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NCT07421830
The goal of this clinical trial is to learn if WE PLAY for Parents can improve caregivers' knowledge, attitudes, confidence, and skills promoting physical activity with their young child with autism. The main questions it aims to answer are: (1) Do participants who complete WE PLAY for Parents improve their knowledge, behavior intentions, perceived behavior control, self-efficacy, and parenting practices related to physical activity promotion with their child (Primary Hypotheses); and (2) Do participants view WE PLAY for Parents as acceptable, understandable, and feasible \[secondary hypothesis)? Researchers will compare the WE PLAY for Parents group \[experimental arm\] to a Waitlist Control group to see if there are differences in the variables listed in the primary hypothesis. Participants will: (1) Complete a set of questionnaires at three timepoints: pre-training, post-training, and 3-month follow-up that each take between 10-15 minutes; (2) be randomly assigned to take the training over the next two weeks or be offered the training after 3 months. The online training takes about 90 minutes. It includes watching informational videos, viewing video clips of adults helping children be active, reading handouts on behavior management tips and social stories, participating in an anonymous discussion board with other parents, and completing a self-assessment.
NCT07472829
Recent studies indicate that children with ASD have a significantly higher risk of co-occurring speech sound disorders than typically developing children. Early atypical speech development may be a critical yet overlooked bottleneck hindering their language improvement. Given the unique phonetic features of Mandarin, it is essential to investigate speech development in Mandarin-speaking children with ASD. This study aims to construct developmental trajectories and establish early identification and prognosis prediction models for this population.
NCT07419919
Physical fitness and psychological indicators are key factors in healthy development. Individuals with autism spectrum disorder (ASD) tend to have lower levels of physical fitness and mental health than their neurotypical peers. This study examined the effects of 10 months of judo training on physical fitness and psychological indicators in children and adolescents with ASD and neurotypical individuals training in integrated groups. Ninety children and adolescents aged 7-14, with and without ASD, participated in the study. Physical fitness was measured using the EUROFIT test, and psychological indicators were measured using the Staic psychological test and the Juczyński questionnaire.
NCT07189442
This pilot study will test whether combining L-theanine and paraxanthine improves sustained attention, inhibitory control, and overall cognition in adults with ADHD and ASD. Two parallel randomized, single-blinded, repeated-measures crossover trials will be conducted. Participants will complete neuropsychological testing, fMRI scanning, and self-report measures following administration of the L-theanine-paraxanthine combination compared to placebo.
NCT07329673
The purpose of this study is to evaluate QbMobile's ability to collect objective data to identify specific symptom profiles in differential diagnoses (ASD, MDD, Bipolar Disorder and Anxiety Disorder) that are common with ADHD.
NCT07295912
The goal of this clinical trial was to determine if a specific type of cycling exercise improved executive functions in school-aged children with autism spectrum disorder (both boys and girls, aged 8-10 years, no healthy volunteers). The main questions it addressed were: 1. . Did learning to ride a real bicycle improve planning, flexibility, working memory, and inhibition more than stationary cycling? 2. .Was the benefit driven by (A) dynamic balance, (B) spatial updating, or both? Researchers compared four arms to identify if dynamic balance and/or spatial updating were the active components using three interventions groups, namely learning to bicycle (LTB), bicycle treadmill (BT), cycling with training wheels (TW)-and one active control group (stationary cycling, SC). Participants: 1. . Provided a small urine sample three times for BDNF brain-marker testing. 2. . Played four short tablet games (10 minutes each) at 1st intervention session , 4th intervention session and 8th intervention session to assess their Executive Functions. 3. . Attended four 45-minute cycling sessions per week for 2 weeks at their respective school. 4. .Continued all usual therapies; no medicine was administered The trial was completed on 31 December 2024 (RGC Ref 18616522, HREC 2021-2022-0397).
NCT07161804
This study looked at whether homeopathic treatment could help children with Autism Spectrum Disorder (ASD) when used alongside regular therapies like speech and occupational therapy. Over seven years, children between the ages of 3 and 12 were divided into two groups (through computer generated list). One group received individualized homeopathic medicines, and the other received a look-alike placebo (with no active ingredients). Meanwhile, both the groups continued with their regular therapies. Researchers used various tools and parent questionnaires to track the children's progress in areas like communication, behavior, social skills, daily functioning, toilet training and sensory skills.
NCT06878326
Background: Transcranial Direct Current Stimulation (tDCS) is a form of non-invasive brain stimulation that has aroused increased interests in the past decade. Not only that it is transient with little side-effects, and can be well-tolerated by children, it is also affordable and readily accessible, making it an appealing treatment option for autism spectrum disorder (ASD). Objective: (1) To evaluate the therapeutic effects of tDCS on improving cognitive function in patients with ASD, (2) to better understand the neural mechanisms underlying the neuromodulation effects of tDCS in patients with ASD, and (3) to determine whether resting-state functional connectivity measures can predict the therapeutic effects of active tDCS in individuals with ASD. Methods: To assess the therapeutic effects and neural mechanisms of tDCS, 90 adolescents with ASD (age 12-22 years) will receive three stimulation conditions: cathodal tDCS of the left DLPFC, anodal tDCS of the left DLPFC and sham-tDCS with at least a week apart each time. During the active tDCS or sham-tDCS condition, the participants will be administered a computerized test battery (Cambridge Neuropsychological Test Automated Battery, CANTAB®) to evaluate their cognitive function. EEG before and after the tDCS to evaluate the tDCS-induced alteration in their neural activity and functional connectivity. Hypothesis: Drawing together the different evidence linking ASD with cortical hyper-excitability and disordered neural connectivity, as reviewed previously, the investigators hypothesize that, relative to a sham-tDCS condition, active cathodal (inhibitory) and anodal (excitatory) tDCS over the left DLPRC will induce stimulation-linked facilitation of learning and resultant improvement of cognitive functioning in patients with ASD. In addition to the therapeutic effects of tDCS, enhanced neural connectivity, as indexed by altered level EEG theta coherence in patients with ASD, will mediate the beneficial effects of tDCS, relative to sham tDCS, on improvements in cognitive function. Moreover, resting-state functional connectivity will moderate the beneficial effects of active tDCS on cognitive function, relative to sham tDCS, such that participants with greater pre-treatment resting state functional connectively will evidence greater/less response to tDCS, relative to participants receiving sham tDCS.
NCT07176481
The goal of this clinical trial is to learn if a family support program helps Navajo parents and guardians of children with autism spectrum disorder (ASD) or other developmental concerns. The main questions it aims to answer are: * Is the program something families find useful and easy to take part in? * Does the program raise parents' knowledge and confidence in using strategies that support their child's development? * Does the program help children improve in areas such as social communication? Researchers will compare two groups: * One group of parents will join the program right away. * The other group will join the program after waiting. Participants will: * Be randomly placed into the "immediate" or "waitlist control" group using simple randomization. * Take part in sessions led by trained Navajo Family Advisors, who are parents of children with ASD. * Learn and practice strategies they can use at home to support their child * Answer surveys about their experience, knowledge, and their child's progress
NCT06831188
The goal of this clinical trial is to learn if regular exercise intervention may improve the health status of the participants diagnosed with autism spectrum disorder, ages between 5-13 years old. The main question it aims to answer is: * if combined regular exercise program improves motor skills, repetitive movements, aerobic capacity and quality of life of participants? * Researchers will compare the exercising and non-exercising participants to see if regular exercise improves the health related parameters. Participants will do exercise for 12 weeks regularly.
NCT07064967
The goal of this observational study is to learn how brain activity in children with autism spectrum disorder (ASD) differs from typical developing children using magnetoencephalography (MEG). The main questions this study aims to answer are: Do children with ASD show different patterns of neural oscillation compared to typically developing children? Can MEG identify specific brain features that help ASD diagnosis? Participants will undergo MEG scan in both resting and tasking state, and their brain activity will be analyzed for characteristic neural oscillations and connectivity patterns. This study may help develop better tools for early ASD diagnosis.
NCT07054697
This study looked at whether homeopathic treatment could help children with Autism Spectrum Disorder (ASD) when used alongside regular therapies like speech and occupational therapy. Over seven years, children between the ages of 2 and 12 were divided into two groups (through computer generated list). One group received individualized homeopathic medicines, and the other received a look-alike placebo (with no active ingredients). Meanwhile, both the groups continued with their regular therapies. Researchers used various tools and parent questionnaires to track the children's progress in areas like communication, behavior, social skills, daily functioning, toilet training and sensory skills. They found that the children who received homeopathic treatment showed more improvement in these areas compared to those who just received only speech / occupational therapies.
NCT07025603
The goal of this study is to evaluate the effectiveness of the Social ABCs program for young autistic children and their parents. The study will also explore predictors of treatment success and child outcomes. The main questions it aims to answer are: * Does the Social ABCs program help children use more words and communicate better? * Does the program help parents feel more confident and less stressed? * Which children and parents benefit most from the program? Participants will: * Join a 6-week Social ABCs program with weekly group and individual coaching sessions * Complete assessments before and after the program to see how their child and family are doing * Take part in short video-recorded play sessions to see how communication changes over time
NCT06800001
The primary purpose of the study is to investigate whether physical activity can significantly manage stereotyped behavior and anxiety in children diagnosed with Autism Spectrum Disorder (ASD). The study aims to contribute to the existing literature by providing robust evidence on the efficacy of Physical Activity intervention for ASD, which could inform clinical practices and improve treatment outcomes.
NCT06779422
Interventions for parents of children with NDD face two pivotal challenges. Firstly, many overlook the consequential influence of parenting stress, symptoms of parental anxiety and depression on the well-being of parent-child dyads. Though some address parenting stress, they fall short of considering comprehensive health outcomes. Secondly, current evidence has supported ACT as an empirically validated, transdiagnostic psychotherapeutic intervention for parents with dual benefits for the parent-child dyads, but the treatment delivery (e.g., group-based and guided online approaches) is primarily in-person, demanding the presence of expert personnel in every session, limiting its scalability and accessibility. Unlike other psychotherapies like CBT and mindfulness, conventional ACT sessions often adopt a 'one-size-fits-all' strategy, using standardised and pre-packed exercises lacking the personalisation necessary to address individual variations in psychological inflexibility. Leveraging our available innovation, Pai.ACT, an AI-driven chatbot adopting the Focused ACT approach, seeks to offer personalised and scalable mental health solutions for Chinese-speaking parents of NDD children. With our encouraging preliminary data supporting our pre-trained NLP model's accuracy and Pai.ACT's feasibility, the investigators propose to examine Pai.ACT in a full-scale clinical trial. The study will examine the following research questions: 1. Is Pai.ACT more effective than positive parenting advice for reducing parenting stress (primary outcome for parents) of parents and the emotional and behavioural symptoms of their young children with NDD (primary outcome for children) over the 12-month post-intervention follow-up? 2. Is Pai.ACT more effective than positive parenting advice for reducing symptoms of depression and anxiety, improving parental psychological flexibility and parenting behaviour over the 12-month post-intervention follow-up? 3. Is Pai.ACT more effective than positive parenting advice for reducing the use of healthcare and rehabilitation services in children with NDD over the 12-month post-intervention follow-up? 4. What are the perceived benefits, satisfaction, strengths, and limitations of Pai.ACT from the parents' perspectives?
NCT06783101
Correct use of daily medications containing inhaled corticosteroids is key for asthma control, yet children with intellectual and developmental disabilities (IDD) face additional barriers to proper inhaler use. Smart inhalers, a novel technology that provides guidance and immediate feedback on inhaler use techniques, have been shown to enhance correct medication administration in the typically developing pediatric population, but their effectiveness has not been evaluated on the pediatric IDD population. This study aims to investigate whether daily application of smart inhalers (1) is feasible and acceptable in the IDD population, (2) improves the rate of correct medication administration, and (3) results in improvement in lung function. This effort aims to promote better asthma management in the IDD population.
NCT06723522
The goal of this clinical trial is to learn if high definition transcranial direct current stimulation (HD-tDCS) of right inferior frontal gyrus works to improve social impairments in children with autism spectrum disorder (ASD). It will also learn about the underlying brain mechanism. The main questions it aims to answer are: * Does HD-tDCS of right inferior frontal gyrus improve social impairments in children with ASD? * What are the underlying brain mechanisms by which the HD-tDCS of right inferior frontal gyrus improves social impairments in children with ASD? Researchers will compare participants received active HD-tDCS to controls received sham HD-tDCS (performed to mimic the sensation induced by real HD-tDCS before and after the stimulation) to see if HD-tDCS of right inferior frontal gyrus improves social impairments in children with ASD. Participants will: * Receive a dose of 2 mA HD-tDCS of right inferior frontal gyrus lasting for 10 days. * Receive social functioning assessment, functional near-infrared spectroscopy and electroencephalography measurement before and after stimulation * Visit the clinic once every 2 weeks for checkups and tests, a total of 2 times.
NCT06662591
The goal of this observational study is to investigate the genetic and epigenetic mechanisms that may contribute to the development of Autism Spectrum Disorder (ASD) in individuals of different age groups. The study aims to explore how genetic variants and environmental factors interact to influence the risk of ASD. The main questions it aims to answer are: * Which genetic variants are most strongly associated with the development of ASD? * How do environmental factors, such as prenatal exposure, influence these genetic risks? * Can the combination of genetic and epigenetic data improve early detection or intervention strategies for ASD? Participants will: * Provide biological samples for genetic and epigenetic analysis. * Complete detailed questionnaires regarding environmental exposures and family history. * Participate in clinical assessments to evaluate the severity of ASD symptoms. Researchers will compare genetic and environmental data between individuals with ASD and those without the disorder to understand how these factors may contribute to the risk of ASD. This multi-center study will take place across several universities and hospitals in Türkiye, focusing on the potential interplay between inherited genetic factors and environmental influences.
NCT06659731
This study aims at assess sensory perception, and pain perception, in neurodivergent children and adolescent in the autism spectrum. To achieve this goal, the quantitive sensory testing (QST), a controlled and replicable protocol, will be used, to assess perception in different sensory modalities: heat sensations, mechanical detection threshold and pain threshold. As secondary aim, the cortical processing of thermal painful stimuli will be collected through electroencephalography (EEG) in order to investigate if there are differences in the cortical processing of painful stimuli between clinical sample and control sample, and if it could be associated with differences in the subjective experience between the two groups. Finally, it will be explored the association between such differences, and indexes of psychopathology and dispositional measures.
NCT06587594
This research aims to pilot an intervention that will provide practitioners and clinicians with evidenced-based behavioral health strategies for working with autistic adults. The findings will contribute to the needed, yet sparse research of evidence-based behavioral health interventions for this population. The guiding research aims for this study are: 1. To implement a small-scale pilot study aimed at refining the Solution Focused Brief Therapy (SFBT) and protocol for use with autistic adults based on clinician expertise and lived experience. 2. To test the feasibility and acceptability of the SFBT. Namely, how well the intervention is received by this population and if participants can attend and engage in all 4 sessions. 3. To evaluate outcomes before and after the intervention and assess for any improvements through valid and reliable measurements of behavioral health outcomes. This research aims to answer the following research questions: 1. What is the retention rate of participants in the 4-weekly sessions of the SOLVE program? 2. Do participants show progress in their self-identified goals after the intervention? 3. What are the experiences and satisfaction rates of participants in participating in a four-session SFBT intervention? 4. Do participants report higher scores in quality of life and lower depressive and anxiety scores between baseline and immediately post-intervention? The five autistic participants will participate in four one-on-one weekly SFBT sessions conducted by licensed mental health professionals. The intervention is expected to take four to 5 weeks, allowing for cancelations and rescheduling as needed.