588 Clinical Trials for Various Conditions
This study consists of a 6-week, open-label, randomized clinical trial study to compare efficacy and tolerability of the natural treatments omega-3 fatty acids, inositol, and N-acetylcysteine (NAC) in the treatment of mood dysregulation in children and adolescents with non-verbal learning disability (NVLD) or Autism Spectrum Disorder (ASD). Subjects will include youth ages 5-17 years with a non-verbal learning disability (NVLD) or autism spectrum disorder (ASD) and current symptoms of emotional dysregulation.
Non-verbal Learning Disorder, Autism Spectrum Disorder, Autism
The overall purpose of this study is to determine feasibility and preliminary efficacy of pet therapy, or human-animal interactions (HAI), for children (5-12 years of age) with or at risk for LD. Children among 4 reading groups will be randomly assigned to a HAI intervention or control group. The 2 HAI intervention reading groups will receive visits from a registered canine team during children's small group reading sessions twice a week over 12 weeks. The 2 control reading groups will receive care as usual and offered a 1-time visit from the dog at the end of the study (after T3 completed). Two weeks of initial work will focus on preliminary modifications to the protocol. Parents will complete electronic measures of psychological outcomes (child depression, anxiety, QOL) via REDCap at baseline (T1), 2 weeks post-baseline (T2), and 12 weeks post-baseline (T3). The investigators will obtain copies of reading assessments already conducted by the teachers at T1 and T3. Children's salivary cortisol will be obtained from participants in the intervention groups at T1, T2, and T3. Children and their parents will complete concluding interviews at study end (T3) to further inform what they liked and did not like about the intervention. Results of the proposed study will provide critical data for a future full-scale randomized clinical trial (R01) to examine the impact of HAI on psychological, physiological, and reading outcomes in children with or at risk for LD.
Animal-Human Bonding, Learning Problem, Child Development
The purpose of this study is to investigate neurocognitive mechanisms underlying response to intervention aimed at enhancing, and remediating weaknesses in, numerical skills in children, including those with mathematical learning disabilities (MLD).
Math Learning Disability, Child Development, Developmental Disability, Learning Disabilities, Learning Disabled, Learning Curve, Mathematics Disorder, Dyscalculia, Dyscalculia, Primary, Dyscalculia, Acquired, Specific Learning Disorder, With Impairment in Mathematics, Individuality, Behavior, Child, Behavior and Behavior Mechanisms, Behavior, Decision Making, Neuronal Plasticity, Cognition, Cognition Disorder, Cognitive Dysfunction, Cognitive Change, Cognitive Impairment, Mild, Cognitive Developmental Delay, Cognitive Orientation, Cognitive Delay, Mild, Cognitive Deficits, Mild, Cognitive Abnormality, Neuroscience
This study investigates the efficacy of a reading comprehension intervention for English learners in Grades 6 and 7 with reading difficulties. Building on previous intervention studies conducted with students in Grades 4 through 8 over the past 10 years, the investigators utilize a longitudinal, double-cohort design utilizing a randomized control trial assigning students to supplemental reading intervention (RISE) or a no intervention "business as usual" (BAU) comparison condition (i.e., Cohort 1 - Years 1 and 2; 205 students in treatment and 205 in control condition; Cohort 2 - Years 3 and 4; 205 students in treatment and 205 in control condition; total 410 in each condition). Students in each cohort will be treated for 2 years (i.e., 6th and 7th grades or 7th and 8th grades). The primary outcome is reading comprehension. The investigators hypothesize that participants receiving the RISE intervention will outperform those receiving BAU instruction across reading-related elements, including word reading, fluency, and comprehension at end of year two of treatment.
Learning Disorders, Dyslexia
The current literature on academic skill difficulties, whether considered as part of the continuum of ability or as a specific learning disability (LD), indicates that these problems often coexist with conduct problems and juvenile delinquency, and are risk factors for initial law-breaking behavior and for its persistence. However, less is understood about how this relationship develops. It is these broad questions that this project seeks to address. First, what is the causal pathway? Does LD cause delinquency, delinquency cause LD, or are both caused by something else? And can big data analytics applied to statewide datasets of information about juvenile justice (JJ) involvement help to answer this question? Second, as it is known that learning to read and do math (and thus becoming more employable) increases the likelihood of desistance (i.e., not committing any more illegal acts), what are the necessary parts of an intervention designed to teach these skills? And what role might technology play in such an intervention? To answer these questions, we will implement a study that includes two components, (a) a big data component and (b) an intervention component. For (a), we will work with a large historical dataset from the Harris County Juvenile Probation Department. For (b), we will work, in total, with 192 (48 per year) delinquent youth with severe LD in residential placement. These individuals, in a nonconcurrent multiple baseline design, will be offered an educational therapy designed to address severe reading problems in juvenile detainees using a novel mixed media intervention in which the person-to-person intensive 1:1 component is completed while youth are in residential settings (24 sessions, delivered in 90 minute settings 3 times a week) and a "gamified" educational smartphone learning tool follow-up completed upon release (with appropriate network fidelity monitoring and participant reinforcement). The person-to-person component is developed specifically for juvenile offenders with severe LD, combining two well-established and highly-regarded intervention programs designed to systematically build students' repertoire of grapheme-phoneme correspondence rules as well as develop comprehensive reading skills, from beginning reading to proficiency.
Specific Learning Disorder (MeSH Unique ID: D000067559), Dyslexia (MeSH Unique ID: D004410), Conduct Disorder (MeSH Unique ID: D019955)
Over 20% of adolescents living in the United States have a diagnosable psychiatric disorder. However, most adolescents who need mental health services do not receive them due to many reasons, including low resources in families and communities, stigma, lack of mental health providers, and other barriers to mental health care access. Alabama currently ranks 50th in access to mental healthcare and 51st (LAST) in mental healthcare provider availability with only one mental healthcare provider for every 920 persons in need. Most adolescents attend school, so delivering mental health services in the school setting eliminates many barriers to mental health care access. From the point of prevention, participation in universal social and emotional learning (SEL) programs within the school setting improves social and emotional skills, behaviors, attitudes, and academic performance. Mindfulness-based instruction is a promising approach to SEL for improving psychological functioning that is evidence-based, widely available, and scalable to various populations and settings. This project aims to investigate whether a SEL program that incorporates mindfulness-based instruction (MindUP) leads to improvements in not only self-reported well-being (i.e., anxiety, mindful attention, perceived stress, and positive and negative affect), but also objectively measured executive functioning, academic achievement, and regulation of stress physiology. The investigators will partner with schools that serve historically underserved students to test the effectiveness of the MindUP program in 5th and 6th graders. This study has the potential to benefit underserved students and their teachers who will receive training on sustainable implementation of the MindUP curriculum.
Specific Learning Disability, Mental Health Issue
The main purpose of this clinical trials is to explore short-term effects of coordinated intervention versus the business-as-usual school program on the primary endpoints of post-intervention word-reading fluency and arithmetic fluency. The study population is students who begin 1st grade with delays in word reading and calculations. Students who meet entry criteria are randomly assigned to coordinated intervention across reading and math, reading intervention, math intervention, and a business-as-usual control group (schools' typical program). The 3 researcher-delivered interventions last 15 weeks (3 sessions per week; 30 minutes per session). Students in all 4 conditions are tested before researcher-delivered intervention begins and after it ends.
Reading Learning Disability, Math Learning Disability
Benign epilepsy with centrotemporal spikes (BECTS) is the most common pediatric epilepsy syndrome. Affected children typically have a mild seizure disorder, but yet have moderate difficulties with language, learning and attention that impact quality of life more than the seizures. Separate from the seizures, these children have very frequent abnormal activity in their brain known as interictal epileptiform discharges (IEDs, or spikes), which physicians currently do not treat. These IEDs arise near the motor cortex, a region in the brain that controls movement. In this study, the investigators will use a form of non-invasive brain stimulation called transcranial magnetic stimulation (TMS) to determine the impact of IEDs on brain regions important for language to investigate: (1) if treatment of IEDs could improve language; and (2) if brain stimulation may be a treatment option for children with epilepsy. Participating children will wear electroencephalogram (EEG) caps to measure brain activity. The investigators will use TMS to stimulate the brain region where the IEDs originate to measure how this region is connected to other brain regions. Children will then receive a special form of TMS called repetitive TMS (rTMS) that briefly reduces brain excitability. The study will measure if IEDs decrease and if brain connectivity changes after rTMS is applied. The investigators hypothesize that the IEDs cause language problems by increasing connectivity between the motor cortex and language regions. The investigators further hypothesize that rTMS will reduce the frequency of IEDs and also reduce connectivity between the motor and language region
Benign Epilepsy With Centrotemporal Spikes, Language Problems, Learning Disorders
This study is a 12-week randomized-controlled trial of memantine hydrochloride (Namenda) for the treatment of social impairment in youth with Non-Verbal Learning Disorder, High-Functioning Autism Spectrum Disorder, and related conditions. Eligible participants will be males and females ages 8-18. This study consists of up to 6 visits to Massachusetts General Hospital.
Autism, Autism Spectrum Disorder, Nonverbal Learning Disability
This study is designed to examine how much therapy is needed in order to make significant gains in knowledge and use of complex sentences. Students will be randomly placed in individual treatment sessions that take place either once or twice per week for nine weeks. All will receive the same type of treatment, which consists of a focused series of oral and written language activities. While it is anticipated that students in both groups will benefit from treatment, we hypothesize that the twice-weekly session frequency will have a significantly greater impact on level of performance and maintenance of skills after treatment.
Language Development Disorders, Learning Disorders
This project is evaluating programs to improve reading and writing skills in children who have or are at risk for having reading disabilities. The project focuses on children who are at-risk for low achievement in school and on children with dyslexia.
Dyslexia, Learning Disorders
Neurofibromatosis Type 1 (NF1) is a common genetic disorder that is associated with a four times greater risk of learning disabilities, including reading disabilities, and a deficiency of neurofibromin - a protein important in a signaling pathway that regulates learning and memory. Our previous work (NS49096) demonstrated that school-age children with NF+RD can respond to standard phonologically-based reading tutoring originally developed to treat reading disability in the general population. Combining our work with that by other researchers suggesting that a medication (Lovastatin) may counteract the effects of the deficient neurofibromin, and possibly ameliorate learning disabilities in NF1, the investigator propose to examine the synergistic effects of medication plus reading tutoring.
Neurofibromatosis Type 1, Learning Disability, Reading Disability, NF1
This is a single-center, randomized, double-blind, 2-period crossover study to explore the effects of BPN14770 on cognitive function and behavior in subjects with Fragile X Syndrome. Subjects will receive both active treatment with BPN14770 capsules and matching placebo capsules in the course of the study. One treatment will be administered during each of the 12-week study periods.
Fragile X Syndrome, FXS, Fra(X) Syndrome
The majority of school-age children with sickle cell disease (SCD) experience neurocognitive deficits, even in the absence of stroke. In particular, deficits in attention and working memory have emerged as two of the most common neurocognitive sequelae of SCD. Thus, the goal of the present proposal is to address feasibility and compliance of a novel computerized cognitive training program, Cogmed. Pilot data will also be collected to establish preliminary efficacy. Twenty-four children meeting initial age and diagnostic criteria will be identified and approached about participation by their attending physician during regularly-scheduled SCD clinic visits. Baseline assessments will include a brief measure of intellectual functioning, a brief cognitive testing battery evaluating processing speed and working memory, in addition to questionnaires regarding behavior and quality of life. Children will then be randomized to the computerized CT program Cogmed (n=12) or a waitlist control (n=12). Participants enrolled in the computerized CT program will be asked to complete 25-sessions of Cogmed over a five to eight week period (3 to 5 sessions per week). Following completion of the program, children and their parents will be asked to return to clinic for a follow-up visit. After a five to eight-week waiting period, children in the waitlist condition will also be asked to return to clinic for a second visit. Following this assessment, participants initially enrolled in the waitlist will be offered an opportunity to participant in the intervention. If interested, they will follow the same intervention protocol described above. These children will return to clinic for a third visit following completion of the intervention. Compliance rate and its confidence interval will be calculated for the overall study population. A t-test for binomial proportion with continuity correction will be used to examine whether the compliance rate is lower than the target. Participants' change in criterion outcomes will be evaluated (i.e., those neurocognitive measures such as attention, executive functioning and working memory, that are most closely related to the trained tasks).
Sickle Cell Disease, Cognitive Impairment
Background: - Developmental dyscalculia is a learning disability in which individuals have difficulty learning or comprehending mathematics or other number concepts (such as keeping score during games, measuring time, or estimating distance). Developmental dyscalculia affects certain parts of the brain that are required for processing numbers. Research has shown that a form of brain stimulation called transcranial direct current stimulation (tDCS), applied when healthy individuals are being trained to carry out tasks with numbers, improved the ability to process numbers and solve math problems. More research is needed about whether tDCS can improve number processing in people with developmental dyscalculia. Objectives: - To examine whether the effects of transcranial direct current stimulation can help individuals with developmental dyscalculia perform mathematical calculations. Eligibility: - Individuals between 18 and 50 years of age who have been diagnosed with developmental dyscalculia, or are healthy volunteers without dyscalculia. Design: * Participants will have a screening visit and seven study visits. The screening visit and six of the study visits will take place consecutively over the course of 6 days, and the final visit will take place 3 months after the initial participation. * Participants will be screened with a medical history, physical and neurological examination, and a brief examination to test for dyscalculia and determine the participant's dominant hand. * Participants will be randomly assigned to one of two groups for the study. One group will receive tDCS during training to perform a task with numbers, and the other group will receive the same training with sham stimulation. Participants will not know which group they are in. * During the study visits, participants will be trained on number tasks on 6 consecutive days. Before the tDCS or sham stimulation is applied at the beginning of the experiment and at the end of each training day, participants will perform other tasks with numbers. Participants will be evaluated based on the accuracy and speed with which they respond to the questions. * At the followup visit, participants will perform the same number tasks they completed during the study visits. No tDCS will be performed at this visit.
Cognition Disorder, Brain Mapping
This study will test a computer-based treatment for youth with the genetic disorder velocardiofacial syndrome (VCFS) to help them improve skills in memory, attention, and executive functioning.
Velocardiofacial Syndrome
The purpose of this study is to demonstrate whether, in patients diagnosed with Vertical Heterophoria, the symptoms of dizziness, headache and / or anxiety are reduced or eliminated when a kind of correction called vertical prism is added to the patient's normal eye glass prescription. The experiment will involve giving the patient two pairs of glasses (one pair containing the baseline prescription with vertical prism (Standard Treatment Glasses) and the other pair containing the baseline prescription but without vertical prism (Placebo Glasses)) to demonstrate which pair of glasses is most effective in reducing the symptoms of dizziness, headache and / or anxiety in these patients.
Binocular Dysfunction, Vertical Heterophoria, Vision, Binocular, Vision Disparity
We propose a population-based case-control study among 7000 elementary school children in semi-rural Johnston County, NC. Teachers will complete a screening form on each child. Controls will be randomly selected. Mothers of potential cases and controls will be interviewed by telephone about their child's symptoms of ADHD and exposure history, their family history of ADHD, and their reproductive and exposure history. Children's shed baby teeth will be analyzed for lead. Mothers will complete brief parenting scales and the Child Behavior Checklist. School records will be collected. The study goals are to identify risk factors for ADHD including preterm delivery and childhood lead exposure.
Attention-Deficit Hyperactivity Disorder
This study has three aims: Phase I: Through focus group interviews with expert clinicians, leaders of organizations, and parents with children with special needs, this study aims to identify the psychosocial needs of parents of children with learning disabilities, specifically a) the types of concerns that parents find most difficult and stressful b) areas of concern that lack support and resources, and c) areas of need for education and skill training. This study also aims to gather feedback on the Benson-Henry Institute's Relaxation Response Resiliency Program (3RP). Phase II: Informed by Phase I findings, this study aims to develop and determine the feasibility and acceptability of a virtual 8-session Relaxation Response Resiliency (3RP) program for parents of children with Specific Learning Disabilities (SPLD). Phase II: This study also aims to test the effectiveness of a pilot wait-list control trial, establishing efficacy of a virtual resiliency program.
Stress
The investigators are conducting a study to see which program better helps older patients with kidney disease choose their treatment. Investigators are also investigating if either program can reduce the number of hospital or emergency room visits in the first 6 months of the study, as well as potentially improve end-of-life care for older adults. Half of the participants will receive Program A, while the other half will receive Program B. Investigators will compare the two groups to see which participants feel better prepared about their kidney therapy decisions, experience improved end-of-life care, and have fewer emergency room visits and hospital admissions. Participants in Program A will receive information from the National Kidney Foundation and meet with a kidney therapy educator. Participants in Program B will get information about kidney disease treatment and meet with a decision-support specialist who's an expert in decision-making.
Chronic Kidney Diseases
The goal of this pilot clinical trial is to evaluate a culturally tailored computerized education program in hospitalized African-American patients with advanced chronic kidney disease (CKD). The main question it aims to answer are: does computerized adaptive education (CAE) increase patients' knowledge about CKD self-care and renal replacement therapy (RRT) options compared to usual care (UC) and will CAE will be increase patients' intent to participate in CKD self-care and RRT preparation compared to UC
Chronic Kidney Diseases, Hypertension
Pelvic floor disorders (PFDs) are common conditions that can have significant impacts on patients' quality of life and psychosocial well-being. It is well known that patients who have experienced pregnancy and childbirth are at risk of developing these conditions, either during pregnancy, postpartum, or later in life. However, many women are unaware of this predisposing risk factor. Additionally, overall knowledge of these conditions is low in both the general and obstetrics population. Video education has been used in various fields with success in improving patient knowledge of specific topics and conditions. To the researchers' knowledge, no studies have evaluated this modality for educating obstetrics patients on PFDs. The aim of this study is to determine whether the use of an educational video will improve knowledge of PFDs compared to routine prenatal counseling, using a validated knowledge questionnaire.
Pelvic Floor Disorders
The purpose of this study is to determine if patient education and problem-solving training, delivered in self-study, group, and individual intervention modalities, will produce substantial improvements in CVD risk profile via improved self management in urban African Americans with type 2 diabetes and a high CVD risk profile.
Type 2 Diabetes
The purpose of the proposed study is to use transcranial magnetic stimulation (TMS) to evaluate a neurobiological model of spoken word learning in older youth. Specifically, it is hypothesized that: (1) inhibition of the left dorsal stream will impact subsequent learning, processing, and retention of phonologically similar pseudowords; (2) the impact of dorsal stream inhibition on word learning will be associated with baseline levels of variability in neural activity, indicative of underlying differences in cortical excitability.
Dyslexia, Dyslexia, Developmental, Learning; Developmental Disorder, Reading
The goal of this clinical trial is to measure the effects of using a storybook versus standard child life intervention with parents of children newly diagnosed with leukemia on parental stress. The main questions it aims to answer are: * What effect will the storybook have on parent/legal guardian stress at three timepoints: baseline, discharge, and follow up? * Will this storybook impact parent/legal guardian comfort levels and improve their child's understanding? Participants will be asked to complete surveys at three timepoints, prior to and following child life intervention and about 3.5 months later. During child life interventions, participants will receive resources and support to explain leukemia to their school aged, 3-16-year-old, child (patient or sibling). Researchers will compare Intervention and Control Groups to see if parental stress is lower in those who received the storybook in addition to the standard child life intervention versus the standard child life intervention alone.
Leukemia
The goal of this clinical trial is to compare two health system-based approaches for offering kidney failure treatment options to older patients with kidney failure, specifically, to ensure patients are actively involved in a shared decision making (SDM) process covering a full range of treatment choices and have meaningful access to that full range of choices. These include standard in-center or home dialysis as well as alternative treatment plans (ATPs): active medical care without dialysis, time-limited trial of dialysis, palliative dialysis, and deciding not to decide. Approach 1 - Educate and Engage: Nephrology practices encourage their patients to a) participate in a kidney disease education program providing a balanced presentation of all options including ATPs, b) use evidence-based patient decision aids that include ATPs, and c) engage in SDM with staff trained in communication skills and best practices. Approach 2 - Educate and Engage Plus Kidney Supportive Care Program: Nephrology practices add a primary palliative care program to support patients who choose ATPs and their families. The program provides care coordination, symptom management, advance care planning, and psychosocial support to supplement usual care from their nephrologist. To compare the two approaches, the investigators will conduct a repeated, cross-sectional stepped wedge cluster randomized trial involving 20-25 chronic kidney disease clinics at 8 practice organizations around the United States. Aim 1: Compare the effectiveness of Approaches 1 and 2 in a) increasing proportion of patients choosing ATP and b) reducing patient-reported decisional conflict about treatment. Aim 2: Compare the patient and family experience of ATP care between Approaches 1 and 2 in terms of quality of life, services used, and end of life (EOL) experience. Aim 2a will focus on experience while patients are receiving an ATP. Aim 2b will describe the EOL experience. Aim 3: Evaluate implementation of each approach through a mixed-methods design based on the expanded RE-AIM framework. For Aims 1 and 2, researchers will collect information by chart review and surveys with patients and caregivers. For Aim 3, information will be reported by site managers as part of monthly progress reports. Clinic administrators, clinical providers, and staff will complete surveys before and after implementation of each approach.
Chronic Kidney Disease
This study is a nonrandomized, pilot study of an interdisciplinary, patient-centric model of health care delivery in a "boot camp" style structured clinic for people diagnosed with Parkinson's disease (PwPD). 20 participants will attend a three session EMPOWER PD clinic and a two month follow up interview. The primary objective is to assess feasibility and acceptability of the newly developed clinic intervention as well as individual perception of experience and barriers.
Parkinson Disease
This study is intended to correct an important systemic deficit in the care of chronic kidney disease (CKD), VHA's fourth most common healthcare condition with high mortality and healthcare burden. Currently, many Veterans with CKD have poor awareness of their condition. This leads to suboptimal care. The investigators anticipate that the proposed comprehensive pre-end stage renal disease (ESRD) education (CPE) will enhance Veterans' CKD knowledge and their confidence in making an informed selection of an appropriate dialysis modality, and lead to an increase in the use of home dialysis (HoD) - an evidence-based, yet underutilized dialysis modality. Further, this study will allow us to examine whether such Veteran-informed dialysis choice can improve Veteran and health services outcomes. If successful, this study may deliver a ready to roll-out strategy to meet the CKD care needs of the Veterans and reduce VHA healthcare costs.
Chronic Kidney Disease, End Stage Renal Disease, Hemodialysis, Peritoneal Dialysis
This is a single site, single dose clinical trial of intravenous (IV) ketamine for medically hospitalized adolescents and young adults with anorexia nervosa or atypical anorexia nervosa. Eating disorder symptoms will be measured pre- and post-ketamine infusion. Investigators hypothesize that ketamine will increase cognitive flexibility, making medical hospitalizations less distressing by improving the ability to learn new, positive associations with food.
Anorexia Nervosa, Atypical Anorexia Nervosa
The primary objective of this study is to evaluate the ability of TOME to increase Medication for Opioid Use Disorder (MOUD) and opioid-overdose knowledge in pregnant and postpartum persons.
Opioid Use Disorder, Pregnancy Related, Substance Use, Drug Abuse, Drug Abuse in Pregnancy, Drug Addiction