Active clinical trials for "Developmental Disabilities"

Children with autism spectrum disorders often engage in problem behaviors such as self-injury, destruction, aggression, and stereotypy. Prior research has clearly shown that these problem behaviors may interfere with learning, daily functioning, and social participation. As such, engaging in problem behaviors has a negative impact on the health and quality of life of children with autism spectrum disorders and their families. One promising solution to reduce problem behaviors in this population is the Prevent-Teach-Reinforce (PTR) model, which relies on the evidence-based practices of positive behavior support. Although the use of PTR has been gaining considerably support in schools, the model has never been evaluated as part of a rigorous large-scale study using parents as interventionists. Thus, the purpose of the project is to conduct an assessment of the effectiveness of a home-based version of the PTR model in reducing problem behaviors in children with autism spectrum disorders and in improving families' quality of life. Our hypotheses are that implementing the PTR will (a) produce larger reductions in problem behaviors than participating in an individual parent training session, (b) increase engagement in prosocial behaviors, (c) decrease parental stress, and (c) improve the quality of life of the family. The results of the study will allow an examination of whether PTR is an effective and acceptable model to reduce problem behaviors at home in this population. Given that problem behaviors incur high societal costs when they persist into adolescence and adulthood, the study may potentially lead to large cost reductions in the treatment of difficulties associated with autism spectrum disorders. By reducing engagement in problem behaviors, the implementation of the model may also promote and facilitate the social participation as well as improve the quality of life and health of children with autism spectrum disorders and their families.

Nearly all children with autism spectrum disorders engage in non-functional repetitive vocal and motor behaviours commonly referred to as stereotypy. These repetitive behaviours may considerably interfere with the child's daily functioning, learning, and social inclusion. As such, stereotypy generally has a negative impact on the child and family's health and quality of life. Several behavioural interventions have been developed to reduce engagement in stereotypy in children with autism spectrum disorders, but the limited number of specialists available, the long waiting lists associated with public health services in Canada, and the high costs of private services have considerably restricted accessibility. One potential solution to the limited availability and high costs of services is using a mobile application to recommend, teach, and monitor interventions designed to reduce engagement in stereotypy. To this end, the purpose of the study is to evaluate the effects of the iSTIM (i.e., individualized Stereotypy Treatment Integrated Modules), a mobile application designed to assist parents in reducing stereotypy in children with autism spectrum disorders. Specifically, we will assess whether the iSTIM correctly estimates the frequency or duration of stereotypy, offers suggestions consistent with recommended clinical practices, effectively reduces engagement in stereotypy, and is socially acceptable, safe, and easy to use for parents of children with autism spectrum disorders. The results of the study will allow us to determine whether the mobile application may be used to treat this core symptom in children with autism spectrum disorders, which could potentially reduce waiting times and costs of providing health services to this population. By reducing engagement in stereotypy, the iSTIM may also promote and facilitate the social participation as well as improve the quality of life and health of children with autism spectrum disorders and their families.

The investigators will assess the efficacy of parent delivered interventions in the treatment of social and communication deficits in children with autism. By collecting information about parent and child functioning before and after intervention, the investigators will be able to determine whether the intervention is effective in improving child social communication and reducing parent stress.

Children with developmental disabilities often sustain decreased range of motion in their extremities. The decrease in flexibility may be due to neuromuscular disorders such as spasticity or dystonia. Other causes may be imbalance in muscle strength surrounding a joint, leading to inappropriate habitual posture. Over time, muscle contracture may result for those muscle groups that are placed in a shortened position for an extended period of time. The most common site of muscle contractures among these children are gastrocnemius/soleus (lower limbs), and latissimus dorsi muscles (upper limbs). Muscle contractures can lead to further decline in functional abilities. Therefore, it is important to identify effective intervention strategies to enhance or maintain muscle flexibility in children with developmental dysfunctions. Commercially available endermotherapy device has been used to soften scar tissue following burn injuries. The mechanical stimulation applied may also have beneficial effects on relaxing the muscle tissue. The overall aim of the proposed study is to determine whether endermotherapy treatment has immediate effect in improving joint range of motion among children with developmental disabilities. The research hypothesis is that children in the endermotherapy group will have significantly more gain in ankle passive range of motion than those in the control group.

The purpose of this study is to determine the effectiveness of D-cycloserine for improving social impairment in child with pervasive developmental disorders (PDD).

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.

The purpose of this study is to determine if methylphenidate (a common brand name is Ritalin), a medicine used for treating older children with Attention Deficit and Hyperactivity Disorder (ADHD), is also safe and helpful for problems related to symptoms of ADHD in young children with Developmental Disorders (DD)

The purpose of this study is to determine whether treatment with oral N-acetylcysteine (NAC) will improve behavior problems often associated with autism spectrum disorders.

This study will evaluate the efficacy and safety of methylphenidate for treating hyperactivity, impulsiveness, and distractibility in 60 children and adolescents with Pervasive Developmental Disorders (PDD). Methylphenidate (Ritalin)is approved by the Food and Drug Administration for the treatment of children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD). Data supporting its safety and effectiveness in treating ADHD symptoms in PDD are limited. Children and adolescents who do not show a positive response to methylphenidate will be invited to participate in a pilot study of the non-stimulant medication guanfacine (Tenex).

The population cared for in the Transitional and Lifelong Care (TLC) clinic is youth and adults with childhood-onset disability, of which the large majority are adults with brain-based, neurodevelopmental conditions such as cerebral palsy, spina bifida and developmental disability. The TLC program was created to address the health inequities that have long existed for this population because of the gaps in care they experience once they transition from pediatric healthcare services to the adult healthcare sector. The TLC program offers coordinated and comprehensive management of co-occurring mental, social and physical health conditions for this group of adults with neurodiverse conditions. The proposed study will provide much needed evaluation of the TLC model as an intervention to provide transitional and lifelong care that reduces the barriers experienced because of the undefined clinic path - potentially more appropriately referred to as a "cliff" by a Freeman et al., (2015) - for these individuals. With appropriate evidence of effectiveness, scaling of the TLC program to other Ontario Health regions and more widely across Canada would improve access healthcare providers who are knowledgeable and competent in the management of physical and mental health conditions for adults with neurodiverse conditions as well as service integration and coordination between social and health sectors. The TLC clinic was co-designed with adults with neurodiverse conditions and health care providers in 2014 and represents a significant and sustainable change in the way healthcare has been delivered for this population in the Ontario Health West region over the last 7 years. More than 750 people have accessed coordinated and comprehensive care from Physiatrists, a Nurse Practitioner, Social Worker, Physiotherapist, Occupational Therapist, Speech Language Pathologist, Registered Dietitian and Rehabilitation Therapist in the TLC program since it began, documenting the effectiveness of this care has the power to re-shape care received for adults with neurodiverse conditions that onset in childhood in Canada.