Attention-Deficit/Hyperactivity Disorder (ADHD)

Long Beach, CA

77 Attention-Deficit/Hyperactivity Disorder (ADHD) Trials near Long Beach, CA

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No Placebo
Highly Paid
Stay on Current Meds
Pivotal Trials (Near Approval)
Breakthrough Medication

Centanafadine for ADHD

Long Beach, California
This trial aims to test the safety and tolerability of a daily ADHD medication in children and teens aged 4-17. The medication releases its effects slowly over the day to help manage symptoms consistently. HLD200 is a form of methylphenidate designed to provide benefits from morning until evening.
No Placebo Group
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:4 - 18

680 Participants Needed

SPN-812 ER for ADHD

Long Beach, California
Open label extension, long-term multicenter study of safety and efficacy of SPN-812 in pediatric ADHD patients
No Placebo Group
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:4 - 18

1400 Participants Needed

SPN-812 for ADHD

Long Beach, California
This study will evaluate the efficacy and safety of SPN-812 (viloxazine extended release) in children 4 to 5 years of age with ADHD.

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 4
Age:48 - 69

286 Participants Needed

TAK-503 for ADHD

Long Beach, California
The main aim of this study is learn more about long-term TAK-503 treatment in children and teenagers with ADHD for whom earlier stimulant treatment did not work. The study has two parts (A and B). In Part A, participants will take tablets of TAK-503, atomoxetine or placebo and in Part B TAK-503 tablets.

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Phase 4
Age:6 - 17

396 Participants Needed

NRCT-101SR for ADHD

Anaheim, California
To evaluate the efficacy and safety of NRCT-101SR compared to placebo in subjects 13-17 years of age with ADHD
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 2, 3
Age:13 - 17

160 Participants Needed

Evening Dosed Methylphenidate for ADHD

Anaheim, California
This study will evaluate the efficacy, safety and pharmacokinetics of HLD200 (20 mg and 40 mg) in children aged 4 to 5 years with ADHD.
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 3
Age:4 - 5

168 Participants Needed

Azstarys® for ADHD

Anaheim, California
The is a multicenter, dose-optimized, open-label, safety/ tolerability and pharmacokinetic (PK) study with Azstarys® in children 4 and 5 years of age with attention-deficit/hyperactivity disorder (ADHD). The primary objective is to determine the safety and tolerability of treating children 4 and 5 years-of-age with ADHD with Azstarys® for up 12 months. Approximately 100 subjects will be enrolled. Approximately 20 sites will participate.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Phase 4
Age:4 - 5

123 Participants Needed

Trigeminal Nerve Stimulation for ADHD

Los Angeles, California
This is an open-label trial of trigeminal nerve stimulation (TNS) for children aged 8-12 years with attention deficit hyperactivity disorder (ADHD) putatively due to prenatal alcohol exposure (PAE). TNS has been successful in treating pediatric ADHD generally and it is US Food and Drug Administration (FDA)-cleared for this condition. But this will be the first time it is tried for ADHD specifically associated with PAE. In TNS, a weak electric current is applied to the child's forehead overnight while sleeping to gently stimulate the brain. TNS is administered at home by the parent to the child. TNS is safe and well tolerated. Efficacy of TNS in ADHD is \~50%. The purpose of the present pilot study is to determine the feasibility of TNS for children with PAE and ADHD. Feasibility means safety (any serious side effects?), tolerability (do children comply with TNS? are they comfortable with it?), and a rough idea of efficacy (does TNS seem to work in most kids?) A secondary goal of the study is to get a more precise idea of brain mechanisms of TNS with magnetic resonance imaging (MRI). Families who participate will make three clinic visits: eligibility (4-5 hours), pre-TNS (2-3 hours including MRI), and post-TNS (2-3 hours including MRI). Children will receive TNS, applied by the parent, for 8 hours every night while sleeping for 4 weeks. Four weeks after treatment, families will take part in a telephone follow-up, to see whether any improvements made last.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:8 - 12

30 Participants Needed

Digital Health Intervention for ADHD

Irvine, California
To conduct an RCT to evaluate the efficacy of the system, we will recruit 60 children (ages 8-12) with ADHD who will be randomized to either immediate (n=30) or delayed (n=30) treatment (i.e., a wait-list control group). Among those randomized to immediate treatment, half will be assigned to DHI (delivered via a smartwatch and smartphone application) and half will be assigned to an active control treatment as usual (TAU) group who will receive the smartwatch with no assigned activities, applications, or interventions on the devices. The intervention period will last 16 weeks; after a participant has been in the delayed treatment group for 16 weeks and has completed the post-waiting period assessment, he or she will be assigned to either the intervention or active control group. Thus, 30 participants will complete the intervention and 30 will complete the active control, with half of the total sample also completing a wait-list period.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:8 - 12

60 Participants Needed

Cultural Pride Reinforcement for Childhood Behavior

Los Angeles, California
African American children disproportionately experience racism, which is associated with behavioral health problems and school failure. Behavioral health problems impede learning and are more likely to be chronic, severe, disabling, and untreated in African Americans compared to Whites. Clinic-based interventions that boost cultural pride may improve outcomes related to behavioral health in young African American children. However, little is known about cultural pride interventions in this population. It is important to understand these processes in young children because early childhood is a period during which racial bias may develop and stymie behavioral health and learning, and cultural pride may support it. This project will recruit patients from primary care clinics in Los Angeles. The project will test a cultural pride intervention (Cultural Pride Reinforcement for Early School Readiness (CPR4ESR)) in young African American children. CPR4ESR provides culturally themed children's books and advice at health supervision visits of children enrolled at ages 2-4 years. It is based on a well-established national program called Reach Out and Read (ROR). ROR provides children's books and book-sharing advice at health supervision visits with reports of increased book-sharing behaviors and literacy. The specific aims of the proposed project are to: 1) assess the feasibility and acceptability of CPR4ESR implementation among parents and providers, 2) evaluate the capacity of CPR4ESR to improve cultural pride reinforcement and book-sharing behaviors in caregivers of young African American children, and 3) evaluate the capacity of CPR4ESR to improve behavioral health and literacy in young African American children. The interviews conducted in Aim 1 will guide refinement of the intervention tested in Aims 2 and 3. The mechanism by which CPR4ESR impacts behavioral health and literacy will be evaluated by statistical modeling. We hypothesize that: 1) caregivers who receive CPR4ESR will exhibit more CPR and book-sharing behaviors than those who do not, 2) children who receive CPR4ESR will exhibit better behavioral health and literacy than those who do not, and 3) increases in caregiver CPR and book-sharing behaviors will be associated with enhanced child behavior and literacy. This project will inform the development of interventions that address the negative health impact of racism on young African American children.
No Placebo Group

Trial Details

Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:2+

134 Participants Needed

Focused Ultrasound for ADHD

Santa Monica, California
This trial is testing if using sound waves to stimulate the brain can help people with ADHD by improving areas that control attention and behavior. Recent research has shown that acoustic white noise can improve task performance in people with attention deficits and/or ADHD.
No Placebo Group

Trial Details

Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Age:18 - 60

100 Participants Needed

Stimulant Medications for ADHD in Autism Spectrum Disorder

Los Angeles, California
This study is a pragmatic clinical trial examining the comparative effectiveness of two stimulant medications (methylphenidate and amphetamine) in the treatment of ADHD in children and adolescents with autism. Using a sequential, multiple assignment randomization trial (SMART) design the study will not only assess these two medications but also the role of an increasingly popular class of ADHD medication, the alpha-2 agonists. Findings from this study will help improve clinicians' approach to medication selection and reduce the repeated trials of multiple medications that are current standard care.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 4
Age:4 - 17

500 Participants Needed

Light + Online Therapy for ADHD

Los Angeles, California
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 and delayed sleep-wake schedules.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:14 - 17

6 Participants Needed

eTNS for ADHD

Los Angeles, California
This trial tests a treatment called TNS, which sends a small electrical signal to the forehead during sleep, in children aged 7-12 with ADHD. The signal helps activate brain areas that improve attention and impulse control.

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:7 - 12

280 Participants Needed

PBT-EF for Obesity and ADHD

San Diego, California
This trial is testing a new program that helps parents teach their overweight or obese children with ADHD how to manage their weight and improve their behavior. The program includes special training to help kids focus better and control their impulses. The goal is to make it easier for these children to stick to healthy habits. Parents focused CBT can be considered as a complementary treatment for reducing ADHD symptoms and BMI and increased self-esteem in the obese ADHD children.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:8 - 12

30 Participants Needed

Enhanced Collaborative Life Skills Program for ADHD

San Diego, California
The proposed project aims to integrate team-based implementation strategies with an established school-based intervention for children with ADHD, the Collaborative Life Skills Program (CLS), to enhance its implementation and optimize its effectiveness. The investigators will tailor three empirically-supported team development interventions, Team Charters, Team Communication Training (Student Handoff Protocols), and Team Performance Monitoring, and integrate them into a team-enhanced CLS implementation protocol (CLS-T). Team Charters are a written document developed collaboratively by the team at the outset of their work together outlining expectations, goals, roles and responsibilities, and relevant policies and procedures for team collaborative operations. Research shows that Team Charters strengthen affective emergent states, such as trust and cohesion among team members, as well as cognitive emergent states, such as shared mental models. They also strengthen team processes, such as goal specification, communication, and coordination to optimize team effectiveness. Handoff protocols are widely used interventions for ensuring continuity in patient care and minimizing errors in medical settings. They have also been found to improve affective (e.g., trust, cohesion) and cognitive (e.g., shared mental models, situation awareness) emergent states among team members, enhancing team communication and coordination. Finally, Team Performance Monitoring provides feedback to teams that can motivate performance, provide opportunities for adaptation in the event of challenges, and prompt communication among team members. The investigators will conduct a Hybrid Type III cluster randomized trial in 24 schools in two large urban school districts, to evaluate whether CLS-T implementation results in improved implementation outcomes and child outcomes in comparison to standard CLS implementation.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:7 - 11

144 Participants Needed

Active tDCS + Cognitive Training for Mild TBI in Active Duty Service Members

San Diego, California
The proposed study will evaluate a new approach to cognitive rehabilitation of mild traumatic brain injury (mTBI) using a brain stimulation technique called transcranial direct current stimulation (tDCS). Specifically, we will investigate how tDCS combined with cognitive training improves deficits to attention and working memory in Active Duty Service Members with a history of mild traumatic brain injury (TBI). Measures of attention-related brain activity, neurocognitive assessments, and self-reported clinical outcomes will be used to determine effects of tDCS vs. sham tDCS when paired with a cognitive training intervention. By doing this study, we hope to find a reliable, noninvasive, and efficient method of treating mild TBI cognitive symptoms.

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 55

60 Participants Needed

Brain Stimulation + Cognitive Training for Mild Traumatic Brain Injury

San Diego, California
The proposed study will evaluate a new approach to cognitive rehabilitation of mTBI using a brain stimulation technique called "Remotely Supervised Transcranial Direct Current Stimulation combined with Cognitive Training" (RS-tDCS+) which has shown promise for improving complex attention in both healthy and clinical populations. RS-tDCS+ is a home-based, low-risk, non-invasive technique that is designed to boost cognitive training by enhancing learning and the brain's ability to reorganize connections. This study will evaluate RS-tDCS+ for improving complex attention in Active Duty Service Members (ADSM) and Veterans with a history of mTBI. Different tests of complex attention and symptom questionnaires will be used to determine the effects of real versus sham (placebo) RS-tDCS+. Second, the investigators will investigate electrical and connectivity changes in the brain associated with RS-tDCS+ using electroencephalogram (EEG) and magnetic resonance imaging (MRI). Third, the investigators will investigate the lasting effects of any observed changes by evaluating participants at 1 and 6 weeks post-treatment. Lastly, the investigators will explore the impact of individual differences (e.g., PTSD, depression, sleep quality, time since injury, baseline impairment, age, sex, ADSM versus Veteran) on treatment outcome.

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 60

160 Participants Needed

Collaborative Life Skills for ADHD

San Diego, California
This project aims to develop an adaptation of the Collaborative Life Skills Program (CLS) that will be supported by mHealth technology. CLS is an evidence-based intervention for 2nd-5th grade children with ADHD that is delivered in schools through coordinated efforts among school mental health providers, teachers, and parents. School mental health providers are trained to coordinate evidence-based teacher- (i.e., Daily Behavioral Report Card) and parent-mediated (i.e., Behavioral Parent Training) behavioral interventions, and lead child social and organizational skills training groups. The adapted intervention, which integrates mHealth technology (CLS-M), will improve the usability, feasibility, and acceptability of CLS in schools with limited resources serving children from low-socioeconomic status (SES) and ethnic/racial minority (ERM) backgrounds, reducing disparities in access to evidence-based ADHD interventions in these populations. Barriers to service use in schools where low-SES and ERM families are most likely to receive services include logistical constraints (e.g., time, transportation, childcare, work schedules), perceptual barriers (e.g., cultural mistrust, stigma, perceived efficacy), and insufficient resources (e.g., staff, time, consultation support). Building on prior research, the investigators will develop and test a fully functional web-based mHealth application to support CLS-M that includes an integrated user portal for school mental health providers, teachers, and parents. The application will also include separate interfaces that support key features to facilitate each person's role in CLS implementation at school or at home, such as access to shared information about child assessments, goals, and automatically generated graphs of child Daily Behavioral Report Card performance. Messaging features will facilitate communication among school mental health providers, parents, and teachers, and calendar features that integrate with third- party calendar applications (e.g., Google Calendar) will facilitate scheduling, meeting tracking, and sharing links to third-party videoconferencing applications (e.g., Zoom). Based on stakeholder feedback from school administrators, school mental health providers, teachers, and parents, the investigators will work with mobile application developers to design a fully functional web-based mHealth application prototype to support the CLS-M protocol. the investigators will then test and refine the prototype through a series of individual usability tests and an open feasibility trial. the investigators will also collect formative data from stakeholders in rural schools in Imperial County to inform future research on adapting CLS-M for low-SES and ERM families served in this setting. Finally, the investigators will conduct a Hybrid Type I cluster randomized trial in 24 schools in a large urban school district, to evaluate whether CLS-M results in acceptable implementation outcomes and improved child outcomes in comparison to usual school services. The specific aims are to 1) Develop CLS-M and test its usability, feasibility, and acceptability among key stakeholders; 2) Collect formative data to inform future CLS-M adaptations for families living in rural settings; and 3) Evaluate CLS-M implementation and impact on child outcomes relative to typical school services.
No Placebo Group

Trial Details

Trial Status:Enrolling By Invitation
Trial Phase:Early Phase 1
Age:7+

350 Participants Needed

Collaborative Life Skills Tool for ADHD

San Diego, California
The purpose of this study is to integrate digital health (dHealth) technology into the Collaborative Life Skills Program (CLS), an established, school-based behavioral intervention for students with ADHD, to make the program accessible to schools that serve students from low-socioeconomic (SES) backgrounds. Existing evidence-based interventions for students with ADHD are often inaccessible in schools with limited resources to support implementation. By adapting CLS to include a dHealth tool-CLS-D-investigators aim to improve the feasibility of intervention implementation in schools with limited resources and mitigate disparities in access to evidence-based interventions among students with ADHD who are from low-SES backgrounds.
No Placebo Group

Trial Details

Trial Status:Enrolling By Invitation
Trial Phase:Phase 2
Age:7+

216 Participants Needed

Why Other Patients Applied

"ADHD has been a trait that I consider as a blessing, as it can make me more creative, but I struggle with focusing and forgetting things... it affects my work. Looking for a new medicine to try will hopefully help me to get better along with my day-to-day activities and job."

QM
ADHD PatientAge: 27

"I am currently taking Mydayis. I've used vyvanse, adderall, strattera, concerta. I have struggled with this disorder my whole life. At 43, I am attempting to go to law school. I would like to have a different experience than I had in undergrad. I suffer from poor executive dysfunction. Impulsively, and lack of focus. ADHD has impacted every part of my life. "

LX
ADHD PatientAge: 44

"I've been struggling with ADHD and anxiety since I was 9 years old. I'm currently 30. I really don't like how numb the medications make me feel. And especially now, that I've lost my grandma and my aunt 8 days apart, my anxiety has been even worse. So I'm trying to find something new."

FF
ADHD PatientAge: 31

"I have been living with untreated ADHD my entire life life. It’s getting to the point where most days can be quite debilitating and I experience adhd paralysis on a regular basis. My PCP won’t even listen to my concerns and I don’t know where to turn to get help. Hoping to get better care this way."

VN
ADHD PatientAge: 49

"Executive function difficulties impact my daily life, and I have not found relief through traditional approaches. I dislike how standard stimulants make me feel. I'm very interested in trying the latest research treatments."

FF
ADHD PatientAge: 35

NRCT-101SR + NRCT-202XR for ADHD

Las Vegas, Nevada
A combination therapy of NRCT-101 with NRCT-202 is being developed for patients with ADHD.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 2
Age:13 - 17

60 Participants Needed

Digital Exposure Treatment for Youth with Chronic Pain

Menlo Park, California
This project proposes to systematically develop and evaluate the feasibility and preliminary effectiveness of a digitally delivered, graded exposure treatment for youth with chronic musculoskeletal pain, utilizing a sequential replicated and randomized single-case experimental design (SCED). SCED provides the opportunity to rigorously evaluate treatment effectiveness at the individual level. Development of iGET Living will be based on a series of short iterations, with alpha testing (Aim 1) on a small sample of adolescents with chronic pain (N = 15). For Aim 1, participants will participate in three, two hour focus groups (one per week over the course of three weeks), resulting in 6 total hours of participation per participant for Aim 1. Aim 2 will involve a sample (N = 20 youth) of naïve end-users. Participants will be enrolled in a baseline period ranging from 7-25 days (done to support SCED methodology) after which they will be enrolled in the online intervention program, lasting 6-weeks. Patients will be contacted 3-months post-discharge from treatment (week 22 of enrollment) and will complete self-report outcome measures at this time.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:10 - 18

35 Participants Needed

Trigeminal Nerve Stimulation for ADHD in Children with Autism

San Francisco, California
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)

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:7 - 14

60 Participants Needed

Affective Control Training for Emotional Instability

Berkeley, California
The goal of this clinical trial is to test a new cognitive training program to improve emotion regulation in adults. The investigators' primary aim is to determine whether participating in this program addresses two key features of emotion dysregulation associated with psychiatric disorders: (1) emotion-related impulsivity and (2) rumination. The investigators will further evaluate participants' perceived acceptability and feasibility of treatment procedures. Secondarily, the investigators will examine the effects of this cognitive training intervention on psychiatric symptoms and overall functioning. The researchers will compare the cognitive training program to a waitlist control. Participants will be asked to complete eight weekly sessions (over two months) involving cognitive training exercises with a "coach", in addition to a baseline assessment before starting the intervention and post-treatment assessment. Each assessment includes a combination of in-person and remote data collection using self-report questionnaires, psychophysiology, and a neuropsychological battery. Participants will also complete one week of ecological momentary assessment before and after the intervention as well as a set of follow-up questionnaires administered remotely six weeks following their final training session. Researchers will compare participants randomly assigned to complete the intervention without delay to a control group of participants randomly assigned to a two-month waitlist before joining the intervention. Before beginning cognitive training, participants in the control condition will complete an additional pre-intervention/post-waitlist assessment, which will follow parallel procedures to the initial baseline assessment.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 65

100 Participants Needed

School Clinician Training Program for ADHD

San Francisco, California
Neurodevelopmental disorders of Attention-Deficit/ Hyperactivity Disorder (ADHD) and Oppositional Defiant Disorder (ODD) are extremely common but underserved with Evidence- Based Treatments (EBT) worldwide. Thus, a school clinician training and ADHD/ODD intervention (i.e., the Collaborative Life Skills \[CLS\] program) was developed, implemented and evaluated for Mexico: a setting with high unmet need. Technology was integrated into the in-person program (CLS-FUERTE) to create a digitally enhanced version (CLS-R-FUERTE). Given findings demonstrating feasibility, acceptability, and efficacy of both program versions, a Type 2 Hybrid Effectiveness-Implementation Design will be applied to evaluate the program effectiveness, mechanisms of intervention change, and maintenance barriers/facilitators in a scaled-up cluster randomized controlled trial across two Mexican states -while simultaneously exploring an implementation strategy in which the program is adapted to enhance maintenance given each school's needs/resources (i.e., CLS-A-FUERTE). The implementation process is guided by the Exploration, Preparation, Implementation, and Sustainment (EPIS) model with evaluation following the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) Framework.
No Placebo Group

Trial Details

Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Age:5+

872 Participants Needed

Fidget Ball for ADHD

Sacramento, California
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.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 30

109 Participants Needed

Virtual Reality Therapy for ADHD

Sacramento, California
This trial uses virtual reality (VR) therapy to help children with ADHD improve their focus by getting used to distractions. The VR sessions simulate a classroom with various distractions, allowing children to practice ignoring them. The goal is to help these children perform better in real-life situations by reducing their susceptibility to distractions.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:8 - 12

50 Participants Needed

Quillivant XR for ADHD in Down Syndrome

Sacramento, California
Children with Down syndrome (DS) have a 3-5 time greater prevalence of Attention Deficit Hyperactivity Disorder (ADHD) than typically developing (TD) children. Despite this higher risk of ADHD, rates of stimulant medication treatment are disproportionately low in children with DS+ADHD, even though stimulants are the most efficacious ADHD treatment and are recommended by consensus guidelines for use in children with intellectual disability and ADHD. The investigators propose the first randomized clinical trial (RCT) of stimulant medication in children with DS+ADHD. This RCT may provide evidence regarding the short- and long-term safety and efficacy of stimulant use in children with DS+ADHD, both with and without CHD. All children enrolled in the study will complete a comprehensive assessment battery evaluating ADHD diagnostic criteria, as well as behavioral, cognitive, academic, and functional impairments.

Trial Details

Trial Status:Recruiting
Age:6 - 17

100 Participants Needed

Methylphenidate for Intellectual Disability and ADHD

Sacramento, California
This study is a randomized, double-blind, placebo-controlled, crossover trial of extended-release liquid methylphenidate (XRMPH) to evaluate the sensitivity of the NIH Toolbox Cognition Battery (NIHTB-CB) to changes in cognition in children and adolescents ages 6 to 17 with intellectual disability (D) and comorbid Attention Deficit Hyperactivity Disorder (ADHD). The sample will include 68 males or females (expected male: female ratio of 1.8:1 with ID and ADHD as determined by structured diagnostic interview and Conners 3 scores. Additional inclusion criteria will include Full Scale IQ above 50 and mental age greater than or equal to 3 years. In addition, participants must be able to complete NIHTB-CB testing and provide valid scores at baseline. After baseline testing, participants will then be randomized to drug or placebo in a 1:1 ratio (N=34 per group) at the end of the baseline visit. XRMPH in oral suspension supplied as Quillivant XR in 5 mg/ml (Tris Pharma, Monmouth Junction, NJ) will be the active treatment. The XRMPH or matching placebo will be started at a dose of 0.3 mg/kg/day and individually titrated over two weeks. Phone calls at the end of weeks 1, 2, and 3 will be used to collect adverse event and response data. If there is no evidence of side effects and ongoing symptoms of ADHD, the dose will be increased to 0.5 mg/kg/day at one week and 0.7 mg/kg/day at 2 weeks (maximum dose of 60 mg per day consistent with FDA labeled use in youth). The Clinical Global Impression (CGI) will be used as a guide to define optimal dose. If side effects occur the dose will be reduced to the dose level at which there were no side effects. Final optimal dose will be established by the end of week 3 and this will be maintained for 2 weeks until 5 weeks post randomization, at which time the follow-up parent and teacher Conners scales, NIHTB-CB, Go/No-Go, and PedsQL will be completed. Participants will have a washout period of 1 week, will then complete re-assessment at the second baseline, and then will cross over to the other treatment (Quillivant to placebo; placebo to Quillivant), also in a double-blind fashion. In the second treatment arm, patients will have the same titration, monitoring and treatment periods as in the first arm, again followed by repeated assessments at the conclusion of 5 weeks. The accrual of participants and number of visits is shown in the Timeline per 6-month period.

Trial Details

Trial Status:Enrolling By Invitation
Trial Phase:Phase 1
Age:6 - 24

68 Participants Needed

Daily Routines for ADHD

Tucson, Arizona
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

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:11 - 17

25 Participants Needed

123

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