Active clinical trials for "Autism Spectrum Disorder"

ASD is a diverse disorder starting in early childhood and characterized by social communication impairment as well as restricted interests and repetitive behaviors. It affects 1:68 children and is an enormous medical and economic problem for which there is no established, mechanism-based treatment. Sulforaphane is an isothiocyanate derived from broccoli, and has potent activity in transcriptionally up-regulating genes that control mechanisms whereby aerobic cells protect themselves against oxidative stress, mitochondrial dysfunction, and inflammation. This study is a clinical trial of oral sulforaphane (as broccoli seed powder) in 50 boys and girls (3-12 years) with ASD in 3 phases over 36 weeks. In Phase 1, 25 children will receive active drug and 25 will receive placebo for 15 weeks; in Phase 2, all children will receive sulforaphane from 15-30 weeks; in Phase 3, children will receive no treatment for 6 weeks. Study visits will take place at screening, 7, 15, 22, 30 and 36 weeks, when the Ohio Autism Clinical Clinical Impressions Scale - Severity and Improvement (OACIS-S and OACIS-I), Aberrant Behavior Checklist (ABC) and Social Responsiveness Scale (SRS) will be recorded. Children will be monitored with physical examinations and for toxicity with clinical laboratory studies and examine possible biomarkers: Nuclear factor-erythroid factor 2 (Nrf2), oxidative stress and mitochondrial function, the mechanistic target of rapamycin (mTOR) pathway and cytokine expression. In addition, prior to the main clinical trial, a pilot study will be carried out in 10 children with ASD, 6-12 years of age, who will receive sulforaphane, 2.2 micromoles/kg daily for 14 days. Blood and urine samples before and at the end of treatment will be collected, in order to measure several parameters that are likely to demonstrate expected effects of sulforaphane, to standardize the assays and procedures, and to determine the most effective measures.

The purpose of this study is to determine the effect of a prebiotic (BGOS) on gut microbiota and metabolites in children with autism spectrum disorders.

This study will develop and test a treatment aimed at reducing anxiety in social situations for children and adolescents with autism spectrum disorders.

The goal of this project is to test an intervention program for caregivers and their young children with autism that is focused on improving social communication. This study specifically targets underserved populations, specifically children from low SES and racial/ethnic minority families. Participants will include 40 children (aged 24 months to 60 months) and their caregivers who will be randomized (as if by flipping a coin) to one of the two treatments: Parent education sessions for two hours a week for 12 weeks or parent-child intervention sessions with the child for one hour, twice a week for 12 weeks. Young children with autism have difficulty with engaging in joint attention with others (e.g. pointing, showing. Joint attention skills are important to later development of language. Therefore, targeting this problem in young children may result in better language outcomes for these children. In order to examine the effects of the interventions, all participants will be complete cognitive, language, communication and play-based assessments prior to treatment, at the end of the first 12 weeks of the intervention, and post-treatment immediately following the intervention (approximately 2.5 to 3 hours each).

This research is being done to test the effectiveness of two treatments aimed at increasing language and social skills in children with autism spectrum disorder. If children show improvement in these treatments, we hope that the availability of public services for minority and low income families will be increased. Minority and low income families with children between 22 and 33 months of age with Autism Spectrum Disorders may join.

This project will examine the efficacy of two different treatment approaches aimed at facilitating change in social and communications outcomes of toddlers with autism.

Background: - Autism spectrum disorders (ASD) are developmental disabilities characterized by impaired social interaction and repetitive and/or stereotypical behaviors. Research studies suggest that some individuals with ASD have very low blood cholesterol levels. This low cholesterol level and other abnormal sterol levels may be important markers for subtypes of ASD. Providing additional cholesterol to the diets of children with ASD may help improve behavior. - These findings will guide the medical community in identifying individuals who should be tested for sterol disorders. This study will also help researchers learn whether adding extra cholesterol to the diet will improve behavioral and other autism spectrum characteristics seen in individuals with ASD and low cholesterol. Objectives: To determine cholesterol levels in children with autism spectrum disorders. To compare behavioral and other characteristics among children who have autism spectrum disorders and high, low, or normal cholesterol levels. To determine whether adding cholesterol to the diet will improve behavioral and other characteristics in individuals with ASD and low cholesterol. Eligibility: - Children between the ages of 4 and 12 who have been diagnosed with an autism spectrum disorder. Design: Initial screening study will involve a collection of blood samples (for study purposes and cholesterol testing). Children who have low cholesterol levels will take part in a study in which they will receive either cholesterol supplementation or a placebo, and will have detailed physical and psychological examinations to measure possible improvement in behavioral or other characteristics. Children who have high or normal cholesterol levels will have further blood samples taken, and will undergo an additional set of examinations for comparison purposes. Researchers may request blood or DNA samples from other family members (parents or siblings), which will be collected through blood draws and cheek swabs.

Comorbid anxiety disorders affect as many as 80% of youth with autism spectrum disorders, causing substantial distress and impairment over and above the autism spectrum diagnosis alone. Cognitive behavioral therapy (CBT) is the gold standard treatment among typically developing youth with an anxiety disorder and when adapted, shows promise in children with ASD and comorbid anxiety. However, there is currently no psychotherapy protocol tailored to meet the unique needs of young adolescents with Autism spectrum disorders (ASD) and comorbid anxiety. Given this, the present study seeks to develop and test a new CBT therapy in adolescents with autism and comorbid anxiety.

This study will compare the efficacy of a behavioral parent training program (PT) aimed specifically at common sleep disturbances compared to parent education (PE) program focusing on general issues related to autism. In a sample of 40 well characterized young children who meet criteria for an autism spectrum disorder (24-72 months), the investigators will test whether the five session PT program is superior to the PE program in decreasing sleep disturbances. The primary aim of this study is to evaluate the efficacy and feasibility of a PT program for sleep disturbance in young children with autism compared to PE. To this end, there are two hypothesis: Hypothesis 1: After the end of treatment, PT will be significantly more effective than PE in improving parent reports of a) bedtime struggles and resistance; b) sleep latency; c) night wakings; d) morning wakings; and / or e) sleep association problems as measured by the composite sleep index score from the modified Simonds and Parraga Sleep Questionnaire (MSPSQ; Simond & Parraga, 1982; Wiggs & Stores, 1998). Hypothesis 2: At the end of treatment, children in the PT group (n=20) will display significantly improved total sleep period as measured by actigraphy in comparison to children in the PE group (n=20). The secondary aim of this study is to evaluate the impact of participating in PT on child's daytime behavior and functioning and parenting stress compared to PE. To measure this aim, there are 4 exploratory hypothesis: Exploratory Hypothesis 1: Lower Irritability subscales scores will be reported on both parent and teacher / therapist completed Aberrant Behavior Checklist (ABC) for the PT group than the PE group at 4 weeks and 8 weeks Exploratory Hypothesis 2: Lower Child Behavior Checklist (CBCL; parent completed) and Caregiver-Teacher Report Form (C-TRF; teacher completed) scores will be reported for the PT group than the PE group at 4 weeks and 8 weeks. Exploratory Hypothesis 3: The PT group will have higher scores on the Vineland Adaptive Behavior Scales: 2nd Edition (VABS-II) at 4 weeks and 8 weeks compared to PE group. Exploratory Hypothesis 4: Parents receiving PT will report significantly lower scores on the Parenting Stress Index (PSI) at 4 weeks and 8 weeks compared to parents receiving PE.

This study will determine the effectiveness of mirtazapine in reducing anxiety in children with autistic disorder, Asperger's disorder and Pervasive Developmental Disorder.