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Tundra lists 65 Autism Spectrum Disorder (ASD) clinical trials. Each listing includes eligibility criteria, study locations, and direct links to research sites in the Tundra directory.
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NCT07159308
Motivation for Daily Living Skills
The goal of this clinical trial is to enhance motivation to complete daily living skills among 16 to 25-year-old autistic teens and young adults. Here are the main questions the trial aims to answer: Can this trial improve motivation to complete daily living skills for skills that people know how to do but struggle to do them consistently? Can this trial improve completion of the daily living skill that the participant identifies they want to do more often? Do people report feeling more empowered to complete the daily living skill they want to do more often? Are there any characteristics of a person that make them more or less likely to benefit from the treatment? Researchers will compare treatments that target different types of motivation: * One treatment focuses on internal motivation and explores what is important to someone and then connect that value back to their daily living skill goal. * A second treatment focuses on external motivation and will explore a person finding outside sources of motivation, like rewards. * A third treatment will use a combination of both methods. Autistic teens and young adults enrolled in this study will also be asked to choose someone in their life to be involved in the study with them. This person is called an "Important Person" (IP) and can be anyone close to them, like a family member, friend, roommate, partner, etc. The IP will be expected to support the teen/young adult throughout this treatment. Participants and their IPs will: * Complete five 'talk' therapy sessions that will last 60 to 90 minutes. The IPs will join the last 15 minutes of each session. * Be assigned to one of the three motivation treatments. * Fill out questionnaires before the first session, after sessions 2 through 5, and up to 4 weeks after therapy ends.
Gender: All
Ages: 16 Years - 25 Years
Updated: 2026-10-14
1 state
NCT07439510
A Study to Investigate the Effects and Safety of Codabakalner for the Treatment of FXS in Male Participants and Adult Participants With ADS
This is a Study to Investigate the Effects and Safety of Codabakalner for the Treatment of Fragile X Syndrome in Male Participants and Adult Participants with Autism Spectrum Disorders
Gender: MALE
Ages: 18 Years - 45 Years
Updated: 2026-10-09
NCT07329673
An Examination of the Performance of QbMobile in Differential Diagnosis Associated With ADHD Symptoms
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.
Gender: All
Ages: 6 Years - 60 Years
Updated: 2026-09-25
1 state
NCT06878326
Resting-State Functional Connectivity as a Predictor of tDCS Effects in Adolescents With Autism Spectrum Disorder
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.
Gender: All
Ages: 12 Years - 22 Years
Updated: 2026-09-25
1 state
NCT07304440
Adia Med of Winter Park LLC Autism Spectrum Disorder Research Study
This 12-month study tests whether AdiaVita (umbilical cord blood-derived stem cells and exosomes) plus glutathione improves autism symptoms more than glutathione alone in children ages 3-12. About 100 children with confirmed autism will be randomly assigned to one of two groups. One group receives monthly IV AdiaVita plus IV glutathione for 3 months. The other group receives IV glutathione plus a saline placebo infusion for 2 months. Both groups also use a topical glutathione spray twice a day at home. Symptoms are tracked with the Autism Treatment Evaluation Checklist (ATEC), completed by a parent and by a therapist or teacher. Safety is monitored at clinic visits through Month 12. Children who first receive glutathione only, may crossover to receive AdiaVita at no extra cost if they stay medically stable and their family agrees. Participation is voluntary. The study fee is $12,000.
Gender: All
Ages: 3 Years - 12 Years
Updated: 2026-09-22
2 states
NCT06779422
Pai.ACT - An Artificial Intelligence Driven Chatbot Assisted ACT (Full Scale RCT)
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?
Gender: All
Ages: 21 Years - Any
Updated: 2026-09-10
NCT07804680
This Study Will Evaluate Cardiorespiratory and Muscular Fitness to Examine Associations With Anthropometric Characteristics and Other Indicators of Cardiometabolic Risk Among Patients With or Without Autism Spectrum Disorder
The goal of this observational study is to evaluate cardiorespiratory and muscular fitness in children with obesity, with and without autism spectrum disorder (ASD), and examine how fitness relates to body measurements, body composition, and cardiometabolic health. The main questions it aims to answer are: * Do children with and without ASD differ in cardiorespiratory fitness and handgrip strength? * Are fitness levels related to body composition and measures of cardiometabolic health? Researchers will compare children with ASD to children without ASD to see if there are differences in fitness, body composition, and cardiometabolic health. Participants will have information from their medical records reviewed, including: * Cardiorespiratory fitness and handgrip strength test results * Height, weight, BMI, and body composition measurements * Blood test results, including HbA1c and cholesterol levels * Age, sex, and other demographic information
Gender: All
Ages: 6 Years - 18 Years
Updated: 2026-09-04
1 state
NCT07800026
Effectiveness of Dance Therapy for Students With Mild Autism Spectrum Disorder in China
This study aims to evaluate the effectiveness of Dance Movement Therapy (DMT) in improving social play, emotional regulation, group skills, and communication skills among students with mild autism in China. The study will use a cluster randomized controlled trial with a pretest-posttest design. A total of 96 students aged 8-13 years will be recruited from special education schools in Linfen, Shanxi Province, China. Existing intact classes will serve as clusters and will be randomly assigned to either the DMT group or the Regular Art Class (RAC) control group. Both groups will participate in 12 weeks of intervention, conducted twice weekly, with each session lasting 45 minutes during regular art class time. Outcomes will be assessed before and after the intervention to evaluate and compare changes between the two groups.
Gender: All
Ages: 8 Years - 13 Years
Updated: 2026-09-02
1 state
NCT07798297
Transitional Intervention for Hyperacusis in Autism
The main goal of this clinical trial is to evaluate the effectiveness, benefits, and post-treatment persistence of an intervention for loudness hyperacusis in adults with autism spectrum disorder (ASD). The main questions it aims to answer are: * Does the intervention increase loudness tolerance * Does the intervention reduce symptoms related to loudness hyperacusis Researchers will compare measures related to loudness hyperacusis before, during, and after the intervention. Participants will: * Be randomly assigned to either one of two groups. One group will receiver the intervention immediately. This group will be evaluated during the 6-month intervention and evaluated for 6 months after the end of the intervention. The other group will be evaluated for 6 months before the intervention and during the 6-month intervention. * Visit the test site once every month over the course of a year for evaluation and intervention activities * Keep a diary of their symptoms and the number of hours per day they engage in the intervention
Gender: All
Ages: 18 Years - 39 Years
Updated: 2026-09-01
2 states
NCT07189442
L-theanine and Paraxanthine for Cognitive Improvement in Adults With ADHD and ASD
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.
Gender: MALE
Updated: 2026-08-24
1 state
NCT06479668
Characterize the Links Between Sleep, Emotional Dysregulation and Learning in Neurodevelopmental Disorders.
The aim of this protocol is to disentangle the links between symptoms of emotion dysregulation, sleep disorders and cognitive deficits by measuring the effects of an emotional induction task on childrens' sleep with autism spectrum disorders (ASD) and attention deficit hyperactivity disorder (ADHD).
Gender: All
Ages: 7 Years - 12 Years
Updated: 2026-08-24
1 state
NCT07276750
Coaching and Leadership in Autism Support Settings
Schools serve a large number of autistic children, yet face two critical gaps that stifle the delivery of evidence-based practices: 1) an intervention gap characterized by limited availability of evidence-based practices educators can use to address externalizing behaviors when they occur in the classroom; and 2) an implementation gap consisting of insufficient evidence-based practice fidelity and sustainment over time. To address these gaps, this project proposes a hybrid type 2 effectiveness-implementation trial that simultaneously tests: 1) the clinical effectiveness of an efficient, educator-delivered clinical intervention to reduce autistic children's externalizing behaviors (Research Units in Behavioral Interventions in Educational Settings; RUBIES), and 2) the implementation effectiveness of an organizational implementation strategy designed specifically to enhance sustainment of evidence-based practices in public schools (Helping Educational Leaders Mobilize evidence; HELM). Consistent with the National Institute of Mental Health (NIMH)'s experimental therapeutics approach, the project also examines the mechanisms through which RUBIES impacts clinical outcomes and through which HELM influences implementation outcomes. The proposed study directly responds to high priority research areas of the US Department of Health and Human Services Interagency Autism Coordinating Committee's Strategic Plan for Autism Research, which calls for expanded research on the translation of proven-efficacious interventions into the community, NIMH Strategic Priority 3.3 to test interventions for effectiveness in community practice settings, and NIMH Strategic Priority 4.2 to expedite adoption, sustained implementation, and continuous improvement of evidence-based mental health services. If successful, this study will have substantial public health impact because it will produce an effective intervention for a prevalent problem among a high impact population in schools across the United States of America and will determine how to sustain this (and other) intervention(s) with high fidelity, to the betterment of health.
Gender: All
Ages: 5 Years - Any
Updated: 2026-08-21
1 state
NCT07758088
Dance, Yoga, And Mindful Movement Training For ASD
The goal of this study is to learn if a dance, yoga, and mindful movement program can improve the lives of adults with autism spectrum disorder (ASD). ASD is a condition that can affect how a person communicates, connects with others, and experiences daily life. This study focuses on adults ages 18 to 35. The main questions it aims to answer are: * Can a dance, yoga, and mindful movement program improve social skills and communication for adults with ASD? * Can it improve their quality of life and sense of well-being? * Can it improve their physical, mental, and emotional health? Dance, yoga, and mindful movement have been studied in children with ASD, but very little research has looked at how they may help adults. This study hopes to help fill that gap. Participants will: * Take part in a 12-week dance, yoga, and mindful movement program * Answer survey questions at the start and end of the program about their social skills, communication, quality of life, well-being, and overall health
Gender: All
Ages: 18 Years - 36 Years
Updated: 2026-08-12
1 state
NCT07747129
Promoting Physical Activity Among Young Children With Autism
Higher amounts of physical activity are linked to multiple health benefits including improved cognition, academic success, and classroom behavior for children. These relationships start in early childhood during the preschool years. Additional research is needed to determine the rates of physical activity among children with autism spectrum disorder. However, research suggests that compared to their typically developing peers, children with autism participate in fewer types of physical activities, often have delays in a range of motor skills, and face physical activity barriers including behavior problems, social communication challenges, and adults' uncertainty about how to modify physically active games to include them. Young children need adult guidance, support, and opportunities to be more active, and early care and education programs are a critical setting for physical activity promotion. Faculty at Northeastern University developed and pilot tested WE PLAY (Wellness Enhancing Physical Activity for Young Children), a teacher training, that is accessed online at no cost. WE PLAY was designed to promote physical activity at the child-level, to promote knowledge, confidence, and skills to lead active play at the teacher-level, and to impact social and environmental challenges at the program-level. Three three pilot studies demonstrated that WE PLAY was efficacious in increasing physical activity when implemented with preschoolers with and without autism and it was viewed as feasible, understandable, and acceptable by early childhood educators. This clinical trial will test the efficacy of WE PLAY in children with autism spectrum disorder and their teachers. The researchers hypothesized that at post-training and follow-up, children in the WE PLAY group will engage in higher levels of physical activity in school relative to children in the control group. Further, the researchers hypothesized that at post-training and follow-up teachers in the WE PLAY group will demonstrate increased behavior intentions, perceived behavior control to perform physical activity facilitating behaviors relative to control group teachers. Additionally, this study will explore the effects of malleable teacher and system-level factors between the intervention and child physical activity. The researchers hypothesized that malleable teacher and system variables including behavior intentions, perceived behavior control, physical activity promotion practices, teachers' perceived physical activity promotion role, teacher autonomy, and supervisor support will mediate or moderate the relationship between study group and child physical activity levels. A national sample of 150 teacher-child dyads from early childhood education programs across the United States will be randomized into two conditions (WE PLAY vs. Control). Data will be collected across three periods over 20 weeks (pre-training = 0 weeks, post-training = 4 weeks, follow-up = 20 weeks). WE PLAY teachers will be asked to complete the WE PLAY training. Control group teachers will complete another online training on a topic that is not related to physical activity. Children with autism (ages 2.9 to 5.11) will wear accelerometers during waking hours for five consecutive days at each of the three data collection periods and their teachers will complete online surveys at each of the three data collection periods. The proposed study addresses a critical need for young children with autism. If WE PLAY is determined to be efficacious on a large scale it would lead to interventions that could be integrated in a variety of settings, including early care and education programs and community settings, which could improve physical activity levels in young children, setting them up for greater success throughout their lives.
Gender: All
Ages: 33 Months - 71 Months
Updated: 2026-08-05
2 states
NCT07469566
Characterization of the Natural History of Microduplication Syndrome 7q11.23
7q11.23 duplication syndrome (7q duplication syndrome/7DUP) is caused by a microduplication of the 7q11.23 chromosomal region, encompassing 26-28 genes, including the GTF2I gene. This syndrome, often considered as a "mirror" phenotype of Williams-Beuren syndrome (WBS), is characterized by a wide range of neurodevelopmental impairments, including a neurodevelopmental disorder (NDD), autism spectrum disorders (ASD), selective mutism, mild dysmorphic features, and aortic dilation. Notably, one of the core clinical features of 7DUP is socialization impairment, which varies in severity across individuals. The GTF2I gene, identified as critical in the pathogenesis of both WBS and 7DUP, exhibits opposite expression patterns in the two syndromes, with reduced expression in WBS and overexpression in 7DUP. The gene's dysregulation in 7DUP plays a pivotal role in the pathogenesis of the associated NDD and social deficits. Despite progress in characterizing the genetic underpinnings of 7DUP, there remains a critical gap in understanding the developmental trajectory of socialization impairments in affected individuals, especially during their transition through different developmental stages, from early childhood to adulthood. Recent advancements in the study of neuronal models derived from induced pluripotent stem cells (iPSCs) and brain organoids have shed light on the molecular mechanisms driving 7DUP-related NDDs. Histone deacetylase inhibitors (HDAC inhibitors), which have been widely used in oncology, have shown promising preliminary results in reducing abnormal GTF2I expression in glutamatergic neurons differentiated from 7DUP patient-derived iPSCs. Preclinical studies in mouse models further demonstrated that these drugs can ameliorate socialization deficits, highlighting their therapeutic potential in addressing the core neurodevelopmental challenges in 7DUP. However, despite these advancements, no longitudinal clinical studies have characterized the developmental trajectory of socialization impairments in 7DUP patients. Understanding this trajectory is critical, as it can inform the timing and potential impact of therapeutic interventions, such as HDAC inhibitors. Given the complexity and variability of the 7DUP phenotype, a comprehensive clinical characterization of socialization impairments across the lifespan is essential to improve diagnostic accuracy, optimize intervention strategies, and ultimately improve patient outcomes. The aim of this research is to characterize the developmental trajectory of socialization impairments in patients with 7DUP, from early childhood through adulthood. By identifying patterns of socialization difficulties, this innovative study will allow to efficiently prepare future therapeutic trials, by specifying the phenotype of the patients, and by determining the most relevant outcome measures, taking into account, on one hand, their neurodevelopmental involvement and, on the other hand, the type of experimental design to be used in the context of rare diseases.
Gender: All
Ages: 5 Years - 50 Years
Updated: 2026-08-03
NCT06866275
Suramin for the Treatment of Autism Trial: KZ101 in a Male Pediatric Population With Autism Spectrum Disorder (ASD)
Suramin has been found to correct the symptoms, metabolism, and brain synaptic abnormalities in two classical genetic and environmental mouse models of autism. A preliminary clinical trial (SAT-1) examined the safety and activity of a single low-dose of suramin in children with ASD and concluded suramin showed promise as a novel approach to treatment of ASD. The current study, STAT-2A, will be a randomized, double-blind, crossover, 30-week study to evaluate the preliminary proof of concept, safety, and PK of suramin sodium (KZ101) with repeat dosing by IV infusion in males 5-14 years of age who have been diagnosed with ASD. The study will be conducted at approximately 3 sites contributing approximately 15 subjects per site. Total enrollment of approximately 45 subjects is planned to achieve approximately 36 participants completing the study.
Gender: MALE
Ages: 5 Years - 14 Years
Updated: 2026-07-30
2 states
NCT07728864
Sexuality and Relationship Education for Autistic Adults: Our Love, Our Style
The goal of this sequential multiple assignment randomized trial is to conduct a preliminary evaluation of Our Love, Our Style (OLOS), a web-based sexuality and relationship education program for autistic young adults in South Korea. This study aims to develop a tailored sex and relationship education model for autistic adults in collaboration with autistic adult research partners by employing a community-based participatory research (CBPR) approach, and to progressively evaluate and expand the effectiveness of an adaptive intervention that reflects individual learner characteristics using a sequential multiple assignment randomized trial (SMART) design. Through this process, the study seeks to strengthen the sexual health and relationship-building capacities of autistic adults and, ultimately, to promote greater independence, improved quality of life, enhanced autonomy, and social inclusion in South Korea. Participants will be randomly assigned to one of the two initial groups; the web-based learning group vs. the web-based learning and coaching group. During the first-stage intervention (4 weeks), the web-based learning group engages in individual learning through the sex and relationship education web portal developed in Year 1, while the web-based plus group-coaching group participates in both web-based learning and small-group sessions. Following the completion of the first-stage intervention, an interim assessment is conducted to evaluate learners' responses, and participants are classified as responders or non-responders according to their quiz performance within the program. Responders maintain the original intervention, whereas non-responders receive an additional, more intensive intervention. In the second-stage intervention, non-responders in the web-based learning group receive an additional group-coaching component (web-based → web-based + group coaching), whereas non-responders in the web-based plus group-coaching group receive additional individual coaching to provide more intensive learning support (web-based + group coaching → web-based + group coaching + individual coaching). For non-responders, both group coaching and individual coaching are provided either via Zoom or in person according to participant preference, with each session lasting approximately 60 minutes. The intensive learning intervention incorporates more concrete and realistic examples and uses strategies such as modeling, role-play, and quizzes, which are difficult to implement in a web-based format alone, in order to enhance learning effectiveness through real-time interaction and positive reinforcement. To assess the durability of the intervention effects, pre-intervention, post-intervention, and follow-up assessment outcomes will be compared and analyzed using the evaluation measures to examine the retention of sexual knowledge, changes in relationship-building abilities, and improvements in social skills. Additionally, mental health and quality of life will be examined through supplementary assessment tools. This will allow for a broader understanding of the overall effectiveness and potential benefits of the sex and relationship intervention, as well as an in-depth evaluation of its impact across multiple domains of participants' lives.
Gender: All
Ages: 18 Years - 40 Years
Updated: 2026-07-27
NCT07701915
TeleABA for Hospitalized Adolescents and Young Adults With Autism Spectrum Disorder
This study is evaluating whether a telehealth-based applied behavior analysis (ABA) program can improve the care of adolescents and young adults with autism spectrum disorder (ASD) who are hospitalized because of severe challenging behaviors, such as aggression, self-injury, property destruction, or elopement. Participants will be randomly assigned to receive either standard hospital care alone or standard hospital care plus a Telehealth Applied Behavior Analysis for Hospitalized Adolescents and Young Adults With Autism Spectrum Disorder (TeleABA) program. The TeleABA program includes assessment by a Board Certified Behavior Analyst (BCBA), individualized behavior support recommendations, coaching for hospital staff, caregiver training, discharge planning, and four weekly telehealth sessions with caregivers after the participant leaves the hospital. Researchers will compare the two groups to determine whether the TeleABA program improves behavioral outcomes, caregiver confidence and stress, hospital experiences, and the transition from the hospital to home. The findings may help identify more effective ways to support individuals with autism and their families during and after behavioral health hospitalizations.
Gender: All
Ages: 12 Years - Any
Updated: 2026-07-14
1 state
NCT07170163
Navigating the Transition to Adulthood: A Dual Language Mobile App for Latino Youth With ASD and Their Families
The purpose of this study is to determine useability and satisfaction characteristics,product usage data,methodological feasibility parameters and feasibility metrics of the mHealth app adapted intervention on the mental health, quality of life, and adaptive functioning of Latino transition aged young adults with ASD and their parents.
Gender: All
Ages: 18 Years - 25 Years
Updated: 2026-07-10
1 state
NCT07522190
Trial of Center-Based Early Start Denver Model vs. Pivotal Response Treatment in Children With Autism
The goal of this study is to compare two well-established early autism interventions, Early Start Denver Model (ESDM) and Pivotal Response Treatment (PRT), to better understand which approach is most effective for improving communication skills in young children with autism and which children may benefit most from each treatment. Additionally, after completing either the ESDM or PRT, some participants who meet specific clinical criteria may be offered home-based Developmental Reciprocity Treatment (DRT). The study will include boys and girls 2 to 4 years 11 months old diagnosed with ASD. The main questions this study aims to answer are whether center-based ESDM and center-based PRT improve communication skills in young children with autism, and whether certain children respond better to one treatment approach than the other. Participants will be randomly assigned to either ESDM or PRT for 24 weeks in a center-based program, attend treatment session 4 days per week (\~3 hours/day), complete developmental and autism assessments at baseline, 12 weeks, and 24 weeks, have a parent participate in weekly parent training sessions, and complete follow-up assessments at weeks 36 and 48.
Gender: All
Ages: 2 Years - 4 Years
Updated: 2026-07-08
1 state
NCT07670000
Mental And Speech Developmental Delay Autism Spectrum-Type Behavioral Disorder
FAMILY SYSTEM CITADEL 2060.METHODOLOGY "VOICE OF SLEEP MAMABEE 2026-2085 Systemic work with brain neurons through training modules at the border of sleep in clinical, psychological and strategic logic. Training modules of fairy tale in brain simulation, restoration of the nervous system core in real time. Strategic model of the generational horizon: 2nd, 3rd, and 4th generations. AUTONOMOUSLY. OPERATES REMOTELY: FORMAT: Training basic modules are listened to before sleep. Transit modules are listened to during the day. PSYCHOLOGICAL COMFORT AND PROTECTION: Complete exclusion of direct contact between the child and doctors to avoid stress. The child remains in an absolutely safe, familiar home environment. Listening to the modules is conducted according to the protocol of the approved family physician or psychologist under strict control: "Mother ⇄ Child". SEQUENCE OF PROGRAM MODULES: FOUNDATION: Four sequential modules for the formation of new neural connections in the brain. TRANSIT MODULES: Three verb-based poems for locking in sequential results and retaining neurons. BASIC MODULE (foundation): Systemic cultivation of the child's personality vertical from birth. One national-historical poem lays an unbreakable inner core for life, changing a person's fate and protecting the legacy of the whole family for decades to come. Three levels of monolithic strength: neurobiological, psychogenetic, and geopolitical.: PROGRAM COMPLETION: Fifth module, "The Road Home." The child independently walks to the grocery store and back as consolidation of an autonomous everyday living skill. CLINICAL OUTCOME (February-June 2026, 0-3-6 cycle) Speech development: 3rd month of the 0-3-6-9 work cycle April 21, 2026. Progress in communication: the first clear, quick, and conscious answer to the mother's question. Transition from echolalia to conscious speech. Fine motor skills: A sharp developmental leap was recorded. The child began assembling puzzles significantly faster and more accurately. Physical activity: Growth in training performance indicators was recorded. The child began running faster and regularly updates his personal sports records. Independence: Began performing complex motor exercises without visual prompts, guided only by the coach's verbal instructions. First steps toward an independent trip to the grocery store: gets dressed, takes the bag, and locks the door with the key. Independence: The child demonstrates the first successful steps toward going to the store independently on foot. He gets fully dressed by himself, takes the bag, and closes the front door behind him with the key. Psycho-emotional state of the child. Sleep quality: Since February, from the start of listening to the fairy tales, deep, healthy, and stable nighttime sleep without awakenings has been noted. Dynamics of the mother's psycho-emotional state May 1, 2026: The mother recorded a state of complete inner calm. Restoration of the core nervous system. Return of life resources over 19 years. Audio modules: Individual podcasts were written for the mother. She regularly listens to them at night. CORE OF THE SYSTEM NEUROBIOLOGICAL CONNECTION BETWEEN MOTHER AND CHILD: The brain of a child on the autism spectrum instantly reads the mother's stress micro-signals (cortisol field). The system works directly with the core of the mother's nervous system: it restores sleep, returns the will to live, and enables positive resolution of set tasks. Healthy parents = healthy child, a fundamental condition for neuroplasticity, which automatically relaxes the child's tense nervous system. Strategic level: Turning the diagnosis into a profession, survival experience, and dynastic continuity of all families with a 2026-2085 horizon. The national-historical foundation and the value of family cultivate the child's personality vertical, making him resilient to any external crises, emigration, social upheavals, and attempts to erase his personality. By protecting the child's brain through training modules, you protect the family's assets and culture for decades ahead. CHILDREN IN THE SYSTEM (METHODOLOGY TARGET GROUPS): Children with ASD, ADHD, Down syndrome, motor alalia, speech development delay, trauma-related adaptation difficulties, mutism, sleep disorders, rehabilitation needs, and high-perception children in bilingual or elite environments. NATALIA POLUEKTOVA Independent Humanitarian Strategist. Children and Families in Healthcare. Preservation of Generational Heritage.
Gender: All
Ages: 3 Years - 70 Years
Updated: 2026-07-02
1 state
NCT07216768
ADAPT: Approach to Dance for Autism
It is well documented that motor impairments are associated with a diagnosis of autism spectrum disorder (ASD). Yet, appropriate therapies are scarce. Dance has been shown to not only promote fine and gross motor skills, but also psychological well-being, cognition, and social participation in neurotypical dancers. Little research has been conducted to gauge if these benefits translate to those with ASD. Ballet for all Kids (BFAK) is a recreational dance program that has been teaching ballet to children with ASD for over a decade, but has yet to be empirically studied. This study expands on the goals of former STUDY 24-00144, Approach to Dance for Autism (ADAPT), NCT06424366, to elucidate the impact of participation in a recreational dance program on children with ASD.
Gender: All
Ages: 6 Years - 12 Years
Updated: 2026-06-16
1 state
NCT07634107
How Trunk Control Links Autism Severity to Functional Exercise Capacity in Children With ASD
The goal of this observational study is to learn if trunk control (the ability to balance and stabilize the upper body while sitting or moving) links autism severity to functional exercise capacity in children aged 4-12 years with Autism Spectrum Disorder (ASD). The main questions it aims to answer are: 1. Does trunk control explain why children with more severe ASD have lower functional exercise capacity? 2. Do trunk control and functional exercise capacity differ across ASD severity levels (Level 1, 2, and 3)? Participants will complete two assessments in a single 30-40 minute session during their routine clinic visit: 1. A trunk control test, where a trained physiotherapist observes seated balance and movement. 2. A 6-Minute Walk Test (6MWT), where the child moves along a flat hospital corridor for 6 minutes and the total distance covered is recorded as a measure of functional exercise capacity. No treatment or intervention is involved. All assessments are safe, non-invasive, and conducted at a tertiary care children's hospital in Pakistan.
Gender: All
Ages: 4 Years - 12 Years
Updated: 2026-06-10
1 state
NCT07597694
Verbal Intent and Gaze Cues on Action Prediction in ASD
A 2×2×3 mixed design (intent word × object type × group: TD, ASD, ID) was used. Age-matched children watched videos and judged which object a model would pick; their choices and eye movements were recorded.
Gender: All
Ages: 3 Years - 10 Years
Updated: 2026-05-19
1 state