Effectiveness of a Developmental Reciprocity Treatment Program in Autism
Autism Spectrum DisorderAutismThis is a research study examining the effectiveness of a Developmental Reciprocity Treatment Program (DRT-P) in treating social deficits in children with Autism Spectrum Disorders (ASD). Developmental Reciprocity Treatment is an early intervention that applies developmentally-informed teaching methods in naturalistic settings in order to target social and communication deficits. Researchers have begun to develop strategies to investigate the effectiveness of combining a parent training program teaching parents how to implement DRP with in-home, therapist-implemented treatment. To determine the effectiveness of the DRT-P, it will be compared to a delayed treatment group (DTG) by conducting a randomized controlled 24-week trial. This research will allow us to help in the development of therapeutic approaches that can meet the increasing service demands for families. We hope that investigating interventions that aim to improve core deficits will aid in providing better care for children with autism.
Efficacy and Safety of Bumetanide Oral Liquid Formulation in Children Aged From 2 to Less Than 7...
Autism Spectrum Disorder (ASD)The purpose of this study was to evaluate the efficacity and the safety of bumetanide/S95008 in the improvement of Autism Spectrum Disorder core symptoms.
5Minutes4Myself: A Wellness Program for Caregivers
AutismStress1 moreThis research study refines a wellness program designed for caregivers of autistic children called 5Minutes4Myself and further investigates its feasibility. Participants will attend a workshop to consent, participate in focus groups on lifestyle issues, and complete a baseline survey. Participants will have an individualized consultation with a coach to develop their tailored wellness program and be introduced to an app that support habits to build wellness activities into their daily life. The app provides the participant with their goal profile, tailored reminders, weekly check-ins, and delivers a micro-mindfulness program. Coaches will check-in monthly with participants and work together to modify their program as desired. After 4-6 months, participants will gather for a closing workshop to discuss their lifestyle and to evaluate the program. Pre-/post-surveys will examine health, well-being, stress, depression, and mindfulness. The app usability will be assessed using the Modified Systems Usability Scale (MSUS) as well as usage data.
A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Balovaptan in Children...
Autism Spectrum DisorderThis was a Phase Ib, multicenter, open-label study in children 2-4 years old with autism spectrum disorder (ASD) to investigate the pharmacokinetics, safety, and tolerability of an oral dose of balovaptan once a day (QD). The study was to consists of a 6-week treatment period to evaluate the pharmacokinetics of balovaptan in 2 to 4 year old children followed by an optional extension period of 48 weeks.
TSO in Pediatric Autistic Spectrum Disorders
Autistic Spectrum DisordersThe primary objective of this study is to evaluate and compare the safety and efficacy of Trichuris suis ova (TSO) therapy (versus placebo) in pediatric patients with autism. Evaluation of the safety and tolerability of treatment with TSO in the target population across the dose range being tested is considered a primary objective, while the primary efficacy objective will be assessed via the change from baseline in the Aberrant Behavior Checklist (ABC) subscale scores. Dose response will be considered a primary objective as well. Secondary assessments of efficacy will be assessed via: • The change from baseline in the Clinical Global Impression scale (CGI-I)
Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder or Pervasive Developmental...
Autism Spectrum Disorder (ASD)Autism5 moreThe objective of this study is to evaluate the long-term safety and tolerability of memantine in the treatment of pediatric patients with autism, Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS).
T-ABA Group Based Early Intervention For Parents of Children With ASD
AutismThis study is a 10-week, randomized, parallel groups design which will evaluate the efficacy of T-ABA with combined parent training and individual child sessions versus T-ABA with individual sessions alone. T-ABA refers to Targeted Applied Behavior Analysis treatment, a form of behavior therapy used to promote skill development and reduce disruptive behavior in individuals with autism. Four key outcome assessment points will be used: baseline (week 0), midpoint (week 5), end-of-study (week 10), and follow-up (week 20). Participants receiving T-ABA parent training only will be offered eight individual therapy sessions at the end of the study. Total study participation is estimated to be ~ 10 weeks with a single follow-up assessment.
Omega-3 Fatty Acids Monotherapy in Children and Adolescents With Autism Spectrum Disorders
Autism Spectrum Disorder (ASD)The primary aim of this study is to examine the efficacy and tolerability of short-term omega-3 fatty acids monotherapy in youth with Autism Spectrum Disorders (ASD). The investigators hypothesize that Omega-3 fatty acids will be efficacious in improving the core and associated features of ASD in youth, and that Omega-3 fatty acids monotherapy will be safe and well tolerated by youth with ASD. The secondary aim of this study is to examine the neuropsychological effect of Omega-3 fatty acids monotherapy in youth with ASD. The investigators hypothesize that omega-3 fatty acids will be efficacious in improving cognitive functions in youth with ASD.
Memantine in Adult Autism Spectrum Disorder
AutismAsperger's Disorder1 moreThe purpose of this study is to see if memantine is helpful in managing problematic symptoms in adults with autism, Asperger's disorder, or Pervasive Developmental Disorder not otherwise specified (NOS).
Extended Management and Measurement of Autism
Autistic DisorderThis open-label research study will continue to monitor the safety of fluoxetine in children after their completion of a previous double-blind placebo controlled clinical study, with fluoxetine. The study will also look at the effect of fluoxetine on IQ (Intelligence Quotient) over an 18 month period.