Clinical Research Directory

An Empowering Parent Training Intervention to Increase Physical Activity in Preschool Aged Children With Autism

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.

Single Session Support for Parents of Children With Neurodevelopmental Disabilities Struggling With Anxious Avoidance

This study will inform the development of a brief online program to help parents better understand and respond to anxiety-related behaviors in children with neurodevelopmental disorders (NDDs) such as autism spectrum disorder (ASD), attention-deficit/hyperactivity disorder (ADHD), intellectual disability, and learning disorders). Many neurodiverse children experience high levels of anxiety, which can appear as avoidance, emotional distress, or challenging behaviors that are difficult for parents to interpret and manage. The purpose of this research is to evaluate EMPOWER-ND with its digital, single-session intervention (SSI) that provides practical parenting strategies for addressing anxiety-related behaviors in neurodiverse children. Parents of eligible children aged 5-14 with neurodevelopmental conditions will be invited to enroll in the research study.

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.

Expression Intensity Modulates Social Intention Understanding in ASD Children

Children watch videos of a single model playing with toys, judge whether the model desires a new toy based on observing the model's varying expression intensities, and form a judgment on whether the model intends to obtain a new toy or not. During this process, children's eye-tracking data are recorded, and changes in blood oxygen levels in the cerebral cortex are captured via functional near-infrared spectroscopy (fNIRS) equipment. This study discusses children's social attention and the corresponding neural mechanisms during the intention understanding process.

External Trigeminal Nerve Stimulation for Children With ASD + ADHD to Reduce Elevated Symptoms

The goal of this clinical trial is to learn if external trigeminal nerve stimulation (eTNS) works to treat ADHD symptoms in children on the autism spectrum (ASD). It will also learn about the efficacy and tolerability of the eTNS device. The main questions it aims to answer are: * Does eTNS reduce ADHD symptoms? * Does eTNS improve core and associated features of ASD? Participation spans 8-12 weeks and includes: * 4-5 in-person visits * 4 brief virtual check-ins * Nightly use of the eTNS device with a small sticky patch applied to child's forehead * Randomized assignment (those who start with the sham device may try the active device later)

Adapted Group Therapy Compared With Usual Care for Anxiety and Depression in Adults With an Autism Diagnosis

The goal of this clinical trial is to learn whether an adapted group therapy works to treat anxiety and depression in adults with an autism diagnosis. The therapy is a form of cognitive behavioral therapy (CBT). CBT is a talking therapy. It helps people work with their thoughts, feelings, and habits. This version is adapted for adults with an autism diagnosis. The room is quiet and calm. Each session follows the same plan. The group uses a workbook. The clinic already offers this therapy. No one has yet tested how well it works compared to usual care. The main questions it aims to answer are: * Does the group therapy help participants feel better overall after 12 weeks? * Does it lower symptoms of anxiety and low mood more than usual care? * Do participants still feel better 3 months after the therapy ends? Researchers will compare the adapted group therapy with usual care. Usual care is the one-to-one follow-up that participants already get at the clinic. A computer places each participant in one of the two groups at random. This means chance decides, not the researchers and not the participant. Adults can take part if they: * Are 18 years or older * Have an autism diagnosis * Have anxiety or low mood * Already get care at the clinic Participants will: * Keep their own therapist and their usual care for the whole study * Start the group therapy now, or stay with usual care and get the same group offer later, about 6 to 7 months after the start * Meet in a group of 6 to 10 people for 1 hour a week for 12 weeks, if they start the group therapy now * Answer questionnaires on a phone or computer at the start, each week for 12 weeks, and again after 3 and 6 months * Choose whether to wear a heart rate band during group sessions. This is optional. Participants can take it off at any time. The study takes place at one outpatient clinic in Oslo, Norway.

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.

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

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.

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.

Neuromotor Task Training in Autistic Children With Motor Difficulties

The goal of this clinical study is to learn whether Neuromotor Task Training (NTT) may help improve functional motor skills in autistic children who have motor difficulties. The main question it aims to answer is: Does Neuromotor Task Training help autistic children improve a motor skill that is difficult for them in daily life? This study will include autistic children with motor difficulties. Each child will work on one functional motor skill chosen according to their needs and daily-life goals. Examples may include skills such as catching a ball, jumping rope, putting on a coat, or another meaningful motor task. Participants will take part in an initial assessment of their motor abilities. They will then choose, with their family and the researcher, a functional motor skill to work on. The selected skill will be assessed repeatedly before, during, and after the training period. Participants will receive Neuromotor Task Training sessions focused on this skill. They will also be followed after the training period to see whether the motor skill is maintained. Neuromotor Task Training is a task-oriented rehabilitation approach. It focuses on practicing meaningful motor skills in conditions that are progressively adapted to the child. The task, the environment, and the feedback provided by the therapist may be adjusted during the sessions to support motor learning. This study uses a single-case experimental design. This means that each participant's progress is measured repeatedly over time. The researchers will examine whether motor performance changes after the start of the training and whether these changes are maintained after the training period.

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.

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?

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

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.

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

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).

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.

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

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.

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.

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.

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.

Exercise Efficacy on Autism Spectrum Disorder

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.