23 Clinical Trials for Various Conditions
Background: During the first few decades of life, the brain changes dramatically in shape and function. Sleep lets researchers measure these changes. Researchers want to create a database of sleep and neurodevelopmental data in a group of infants and children to learn more. Objective: To address a knowledge and data gap in the field of sleep and neurodevelopment in infants and children. Eligibility: Children ages 6 months to 76 months who may or may not be at risk for neurodevelopmental and neuropsychiatric disorders. Also, children ages 6 months to 8 years who have a referral for a sleep study. Design: Participants will have neurodevelopmental testing. They will have a medical, psychiatric, and family history. They will have a physical and neurological exam. They will be interviewed and complete surveys. They will give a cheek swab and/or blood sample. Some participants will have 1 study visit that lasts 2 days. Other participants will have up to 4 study visits. Each visit will last 2 days. Visits occur every 8 months to 1 year, for a total participation time of 2 years. Participants will have a 20-minute daytime electroencephalogram (EEG), if possible. This EEG session will be used to calibrate the machine for the overnight study. Participants will take part in an inpatient overnight sleep study. Electrodes will be placed on the participants. For young children, parents will help place the EEG leads. Other sensors may also be placed. A gauze cap will be placed on participants head to protect the leads and keep the participants from moving them. 'Lights out' will occur as close to participants bedtime as possible.
In this study, investigators will study the impact of a 1:1 caregiver coaching intervention using the JASPER (Joint Attention, Symbolic Play, Engagement, Regulation) behavioral therapy curriculum compared to a psychoeducational curriculum that will be provided to caregivers for self-directed learning. Investigators want to determine the impact of both interventions on the child's development and behavior, and caregiver implementation of strategies.
The purpose of this study is to evaluate the safety and effectiveness of intranasal FE 992097 in children and adults with Prader-Willi Syndrome.
Many children and adolescents with autism spectrum disorder (ASD) experience high levels of anxiety which can further inhibit their ability to master developmental tasks such as succeeding in school and developing and maintaining friendships. Despite the need for effective treatments for children with ASD and anxiety, there have been few studies that have addressed this issue. Recently, preliminary evidence has supported the use of cognitive-behavioral therapy (CBT) to treat anxiety disorders in children with ASD. This study will utilize a CBT treatment program called Coping Cat. Coping Cat has been found to be one of the most effective treatments for typically developing children with anxiety and has also been shown to be effective for treating anxiety in children with other disorders such as physical impairments, selective mutism, and Attention Deficit Hyperactivity Disorder. The investigators goal is to demonstrate that Coping Cat is an effective treatment for children with ASD and anxiety. Finding effective treatments for children with ASD and anxiety could increase adaptive social relationships, decrease stress among families, and prevent the maintenance of anxiety into adulthood.
This 24-week study will compare the safety and effectiveness of medication treatment alone (risperidone or aripiprazole) to medication treatment in combination with a parent management training program.
This study is being done to see if outcomes for both a premature infant's parents and the infant born prematurely who have spent time in the neonatal intensive care unit (NICU) can be improved through parent cognitive behavioral therapy (CBT) sessions.
This study will examine the efficacy of a computerized cognitive behavioral therapy (CCBT) program for children with anxiety and autism spectrum disorders.
Autism spectrum disorders affect as many as 1 out of 150 children and are related to significant impairment in social, adaptive, and school functioning. Co-occurring conditions, such as anxiety, are common and may cause substantial distress and impairment beyond that caused by the autism diagnosis. Although effective interventions have been developed for typically developing youth with anxiety disorders, this approach needs to be adapted for children with autism. Accordingly, we are proposing a randomized controlled trial to examine the effectiveness of CBT relative to treatment as usual (TAU) in 46 youth ages 7-11 with autism spectrum disorders and comorbid anxiety disorder(s).
The goals of this clinical trial are to identify factors associated with the development of problem behavior in Cornelia de Lange syndrome (CdLS) and to develop an effective behavioral assessment and treatment model for problem behavior in children with CdLS. The hypotheses are as follows: 1. Based on pilot data, the investigators hypothesize that individuals with CdLS will exhibit preferences for auditory stimuli relative to other categories (e.g., visual, tactile) of stimuli. 2. Based on pilot data, the investigators hypothesize that individuals with CdLS will exhibit problem behavior to obtain adult attention or to escape task demands relative to tangible and control conditions, as measured by functional analysis results. 3. Function-based behavioral treatments will reduce problem behavior in individuals with CdLS by 80% or greater relative to baseline rates. 4. Individuals with CdLS and problem behavior will exhibit more impaired communication, demonstrate increased emotion dysregulation, and exhibit more severe symptoms of Autism Spectrum Disorder (ASD) relative to those with CdLS and no problem behavior. Participants in the intervention group (families of children with CdLS and problem behaviors) will be asked to complete study measures and attend 2 full days and one half-day of clinic services at Kennedy Krieger Institute so that the study team can provide assessment and treatment of child problem behaviors, and then train parents to apply the intervention. Participants in the control group (families of children with CdLS and no problem behavior) will be asked to complete study measures once every 3 months for a 2-year period to monitor the children. This study will improve the ability to effectively treat problem behavior is CdLS, as well as identify key variables associated with problem behavior in CdLS which may be examined in future studies and clinical practice to foster early intervention and prevention efforts.
The goal of this clinical trial is to test efficacy of the REACH program in parents with irritable bowel syndrome (IBS) and their young children. The main question it aims to answer is: -How can parents with IBS help their young kids develop healthy habits? Participants will be asked to complete online surveys and to use a website. Researchers will compare results from parents who use one of two websites chosen by chance, like flipping a coin. One website focuses on child health and safety behaviors. The other website focuses on strategies to promote child wellness behaviors.
Enhancing independence and quality of life are key modifiable outcomes that are short- and long-term goals for children with Down syndrome (DS) and for their parents. The study investigated the efficacy of assistive technology in improving children with Down Syndrome's independence and quality of life. Using a commercially available assistive technology, the MapHabit system, the investigators implemented the software with participants' families for 4 weeks. The investigators hypothesized that the assistive technology will improve adaptive behavioral skills and overall quality of life.
Aversive sensory phenomena such as premonitory urges play a central role in the behavioral treatment model of tics. Extinction learning and extinction recall are learning processes implicated within this model, but have not been directly evaluated in youth with Tourette syndrome (TS). This study examines extinction learning and extinction recall in youth with TS using an experimental task. This study will also explore the relationship between extinction processes (i.e., extinction learning and extinction recall) and treatment outcomes with behavior therapy. Findings from this investigation will be used to update the behavioral treatment model, which serves as the basis for evidence-based behavioral interventions.
This is a pilot study of children between the ages of 8 to 11 years of age who are obese and participating in an intense family based intervention with a family-focused multi-component lifestyle intervention. In addition, a beta-carotene supplement will be administered to randomized participants.
Anxiety disorders affect 40 to 50% of children with autism spectrum disorders (ASD), contributing to substantial distress and impairment. The goal of this study is to examine the effectiveness of a personalized type of psychotherapy against standard-care psychotherapy for addressing anxiety in youth with ASD.
Due to the considerable prevalence of anxiety in youth with autism spectrum disorders, this study seeks to establish the efficacy of a modified cognitive behavioral therapy protocol in 50 adolescents versus other available treatment options.
The purpose of this study is to compare two different treatment approaches to social skills groups for high-functioning children with Autism Spectrum Disorder (ASD). This project will examine changes in both behavior and the brain following treatment.
Obsessive-compulsive (OC) symptoms are often present among youth with Prader-Willi Syndrome (PWS). They are also associated with considerable problems in the daily functioning of the child and his/her family. Although medication and behavioral treatments exist that target OC symptoms among youth without PWS, these treatments have not been thoroughly adapted for this population nor scientifically tested. Although medication has been helpful in addressing OC symptoms in several published case reports, the associated efficacy is modest and the potential for side effects is a realistic concern. Given that behavioral treatment for OC symptoms has superior efficacy to pharmacotherapy in youth without PWS without the accompanying risk for adverse side effects, it follows that an adapted version of behavioral therapy may hold promise in treating clinically problematic OC symptoms in youth with PWS. Thus, the purpose of the proposed grant is to develop and pilot-test a behavioral treatment for OC symptoms for use in youth with PWS. This study will allow us to develop and test a treatment protocol aimed at reducing OC symptoms that are clinically problematic and negatively impact functioning and quality of life in the child and his/her family.
The study aims to clarify the functional anatomy of key brain circuits associated with cognitive control in children and adolescents with chronic tic disorders (CTD) and to compare and contrast hypothesized mechanisms related to increased tic control associated with Habit Reversal Training, a behavioral treatment that been previously shown to be effective in treating CTD. We also seek to better understand the relationship between fMRI and quantitative EEG in relevant brain circuits with the hope of establishing EEG as a valid and cost-effective marker of treatment responsiveness. A total of 25 subjects will be randomized to 10 weeks of Habit Reversal Training (HRT), a behavioral treatment, and 25 to 10 weeks of minimal-contact waitlist. Treatment responders will be re-assessed at three months. Waitlist nonresponders will be provided with 10 weeks of HRT. Study assessments, including a neurocognitive battery and quantitative EEG will be administered at baseline, Wk 5, Wk 10, and 3-month follow-up. Neuroimaging (fMRI) will be conducted at baseline and Wk 10.
This study will examine the effect of bright light or melatonin treatment on sleep in children with Smith-Magenis syndrome (SMS), a genetic disorder characterized by certain physical, behavioral and developmental features. Patients have a disrupted sleep cycle involving early waking, frequent daytime napping and frequent nighttime awakenings. Melatonin is a hormone normally produced at night in healthy people. People with SMS produce high levels of melatonin during the daytime and very low levels at night. This may affect their behavior, mood, attention span and sleep patterns. Healthy volunteers between 18 and 45 years of age and children with SMS who are between 3 and 16 years of age may be eligible for this study. Healthy subjects are admitted to the NIH Clinical Center overnight. In the morning they take one dose of time-release melatonin and have blood and saliva samples collected hourly from 7:00 AM to 6:00 PM. Children with SMS participate in a 2-part study, as follows: Part 1 Inpatient Trial Pre-trial at-home phase: During the month before NIH inpatient admission, participants do the following: * Wear an actiwatch device or keep a daily sleep diary to monitor daytime alertness, mood shifts and sleep patterns. * Complete a behavior assessment survey related to the child s behaviors and sleep patterns. * Obtain frequent body temperature measurements. * Collect several saliva samples over a 24-hour period. NIH admission phase: * Children are admitted to the NIH Clinical Center for 2-3 nights for bright light treatment. They remain in their rooms for alternating periods of exposure to standard dim room light and bright light, using a light box placed within 3 to 5 feet of the child. An electroencephalogram (EEG) with additional electrodes to track eye movements is used to monitor the child s attention. Between 8AM and 6PM serial blood samples are collected to measure melatonin levels. A parent rates the child s mood and behavior during the 2-day test period. * Children are admitted to the NIH Clinical Center for 2-3 nights for melatonin treatment. They take a single dose of melatonin or placebo tablet at bedtime. During the daytime, EEG electrodes are placed to track eye movements. Between 7 PM and 7 AM serial blood samples are collected to measure melatonin levels. A parent rates the child s behavior and mood as described for the bright light study. * Children may receive either or both of the bright light and melatonin treatments. Part 2 Outpatient Trial Children participate in a combined bright light with melatonin trial at home. They undergo the same procedures outlined in the pre-trial at-home phase of Part 1 (actiwatch, behavior assessments, body temperature measurements, saliva samples) over an 11-week period. If saliva samples cannot be collected for melatonin testing, 24-hour urine samples may be collected instead.
This study measures the occurrence of certain side effects linked to antidepressant use and evaluates the effectiveness of the medication sertraline plus cognitive behavioral therapy to treat people with obsessive-compulsive disorder.
This protocol matches child subjects with peer mentors of similar age who have learned to function successfully with a chronic pain disorder. The trained mentors will present information to the subjects in a supervised and monitored interaction via telephone and computer for 2 months and encourage participation in skill-building programs. Children will be tested for improvement in pain and functioning at 2 months and again at 4 months to see if improvements persist. The investigators hypothesize that children who received peer mentor support will show more improvement in pain and functioning at 2 and 4 months into treatment than those in a control group who do not receive mentor support.
This study evaluated whether Fibromyalgia Integrative Training program for Teens (FIT Teens), a combined cognitive behavioral therapy and neuromuscular exercise training program is more effective in reducing disability in adolescents with Juvenile Fibromyalgia compared to cognitive behavioral therapy (CBT) alone or a graded aerobic exercise (GAE) program alone. One third of participants received the FIT Teens training; one third received CBT training; and one third of participants received the GAE training.
Autism spectrum disorders affect as many as 1 out of 88 children and are related to significant impairment in social, adaptive, and school functioning. Co-occurring conditions, such as anxiety, are common and may cause substantial distress and impairment beyond that caused by the autism diagnosis. Accordingly, we are proposing a randomized controlled trial to examine the effectiveness of a form of cognitive-behavioral therapy relative to treatment as usual (TAU) in 50 youth ages 6-12 with autism spectrum disorders and comorbid anxiety.