Active clinical trials for "Autism Spectrum Disorder"

This research project will investigate if a supplement containing a unique combination of prebiotics and probiotics can influence behaviour in children diagnosed with autism spectrum disorder. The study will use a combination of human milk oligosaccharides (HMOs, prebiotics) and probiotics as an oral powder.This clinical trial will have two consecutive phases. Phase 1A is an 8-week randomised, double-blinded, placebo-controlled trial. Participants will be recruited and randomised (1:1) to receive either the investigational product (treatment group, n=30) or the placebo (control group, n=30). Phase 1B is an 8-week open-label study. All participants that complete Phase 1A will move into Phase 1B (n=60). This allows all participants to receive the investigational product and will provide additional information on increased duration of treatment.

There are limited approaches to specifically address auditory sensory over- and under-responsivity (SOR) in children with Autism Spectrum Disorder (ASD). Exposure therapy (or systematic desensitization) may be a treatment option; researchers are investigating this approach. Many children receive sensory integration therapy, but this approach does not specifically target auditory SOR. Some families are advised to have their children avoid noxious stimuli or use compensatory techniques such as wearing headphones or ear plugs. While preliminary research suggests that use of noise attenuating headphones may reduce sympathetic activation for children with ASD and auditory SOR, this approach does not seek to change or alter the underlying cause of sympathetic activation (Pfeiffer et al., 2019). Sound-based interventions are promising options to treat hyperacusis and subsequent auditory SOR in children with ASD. The objective of this study is to investigate changes in adaptive life skills and behavioral responses in children with ASD using Advanced Brain Technology's The Listening Program ® Spectrum music utilizing Waves ™ (bone conduction) headphones. Our study will investigate the effects of a sound-based intervention developed in 2012 to specifically address the needs of children with ASD and children with hyperacusis and/or auditory SOR - The Listening Program® Spectrum music utilizing Waves™ (bone conduction) headphones by Advanced Brain Technologies. This program emphasizes low frequency music over an extended period of time; the duration recommended by Advanced Brain Technologies is 40 weeks.

There are very few treatments that are effective in reducing severe behavioral problems associated with autism. These behaviors include aggressive and self-harm behaviors, frequent repetitive behaviors and severe hyperactivity. This study is being conducted to determine whether cannabidiol can reduce any or all of these problem behaviors.

Approximately 15,000 children with autism spectrum disorder (ASD) in military families currently receive applied behavior analysis (ABA) interventions through TRICARE insurance. This includes early intensive behavioral intervention (EIBI), which involves 20 or more hours per week of individualized instruction based on ABA and is often considered the standard of care for toddlers and preschoolers with ASD. More recently, research has found that less intensive, time limited ABA interventions can effectively target specific core and associated features of ASD. With these latest data, the investigators assert that an individualized approach to adapting and combining targeted interventions could be at least as effective as EIBI, yet substantially reduce expenditures of time and resources. The investigators call this approach adaptive, modular ABA (MABA), and propose to compare EIBI as usual, provided for approximately 20 hours per week, and MABA, provided for up to 10 hours per week, in a 24-week RCT of 132 children with ASD, under age 5 years, in military families. The investigators hypothesize that, at the end of intervention, MABA will be no less effective than EIBI as usual, or only slightly so, on the primary outcome measure (a standardized measure of adaptive skills). The primary investigators also hypothesize that, at follow-ups conducted 24 weeks after intervention and 90 weeks and/or when children are 5 years old, MABA will be superior to EIBI on primary and secondary child outcomes (tests of cognitive and language function, parent- and provider-rated ASD symptoms and adaptive skills) and on parent outcomes (parent stress and sense of competence).

There is an unmet need for nutrition interventions that address both autism spectrum disorder (ASD) specific feeding challenges and unbalanced eating habits among children with ASD to prevent future chronic health conditions. Children with ASD tend to consume few fruit and vegetables and mainly high-energy dense foods, including sugar-sweetened beverages and processed snacks. Obesity prevalence in children with ASD is up to 40% higher than in typically developing children, and recent studies show significantly elevated risks of hyperlipidemia and hypertension among individuals with ASD, regardless of using psychotropic medications. Our interdisciplinary team conducted a preliminary study to examine diet quality and mealtime behaviors among diverse children with ASD in Florida (34% Hispanic/Latino) and parental preferences for nutrition interventions. Based on the study findings, we developed the manual for our nutrition intervention, Autism Eats, for children with ASD enrolled in the Part C of Individuals with Disabilities Education Act (IDEA) Early Intervention (EI) services. Our Autism Eats manual and parent materials are based on ASD-specific feeding strategies such as food chaining combined with behaviorally-focused nutrition intervention strategies such as goal setting and weekly meal planning to promote healthy eating. Among children with ASD enrolled in Part C EI services in Florida, we will conduct a randomized controlled trial (RCT) with the nutrition intervention program, Autism Eats, and the enhanced usual care (EUC) comparison program. The Autism Eats intervention is to prevent problematic mealtime behaviors and promote development of healthy eating habits. We expect that implementing the Autism Eats will be feasible and the intervention will be well-received by EI providers and parent-child dyads. We will examine differences in children's food intakes (fruit and vegetables), food variety, diet quality, and problematic mealtime behaviors between children in Autism Eats and those in the EUC groups at post-intervention and 5-month follow-up from baseline.

Study Design: Ninety children with Autism Spectrum Disorder (ASD), between the ages of 2 to less than 7 years, and their parents will be recruited for this 10 week randomized clinical trial. Participants will be randomized to five individually delivered sessions of Sleep Parent Training (SPT) or five individually delivered sessions of Sleep Parent Education (SPE). Delivery of the programs will be via telehealth platform which also includes parent-child coaching in real-time. In addition to baseline, outcome measures will be collected at week 5 (midpoint of trial) and week 10 (endpoint of trial) as well as follow-up at week 16 to determine durability of treatment.

The investigator would like to investigate the impact of theta-burst stimulation over cerebellum in adults with autism spectrum disorder

In Singapore, Autism Spectrum Disorders (ASD) is ranked number one in disease burden for children 0-14 years of age. The Child Development Unit at the National University Hospital serves 3000 children annually, of which 25-30% of children have been diagnosed with ASD. Therapist roles are to provide interim therapy for these children before entry into community-based Early Intervention Centres (EIPIC), which currently have waiting times of 6-9 months. Current limitations with interim care includes long wait times, high cost for families, lack of manpower and space to serve the patients, poor parental involvement due to their work commitments, parental difficulties attending frequent, needed, in-hospital therapy and difficulty generalizing patient treatment to the home/community setting (decreasing effectiveness). The proposed Telerehabilitation (also called Telerehab) initiative involves the use of video conferencing technology to help address the aforementioned deficits. Offering early intervention through Telerehab will enable previously unattainable benefits such as seeing the child in their home environment, allowing multiple caregivers to have access to the early intervention training, more frequent contact with families and the ability to trouble shoot real life difficulties in real time. The important advantages to the caregivers include less financial burden arising from time off from work and travel, more access to treatment over a longer period of time and ability to access a multidisciplinary team. An additional benefit for the children is they need not travel to unfamiliar environments, which is frequently distressing for children with ASD. Lastly, Telerehab is a sustainable initiative allowing for less manpower to cover the growing number of patients, and the possibility to be implemented in other government run hospitals and clinics facing similar challenges. Elaboration of benefits:1) Importance of parent and caregiver empowerment. Early Intervention in the current model has been predominantly centre based with initiatives to increase caregiver education. A large body of literature suggests that early intervention is highly successful when provided at the age of diagnosis, with younger children yielding better outcomes. Caregiver involvement is vital to long-term success, as they spend a significant amount of time with their child; they can support the generalizations of new skills. National Research Council identifies parent training to be the key component for successful intervention for children with autism. Parent training improves quality of life by reducing parental stress and increasing optimism.2) Addressing nationally identified gaps. The Enabling Master plan recommendations for 2012-2016 (under Ministry of Family and Social Development) identifies gaps in family involvement and support in acquiring necessary skills and knowledge to be competent in helping their children make developmental gains. Child Development Unit (CDU) envisions that Telerehab is a viable avenue for supporting parents in learning EI skills.3) Improving existing parent training programmes. CDU has successfully piloted a parent-training program for children with ASD called SPEECCH. In our study of the impact of this parent-training program, children made measurable progress in all four skill areas assessed (p<0.001). Focus on achievable and observable family- centred developmental goals showed evidence for increased parental understanding of children's learning and behaviour amp; effective use of strategies for facilitating communication and interactions to support their child's development (p<0.001). However this intervention service could not be sustained due to high caseload demands and insufficient manpower. Parent interviews during review visits identified having sustained contact with therapists and parent coaching to be key areas of need. Currently the service provides intervention for 24 children with ASD weekly for one hour across 12 weeks, and continued support for up to 20 weeks (maximum of 16 hours of intervention). Of the new referrals of 150 children with ASD, if a sustained service is to be provided, only a small group of children will receive intervention. In order to address the demand, the frequency and intensity of intervention has had to be sacrificed to be able to provide some service to all patients. Hence to maximize the impact of early intervention, a sustainable model of service delivery using technology through videoconferencing is being proposed.

The purpose of the project is to evaluate the feasibility, acceptability, and effectiveness of the internet-delivered Acceptance and Commitment Therapy treatment (I-Navigator ACT) for parents who experience stress, distress, depression or anxiety that may be associated with being a parent of a child with disabilities. The project consists of three studies: Study 1: An open feasibility trial in which parents participate in an individual, clinician-supported internet-delivered Acceptance and Commitment Therapy treatment. Study 2: A randomized controlled trial in which participants are randomly assigned either: Navigator ACT group treatment, where parents participate in an Acceptance and Commitment Therapy group together with other parents, led by two group leaders, or I-Navigator ACT internet-delivered Acceptance and Commitment Therapy treatment, where the parent participates on their own, coached by a clinician via a message function. Study 3: A qualitative study in which a smaller sample of parents from the open feasibility trial participate in semi-structured interviews. The interviews take place after the parents have completed I-Navigator ACT. All three studies are conducted in a clinical health care context.

This is a 20-week open-label study to evaluate the safety and efficacy of full-spectrum medicinal cannabis plant extract < 0.08% THC (FEN164) in children with Autism Spectrum Disorder.