Cholesterol in ASD: Characterization and Treatment
AutismAsperger Disorder1 moreBackground: - 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.
Open-Label Extension Study of Kuvan for Autism
Autistic DisorderThis is an open-label extension study available only to subjects who completed an earlier double-blind, placebo-controlled study of sapropterin in children with autism.
Trichuris Suis Ova in Autism Spectrum Disorders
AutismThe purpose of this study is to determine whether Trichuris Suis Ova (TSO) is safe and effective in treating adults with autism spectrum disorder
Study of Glutathione, Vitamin C and Cysteine in Children With Autism and Severe Behavior Problems...
AutismSevere Behavior DisorderThis is a double-blind, placebo-controlled crossover study to evaluate the safety and efficacy of glutathione alone or glutathione, vitamin C and NAC treatment in children with autism who also have severe behavior problems. The investigators hypothesis is that children with autism will show improvement in both learning capabilities and behavior with either glutathione, or glutathione, vitamin C and NAC therapy.
A Trial of CM-AT in Children With Autism- Open Label Extension Study
AutismThe purpose of this study is to determine whether CM-AT is effective in treating the core symptoms of autism.
Buspirone in the Treatment of 2-6 Year Old Children With Autistic Disorder
Autistic DisorderThe purpose of this study is to evaluate the effects of twice-daily oral buspirone on core features of autism in autistic children aged 2-6 years as measured by the change from baseline in the Autism Diagnostic Observation Schedule (ADOS) Composite Total scores compared to placebo at 6 months.
Social Skills and Anxiety Reduction Treatment for Children and Adolescents With Autism Spectrum...
Autistic DisorderChild Development Disorders1 moreThis study will develop and test a treatment aimed at reducing anxiety in social situations for children and adolescents with autism spectrum disorders.
An Open-Label Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder,...
Autism Spectrum Disorder (ASD)Autism5 moreThe purpose of this study is to evaluate the safety and tolerability of memantine in pediatric (6-12 years old) patients with autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) and to identify responders for participation in a follow-up randomized withdrawal study.
Treatment of Sleep Disturbances in Young Children With Autism
AutismAutism Spectrum DisordersThis 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.
Atomoxetine Versus Placebo for Symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) in Children...
Autistic DisorderAttention Deficit Disorder With HyperactivityThe purpose of this study is to determine whether atomoxetine is effective in reducing ADHD (Attention Deficit/Hyperactivity Disorder) symptoms in children and adolescents with ASD (Autism Spectrum Disorder).