Active clinical trials for "Attention Deficit Disorder with Hyperactivity"

The goal of this clinical trial is to evaluate the efficacy and safety of NRCT-101SR compared to placebo in adult patients with ADHD aged 18 years and older.

This study aims to determine the feasibility, acceptability and potential efficacy of an individual, video-conferencing based Focused Acceptance and Commitment Therapy (FACT) on the mental well-being of parents of children with Special Health Care Needs(SHCN). The study also aims to explore the experience of parents after participating in the individual-based FACT sessions offered by the trained FACT interventionists.

This study is designed to explore the effect of Multitask game-based digital therapy versus Schulte Grid digital game on attentional functioning (measured by the TOVA), ADHD symptoms, executive functioning, and clinical impairment, in children diagnosed with ADHD. Investigators will also evaluate the safety of digital therapy for intervention treatment of childhood attention deficit hyperactivity disorder.

The investigators have developed BUILT in hopes of empowering families to adopt and sustain healthy food, sleep, and exercise routines that optimize child focus, attention, and behavior. Over 8-weeks, the BUILT program will explore what science says about the effects of sleep, nutrition, and exercise on brain development and behavior; investigate the food, sleep, and exercise routines of the world's best athletes and intellectuals; and experiment with home routines to find those that best fits with participating families. It is hypothesized that families participating in BUILT (N=150) will show significant improvements in child health behaviors (sleep, nutrition, physical activity, recreational screen time), child mental health (ADHD symptoms [primary outcome], child functional impairment), child physical literacy, and family dynamics (cohesion, structure, communication) from baseline to posttest.

The primary aim of the present research project is to examine the feasibility, as measured by treatment perceptions, and tolerability, as measured by adherence and attrition, of two weeks of flashed light therapy alone followed by four weeks of daily flashed light therapy combined with four weekly videoconference-delivered cognitive behavioral therapy sessions targeting circadian rhythms and sleep in four adolescents aged 14 to 17 years with attention-deficit/hyperactivity disorder-combined type and delayed sleep-wake schedules.

Limited psychological support for parents of children with special needs in Hong Kong can profoundly impact the child rehabilitation process and the well-being of parent-child dyads. Leveraging previous evidence from our team's research, we have developed Pai.ACT, the first deep learning-based mental health advisory system for parents. Pai.ACT incorporates the counselling logic of Acceptance and Commitment Therapy (ACT) through natural language processing, enabling parents to engage in human-like voice-to-text conversations and receive assessments and stepped-care mental health interventions, including guided self-help materials and real-time, individual-based counselling based on ACT. Following the research and development phases, we aim to kick off the utilisation of Pai.ACT by (1) pilot-testing its feasibility, acceptability, and potential efficacy in improving mental health outcomes for parents of children with special needs and (2) researching to determine the most optimal service model for parents by exploring their perceptions through focus group interviews. Pai.ACT offers accessible and comprehensive mental health services to all Chinese-speaking parents, addressing their psychological burden in caring for children with special needs. Pai.ACT could bring substantial and enduring societal benefits to Chinese-speaking families by integrating mental health support services for family caregivers with current child rehabilitation services and non-governmental organisations. Furthermore, this could contribute to reducing the public stigma attached to special needs children while increasing mental health awareness.

One purpose of this trial is to extend the safety and efficacy evidence basis for Azstarys in adults with ADHD. This open-label, treatment study will examine the efficacy of Azstarys on ADHD symptoms using the AISRS 18-item total score on the AISRS-expanded; the Adult ADHD Investigator Symptom Rating Scale. The investigators will also examine Executive Function later in the day (early evening, about 12 hours after first morning dosing).

This study aim to evaluate the effect of marine monounsaturated and polyunsaturated fatty acids on children aged from 6-16 years, with ADHD/ADD and related symptoms. The study is a randomized, double-blind placebo-control study including approximately 330 children from Norway. The primary outcome measure is ADHD core symptoms reported by caregivers, teachers and the child at 0 months (baseline), 6 months (end of treatment) and 12 months (6 months post treatment). The secondary outcome measures are reading and writing disabilities, cognitive functions, and physical Health.

Obstructive sleep apnea (OSA) and attention-deficit/hyperactivity disorder (ADHD) are two common, severe disorders in children. Unfortunately, pediatric OSA is closely associated with ADHD, and both diseases can cause cognitive impairment, behavior problems, and low academic performance. OSA can damage the brain and induce autonomic dysfunction, and then cause cognitive, behavioral, and quality-of-life problems. The presence of ADHD can further exacerbate these adverse effects of OSA. Therefore, the identification of robust biomarkers of OSA and ADHD is a key imperative to facilitate early identification of the pathological features and mechanisms and to optimize the treatment of OSA and ADHD for the pediatric population. Diffusion MRI of the brain is one of the most widely used technology for assessment of brain tissue integrity and heart rate variability is one of the most widely used measurements of autonomic function. However, the effects of ADHD and adenotonsillectomy on MRI and HRV biomarkers in children with OSA have not been reported. We hypothesize that comorbid ADHD can deteriorate brain damage and autonomic dysfunction, and adenotonsillectomy can reverse these alternations in children with OSA. The aims of this study are (1) to investigate the differences in pediatric brain tissue integrity, autonomic function, attention, behavior, quality-of-life, and sleep factors between the 'OSA with ADHD', 'OSA without ADHD', and 'healthy control' group; (2) to evaluate the efficacy of adenotonsillectomy versus watchful waiting with supportive care, with respect to the same variables of interest; (3) to evaluate whether the relative efficacy of the treatment differs according to baseline ADHD, weight, or OSA severity; and (4) to develop a predictive model for surgical success rate using both conventional well-known factors and MRI/HRV biomarkers. This is a 3-year prospective study that includes two parts. The Part I study is a cross-sectional study recruiting 100 children (5 to 9 years of age) to investigate the differences in brain tissue integrity (voxel-based morphometry and fractional anisotropy; assessed by structure MRI [T1] for volumetric alternations of gray and white matter, resting-state functional MRI for functional connectivity, and diffusion MRI for white matter integrity), autonomic function (time-domain and frequency-domain analyses; assessed by a wearable, real-time HRV measurement), severity pf attentive and behavioral problems (assessed by the Swanson, Nolan and Pelham IV-Teacher and Parent Rating Scale), quality-of-life (assessed by OSA-18), and sleep factors (apnea-hypopnea index, obstructive apnea index, arousal index, mean and least oxygen saturation, and sleep stage; assessed by polysomnography) between the OSA with ADHD group (Study Group 1; n = 40), the OSA without ADHD group (Study Group 2; n = 40), and the healthy control group (Control Group; n = 20). The Part II study is a randomized controlled trial includes a total of 64 children with OSA (32 children will be recruited from Study Group 1 and Study Group 2, respectively). We randomly assigned (1:1) these 64 pediatric patients with OSA to adenotonsillectomy or a strategy of watchful waiting with supportive care, matched by ADHD, obesity, and severe OSA. Variables of interest using the same methodology are assessed at baseline and at 7 months.

Mounting evidence suggests that closed-loop brain-training, commonly known as neurofeedback (NFB), may represent a new therapeutic opportunity for patients with Attentional Deficit/Hyperactivity Disorder (ADHD), which manifests as difficulties with attention and inhibitory control. In this context, the investigators have focused on an attention-enhancing form of NFB based on the EEG alpha rhythm, known to influence sensory detection and attention. In light of recent evidence showing that both attention and impulsivity can be modified with a single-session of alpha-NFB, the objective is to determine whether these effects stabilize in the long-term, after multiple, daily sessions of training at home. A short- (single-session) and a long-term (multi-session) experimental design will be used to collect EEG, behavioral, and clinical data pre-to-post NFB. The single-blind study will recruit 48 adult ADHD participants randomly assigned to either NEUROFEEDBACK or CONTROL groups. Each participant will undergo individual at home sessions of 45-minute video-replay of popular television (TV) series while recording their 1-channel EEG (30 sessions, 5 sessions/week, 6 weeks total). In the NEUROFEEDBACK group, self-regulation of alpha rhythm will be reflected in the dynamically varying opacity of the video-replay window, i.e. the window would turn lighter/darker and reveal/obscure video content during episodes of low/high alpha amplitude, respectively. In the CONTROL group, the recording will be passive without real-time EEG neurofeedback (i.e. constant brightness and volume). Before and after at home training, each participant will have two visits in the lab: (1) complete clinical and neuropsychological evaluation and (2) EEG session including resting state and task-related EEG before and after a short NFB intervention (30 minutes). For the CONTROL group participants, the latter will be replaced by a sham intervention utilizing non-contingent feedback. Given that stronger alpha rhythmicity is associated with increases in inhibitory/excitatory balance, it is expected that alpha-NFB (i) will homeostatically normalize alpha rhythm power and (ii) the degree of normalization will be a dimensional predictor of individual improvement in behavioral and clinical measures of executive function, impulsivity and inattention. These results should lay the foundation for building neurocognitive treatments, by harnessing neuroplasticity mechanisms intrinsic to the brain.