Effects of Structured Skills Training Group in Treatment of ADHD in Adults
Attention Deficit Hyperactivity Disorder (ADHD)This study aims to examine if structured skills training group therapy for ADHD in adults has beneficial effects superior to 'treatment as usual' including medication in a controlled outpatient setting on clinically relevant outcomes including symptoms, functioning and quality of life measures. The trial is designed as a multicenter randomized controlled, parallel group study. Patients are randomized into 1 of 2 treatment arms with 14-week duration: one arm with initial intervention by structured skills training groups by weekly sessions or one with control condition (treatment as usual). Then after 15 weeks patients in the control condition arm are switched to the active intervention by 14 weeks of structured group therapy. All patients are assessed for defined outcomes after six months.
Dasotraline SEP360-105 Pediatric PK/PD Study
Pediatric Attention Deficit Hyperactivity DisorderPediatric PK study of SEP-225289 (Dasotraline)
Cognitive Training in Children With Attention Deficit/ Hyperactivity Disorder (ADHD)
ADHDThe purpose of this study is to determine the effect of computer program C8 on specific cognitive functions, symptoms and functional outcome compared to treatment as usual in children with ADHD. Furthermore, if the effect is sustained 12 and 24 weeks after training. In addition, it will be investigated, whether younger children benefit more from training than older children.
Tocotrienols for School-going Children With ADHD
Attention Deficit Disorder With HyperactivityThe purpose of this study is to determine if tocotrienol supplementation given to school going children with ADHD will result in reduction of their ADHD symptoms.
PRC-063 in an ADULT Workplace Environment
Attention Deficit Hyperactivity Disorder (ADHD)The primary objective of this study is to assess the time of onset and time course of efficacy over 16 hours of PRC-063 compared to placebo in adults diagnosed with ADHD in a simulated adult workplace environment (AWE) setting, as measured by the PERMP (an individually-adjusted math test) at pre-dose, 1.0, 2.0, 5.0, 8.0, 11.0, 14.0 and 16.0 hours post-dose.
Efficacy of an Organizational Skills Intervention for Middle School Students With ADHD
Attention-Deficit/Hyperactivity Disorder (ADHD)Attention-Deficit/Hyperactivity Disorder (ADHD) is one of the most commonly diagnosed childhood disorders, with prevalence rates estimated at 8%. Several of the primary symptoms of ADHD relate to problems with temporal and materials organization (i.e. has difficulty organizing tasks and activities, loses things, is forgetful, and fails to finish school-work). In the school setting, problems with organization manifest as forgetting to complete or losing homework assignments, difficulties planning for the completion of long-term projects and studying for tests, and problems keeping class materials organized. These organizational difficulties become particularly problematic in middle school and are associated with low school grades and high parent and teacher ratings of academic impairment. In fact, organization of homework materials is one of the strongest predictors of academic performance in students with ADHD, above and beyond the impact of intelligence, school services, and ADHD medication use, and mediates the relationship between symptoms of ADHD and school grades. Given the relationship between temporal and materials organization and poor school performance, it is clear there is a need for interventions to address these difficulties. The PI sought to address this need by completing an IES Goal 2 study to develop a school-based intervention targeting organizational skills that was feasible for school mental health (SMH) providers to implement. The Homework, Organization and Planning Skills (HOPS) intervention was developed and refined based upon input from 20 school mental health (SMH) providers, students with ADHD and their families. SMH providers implemented the HOPS intervention, rated the intervention as highly user-friendly and feasible to implement, and demonstrated excellent fidelity to intervention procedures. Students who received the HOPS intervention made significant improvements in homework problems and organizational skills compared to a waitlist control. The feasibility and fidelity data demonstrate that the intervention has potential for widespread dissemination. Preliminary outcome data suggest that the intervention may significantly improve the academic performance of students with ADHD. However, the small sample size (N=23 HOPS & N=24 control) precludes firm conclusions about efficacy and moderators and mediators of intervention response. Accordingly, the primary goal of this Goal 3 study is to evaluate the efficacy of the HOPS intervention, which focuses teaching students' organization and time-management skills, as compared to an intervention targeting on-task behaviors during homework completion and efficiency of work completion, the Homework Support Intervention (HSI), and to assess moderators and mediators of intervention response. Middle school students with ADHD (N=260) will be randomly assigned to receive the HOPS intervention or the HSI intervention. Students in both groups will receive the same amount of intervention in terms of duration and frequency of intervention sessions. Six cohorts of students will be recruited for the project. Each cohort will consist of 22 students at each of two schools (44 per cohort) who will be randomly assigned to each of the two conditions. Objective measures of skills implementation, parent and teacher ratings of organization, homework problems, and academic impairment, and school grades will be examined pre and post intervention as well as at 8-week and 6-month follow-ups. Treatment fidelity and integrity will be closely monitored. Moderator and mediator analyses will be used to answer important questions about the types of students most likely to benefit from organizational skills intervention and the key mechanisms of change that lead to improved academic performance. This study has significant potential to improve the academic performance of students with ADHD because the intervention was designed with SMH provider input and has clear potential for widespread dissemination upon proof of efficacy.
Efficacy of GXR as Adjunctive Therapy With Psycho-stimulant on Executive Function in Children With...
Attention Deficit Hyperactivity DisorderThis study looks to examine whether or not INTUNIV extended release can help children aged 6-12 years diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD) in improving Executive Function when added to their usual care stimulant therapy. Executive functions are a set of mental processes that include emotional control, planning, organization, working memory, inhibition of behaviors, and managing time and space. As children with ADHD usually have difficulties with Executive Function, and Executive function difficulties lead to more difficulties in school and behaviour, it is anticipated that adding INTUNIV extended release to usual stimulant therapy will improve Executive Function scores as rated by parents and teachers. Improvements in quality of life will also be measured.
Trigeminal Nerve Stimulation for Attention Deficit Hyperactivity Disorder (ADHD)
Attention-Deficit/Hyperactivity DisorderThis proposal seeks to obtain preliminary data on the potential efficacy, tolerability, and feasibility of trigeminal nerve stimulation (TNS) as a treatment for Attention-Deficit/Hyperactivity Disorder (ADHD). If successful, this open-label, exploratory, pilot study will provide a basis for a federal grant application and larger controlled trials.
Guided Self-Help for Parents of Children With Attention-Deficit/Hyperactivity Disorder (ADHD)
Attention-Deficit/Hyperactivity DisorderCognitive-behavioral based guided self-help for parents of children with Attention-Deficit/Hyperactivity Disorder (ADHD) is investigated in a feasibility and effectiveness study. The treatment is offered under routine-care conditions of the health-care system in Germany. Practicability, treatment participation and effectiveness is documented and tested in a one-group pre-test/post-test design.
Open-label Extension Evaluating Methylphenidate Hydrochloride Extended Release in Adults With Attention...
Attention Deficit/Hyperactivity DisorderThis study will evaluate the long-term safety of methylphenidate hydrochloride extended release in adults with attention deficit/hyperactivity disorder