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NCT07654205
The primary goal of this clinical trial is to test if a smartphone-based intervention is feasible \& acceptable among young adults with ADHD who also engage in risky drinking behaviors. A secondary aim is to test preliminary intervention efficacy. The main questions it aims to answer are: Is the smartphone intervention feasible \& acceptable for participants (e.g., are they responding regularly, is there a low level of burden reported)? Does the smartphone intervention improve symptom awareness, inhibitory control, and problematic alcohol use? Participants will: Attend a virtual baseline visit to assess ADHD, alcohol use, and other life experiences. Complete either the TIPS smartphone intervention or a control smartphone protocol over the course of 31-days, starting the first Friday after the baseline visit. Attend a virtual follow-up visit, where many of the same questions from the baseline visit will be asked again.
NCT06878690
Specific learning disorders, or SLD, are cognitive and behavioral conditions that emerge during childhood and involve significant difficulties in acquiring and performing specific intellectual, motor, language, and social functions. These disorders impact personal, social, academic, and professional functioning throughout life. In France, between 6% and 8% of the population, including both children and adults, are affected by at least one type of SLD. SLD are also frequently associated with Attention Deficit Hyperactivity Disorder (ADHD), with prevalence rates ranging from 33% to 70%, depending on the study. This comorbidity leads to more severe attention and learning difficulties than when ADHD or SLD occur independently. ADHD is a common neurodevelopmental disorder that affects cognitive attentional processes, with or without hyperactivity. It is estimated to affect approximately 5.3% of children and adolescents worldwide and about 3% of adults. The assessment of these disorders is conducted through a neuropsychological evaluation, which determines the type and severity of cognitive impairments. Several studies report that 55% to 74% of children with ADHD experience sleep difficulties. To date, only two studies have examined the prevalence of sleep disorders among children with SLD disorders. One of these studies focused exclusively on dyslexia, with or without ADHD. The results revealed significantly higher scores among dyslexic children compared to controls when completing sleep disorder assessment questionnaires (SDSC). The main difficulties were related to "sleep onset and maintenance disorders," "sleep-related breathing disorders," and "wakefulness disorders." The second study, using the same questionnaire, compared children with ADHD, SLD disorders, and both combined. The group with co-existing SLD and ADHD disorders exhibited significantly more sleep disturbances than the other groups, primarily sleep onset and maintenance disorders. Despite the importance of these studies, they focused only on sleep disorders associated with dyslexia, without considering other learning disorders such as dyspraxia, dyscalculia, or dysgraphia. Furthermore, when ADHD was taken into account, the studies did not differentiate between its various forms, limiting the interpretation of the results. Additionally, no research has tracked the evolution of sleep disorders in the SLD +/- ADHD population from childhood through adolescence and into adulthood. In this study, the investigators aim to evaluate sleep disorders in the SLD population (with or without ADHD) in France through online questionnaires. These questionnaires will be offered to 1,000 children (aged ≥4 years) and adults diagnosed with at least one specific learning disorder. Primary Objective: The main objective of this study is to assess the frequency and nature of sleep disorders in patients (both adults and children) with specific learning disorders, with or without ADHD. Secondary Objectives: * Characterize the "SLD" patient population in France by considering age and gender: o Determine the prevalence of co-morbidities, such as: ADHD Anxiety and depressive disorders Other reported medical conditions * Assess the types of care provided (medication or other) for both children and adults * Determine the frequency of SLD in a familial context * Identify whether the following factors are associated with a higher frequency of sleep disorders: * Single SLD vs. multiple SLD * The presence of ADHD, anxiety-depressive disorders, or other medical conditions alongside SLD * Demographic characteristics (age, gender, etc.) * Family history of SLD among relatives (parents and siblings) * Medication use
NCT05386251
The purpose of this study is to test the effectiveness of a telehealth-delivered skills training versus active control group for middle and high school students with ADHD symptoms. Both programs will be delivered digitally (via Zoom). Investigators will measure student functioning at baseline, post-group, and three-month follow-up. The primary outcomes are ADHD symptoms, student grade point average, and attendance as reported in the gradebook. Secondary outcomes include parent academic support, autonomy, academic motivation, and organization skills. Participant satisfaction with the group will be measured post-group. Group attendance and homework completion will also be measured.
NCT05842330
Attention deficit hyperactivity disorder (ADHD) is characterized by difficulties paying attention, poor impulse control, and hyperactive behaviors. It is associated with several health and social detrimental outcomes and leads to increased risks of criminality and recidivism. However, to date, ADHD treatment has been neglected in prison. This project will test the efficacy of ADHD treatment using a randomized controlled trial.
NCT07478458
This study aims to evaluate a new driving simulator, called ADRIS 2.1, developed for adolescents aged 13-18 years with Attention Deficit Hyperactivity Disorder (ADHD). ADHD is a common neurodevelopmental disorder that can affect attention, self-control, and decision-making. These challenges may impact daily activities, including driving. The ADRIS simulator allows participants to "drive" in a virtual environment while their performance is monitored. The system measures driving errors (such as not stopping at red lights), head and body movements, and heart rate, helping researchers understand how ADHD may affect driving-related behavior. Participants in the study will include both adolescents with ADHD and typically developing adolescents. All participants will complete standardized cognitive and behavioral assessments and take part in at least one driving simulation session. Adolescents with ADHD will return for follow-up visits and a subgroup will participate in a 6-week training program using the simulator. The main goal of the study is to measure differences in driving performance and attention between adolescents with and without ADHD. The study will also explore whether the simulator can detect improvements over time and in response to clinical treatment or simulator-based training. The results may help inform future clinical evaluations and support tools for adolescents with ADHD, with the potential to improve safety and quality of life.
NCT05333887
Behavioural parent training (BPT) is a front-line treatment for children with attention-deficit/hyperactivity disorder (ADHD) that teaches parents how to support their child and manage behaviour. Parents of children with ADHD who have their own elevated ADHD/depressive symptoms may be less likely connect/engage and benefit from BPT. The current study modifies a BPT program that specifically addresses peer difficulties as these are common in children with ADHD. The goal of the modifications is to enhance the treatment process (how much parents connect and engage with the treatment) for parents with elevated ADHD/depressive symptoms. The Investigators will test whether this intervention increases parent engagement/connection to the program and whether it improves parenting behaviour.
NCT07465081
The goal of this interventional study is to determine whether reducing ultra-processed food consumption in children and adolescents can improve cognitive function. The main question it aims to answer is: Does reducing ultra-processed food consumption through online nutritional education improve cognitive function in children and adolescents with attention difficulties? Researchers will compare a nutritional education group to a non-intervention group to assess whether reducing ultra-processed food intake leads to cognitive improvement. Participants will: Attend a weekly online nutritional education course for 12 weeks Be encouraged to replace ultra-processed foods with whole foods
NCT07459699
The effect of probiotics on the gut-brain axis in children with attention deficit hyperactivity disorder will be studied.
NCT06810180
Attention deficit/hyperactivity disorder (ADHD) can present differently in individuals, with some individuals having difficulty with attentional control, hyperactivity, impulsivity, emotion dysregulation, and/or neurobehavioral functioning. The factors contributing to these different presentations remain unclear, but altered patterns of physical activity, sleep, and circadian rest/activity rhythms may play a key role. The goal of this study is to leverage wearable technology (i.e., a wristband) to investigate the relationships between physical activity during the day, sleep patterns and disturbances, and 24-hour circadian rest/activity rhythms with differences in ADHD symptoms, emotion dysregulation, and related brain and behavioral features of attention-deficit/hyperactivity disorder (ADHD). The investigators hope this study will help improve assessment and intervention for individuals with ADHD by understanding how these factors relate to ADHD symptom expression and associated brain differences in ADHD. Participants taking stimulant medication must withhold stimulant medication 24 hours before their research appointment and the morning of their research appointment. Stimulant medication may be restarted after the appointment is complete. Participation in this study will require children to complete an initial 2-hour research appointment, two (2) weeks of activity and sleep monitoring at home using a wearable wristband and answering questions sent to a smartphone, and a second 4-hour research appointment after the 2-week period. During the first research appointment, children will complete a cognitive assessment and a practice magnetic resonance imaging (MRI) scan. Parents/legal guardians will participate in the 30-45-minute sleep device training session with one of the research staff. During the two weeks of activity/sleep monitoring at home, parents and children will answer questions about their sleep routine, ADHD symptoms, and emotional responding each morning and evening. Parents will be asked to install a questionnaire application on their smartphone. A prompt will be sent to their smartphone multiple times per day reminding parents to complete the brief assessment. After the 2-week period, children will complete a 4-hour research appointment. During this research appointment, children will complete a 60-minute MRI scan and computer-based activities that assess cognitive skills, reward-based decision-making, and frustration tolerance. At the end of the research appointment, children will return the device to our research team. Parents may delete the questionnaire application from their phone at the end of the research appointment. Participation will also require parents/legal guardians to complete questionnaires about their child. Questionnaires will be provided to the primary caregiver by email or at the beginning of their child's first research appointment. Parents agree to complete and return the questionnaires within one month of their child's research appointment. Parents may be provided with additional questionnaires to give to their child's primary schoolteacher. This information is collected to better understand children's abilities, behavior, strengths, and weaknesses. There are minimal risks associated with this study. Risks include fatigue, boredom, and mild discomfort. There is no cost to participating in this study. There is no direct benefit to participants for participating in this study.
NCT06655610
The investigators will assess the use of the Monarch eTNS device as a non-pharmacological treatment for patients aged 7 to 17 years with ADHD. The investigators will compare the eTNS device to a sham device. Participants will use the device for four weeks during night time. During the trial, participants will receive different questionaires to assess symptoms and will also keep a logbook to record their experience with the device. At the end of trial, the investigators will assess what the families thought of the device, and whether it is indeed feasible to further explore the effect of the device in a larger clinical trial.
NCT07314333
This study will look at how centanafadine works when taken together with stimulant medicines in healthy adults, and whether combining them affects how the body responds.
NCT07041333
The aim of this study was to investigate the effect of treatment of ADHD with methylphenidate on neuroinflammation by examining the levels of Interleukin-6 (IL-6), S100B, Claudin-5 in serum samples of patients who were diagnosed with attention deficit hyperactivity disorder (ADHD) and started or planned to start methylphenidate for treatment as per routine, at month 0 before the initiation of methylphenidate treatment and at month 3 after the initiation of treatment.
NCT07426302
This study aims to evaluate the effectiveness of a virtual reality-based intervention using the Virtual Reality Rehabilitation System (VRRS) to improve executive functions in autistic and ADHD youth aged 8 to 18 years. Executive functions, such as working memory, cognitive flexibility, and inhibitory control, are frequently impaired in individuals with autism and/or ADHD and significantly affect daily functioning. Participants will be randomly assigned to either an experimental group that receives VRRS-assisted cognitive training or a control group that receives treatment as usual. The intervention includes gamified tasks within immersive virtual environments specifically designed to stimulate executive skills. The primary outcome is the change in executive function scores from baseline to post-intervention, assessed using validated neuropsychological instruments. The study adopts a randomized controlled design.
NCT06906328
MEthylphenidate in ADHD - Addiction(s) comorbidity: benefit of adding a cognitive remediation program to improve short- and medium-term therapeutic response
NCT07417878
This study aims to better understand the biological mechanisms involved in attention deficit hyperactivity disorder (ADHD) and to clarify why some children and adolescents respond well to methylphenidate (MPH)-the most commonly prescribed medication-while others do not. Although MPH is effective for many patients, a significant number experience limited benefits or problematic side effects such as appetite loss and sleep difficulties. Recent research suggests that inflammation and oxidative stress in the body may play an important role in ADHD. Some animal studies also indicate that MPH itself might trigger inflammatory processes, but this has never been examined directly in humans. The main goal of this research is to determine whether children with ADHD show differences in their nutritional, immune, and inflammatory profiles compared to children without ADHD, and whether these biological factors influence symptom severity, digestive problems, and response to treatment. The study also seeks to understand whether MPH has a measurable inflammatory effect in young patients and whether this could be linked to treatment tolerability. To answer these questions, the study combines several approaches. First, a case-control comparison will examine differences between children/adolescents with ADHD and age- and sex-matched controls. Second, a one-year follow-up of the ADHD group will evaluate changes over time and help identify biological predictors of treatment response and side effects. Finally, a cross-sectional analysis will investigate the role of polyphenols-natural antioxidant compounds found in food-in relation to inflammation, treatment outcomes, and gender differences. The primary focus is on comparing levels of the inflammatory marker IL-6 between children with ADHD and controls. Secondary objectives include assessing additional inflammatory and immune indicators, nutritional status, gastrointestinal symptoms, ADHD severity, irritability, and MPH tolerability. By identifying specific inflammatory and immune markers associated with ADHD and treatment response, this study hopes to improve understanding of the disorder and guide more personalized and effective treatment strategies for young patients. It will also provide the first human data on whether psychostimulant medications may have inflammatory effects.
NCT07217652
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.
NCT05832957
Background: Attention deficit hyperactivity disorder (ADHD) is associated with a high risk for driving accidents. Adolescents with ADHD are 1.2 to 4 times more prone to be involved in car accidents. Driving accidents are the leading cause of death among adolescents. Objective: Examining a multidimensional applied intervention based on serious gaming principles to improve the driving capabilities and skills of adolescents with ADHD Methodology: The study will include 90 adolescents (aged 15-18 years old) with ADHD diagnosis who did not yet start driving lessons. Participants will undergo a stratified randomized clinical trial, single-blinded. The stratified randomization process will include gender, age, and medication status. There exist three different intervention modalities: (1) A personalized cognitive-functional intervention- 'Drive-Fun' (group1) (2) educational intervention (group2); and (3) no intervention (group3). Meetings will entail 11 once-a-week sessions. Participants will be evaluated before intervention (baseline), after the intervention, and at a 6-month follow-up. Evaluations will include simulated driving skills, meta-cognitive abilities, eye tracking, and brain activity (EEG) measures. The evaluation and the intervention will be conducted by two certified occupational therapists. Participants and the therapist performing the evaluations will be blinded to group type and intervention. The potential scientific contribution of the proposed research: Given the great risks of injury to adolescents with ADHD and other road users, it is important to identify dangerous driving behaviors as well as develop methods that can lead to better driving skills and a safer driving experience. It is anticipated that evidence will be presented by the evaluation battery that the personalized intervention program developed will significantly improve potential driving skills on the simulator and hopefully also actual driving.
NCT04526600
This project will study how fidgeting relates to cognitive and emotional functioning in adults with attention-deficit/hyperactivity disorder (ADHD). It will determine, in a laboratory setting, whether movement and access to a "fidget device" providing sensory and motor stimulation can improve cognitive and emotional regulation (including on physiological measures) in adult ADHD. The investigators will also acquire pilot data for machine learning analyses to be used in future, large scale studies to identify gestures and touch characteristics associated with improved cognitive and emotional regulation to see if the data can predict and subsequently develop recommendations to improve performance and emotional control in natural settings (e.g., home, office, college classroom) for adult ADHD.
NCT05972044
FOCUS (Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol) is a Phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel- group trial to assess the efficacy and safety of solriamfetol in adults with ADHD.
NCT07189442
This pilot study will test whether combining L-theanine and paraxanthine improves sustained attention, inhibitory control, and overall cognition in adults with ADHD and ASD. Two parallel randomized, single-blinded, repeated-measures crossover trials will be conducted. Participants will complete neuropsychological testing, fMRI scanning, and self-report measures following administration of the L-theanine-paraxanthine combination compared to placebo.