 and 6 months after finalizing the group training. * If in the experimental group, use the ParenteAI app to get real-time coaching and support for managing their child's behavior at home. * Provide feedback on their experience and satisfaction with the program.

The goal of this basic experimental research study is to examine how the human thalamus supports flexible thinking and behavior. Specifically, the research aims to elucidate how the mediodorsal (MD) thalamus encodes and updates "context"-the mental framework that determines which rules or actions are relevant in a given situation. This work may contribute to understanding why certain psychiatric conditions, such as schizophrenia and ADHD, involve difficulties with cognitive flexibility and control. The primary research questions are: Does the MD thalamus represent the context that organizes how working memory guides task selection? Does the MD thalamus signal when context needs to be updated after a change in task demands? Do these thalamic representations support generalization to new situations or rules? Participants will complete cognitive tasks while undergoing high-resolution brain imaging using 7-Tesla MRI. The investigators will combine behavioral data, computational modeling, and advanced neuroimaging analyses to examine how the thalamus interacts with the cortex during flexible decision-making.

The goal of this clinical trial is to learn if external trigeminal nerve stimulation (eTNS) works to treat ADHD symptoms in children on the autism spectrum (ASD). It will also learn about the efficacy and tolerability of the eTNS device. The main questions it aims to answer are: * Does eTNS reduce ADHD symptoms? * Does eTNS improve core and associated features of ASD? Participation spans 8-12 weeks and includes: * 4-5 in-person visits * 4 brief virtual check-ins * Nightly use of the eTNS device with a small sticky patch applied to child's forehead * Randomized assignment (those who start with the sham device may try the active device later)

Attention Deficit Hyperactivity Disorder (ADHD) affects more than 5 % of children and adolescents, with a globally increasing prevalence. The condition imposes a significant burden on affected individuals, their families, and healthcare systems. Early and accurate diagnosis is crucial to ensure timely therapeutic and educational interventions. However, current diagnostic practices rely heavily on clinical interviews and behavioral observations, which are inherently subjective and resource-intensive. There is a growing need for objective diagnostic tools that can complement or even partially replace current clinical assessments. One promising approach involves eye-tracking technology, as ADHD is associated with altered oculomotor control and attention-related neural circuits. These changes may be reflected in measurable eye movement parameters, including saccadic latency and fixation stability. This clinical investigation uses a certified, CE-marked medical eye-tracking device (neos™) to assess whether specific eye movement parameters can serve as objective biomarkers for ADHD. Although the device was originally designed to assess visual pathway integrity, it also captures parameters related to attention and executive function through standardized protocols. The test is examiner-independent, non-invasive, and takes approximately 10 minutes. The study is observational and non-interventional, involving two groups of participants aged 8 to 16: 50 children with a clinically confirmed diagnosis of ADHD and 50 age-matched non-ADHD controls. All participants will complete a single neos™ eye-tracking assessment. The primary hypothesis is that children with ADHD will demonstrate greater variability in saccadic latency and a higher frequency of large saccades (\> 3°) during fixation compared to controls. These differences will be analyzed as potential diagnostic biomarkers. Diagnostic accuracy will be evaluated using receiver operating characteristic (ROC) analysis, with sensitivity, specificity and area under the curve (AUC) values reported. Secondary hypotheses include: Oculomotor parameters derived from the neos™ system can distinguish between ADHD subtypes (predominantly inattentive, hyperactive-impulsive and combined). Combined oculomotor metrics correlate with ADHD symptom severity, potentially enabling a quantitative assessment of disease burden. The results of this study could pave the way for the clinical adoption of objective, scalable and rapid diagnostic tools for ADHD. Beyond clinical use, such tools may also be adapted for population screening, telemedicine or integration into consumer-grade technologies such as virtual reality headsets. By validating a market-approved device for a new mental health indication, this study represents a critical step toward bridging research and clinical application in ADHD diagnostics.

Parents of children with special needs in Hong Kong often face limited psychological support, which can negatively impact the child rehabilitation process and the well-being of parent-child relationships. To address this gap, we have developed Pai.ACT, the first deep learning-based mental health advisory system for parents. Pai.ACT features an AI chatbot that integrates the counselling principles of Acceptance and Commitment Therapy (ACT) through natural language processing, providing parents with a human-like voice-to-text experience. Using data from chatbot interactions, the Pai.ACT platform offers assessments regarding the individual's psychological inflexibility status and delivers stratified mental health interventions by: * Low-risk: Users access self-help ACT digital modules tailored to their specific psychological inflexibility processes. * Moderate-risk: In addition to the self-help modules, users receive 4-6 sessions of video-conferencing-based ACT interventions (45-60 minutes per session) conducted by our trained counseling team. * High-risk: Users are directed to specialized mental health services provided by collaborating units. The study includes a regional randomised controlled trial (RCT) in Hong Kong's Sha Tin District, in collaboration with the Shatin District Office. The goal of this regional study is to evaluate the feasibility, acceptability, and potential efficacy of combining AI-driven mental health support across all of Hong Kong. Focus group interviews will also explore parents' perceptions of Pai.ACT and help identify the most effective service model for scaling its use. Pai.ACT provides accessible and comprehensive mental health services to Chinese-speaking parents, helping to alleviate the psychological burden of caregiving. By integrating mental health support with child rehabilitation services and non-governmental organisations, Pai.ACT has the potential to enhance family caregivers' well-being, reduce stigma associated with special needs children, and promote more significant mental health awareness in Chinese-speaking communities.

The goal of this study is to evaluate the feasibility and effectiveness of a health promotion intervention for Ultra-Orthodox Jewish mothers of children with ADHD. This study will examine the impact of a culturally tailored group-based intervention aimed at reducing stress, enhancing health, and improving the well-being of mothers. The main questions this study aims to answer are: 1. Is the intervention feasible for mothers to participate? 2. Does the intervention improve maternal knowledge about ADHD and reduce stigma? 3. Does it help reduce maternal stress and enhance self-care practices? Participants include: Mothers: Ultra-Orthodox Jewish mothers with a child (ages 6-12) diagnosed with ADHD and no other major health conditions in the family (other than ADHD). Educators: School educators with at least 5 years of experience teaching children with ADHD in the Ultra-Orthodox community. What participation involves: Mothers will attend six weekly teletherapy group sessions, with 6-8 mothers per group. They will complete questionnaires before and after the intervention (approximately 30 minutes each) and participate in a 90-minute remote focus group to provide feedback on the program. Educators will attend a single teletherapy group session (90 minutes) during the program (session 5) and participate in a 90-minute remote interview to provide feedback on the program.

The goal of this clinical trial is to learn adjusting daily or nightly routines improves executive functioning in youth with ADHD. It will also learn about the acceptability of the intervention. The main questions it aims to answer are: 1. Does the intervention improve sleep for youth with ADHD? 2. Does the intervention improve areas of executive functioning for youth with ADHD? 3. Is this an acceptable intervention for youth with ADHD? Researchers will compare the two intervention conditions to see if their are impacts in executive functioning and sleep. Participants will: Complete cognitive testing, executive function tasks, questionnaires, and an interview at baseline and at one month Wear an actigraph watch for one month Bring a parent with them to three meetings Complete daily sleep diaries for one month