Active clinical trials for "Autism Spectrum Disorder"

The purpose of this project is to conduct a feasibility test of an ASD executive functioning intervention adapted for mental health settings, including examining the effectiveness and process of implementing this adapted intervention in community mental health programs.

Antipsychotic medications are commonly prescribed in children and adults with ASD (Curtin, Jojic & Bandini, 2014). But weight gain has been known to be one of the less desirable effects of these medications, increasing one's risk for overweight and obesity. Based on experience in Holland Bloorview's Nutrition Clinic, working with a dietitian to follow specific dietary advice, such as having more protein while keeping the amount of calories the same, may be a possible and useful way to limit weight gain. This study's objective is to evaluate the feasibility (study designs, methods, processes) and acceptability (client/family satisfaction, perceived effectiveness) of a controlled energy diet with elevated protein intake in children and youth with ASD who are currently taking prescribed atypical antipsychotic medication.

The main objective of the study is to evaluate the effectiveness of a parent's training program (name PEGASE) of young children (aged 2 to 4 years) with Autism Spectrum Disorders. This study is follow up by the Autism Resource Center PACA (CRA PACA), which is located in Marseille's university Department of Child Psychiatry. This center is a regional expert center in diagnostic and research missions in the field of Autism. The center is promoting new advances in the field of Autism Spectrum Disorders (ASD) The center receives requests for diagnostic assessment from all the region. Autism is to date a major public health problem, current prevalence rates are 1 child / 88 in the United States. This prevalence continues to increase. Autism is a severe neurodevelopment disorder with significant functional impact. An essential axis in the field of health is to develop new treatment strategy including low costs and family impact particularly in quality of life. In France, consensus guidelines (HAS 2012) on the diagnosis assessment for Autism Spectrum Disorders (ASD) people and interventions were edited. Support for grade recommendations have been issued. In this research, the investigators focus on a global, early and coordinated management method: the Early Start Denver Model. This intervention obtained a grade B to the recommendations of the HAS in 2012. Early Start Denver Model (ESDM) is scientifically proven by a lots of studies. Two management modalities are discuss in the ESDM model: the classical ESDM and the ESDM P (parents ESDM). Even if in both ways of care, the parent is put in a central position around the care of the child. In P ESDM, the parent is trained in the techniques of ESDM itself. This parental coaching program at ESDM (P-ESDM) was developed by Rogers et al at Sacramento Davis University. P ESDM is not yet developed in France and has not been the subject of any French-language publication to date. This program is dedicated to young parents of children with autism spectrum disorders aged between 2 and 4 years old. This is a 7-month program (with a duration of inclusion of 3 year). The program is based on ESDM techniques, it meets both the need to include parents in care and the idea of reducing the cost of these care (need fewer hours of care by professionals). This program is offered to all parents of autism spectrum disorders children between the ages of 2 and 4 who go to CRA PACA for an expert diagnostic evaluation. The aim of this study is to objectify the effectiveness of this parental intervention in a French population.

The objective of this study is to gain preliminary information and knowledge on metabolic profile in ASD. The benefit of this study will be to expand our insight of the potential relationship in metabolic processes and neuropsychological functions in ASD. For example, based on the obtained data of the study we can determine whether there is a link between the tryptophan pathway and cognitive functions in autism. The project is based on a systematic and multidisciplinary approach using tracers for delineating the mechanism by which the metabolism of amino acids like TRP is involved in affective and cognitive functions in ASD. Using an innovative approach to the evaluation of amino acids has not been used in adults with ASD. In addition, the obtained data of the study holds promise to develop specific markers (metabolic and/or neuropsychological) for guiding the identification those individuals with increased risk of developing mood disturbances or cognitive impairment, and for predicting the therapeutic effect of a specific nutritional interventions in subjects with ASD.

Specific Aim 1: Obtain proof of concept evidence that cortical metrics will change in response to treatment with Memantine extended release (XR)®, an agent that modulates n-methyl d-asptartate (NMDA) receptor activation, in children with autism spectrum disorders (ASD) who clinically demonstrate treatment response. Hypothesis1: Children with ASD who have dramatic clinical response to Memantine XR® will exhibit changes in their cortical metrics, which will differ less from neurotypical children. Subjective ratings of improvement will be correlated with the change in cortical metrics. The completion of these aims will be essential to design a larger federally funded trial to validate cortical metrics as an outcome measure in a more heterogeneous pediatric ASD sample. Specifically, the feasibility data obtained may demonstrate the potential for detecting changes in cortical metrics over time, so that a larger grant could focus on determining how sensitive and clinically relevant changes in cortical metrics are or may indicate the need to explore different interventions to use in a validation study. We have chosen to use Memantine XR® because of its impact on NMDA neurotransmission, its current evaluation in a large multi-site randomized ASD clinical trial whose initial results are expected shortly, and our own observations of clinical improvements and good tolerability in the ongoing trial.

Despite an increasing number of children with Autism Spectrum Disorder (ASD), fragmentation across child and adult service systems results in poor education, employment and health outcomes for transition-aged youth (TAY). The investigators will develop a transition intervention embedded in a series of systems-level strategies currently being deployed in a large Medicaid Accountable Care Organization (ACO). The investigators will conduct a randomized pilot study of 40 families of TAY with ASD. All families will receive care by providers trained in the Got Transition toolkit (the systems level component of the intervention) and have access to web-based transition resources. Families in the 'intervention refinement' arm will also receive a family-based problem solving education (PSE) intervention.

The objective of this study is to examine caregiver reactions to the use of the hum by Colgate Smart Kids Toothbrush and associated app by children with autism spectrum disorder (ASD).

Background: the autism spectrum disorders (ASD) can be related with abnormalities in cortical structures and cause behavior imbalances. In addition, as soon as the diagnosis is done, the better will be the prognosis. In this context, heart rate variability (HRV) stands out, which is a non-invasive tool representing autonomic modulation, with potential prognostic value. The literature showed there are no changes in HRV at rest using linear methods of analysis, but changes can be identified during tasks. Nonlinear methods of HRV are more sensitive and provide additional information to the linear. Objective: to analyze autonomic modulation using nonlinear and linear indexes of HRV in children with ASD at rest and during tasks in comparison to typical children. In addition, to correlate HRV analysis between them, also between behavior and severity of the disease. Methods: this study involves both typical children and children with ASD. Autonomic modulation will be performed using nonlinear indices (extracted from Poincaré plot, detrended fluctuation of tendency analysis and recurrence plot) and linear indices of HRV in the time (RMSSD e SDNN) and frequency domain (LF, HF, VLF). The tasks consist in games to identify and recognize faces and facial expressions. Behavior and severity of the disease will be evaluated using the Autism Behavior Checklist and the Childhood Autism Rating Scale respectively. Statistical Analysis: to identify differences between moments and protocols two-way analysis of variance will be used along with the Bonferroni post-test or Dunn post-test according to the data distribution. Statistical significance will be set at 5%.

Specific Aims: This study aims to examine the hypothesis that individuals with Autism spectrum disorder (ASD) and their unaffected siblings shared alterations in gray and white matter volume and their associated intrinsic functional connectivity, to build upon limited literature about neuroimaging endophenotypes of ASD. The investigators also aim to test whether these shared differences are associated with behavioral autistic traits.

Autism Spectrum Disorder refers to complex neuro-developmental disorders that affect social communication and behavioral adaptation. Currently, the diagnosis of Autism Spectrum Disorder is based on a clinical examination that is performed classically during the first three years of life. The heterogeneity of the disorders occurring in autism make pathologies difficult to diagnose and manage. The overall goal of this project is the identification of metabolic biomarkers based on clinical profile. The best characterization of physiopathological pathways will ultimately allow the identification of subgroups of subjects and facilitate the development of targeted therapeutics. The proposed work aims to test the hypothesis of a disruption of tryptophan metabolism in Autism Spectrum Disorder via the gut microbiota.