Clinical Research Directory

Cognitively Enhanced Tai Chi for Executive Function in Children With Autism Spectrum Disorder

This study compares three exercise courses for children aged 8-11 years with autism spectrum disorder: Tai Chi with added cognitive challenges, standard Tai Chi, and general exercise. The main question is whether adding cognitive challenges to the same adapted Tai Chi movements improves inhibitory control, working memory and cognitive flexibility more than standard Tai Chi. General exercise provides an active comparison. The planned enrollment target was 165 children. Recruitment has closed with 158 eligible children enrolled. Children were individually randomized within their original school classrooms using a target allocation ratio of 2:2:1. All groups continued their usual necessary educational, rehabilitation and medical services. Courses took place at Chaozhou Special Education School. Each group received 72 sessions over 6 calendar months: 24 teaching weeks, 3 sessions per week, and 45 minutes per session, from December 25, 2025 to June 25, 2026. Children attended supported training groups of 4-6, and follow-up continued for 3 months after the courses ended, with visits 1 month (month 7) and 3 months (month 9) later. The three primary outcomes are accuracy on the existing short Flanker, 1-back and Dimensional Change Card Sort tasks at month 6. Trained computerized-task assessors were kept unaware of course allocation. Supportive secondary outcomes are task reaction times, selected parent and teacher Childhood Executive Functioning Inventory scores, and the parent Strengths and Difficulties Questionnaire impact score. Computerized tasks and the Childhood Executive Functioning Inventory were collected at baseline and months 3, 6, 7 and 9. The Strengths and Difficulties Questionnaire was completed at baseline and month 6.

The Effect of Triple P Training on Children's Repetitive Behaviors and Parents' Mood and Burnout Levels in Parents of Children With Autism

This project will be conducted in a private autism center in order to investigate the effects of Triple P training, which will be given to parents of children with Autism Spectrum Disorder, on the children's repetitive behaviors and the parents' burnout levels. The study is a randomized controlled trial and the study sample will consist of parents of children with Autism Spectrum Disorder. The children/parents included in the study sample will be numbered according to the order of arrival and 35 will be assigned to the intervention group and 35 will be assigned to the control group. During the randomization phase of the study, 70 children/parents with ASD will be randomly assigned to the intervention and control groups using Statistical Analysis Software. Data analysis will be performed using the Statistical Package for Social Sciences (SPSS v26.0, IBM Corp., Armonk, NY, USA). Descriptive data will be analyzed as mean, frequency and percentage. The conformity of quantitative data to normal distribution will be evaluated using the Kolmogorov-Smirnov test. Paired sample t-test will be used to compare dependent groups with normal distribution, independent sample t-test will be used to compare independent groups with normal distribution. P value will be considered significant if it is less than 0.05.

The Effects of a Nurse-led Community-based Sailing Programme on Resilience of School-aged Children With Autism: An RCT

The goal of this randomised controlled trial is to evaluate the effect of a nurse-led community-based sailing programme on resilience of school-aged children with autism in inclusive education. Does intervention improve the resilience of participants? Does intervention improve the quality of life, self-esteem, depressive symptoms, and social functioning outcomes of participants? Researchers will compare the effect of intervention (community-based sailing programme) to the attention control group (Crafting activities) at baseline, post-intervention, and at 3-month and 9-month follow-ups. Participants will: Participants in the intervention group will participate in a nurse-led community-based sailing programme over six days, with each day consisting of 4 sessions, each lasting an hour, for a total of 24 hours. Participants in the attention control group will engage in crafting activities with minimal difficulty, focusing on maintaining attention without any emotional or reflective discussions.

Evaluating the Impact of Telehealth-Based ASD Assessments and Supports on Child and Caregiver Outcomes

The overall goal of this study is to evaluate telehealth and internet-based approaches to meet accessibility challenges for families with concerns about ASD in their infants. In this study, we will gather exploratory data related to the potential of two telehealth tools: 1) The Telehealth Evaluation of Development for Infants (TEDI); and 2) "Help is in Your Hands" (HIIYH), a set of video materials and information on interactive strategies parents can use to support their child's communication development. We will recruit families participating in an ongoing study using the TEDI (R21 HD100372, PI: Talbott) to evaluate infants' behavioral development. As families exit the parent TEDI study and enter the current study, we will ask parents to complete online questionnaires, and randomize them to either receive immediate access to additional online materials (HIIYH) for parents or no additional materials. After 12 weeks, parents will complete online questionnaires and all families will then be given access to the online materials. When children reach 30 months, we will collect additional questionnaires, complete a live telehealth behavioral session with toddlers and their caregivers, and conduct an exit interview with parents to gather feedback about their experience.

DBT Skill Training for Autistic Adults With Difficulties in Emotion Regulation.

One in 44 has autism, 70% of them have additional mental health challenges. Currently, this patient population does not have access to effective treatment within specialist healthcare services and has struggled to benefit from standard treatments. The goal of this project is to increase access to treatment tailored to their challenges. We will investigate whether a treatment program with an adapted version of Dialectical Behavior Therapy (DBT) is feasible, accepted, and perceived as useful for people with autism. The purpose of the treatment is to improve emotion regulation, function better in relationships, and avoid crises, thereby enhancing their ability to achieve personal goals, reduce suffering, and increase quality of life. Autism is a lifelong neurodevelopmental disorder, presenting with great variation and more widespread than previously thought. Difficulties with emotion regulation are a central challenge for many with autism. These difficulties often manifest as an inability to recognize, understand, and manage emotional responses, leading to destructive strategies, behaviors, and suffering. DBT is developed with a focus on emotion regulation and has shown good effects in other patient populations. The project can increase access to treatment for a patient population that currently stands without.

Comparing Cognitive-Behavioral Therapy Versus Mindfulness-Based Therapy for Autistic Adults

Autistic adults are at a greater risk for mental health problems compared to the general population, with 50% meeting criteria for a co-occurring psychiatric condition. Depression and anxiety are the most common of these conditions among autistic adults, contributing to long-term detrimental effects on health, day-to-day functioning, and quality of life. This study will conduct the first large-scale head-to-head comparison of the two most widely studied mental health interventions for autistic adults: cognitive-behavioral therapy (CBT) and mindfulness-based therapy (MBT). Both interventions are well-established, empirically supported treatments for depression and anxiety in the general population, and both interventions have demonstrated efficacy among autistic adults. However, their comparative effectiveness and heterogeneity of treatment effects have not been established in autistic adults. Both interventions will be delivered by telehealth.

Mindfulness-Based Intervention for Parents of Autistic Children in Pakistan

This randomized controlled trial evaluated a culturally adapted mindfulness-based intervention for Pakistani parents of children with autism spectrum disorder. Sixty-eight parents were randomly assigned to one of three groups: a mindfulness-based intervention (n = 23), an active psychoeducation comparator (n = 23), or a waitlist control (n = 22). The mindfulness-based intervention and psychoeducation programs were delivered in eight weekly group sessions. Participants completed assessments at baseline, immediately after the intervention, and one month after the intervention. The study examined changes in mindfulness, self-compassion, and parenting stress among parents of children with autism spectrum disorder.

FOXP1 Syndrome: The Seaver Autism Center for Research and Treatment is Characterizing FOXP1-related Neurodevelopmental Disorders Using Genetic, Medical, and Neuropsychological Measures.

FOXP1, also known as Forkhead-box Protein P1, is a transcription factor protein belonging to the FOX gene family. Disruptions in the FOXP1 gene cause a phenotype characterized by global developmental delay, speech deficits, mild dysmorphic features, and traits of autism spectrum disorder. This study seeks to characterize FOXP1-related neurodevelopmental disorders using a number of genetic, medical and neuropsychological measures.

Effects of Lactobacillus Plantarum PS128 in Children With ASD

Autism spectrum disorder (ASD) is a neurodevelopmental disorder that can cause significant social, communication and behavioral deficits. Probiotics are regarded as active microorganisms. With sufficient amounts, probiotics can regulate intestinal flora, intestinal permeability, inflammation and antioxidant reactions in the body. These reactions may further promote health, regulate metabolic disease progression and prevent complications. Lactobacillus plantarum PS128 (PS128) was reported to be a psychobiotic in several animal and human studies which modulated the levels of neurotransmitters in different brain areas. This study is to evaluate whether the consumption of PS128 can improve the symptoms of patients with ASD. The current randomized, placebo-controlled trial was conducted to investigate the psychophysiological effects of PS128 in school children with ASD.

Pragmatic Trial Comparing Weight Gain in Children With Autism Taking Risperidone Versus Aripiprazole

This study aims to compare two FDA approved medications (aripiprazole and risperidone) for the treatment of behavioral dysregulation in children with autism spectrum disorders. This trial, done in the context of routine clinical care, will seek to evaluate whether aripiprazole or risperidone is associated with more weight gain in children.

ASD and Habituation to Dental Examination

The goal of this effectiveness trial is to investigate if an integrated dental habituation programme can enhance acceptance of a clinical dental examination in children (aged 5-8 years) with autism spectrum disorder (ASD). The main questions it aims to answer are: * Can a dental habituation programme performed by trained dental hygienists increase the acceptance of a clinical dental examination in children with ASD? * Is a dental habituation programme for children with ASD more effective compared to home preparation using visual aids performed by parents/guardians in increasing the acceptance of a clinical dental examination in children with ASD? The study participants will be randomly assigned to either the habituation group (intervention) or the home preparation group (augmented control) to investigate the effectiveness in increasing acceptance and cooperation of a clinical dental examination.

Evaluating the Feasibility of Collecting User Interaction Data at the Emory Autism Center Using MapHabit Software

The purpose of this study is to evaluate the impact of the MapHabit System on autistic transition-age youth (ages 18-24) as they navigate key life transitions including graduating from high school, entering adult services, pursuing employment or education, and community-based living.

Pediatric Patients With Metabolic or Other Genetic Disorders

Background: Some patients with unusual genetic conditions are referred to the National Institutes of Health (NIH). They may not be eligible to join current research studies. Testing such patients is a good way to improve the skills of research staff. The findings could lead to new processes and research. Objectives: To recruit a diverse group of pediatric subjects with genetic disorders. To give clinic staff hands-on experience working with these patients. Eligibility: Children any age with a known or suspected genetic disorder. Design: Participants will be screened with medical history and physical exam. They may have lab and other tests. Family members may give DNA samples. Participants will have: Medical history Physical exam Height, weight, and other measurements taken. A clinical evaluation of their disorder. They may have: Blood, urine, and saliva samples taken Imaging tests. These may include x-rays, scans, ultrasound, or skeletal survey. A sleep study A visit with other specialists at NIH A genetic test from a commercial lab Medical photographs taken Other tests Participants may have follow-up visits. They may get medical or surgical treatment.

Flexibility and the Predictive Brain in Autistic Males and Females

The goal of this study is to compare the neural correlates of predictive brain mechanisms during high-level social and non-social flexibility tasks, between autistic and non-autistic males and females. The aim is to better understand if autistic individuals differ from non-autistic individuals in their cognitive flexibility according to the social and predictable nature of the stimuli, at a behavioral and neurofunctional level using the functional Magnetic Resonance Imaging (fMRI). As autistic females usually present a more subtle profile than autistic males, the investigators will also explore if autistic males and females present neurofunctional differences.

Internet-delivered Cognitive-Behavioral Therapy for Adolescents With Autism and Anxiety

Anxiety is very common in autistic youth. Cognitive behavioral therapy (CBT) is the recommended treatment for both autistic and typically-developing (TD) youth with anxiety, yet most families cannot access CBT due to cost, practicalities of attending in-person treatment sessions, and a shortage of trained providers, especially in rural areas. The goal of this project is to increase access to care for families of autistic adolescents with anxiety through an internet-based treatment model.

SPARK Exercise Program and Game-based Training in Children With Autism Spectrum Disorder

This randomized controlled trial (RCT) will compare the effects of the SPARK program versus game-based circuit training on motor skills and social interaction in 22 children with Autism Spectrum Disorder (ASD) aged 5-12 years. Participants will be randomly assigned to either the SPARK group (n=11) or game-based training group (n=11) at a child rehabilitation center over 10 months. Each intervention will be delivered for 12 weeks, three times per week for 30 minutes. Motor proficiency will be measured using the Bruininks-Oseretsky Test (BOT-2), and social interaction using the Autism Social Skills Profile (ASSP). After ethical approval from Riphah International University, Lahore, data will be analyzed using SPSS version 23.

NTI164 in Autism Spectrum Disorder

This is a double-blind, randomised, placebo-controlled study investigating the efficacy of a full-spectrum medicinal cannabis plant extract on core and associated ASD symptoms over placebo. Participants will be randomly allocated to either NTI164 or placebo at a 1:1 ratio and blood samples will be collected and surveys completed at baseline and Week 16. This study will expand efficacy and safety data of NTI164 and provide additional mechanism of action data of NTI164 in this patient cohort.

Effect of Limosilactobacillus Reuteri on Social Deficits in Children With Autistic Spectrum Disorder

This is a double-blind, randomized, placebo-controlled, parallel-group study in children with Autism Spectrum Disorder (ASD) to evaluate the effect of a probiotic product on the ASD symptoms.

Developing Brain, Impulsivity and Compulsivity

Background: Impulsivity is acting 'without thinking.' Compulsivity is being overly inflexible. People vary in how impulsive or compulsive they are. Extreme versions of these behaviors play a role in mental disorders. Researchers want to study changes in the brain to learn more about these behaviors. Differences in genes may also play a role. Objective: To learn about genetic \& brain features that explain why levels of impulsivity and compulsivity vary across people. Eligibility: People ages 6 - 80 Design: Participants will be screened with a medical history and medical record review. Participants will talk about their mental and behavioral development. They may discuss topics like drug use and sexual activity. They will complete surveys about their compulsivity and impulsivity. Parents of child participants may also complete these surveys. Participants may take memory, attention, and thinking tests. They may give blood or saliva samples for gene studies and they may give blood to make induced pluripotent stem cells. Participants may have their face and irises photographs taken. Participants may have a magnetic resonance imaging scan. It will take pictures of their brain. The scanner is shaped like a cylinder. Participants will lie on a table that slides in and out of the scanner. A coil will be placed over their head. They will lie still, watch a movie, and play a game. Participants may ask family members to join the study. Researchers are particularly interested in recruiting twin pairs to the study. Participants under age 25 may repeat these tests every 1-2 years until they turn 25 or until the study ends. For those over age 25, participation will last less than 1 month.

Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder

This is a multicenter, global, 26-week, open-label study to assess the safety and tolerability of lumateperone in pediatric patients with schizophrenia, bipolar disorder or autism spectrum disorder.

Improving Executive Function in Korean Children With Autism

The purpose of this randomized controlled study is to evaluate the acceptability, feasibility, and preliminary efficacy of an executive function (EF) training intervention for 5- to 7-year-old autistic children in South Korea. This study will have three aims: (1) to assess the acceptability and feasibility of the EF intervention with children with ASD; (2) to examine clinically important effects of the intervention using multimodal methods combining lab-based behavioral tasks and novel electrophysiological measures; and (3) to determine whether the effects are generalized to everyday EF skills in real-world settings using parent-ratings.

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.

Safety and Efficacy of tPBM for Epileptiform Activity in Autism

For this study, the proposed intervention will be noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM) - to the brains of autistic children with abnormal EEGs with epileptiform discharges or with epilepsy. This will occur, twice a week, for 10 weeks. The NIR light is delivered to specific brain areas by Cognilum, a wearable device developed by Jelikalite. The expected outcome is improved focus, improved eye contact, improved speech, improved behavior, and gains in functional skills. Cognilum may impact the clinical practice of treating autism. At the beginning, at five weeks, and at the end of study, the clinician will complete the CARS-2, SRS, CGI, and a caregiver interview; additionally, questionnaires will be administered to caregivers during one of the 1-hour weekly treatment sessions.

The BRAVE (Behaviourally Responsive Assessments of Vital Signs in Emergency) Study

This is a randomized, unblinded, single-centre, pilot feasibility study. A total of 100 patients will be enrolled and randomized to have their vital signs collected using either the Masimo Radius PPG and Radius T in combination with standard equipment, or only the standard equipment. Within the experimental group, Children will have their HR, RR, SpO2, and T measured using the wearable monitors, specifically the Masimo Radius PPG and Radius T devices that are attached to them wirelessly. Blood pressure (BP) will then be measured using standard equipment in the ED, after obtaining wireless vital signs. For the control group, Children will have their vital signs measured using standard hospital vital sign monitoring equipment. The project will be deemed successful if all primary feasibility thresholds are met and preliminary data show a trend toward reduced time-to-vitals and distress without safety concerns. Additional indicators include clear identification of logistical/training needs, dissemination of findings (peer-reviewed publication, PERC/TREKK networks), and a refined protocol for a definitive trial. Achieving these will demonstrate both proof-of-concept and readiness for multi-centre implementation.