Attention-Deficit/Hyperactivity Disorder (ADHD)

Miami, FL

72 Attention-Deficit/Hyperactivity Disorder (ADHD) Trials near Miami, FL

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No Placebo
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Pivotal Trials (Near Approval)
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NRCT-101SR for ADHD

Miami, Florida
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

Centanafadine for ADHD

Miami, Florida
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 for ADHD

Miami, Florida
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

Miami, Florida
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

PCIT + Natural Helpers for Childhood Behavior Issues

Miami, Florida
The purpose of the study is to evaluate the effect of a time-limited (i.e., 18 weeks) community health worker (CHW) intervention, referred to as the Parent Child Interaction Therapy (PCIT) plus natural helper (NH) model, on treatment engagement, retention, and child and caregiver outcomes.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:2 - 12

300 Participants Needed

Preksha Meditation for Cognitive & Respiratory Health

Miami Beach, Florida
The goal of this project is to assess impact of an 8 week course of Preksha Meditation (combination of Green color and buzzing sound meditation), in a group of college students to assess potential benefits to their pulmonary function, cognitive ability (immediate recall, attention), and happiness.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:18 - 24

142 Participants Needed

Stress Management Strategies for Parent-Child Relationships

Miami, Florida
The goal of this randomized study is to learn if adding three additional parent training sessions (focused on alleviating parental stress) to an already well-established treatment (School Readiness Parenting Program \[SRPP\]) in improving outcomes up to 6- and 12-months later for families of children with disruptive behavior disorders. The main questions it aims to answer are: The primary objective of this protocol is to evaluate the effects of three additional cognitive behavioral therapy (CBT) based parent training sessions to the SRPP to reduce parent stress and improve parent-child interactions. The secondary objective of this protocol is to evaluate the behavioral, emotional, and physical health-based functioning among young children with ADHD. Researchers will compare families who receive the SRPP alone to families who receive the SRPP + the three additional CBT focused sessions. Parents will be sent surveys to complete prior to the baseline assessment via REDCap (online). Parent and child participants will undergo 2 hours of baseline assessments evaluating behavioral, cognitive, and academic functioning as well as parent-child interactions. Parents will provide contact information for their child's teacher and the teacher will sent three surveys to complete online via REDCap.
No Placebo Group

Trial Details

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

120 Participants Needed

Evening Dosed Methylphenidate for ADHD

Miami Springs, Florida
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

SPN-812 ER for ADHD

Hialeah, Florida
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

ADHD Interventions + Stimulant for ADHD

Miami, Florida
This trial tests different ways to help children with ADHD behave better in school. It starts with general classroom techniques, adds more focused help if needed, and uses advanced methods or medication if necessary. The study targets young children with ADHD who are not in special education or on medication. Medication has been extensively studied and shown to improve ADHD symptoms in children.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 4

300 Participants Needed

Azstarys® for ADHD

Miami Springs, Florida
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

ADHD Classroom Interventions for Attention Deficit Hyperactivity Disorder

Miami, Florida
This trial looks at how school adjustments, behavior techniques, and medicine help kids with ADHD do better in school. It focuses on children who have trouble paying attention and performing well academically. The treatments work by making school easier, encouraging good behavior, and helping kids focus better.

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Phase 4
Age:5 - 12

288 Participants Needed

Behavioral & Language Interventions for ADHD

Miami, Florida
The goal of this clinical trial is to compare the effect of language and behavioral interventions for students who are English language learners and who have symptoms of attention-deficit/hyperactivity disorder (ADHD). The main question it aims to answer is: \- Which intervention is better for the students: the behavioral intervention, the language intervention, or a combination of the behavioral and language interventions? Participants will be asked to do the following: * Participants' parents and teachers will be asked to complete questionnaires about their behavior. * Participants will be asked to complete tests assessing language, cognitive, and academic abilities. * Members of the research team will complete classroom observations for the participating students. * Participants will be randomly assigned to one of four groups: a school as usual group, a language group, a daily report card group, and a combined daily report card and language group. * If assigned to the language group, participants will receive an 18-week language intervention. * If assigned to the daily report card group, a behavioral consultant will work with participants' parents and teachers to set up a home-school behavior plan called a daily report card. * If assigned to the combined daily report card and language group, participants will receive both the language intervention and the daily report card. * If assigned to the school as usual group, participants will no study interventions. Researchers will compare the language group, the daily report card group, the combined language and daily report card group, and the school as usual group to see which group has the best language learning and classroom behavior at the end of the program.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased

300 Participants Needed

Gameplay Therapy for Attention Deficit Hyperactivity Disorder (ADHD)

Lakeland, Florida
This trial is testing a video game that adults with ADHD can play at home to help manage their symptoms. The game aims to improve attention and reduce hyperactivity by training the brain. Researchers are studying if this new approach is safe and effective. The Secret Trail of Moon (TSTM) is a virtual reality game designed for cognitive training related to core ADHD symptoms and executive dysfunction.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:22 - 55

194 Participants Needed

NRCT-101SR + NRCT-202XR for ADHD

Maitland, Florida
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

Methylphenidate for ADHD

Gainesville, Florida
This trial is investigating how genetic differences in an enzyme called CES1 affect the way ADHD patients respond to the medication methylphenidate. The goal is to understand why some patients do not respond well or experience severe side effects. Methylphenidate (MPH) is a well-established treatment for ADHD, but not all patients respond to it, and some experience adverse reactions.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 4
Age:6 - 17

500 Participants Needed

Interaction Training for Childhood Behavior

Gainesville, Florida
The goal of this behavioral, interventional clinical trial is to provide a specialized workshop training for dental providers (e.g., dentists, hygienists, assistants) to improve interactions with young children (2-10 years old) and parents/caregivers. The training is derived from a well-established behavior management program for preschoolers, Parent-Child Interaction Therapy (PCIT). The main questions it aims to answer are: * Change in behavior of dental providers * Acceptability of training by dental providers All participants will receive the same behavior training; however, one group will receive the training on a delayed schedule. Researchers will compare the immediate intervention and control group to see if the training was effective in the dental providers usage of skills.
No Placebo Group

Trial Details

Trial Status:Not Yet Recruiting
Trial Phase:Unphased

264 Participants Needed

Methylphenidate for Alcoholism

Gainesville, Florida
The purpose of this study is to determine whether changes in attention levels related to taking a single dose of a medication called methylphenidate, also known as Ritalin, affects responses to alcohol cues. The study will observe the effects of methylphenidate or a placebo on attentional bias and craving responses to alcohol cues through fMRI, EEG, and behavioral testing. Participants will be involved in one remote and two in-person sessions.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Early Phase 1
Age:18 - 25

30 Participants Needed

CET + BPT for ADHD

Tallahassee, Florida
This trial combines a computer program to help kids with ADHD improve their memory and focus with a training program for parents to better manage their child's behavior. The goal is to see if using both treatments together can provide greater benefits for children with ADHD and their families.
No Placebo Group

Trial Details

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

200 Participants Needed

ADHD Monitoring Program for ADHD

Charleston, South Carolina
RAMP is a pilot study examining the use of an Attention-Deficit/Hyperactivity Disorder (ADHD) Monitoring Program during the early stages of treating ADHD in children living in rural settings. This trial will enroll 36 caregiver/infant dyads across 2 sites and will evaluate feasibility endpoints rather than clinical outcomes. Enrolled participants will be randomized 1:1 to the intervention group (RAMP reports) or control group (digital education handouts). The study duration is 10 months, including start-up, enrollment and intervention, and data analysis and manuscript submission.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:5 - 11

36 Participants Needed

Why Other Patients Applied

"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

"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 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

"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

"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

Therapy Dogs for Childhood Dental Anxiety

Charleston, South Carolina
The goal of this clinical trial is to assess whether the presence of a certified therapy dog during dental procedures that require an injection reduces anxiety and improves behavior in pediatric dental patients. The main questions it aims to answer are: * Does the presence of a certified therapy dog during dental procedure requiring an injection reduce anxiety and improve behavior in pediatric dental patients? * How do the parents of pediatric dental patients who participate in the study view the use of a certified therapy dog in their child's treatment? * Does the presence of a certified therapy dog result in different concentrations of microbes in the treatment room? All participants will receive standard of care. Researchers will compare the group with a therapy dog present to a group who does not have a therapy dog present to see if heart rate, oxygen saturation, percentage of nitrous oxide administered, and Frankl scores differ between the groups.
No Placebo Group

Trial Details

Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Age:3 - 7

70 Participants Needed

Atomoxetine for PTSD

Charleston, South Carolina
Attention deficits (AD) frequently co-occur with posttraumatic stress disorder (PTSD). The presence of AD is associated with greater PTSD clinical severity and poorer clinical outcomes. Knowledge regarding the mechanism underlying this association is limited, though the emerging evidence has indicated that executive function deficit (EFD) is strongly correlated with AD and PTSD symptoms. While treatments developed for PTSD have existed for years, a substantial portion of individuals do not fully respond to conventional treatment. Accumulating evidence suggest that attention deficit (AD) and EFD may be a driving force for PTSD treatment resistance. However, treatment of executive impairment in PTSD is very limited. As a result, untreated co-occurring AD and EFD in PTSD poses severe negative impacts on patients' functional recovery, treatment outcomes, and quality of life (QoL). Given that up to 50% of patients do not respond well to the first-line pharmacological PTSD treatments, it is imperative to seek novel treatment strategies to improve EF that may improve both standard treatment response and QoL, social function. The proposed study directly addresses this knowledge gap by testing the efficacy of atomoxetine (ATX) in improving EF and attention among Veterans with PTSD, which will further improve Veterans' QoL and social function. ATX represents a promising novel candidate pharmacotherapy for individuals with PTSD. ATX is a non-stimulant selective norepinephrine reuptake inhibitor (SNRI), approved by the FDA for the treatment of ADHD. Studies suggest that ATX, unlike stimulants, lacks addictive properties and shows efficacy in the treatment of comorbid depression and anxiety, which is ideal in the treatment of PTSD. Data from the investigators' preliminary study provides encouraging support for the therapeutic potential of ATX in improving EF in Veterans with comorbid PTSD/ADHD. The investigators' recent research uncovered a higher rate of ADHD among Veterans with PTSD, and the comorbid AD symptoms were correlated with PTSD severity and poorer treatment outcomes. Treatment with ATX showed significant symptoms reduction in ADHD and improvement in inhibitory function in Veterans with ADHD/PTSD. In the proposed study, the investigators will focus on ATX in improvement of EF and attention, and further psycho-social life function and QoL. The investigators will (1) employ a randomized, double-blind design that will consist of 12 weeks of treatment with ATX or placebo medication; (2) use standardized, repeated dependent measures to rigorously assess AD and EFD symptomatology; (3) measure impairment in associated mental and behavioral health problems (e.g., attention deficit, depression, anxiety, suicidality, QoL, family/social functioning); and (4) use response inhibition task GoNogo, working memory and attention tests Digit Span and Trail Making to investigate the underlying pathophysiology of PTSD and prognostic indicators of treatment outcome. To achieve these goals, the investigators have assembled a multidisciplinary team with expertise in PTSD, ADHD clinical trials, and human laboratory paradigms who have successfully collaborated in the past and are uniquely qualified to implement this type of investigation. The proposed project is directly responsive to the mission of the VA-RRD "to maximize Veterans' functional independence, quality of life and participation in their lives and community." Successful completion of this study will provide a platform for a large multi-center trial to further confirm the important role of EF in PTSD treatment outcomes. The findings from this study will provide critically needed evidence to help inform clinical practice guidelines on the treatment of PTSD. The outcome of the proposed research will be significant, because it provides a knowledge base to allow for development of new PTSD intervention strategies. More importantly, this clinical trial may immediately benefit Veterans by enhancing their cognitive function, reducing AD related disability, and further improving quality of life for Veterans who suffer from PTSD.

Trial Details

Trial Status:Not Yet Recruiting
Trial Phase:Phase 4

160 Participants Needed

Family Life Skills Program for Childhood Behavior

Columbia, South Carolina
This study evaluates feasibility and preliminary efficacy of a parent-based prevention program to promote social-emotional and lifestyle behavior health among 3- to 9-year-old children in families experiencing major stressors.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:3 - 9

60 Participants Needed

Parenting Intervention for Child Behavior Improvement

Columbia, South Carolina
The main objective of this project is to test whether providing parenting support, with an added emphasis on ethnic-racial socialization and healthy lifestyle behaviors, improves the social-emotional functioning and healthy lifestyle behaviors of Black and Latinx children.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:3 - 6

60 Participants Needed

Videolaryngoscope vs Regular Laryngoscope for Infant Intubation

Atlanta, Georgia
Nasotracheal Intubation with Videolaryngoscopy versus Direct Laryngoscopy in Infants (NasoVISI) Trial is a prospective randomized multicenter study. The study will be conducted at 8 centers in the United States. It is expected that approximately 700 subjects enrolled to product 670 evaluable subjects.The randomization is 1:1 naso tracheal intubation with the Storz C-Mac Video Videolaryngoscopy (VL) or the Standard Direct Laryngoscope (DL). The primary objective is to compare the nasotracheal intubation (NTI) first attempt success rate using VL vs. DL in infants 0-365 days of age presenting for cardiothoracic surgery and cardiac catheterizations.
No Placebo Group

Trial Details

Trial Status:Recruiting
Age:1+

1400 Participants Needed

Mindfulness Practices for ADHD

Spartanburg, South Carolina
Attention-deficit/hyperactivity disorder (ADHD) is a neurodevelopmental disorder that commonly persists into adulthood and is associated with significant life impairments. The current study evaluates the feasibility, acceptability, and preliminary efficacy of a group-based mindfulness intervention for first-year college students with ADHD. If found to be feasible, acceptable, and efficacious, subsequent research will examine its impact on a larger scale to have a broader public health impact for college students with ADHD.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:17 - 25

100 Participants Needed

Methylphenidate for Post-Traumatic Stress Disorder

Birmingham, Alabama
Posttraumatic stress disorder (PTSD) is frequently accompanied by difficulty concentrating, poor memory, and inability to keep up with tasks, which negatively impacts a person's ability to function at work and in relationships. Currently available treatments do not fully relieve all symptoms. A published research report showed positive evidence that the stimulant medication methylphenidate was beneficial in treating these problems. This study will evaluate the ability of methylphenidate to treat PTSD and associated neurocognitive complaints in Veterans. An innovative feature is the study's N-of-1 design. In this design, every participant will move back and forth every 4-5 weeks between treatment with methylphenidate and treatment with placebo, in random order and under double-blind conditions, over a 20-week period. The investigators will compare the aggregated change in PTSD and neurocognitive symptoms between periods of treatment with methylphenidate versus placebo. Results will help clinicians to better choose the best treatment for Veterans living with PTSD.

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 4
Age:18 - 65

70 Participants Needed

Question Prompt/Video Intervention for ADHD

Chapel Hill, North Carolina
The investigators propose to conduct a pilot randomized controlled feasibility trial to evaluate the feasibility and effectiveness of a pre-visit intervention to improve communication about attention deficit hyperactivity disorder. The investigators will enroll 140 English-speaking youth ages 11-17 with an ADHD medical record diagnosis who screen as having predominantly inattentive subtype, hyperactive/impulsive subtype, or combined inattention/hyperactivity on the Vanderbilt parent assessment scale from three pediatric clinics. Teh investigators will randomize the families to receive both the question prompt lists and video (N=35), just the question prompt lists (N=35), just the video (N=35), or usual care (N=35). This will allow the team to understand whether both the video and question prompt list components are needed for the larger trial. The aims of the investigators are: Aim 1: To examine whether the ADHD question prompt lists and/or pre-visit video significantly impact the proposed mechanisms of the intervention. The team will investigate whether adolescents and parents in each of the intervention groups: (a) ask more questions and receive more provider education about ADHD during their baseline and 3-month visits and (b) have higher self-efficacy at 3 and 6 months than adolescents and parents in the usual care group. Aim 2: To investigate the effectiveness of the ADHD question prompt lists and/or the pre-visit video by examining whether adolescents in each of the intervention groups have improved ADHD symptoms, school and social performance, and quality-of-life at 6 months compared to those in the usual care group. Aim 3: To assess adolescent, parent, and provider feedback on the acceptability, feasibility, tolerability, and safety of using the ADHD question prompt lists and/or the pre-visit video. The results from this pilot trial will be used to inform a larger trial by: (a) identifying the intervention arm with the greatest potential impact, acceptability, feasibility, and tolerability, and (b) determine the best mechanisms and outcome variables to assess in a larger trial.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:11 - 17

140 Participants Needed

Teacher-Led Mental Health Care for Children

Chapel Hill, North Carolina
Purpose: The purpose of this research is to pilot test a novel, alternative, potentially sustainable system of teacher-delivered, task-shifted child mental health care. Participants: \~300 estimated Procedures: This is a RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) guided, mixed methods, clustered evaluation of Tealeaf-NC's Reach, Adoption \& Implementation (Primary Outcomes, implementation-based), as well as evaluating for preliminary indicators of Effectiveness \& Maintenance (Secondary Outcomes, clinically-based).
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:5 - 99

312 Participants Needed

Organizational Skills Training vs Mindfulness for ADHD

Durham, North Carolina
This randomized control trial comparing Organizational Skills Training (OST) and Mindfulness-Based Intervention (MBI) among adolescents with a pre-existing ADHD diagnosis presenting to the Duke ADHD Program. Both treatments are eight 90 minute sessions. The research component will involve a pre-treatment assessment and post-treatment assessment. Both assessments will involve adolescents and one caregiver to complete questionnaires over REDCap. Rating scales will include ADHD symptom severity (Conners 3: self and parent report), functional impairment (IRS: self and parent report), executive functioning (BRIEF-2: parent report), emotion dysregulation (DERS: self and parent report), trait mindfulness (FFMQ: self report), organizational skills (BRIEF-2: parent report), treatment satisfaction (self report and parent report) and credibility (self report and parent report). Post-treatment assessments for feasibility will include attendance (measured over the course of treatment) and homework completion rates on a scale of 1 to 5 in which 5 indicates higher homework completion. We will also assess acceptability via individual items on a Likert scale (self report): overall satisfaction, how much was learned about ADHD, usefulness of information learned, content relevance to individual experience, comprehension of strategies, confidence about using strategies, likelihood of using strategies, helpfulness to share with the group, benefits from hearing from other group members, willingness to recommend the same treatment to others, and whether or not treatment was beneficial.
No Placebo Group

Trial Details

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

30 Participants Needed

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