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Autistic Disorder clinical trials

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NCT ID: NCT05803005 Not yet recruiting - Clinical trials for Autism Spectrum Disorder

Evaluation of Some Inflammatory Markers in Autism Spectrum Disorders

Start date: September 1, 2023
Phase:
Study type: Observational

Evaluate some Inflammatory markers [IL-6, IL-8, TNF_alpha] in children with autism spectrum disorder

NCT ID: NCT05799599 Recruiting - Clinical trials for Autism Spectrum Disorder

Peer Interventions for Preschoolers With Autism

PIPA
Start date: February 13, 2023
Phase: N/A
Study type: Interventional

This proposal will evaluate a series of peer-mediated interventions (PMIs) for preschool children (3 to 6 years) with ASD and limited or no spoken language, using an innovative Sequential Multiple Assignment Randomized Trial (SMART) design. Available evidence supports the beneficial effects of PMIs for improving social communication in children with ASD. Peer-related social competence is vital to a wide range of child outcomes, such as improved communication and fewer behavioral problems. Unfortunately, approximately 30% of children with ASD remain minimally-verbal in kindergarten, restricting participation in inclusive activities. Recent studies report improved communication after a speech-generating device (SGD) is included in treatment. Effective interventions that can be modified is necessary to ensure optimal communication outcomes when children do not make anticipated progress. A strength of the study is that these interventions can be adopted by community-based, early service providers. All participants will receive an adapted Stay-Play-Talk (SPT) peer-mediated intervention that varies in active ingredients. With SMART designs, it is possible to test and identify alternative combinations of PMI approaches, such as the addition of a SGD. In this study, 132 preschoolers with ASD (and N=264 peers without disabilities) will be initially randomized to SPT and SGD with spoken peer input only (SPT Basic; peers taught to model language) or SPT and SGD with augmented peer input (SPT Plus; peers taught to use verbal language models concurrently with the SGD). Each child's response to treatment after 5 weeks will determine that child's next phase in the SMART design. Children showing a positive response will continue in their originally assigned group; slow responders will be randomly assigned to receive added treatment components to improve communication (either SPT Plus or SPT Advanced). SPT Advanced adds direct instruction strategies (i.e., adult prompts, reinforcers, and teaching trials) to increase child vocalizations in SGD interventions. The use of a SMART design extends our prior work by testing the systematic addition of selected peer-mediated strategies in combination with an SGD that allows for flexible application of interventions based on child response. The investigators have assembled an outstanding team of highly qualified investigators with complementary skills in preschool assessment, language intervention, clinical trials, and statistics.

NCT ID: NCT05796310 Recruiting - Clinical trials for Autism Spectrum Disorder

Combination of Predictive Biomarkers to Increase Diagnostics Efficiency of Autism Spectrum Disorder

Start date: July 28, 2022
Phase:
Study type: Observational

Early identification and diagnosis of autism spectrum disorder (ASD) is necessary to promote access to early treatment. Despite the high incidence, in Italy it is estimated that 1 in 77 children (age 7-9 years) (Narzisi et al., 2018), the diagnosis and the choice of rehabilitation treatment for patients with Autism Spectrum Disorder (ASD) are still based on clinical observation. In the absence of targeted pharmacological therapies, early surveillance and evaluation aimed at timely intervention represent the only successful strategy to reduce the severity of symptoms (Palomo R et al., 2006) and improve the quality of life of children affected by ASD and their families, thus also leading to a reduction in costs for the National Health Service (Ganz ML. 2007). However, compared to the great advances in neuroscience, the clinical management of autistic individuals is seriously lagging behind, and the disorder is often diagnosed after 3-4 years of age despite the presence of deficits starting from the very first months of life (Zwaigenbaum L et al. al., 2013). The aim of this project is to bridge the gap between research and clinic, thanks to the convergence of multiple biological and clinical data.

NCT ID: NCT05794620 Recruiting - Clinical trials for Autism Spectrum Disorder

Faecal Microbiota Analysis in Neurotypical and Autism Syndrome Disorder Siblings

FAMILY
Start date: December 20, 2022
Phase:
Study type: Observational

This study aims to accurately characterise the gut microbiota composition of faeces of children with ASD and compare it with the gut microbiota composition of their neurotypical siblings. In addition it aims to also characterise the metagenome and metabolome of the faeces of both ASD and neurotypical siblings.

NCT ID: NCT05792449 Active, not recruiting - Clinical trials for Autism Spectrum Disorder

Tele-rehabilitation Program: An Innovative and Sustainable Early Intervention Service for Children With Autism Spectrum Disorders

Start date: January 7, 2019
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05786898 Recruiting - Clinical trials for Autism Spectrum Disorder

Adaptation of the NEAR Cognitive Remediation Method to Child and Adult Autism by Including Social Scenarios and Skills

NEAR-TSA
Start date: January 24, 2023
Phase: N/A
Study type: Interventional

The investigators currently provide the NEAR method (neuropsychological educational approach to cognitive remediation) for people with neurocognitive difficulties, without distinguishing between ASD and schizophrenia. However, the NEAR method does not address social cognition in the stimulated functions. The aim of this study is to add social scenarios to this neurocognitive method in order to improve not only neurocognitive functions, but also social cognition. Thus, NEAR would be in this adapted form a method that could be completely adapted to autism spectrum disorders in preadolescents and adults. The study will include participants aged 13-40 years, with a diagnosis of ASD. The NEAR TSA method will include 32 sessions: - one session (90-120 min, with one or two breaks) per week for 32 weeks (8 months), for minor participants. - two sessions (90 minutes each, with no breaks) per week for 16 weeks (4 months), for adult participants. The method includes 30 minutes of computerized exercises, 15 minutes of discussion on the exercises performed and the strategies applied, and the rest of the time for "bridging groups". Three evaluation are proposed: - an initial clinical and functional evaluation (T1), before the beginning of the program, - a second clinical, functional and neuropsychological evaluation (T2), within one month since the end of the program - a third clinical, functional and neuropsychologica evaluationl (T3), three months after the end of the program.

NCT ID: NCT05781412 Recruiting - Clinical trials for Autism Spectrum Disorder

Modulation of the Activity of the Cerebellum in Autism (MACA)

MACA
Start date: May 24, 2022
Phase: N/A
Study type: Interventional

Research on the involvement of the cerebellum in social understanding behavior and the mentalizing brain system has just begun. Knowledge about the neurobiology of social understanding is important for understanding the ways to manipulate these processes. Like cerebral tDCS, cerebellar tDCS could then be used to enhance more complex processes, such as mentalizing, in healthy individuals. It can eventually also be examined as a therapeutic tool for patients with mentalizing difficulties such as patients with ASD. In this study, it is examined whether anodal tDCS at the right posterior cerebellum influences social understanding and which cerebro-cerebellar networks play a role in this process.

NCT ID: NCT05759455 Not yet recruiting - Clinical trials for Assessment of Vitamin D Level in Children With Autism in Assiut University Children Hospital

Assessment of Vitamin D Level in Children With Autism in Assiut University Children Hospital

Start date: September 1, 2023
Phase:
Study type: Observational

In the present study, we aim to evaluate the serum level of 25 hydrxy vitamin D in autistic children .

NCT ID: NCT05758220 Not yet recruiting - Clinical trials for Autism Spectrum Disorder

MRI Brain (Volumetry, fMRI & MRS) in Autism

Start date: April 1, 2023
Phase:
Study type: Observational [Patient Registry]

To reach a feasible method for diagnosing Autism Spectrum Disorder (ASD) outcome measures: 1. Primary (main): Measurement of various brain structures, including the total brain volume, the volumes of specific brain regions (such as the amygdala, hippocampus, and cerebellum), and the thickness of the cortex. Detection of other concurrent lesions, e.g. tuberous sclerosis 2. Secondary (subsidiary): levels of various neurotransmitters, such as glutamate and GABA, and other metabolites, such as N-acetyl aspartate (NAA), in specific regions of the brain Assessing neural activity and connectivity in the brain in the resting state

NCT ID: NCT05754073 Recruiting - Clinical trials for Autism Spectrum Disorder

Oxytocin Effects on Bone Metabolism in Children With Autism Spectrum Disorder

Start date: August 1, 2023
Phase: Phase 2
Study type: Interventional

This is a randomized, double blind, placebo-controlled study of the effects of intranasal oxytocin on bone health in children with autism spectrum disorder, ages 6-18 years old. Subjects will be randomized to receive intranasal oxytocin or placebo (30 IU, 2 times daily) for 12 months in the double-blind phase, followed by a 6-month open label phase during which all study subjects will receive intranasal oxytocin (30 IU, 2 times daily). Study visits include screening to determine eligibility, followed by study visits at baseline, week 2, and months 6, 12, 18 and phone calls every two weeks for the first two months and monthly thereafter for the duration of the study. Study assessments include history and physical examinations, anthropometric measurements, electrocardiogram (EKG), adverse event monitoring, laboratory tests for chemistries, hormones and biomarkers for bone metabolism, questionnaires regarding diet and exercise, and imaging to assess body composition, bone density and structure.