Active clinical trials for "Autistic Disorder"

Social skills interventions are sometimes used to treat the social impairments of higher-functioning children with autism spectrum disorder (hfASD; without intellectual disability). Despite the recognized need for such treatments, few children with hfASD receive social interventions. Efforts to develop and implement school social interventions have been hindered by barriers during the school day (e.g., lack of resources, staffing, training, and time). As such, there is a need for feasible and effective social interventions that can be delivered by non-professional (paraprofessional) school staff in school settings including after-school programs. The purpose of this study is to test the feasibility and initial efficacy of an after-school social intervention delivered by paraprofessionals in school settings for children with hfASD. Children will be randomly assigned to the social intervention group or a no-treatment control (waitlist) group. The intervention will be delivered by paraprofessionals four days per week (90 minutes per session) over eight weeks during the children's after-school program conducted at their schools. Sessions include social skills groups, social recreational games to practice skills, and behavioral reinforcement to strengthen learning. Feasibility will be assessed via implementation fidelity (accuracy), parent and child satisfaction ratings, and attendance and attrition rates. Outcomes will test the intervention effect on a child test of social-cognition, parent ratings of social skills and ASD symptoms, and behavioral coding of social competence by naïve raters during unstructured game play. Child outcome measures will be completed for both the social intervention group and no-treatment control (waitlist) group immediately prior to (pretest) and following (posttest) the eight-week intervention, and children initially assigned to the social intervention will also complete the assessments three months later (follow-up). Children assigned to the no-treatment control (waitlist) group will receive the social intervention after the intervention group completes the social intervention.

The purpose of this study is to build upon an earlier study that evaluated the use of a 10-week transdiagnostic Group Behavioral Activation Therapy (GBAT), a telehealth delivered intervention, as a cost effective and accessible way to treat symptoms of anxiety and depression in autistic adults. The current study will pilot and compare relative feasibility, acceptability, and preliminary efficacy of three adapted GBAT groups and a Watchful Waiting (WW) group. The three groups include GBAT+Individual (GBAT+I; individual sessions to supplement the 10 group sessions), GBAT+Engagement Booster (GBAT+E; supplemental materials), and GBAT+Both (GBAT+IE individual sessions and supplemental materials).

This study will be conducted to evaluate the efficacy of GWP42003-P, compared with placebo, in reducing symptom severity in children with Autism Spectrum Disorder (ASD).

This is a multicenter, open-label study to evaluate the efficacy and safety of a daily single oral dose of tasimelteon in treating sleep disturbances in pediatric and adult participants with ASD.

An open label trial to assess the safety and efficacy of transcranial photobiomodulation (tPBM) in improving autistic traits in ADHD youth.

The study will be a randomized controlled trial, which will aim to establish the appropriate and feasible content of the planned motor intervention program. A sample of 30 young children with ASD (4 to 5 years old) will be randomly assigned to treatment and control groups. Children in the treatment group will receive a 8-week motor skill intervention program. Children in the control group will receive a 8-week cognitive training program. Each week will be of 1.5-hour duration. Outcome measurements will consist of the Bruininks-Oseretsky Test of Motor Proficiency-Second Edition Brief Form and Vineland Adaptive Behavior Scales-Third Edition. A two-factor mixed design ANOVA will be conducted to compare pre- and post-tests differences in the treatment and control groups. The findings of the proposed study will be useful for occupational therapists and clinicians to assist caregivers in implementing the intervention program and will contribute to knowledge regarding the effects of motor intervention program on increasing the motor skills of young children with ASD in Taiwan. Practitioners can design a standard treatment manual and provide information for implementing the motor intervention program. The expected results will help clinicians apply empirical knowledge to provide and promote the health and development of young children with ASD.

Although many children diagnosed with autism spectrum disorder (ASD) make significant progress in learning and their cognitive skills improve with applied behavior analysis (ABA), there are a significant number of children who show an absence or a plateau in various skills. Deficits in executive functioning are likely to be involved in many of these cognitive and learning disabilities due to poor functioning of the prefrontal cortex. Currently, the use of biological methods for improving learning and cognition is largely unexplored in research and practice. The aim of this study is to use of transcranial direct current stimulation (tDCS) in combination with ABA to improve the acquisition of educational programs for students with ASD. tDCS is a low-level electrical neurostimulation and is most effective when used in combination with an active training or teaching, facilitating the neuronal circuits used for that task. tDCS has been used for various indications over a couple of decades and has been shown to be very safe and has been well-tolerated by children with ASD. The mechanism of tDCS is not clear, however animal studies show that tDCS can stimulate the flow of calcium ions through channels in the astrocytes, activating them, and facilitating their role in synapse formation and therefore learning.

This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Autism

The current clinical trial is focused on evaluating the efficacy of rTMS for treatment of depression in youth and young adults (hereafter called transition aged youth, TAY) with autism spectrum disorder (ASD). The motivation to undertake the current efficacy study is driven by: (1) the substantial impact of depression on TAY with ASD (based on prevalence and contribution to disability/impairment); (2) lack of evidence-based treatments for depression in autism (there are no current trials rigorously evaluating any treatment for depression, i.e., psychotherapeutic, pharmacotherapeutic, brain stimulation); (3) rTMS has demonstrated efficacy in non-autistic individuals to improve symptoms of depression and may be better tolerated in youth than medication treatment; (4) a prior pilot rTMS study focused on treatment of executive function deficits in autism indicated that high frequency rTMS delivered using a rigorous randomized control trial (RCT) protocol can be feasibly implemented in TAY with autism, is well tolerated (mild to moderate adverse effects and low drop out), and has the potential to improve symptoms of depression.

The AIRB research team will compare the use and effectiveness of each intervention (Mind the Gap, Remaking Recess and Self Determination Learning Model of Instruction) with and without the addition of our implementation strategy, UNITED. In all groups, the research team will train community practitioners using remote delivery of professional development modules specific to the intervention, and active coaching for up to 12 sessions as dictated by the intervention procedures. The research team will pair UNITED with three interventions that cover the ages of early childhood, childhood, and adolescence. These include Mind the Gap (MTG), a family navigation intervention for children newly diagnosed under age 8, Remaking Recess (RR), a school-based social/peer engagement intervention for children ages 5-12, and Self-Determination Learning Model of Instruction (SDMLI), a self- advocacy intervention for adolescents (13-22 years; 22 is the upper age limit of high school for individuals with disabilities). For Remaking Recess, school personnel will be working with children with ASD using the Remaking Recess Intervention (play-based intervention done during recess). School personnel will be trained to implement the intervention. The total time commitment for the school personnel is about 30 hours. The total time commitment for the parents with ASD who will sign consents and fill out a demographic survey is about 15 minutes. The total time commitment for children with ASD or other neurodevelopmental disorders (NDD) is about 5 hours during their regularly scheduled recess period throughout the school year.