Clinical Research Projects

Behavioral Economics in MR/DD and Behavior Disorders (2)
Principal Investigator: DeLeon, Iser
Assessments of severe behavior disorders of children with intellectual and developmental disabilities (IDD) have revealed that behavior problems are often maintained by their functional outcomes (or...
Diffusion Tensor Imaging and Reading Disabilities
Principal Investigator: Denckla, Martha
We intend to test the hypothesis that DTI parameters will reveal abnormalities in fiber bundle architecture in the perisylvian region of children with RD, and that these DTI changes will be...
Electrophysiological Studies of Attention and Perception
Principal Investigator: Ewen, Joshua
This protocol is designed to allow for the recruitment of healthy adult volunteers in order to perform studies of attention and perception in human cognition. The primary purpose of this data...
Pilot Studies for Event-Related Potential Experiments
Principal Investigator: Ewen, Joshua
This protocol is designed to allow for the recruitment of healthy adult volunteers in order to pilot new paradigms for event-related potential (ERP) research. Since a significant portion of the...
Electrophysiological Studies of Autism
Principal Investigator: Ewen, Joshua
Abnormalities of cortical connectivity have long been suspected to be responsible, at least in part, for the autism phenotype. Research to date has used a number of modalities, but none has the time...
Studies of the Link between Autism and Epilepsy
Principal Investigator: Ewen, Joshua
This research consists of a retrospective record review to examine the link between autism, epilepsy and other clinical symptoms (including, but not limited to, intellectual disability, motor...
Neuropathological Assessment of Neonatal White Matter Injury in Human Autopsy Samples
Principal Investigator: Fatemi, S. Ali
Our group is interested in the study of perinatal white matter injury which affects thousands of prematurely born children every year and is the leading cause of cerebral palsy in this population. We...
12708A: An open-label study evaluating the Pharmacokinetics and Tolerability of Lu AA21004 in connection with multiple oral dosing of Lu AA21004 in child and adolescent patients with a DSM-IV-TR(TM) diagnosis of Depressive or Anxiety Disorder
Principal Investigator: Findling, Robert
This open-label study will evaluate the pharmacokinetic, tolerability and safety profiles of Lu AA21004 in connection with a multiple oral dosing in child and adolescent patients with a DSM-IV-TR...
SPD489-405: A Phase 4, Randomized, Double-Blind, Multicenter, Parallel Group, Active-Controlled, Dose-Optimization Safety and Efficacy Study of SPD489 (VYVANSE) Compared with OROS-MPH (CONCERTA) with a Placebo Reference Arm, in Adolescents Aged 13-17 Year
Principal Investigator: Findling, Robert
This study aims to evaluate the efficacy, safety, and tolerability of VYVANSE compared with CONCERTA in adolescents (13-17 years of age, inclusive) with ADHD. The study will have 3 phases 1)...
CIL0522D2402: A Multicenter, Open-Label, Sequential-Cohort, Dose-Escalation, 14-Day Study to Explore the Tolerability and Pharmacokinetics of Iloperidone (Fanapt®) 12 to 24 mg/day Followed by 26 Weeks of Flexible Dosing (6 to 24 mg/day) in Adolescent Pati
Principal Investigator: Findling, Robert
This study aims to obtain tolerability, Pharmacokinetic, safety, and efficacy data in adolescent patients (aged 12 to 17 years) requiring treatment with an antipsychotic agent. The study has 2 parts...
A0501093: SPRITES: SERTRALINE PEDIATRIC REGISTRY FOR THE EVALUATION OF SAFETY: A Non-Interventional, Longitudinal, Cohort Study to Evaluate the Effects of Long-Term Sertraline Treatment in Children and Adolescents
Principal Investigator: Findling, Robert
The primary objectives are to evaluate the long-term impact of treatment with sertraline on aspects of cognition, emotional and physical development, and pubertal maturation. Secondary objectives...
VLZ-MD-21: A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Vilazodone in Adolescent Patients with Major Depressive Disorder
Principal Investigator: Findling, Robert
Purpose This is a double-blind, randomized, placebo-controlled, fixed-dose trial designed to evaluate the efficacy, safety, and tolerability of vilazodone for the treatment of major depressive...
A Randomized, Placebo-Controlled Study to Investigate the Efficacy and Safety of Circadin® to Alleviate Sleep Disturbances in Children with Neurodevelopmental Disabilities
Principal Investigator: Findling, Robert
The purpose of this study is to establish the efficacy and safety of Circadin in children with neurodevelopmental disorders and to determine the dose, this randomized, placebo-controlled study is...
A Multicenter, Randomized, Double-Blind, 12-Week, Parallel Group, Placebo-Controlled Proof of Concept Study to Investigate the Efficacy and Safety of RO5285119 in Individuals with Autism Spectrum Disorders (ASD)
Principal Investigator: Findling, Robert
The main objective of this study is to evaluate the efficacy of a 12-week treatment with RO5258119 compared with a placebo in treating social communication deficits in adult individuals with ASD as...
Studies of Hormone Action in Patients with Altered G-protein-coupled Signal Transduction
Principal Investigator: Germain-Lee, Emily
Includes Substudies Entitled: "Study of Growth Hormone Secretion in Patients with Pseudohypoparathyroidism Type 1a (R01 FD002568)" and "Phase 2 Growth Hormone for Treatment of Albright Hereditary...
Rapalogues for Autism Phenotype in TSC: A Feasibility Study
Principal Investigator: Gipson, Tanjala
Tuberous sclerosis complex (TSC) is associated with autism and seizures. Recent studies in animals using rapamycin have shown cognitive improvement. Human studies have demonstrated a reduction in...
CRAD001M2304: A three-arm, randomized, double-blind, placebo-controlled study of the efficacy and safety of two trough-ranges of everolimus as adjunctive therapy in patients with tuberous sclerosis complex (TSC) who have refractory partial-onset seizures
Principal Investigator: Gipson, Tanjala
This study will investigate the efficacy and safety of everolimus, as adjunctive treatment, in patients ages 2-65 years with Tuberous Sclerosis Complex (TSC) that have refractory partial-onset...
Topical Rapamycin to Erase Angiofibromas in TSC - Multicenter Evaluation of Novel Therapy (The TREATMENT Trial)
Principal Investigator: Gipson, Tanjala
The study is a multi-center prospective, randomized, double-blind, placebo-controlled evaluation of the safety and efficacy of a topically applied formulation of rapamycin to cutaneous angiofibromas...
Features of Self-Injury in TSC
Principal Investigator: Gipson, Tanjala
Our objective in this study is to look at the feasibility of collecting de-identified data on the topography, severity, and frequency of disruptive behaviors in TSC using an on-line survey.
A Treatment Outcome Analysis of Children with Severe Feeding Disorders enrolled in the Pediatric Feeding Disorders Program at the Kennedy Krieger Institute
Principal Investigator: Girolami, Peter
This study will involve a retrospective chart review in order to assess treatment outcomes of children who have participated in the Pediatric Feeding Disorders Program at the Kennedy Krieger...
An Evaluation of Swallowing in Adults and Children Through the Use of a Piezo Electric Pulse Transducer and Surface Electromyogram
Principal Investigator: Girolami, Peter
The primary objectives of this research are to: (1) validate Piezo Electric Pulse Transducer (PPT) device and Electromyogram (EMG) with adults who do not have swallowing difficulties, (2) validate...
The effects of treatment preference and treatment integrity on treatment effectiveness
Principal Investigator: Gonzalez, Melissa
The purpose of this research is to determine if allowing a patient or a caregiver choice between different available treatments will affect the treatment effectiveness. Moreover, data on treatment...
Program evaluation of caregivers' behavioral workshop
Principal Investigator: Gonzalez, Melissa
The Pediatric Feeding Disorders Program at Kennedy Krieger Institute provides services aimed at establishing appropriate feeding responses for children who present with a variety of feeding...
Evaluation of Assessment and Treatment Data in Individuals with Intellectual/Developmental Disabilities
Principal Investigator: Hagopian, Louis
The purpose of this retrospective record review is to develop a database to evaluate the efficacy and efficiency of behavior analytic procedures in assessing and treating severe problem behavior.
Establishing Attention as a Reinforcer for Individuals With Autism Spectrum Disorder
Principal Investigator: Hagopian, Louis
Previous research has shown that some individuals with autism spectrum disorder have an atypical reaction to social attention (e.g., praise) delivered by others. In some cases these individuals do...
Delineating subtypes of self-injurious behavior maintained by automatic reinforcement
Principal Investigator: Hagopian, Louis
Self-injurious behavior (SIB) is a significant problem for many individuals with intellectual disabilities. In approximately three-fourths of individuals, behavioral assessment procedures show that...
Pediatric Psychology Consultation-Liaison Services: A Review of Clinical Practice and Patterns
Principal Investigator: Hendricks, Melissa
Pediatric psychology consultation-liaison (CL) service is the most active form of collaboration between pediatric psychologists and health care specialists. The proposed study is a combination of...
Interrelationships among quantitative measures of white matter injury, sensorimotor function and learning profiles in children with cerebral palsy
Principal Investigator: Hoon, Alexander
Injury to white matter pathways is strongly associated with the severity of spastic diplegia in children born preterm. In previous research, we have shown that there is preferential injury in sensory...
Quantitative mapping of the basal ganglia and related structures in children with dyskinetic cerebral palsy
Principal Investigator: Hoon, Alexander
In previous research over the past decade, we have shown that there is preferential injury in sensory pathways than in descending corticospinal tracts in children born prematurely with...
Comparison of Executive and Adaptive Skills in Individuals Diagnosed with Brain Tumor versus ADHD
Principal Investigator: Jacobson, Lisa
Neuropsychological assessment and screening is a useful means of identifying cognitive deficits in children and adolescents. Expansion of availability of instruments has now permitted an examination...
Kennedy Krieger Institute Family Center - Treatment Effectiveness Study (KKFC-TES)
Principal Investigator: Jamora, Mariflor
The goal of this study is to determine the effectiveness of the various programs within the Kennedy Krieger Family Center (KKFC) using data from a computerized clinical database. Established in 1985...
NP27936: A randomized, double-blind, 12-week, parallel group, placebo-controlled study of the efficacy and safety of RO4917523 in patients with Fragile X Syndrome
Principal Investigator: Johnston, Michael
The purpose of this study is to evaluate the efficacy of 12-week treatment with RO4917523 in patients with Fragile X Syndrome (FXS) as measured by the Anxiety Depression and Mood Scale (ADAMS) social...
A Randomized, Parallel Group, Double-Blind, Placebo-Controlled, Safety and Exploratory Efficacy and Pharmacokinetic, Study of RO4917523 In Pediatric Patients With Fragile X Syndrome: NP28571
Principal Investigator: Johnston, Michael
The purpose of this study is to evaluate the tolerability and safety of two doses of RO4917523 over 12 weeks in comparison with placebo in pediatric patients with Fragile X Syndrome (FXS), as well as...
Clinical Trials Center Intake, Registry and Questionnaire Database Project
Principal Investigator: Johnston, Michael
The Objectives of this protocol are: a. To create a standard intake process for individuals interested in possible participation in clinical trials at the Clinical Trials Unit (CTU), as well as to...
Identification of the Determinants of Exercise
Principal Investigator: Kahng, SungWoo
The overall goals of this project are to develop an assessment procedure, based on functional analysis methodology, to determine what maintains exercise during preferred fitness activities in...
Assessment and Treatment of Problem Behavior in Individuals with Intellectual Disabilities
Principal Investigator: Kahng, SungWoo
The purpose of this research is to prospectively evaluate clinical data obtained from assessment and treatment procedures for behavior disorders in individuals with intellectual disabilities on the...
Effects of training on caregiver implementation of behavior-analytic skills
Principal Investigator: Kahng, SungWoo
This small N study will examine additional effects of our standard of care for caregiver training on the implementation of specific skills with children with severe problem behavior. These skills...
Evaluations of Teacher Training Procedures
Principal Investigator: Kahng, SungWoo
Teachers and staff members responsible for teaching individuals with intellectual disabilities new skills typically receive training from the supervisors within their organization. A variety of staff...
Student-Centered Behavioral Interventions to Reduce Challenging Behavior in the Classroom
Principal Investigator: Kahng, SungWoo
Aggressive behavior in young children is a known risk factor for youth violence (CDC, 2011). New methods for preventing youth violence and juvenile delinquency are needed to address this growing...
Retrospective Review of Extrinsic Factors Associated with Changes in Clinical Status of Patients with Mitochondrial Disorders
Principal Investigator: Kelley, Richard
The specific aims of this retrospective study in patients with known primary mitochondrial disorders are:  To determine which recommended immunizations have been given to patients with known...
X-Linked Dominant Conradi-Hünermann Syndrome: Clinical and Biochemical Phenotype in Affected Males
Principal Investigator: Kratz, Lisa
X-Linked Dominant Conradi-Hünermann Syndrome (CPDX2) is a rare disorder of cholesterol biosynthesis caused by a deficiency of 3beta-hydroxysteroid-8, 7-isomerase (sterol isomerase), an enzyme encoded...
First Trimester Diagnosis of Smith-Lemli-Opitz Syndrome
Principal Investigator: Kratz, Lisa
Is sterol analysis of direct chorionic villus material or amniotic fluid an accurate method for first trimester diagnosis of Smith-Lemli-Opitz syndrome?
Risk factors for persistent self injury
Principal Investigator: Kurtz, Patricia
The purpose of this study is to assess 5 factors believed to be related to the persistence of self-injurious behavior (SIB): parenting practices, child communication, parent depression, parent stress...
An evaluation of choices across social contexts by children with disabilities exposed to bilingual environments: The role of stimulus and language preference
Principal Investigator: Kurtz, Patricia
For children with disabilities who are exposed to bilingual environments, variations in the language in which leisure items (e.g., books, magazines, music) are presented, the language spoken by the...
Sleep and Cognitive Function after Mild Traumatic Brain Injury in Adolescents
Principal Investigator: Lam, Janet
After mild traumatic brain injury, many adolescents complain of sleep problems and encephalopathy. This study aims to measure both of these complaints in an objective way to quantify how they are...
Parent-Mediated vs. Center Based Intervention for Toddlers with ASD: an RCT
Principal Investigator: Landa, Rebecca
The major focus of the study is to evaluate the relative impact of two different intervention experiences on social and communication development of minority and underserved toddlers with ASD and...
Autism and the Development of Relational Awareness
Principal Investigator: Landa, Rebecca
Aims of the proposed research are: to test hypotheses about a deficit in understanding the relationship between objects (e.g., stimulus and reward) in autism, and how this relates to rule learning...
Optimizing Social and Communication Outcomes for Young Children with Autism
Principal Investigator: Landa, Rebecca
The overarching goal of the proposed project is to rigorously test an intervention program for caregivers and their toddlers with autism that is developmentally informed, child-centered and focused...
Developmental and Augmented Intervention for Facilitating Expressive Language
Principal Investigator: Landa, Rebecca
Children who do not communicate with spoken words or an augmentative/alternative communication system are an underserved group among those with autism spectrum disorders (ASD). Because caregivers are...
A Comprehensive Approach to Intervention for Toddlers at Risk for ASD
Principal Investigator: Landa, Rebecca
Research questions are: What are early intervention effects on developmental trajectory and autism symptoms in 14- to 22-month-olds with social and communication delays that indicate high risk for...
Classroom-Based Early Intervention for Toddlers With Autism
Principal Investigator: Landa, Rebecca
The proposed project seeks to continue research into the impact of early intervention targeting interpersonal synchrony on the process of social and communication development in toddlers with non-...
Relationship Status Among Parents of Children with Autism Spectrum Disorders
Principal Investigator: Landa, Rebecca
For this study, we will examine the relationship status of parents of children with autism spectrum disorders (ASD). We would like to understand the relationship status of biological parents of...
Personality Style and Parenting for Fathers of Children with Autism
Principal Investigator: Landa, Rebecca
Goal: To create a better understanding of the experience of fathers of children with autism spectrum disorders (ASD). Specific Aims: To identify the extent which particular personality dimensions...
Social Skills Intervention for School-aged Children with ASD
Principal Investigator: Landa, Rebecca
Primary Objective: Our primary objective for this study is to test the effectiveness of two distinct models of social skills group interventions (SKILLS and ENGAGE) with an ethnically and...
Early Detection, Intervention, and Neurobiology in Autism: Neurobiology Portion
Principal Investigator: Landa, Rebecca
This research is being done to learn more about the brain development in children with autism and related disorders. We will be looking at blood samples to examine substances that influence early...