Clinical Research Directory

Parent-implemented Social Communication Treatment in Autism

An accumulation of research evidence has pointed to parent-implemented communication intervention as effective in reducing the severity of social communication deficits in autistic preschoolers. Despite even high-quality evidence, real-world translation to clinical practice remains challenging, especially for children from lower-income families, for two reasons. First, the intervention outcome is highly variable despite study-level efficacy data, most likely due to unique child and parent factors that make intervention response uneven across individual children. Second, the cost of intervention with the largest effect sizes remains high due to its one-on-one format. With the overarching goal to reduce cost and to increase intervention effectiveness at the individual-child level, this project will conduct a randomized controlled trial (RCT) to compare the effectiveness of two options for intervention to address two specific objectives. The investigators will first ascertain whether parent-implemented communication intervention taught by a speech therapist in a Group format (up to 8 families learning together) is more effective than intervention learnt by the parents themselves (learning the same materials without the guidance of a therapist) at the study level. The investigators will then evaluate what combinations of parent and child behavioral factors determine which format of intervention is likely to be more effective at the individual-child level. It is likely that not all families require the more costly Group format of intervention. Machine learning analytics with cross-validation will be used in constructing predictive models of intervention response, which will increase the likelihood of these models being generalizable to new patients. This study will be among the first examples of fulfilling the promise of Precision Medicine in providing guidance to patients and families with developmental disorders not about whether to receive intervention but which option for intervention to receive in the context of multiple options. This predict-to prescribe approach of autism intervention will likely lead to a paradigm shift in clinical practice and ultimately result in lowering the overall cost and increasing the effectiveness of intervention for autistic children as individuals.

Parent-implemented Social Communication Treatment in Preschool Children With Autism Spectrum Disorder

An accumulation of research evidence has pointed to parent-implemented communication treatment as effective in reducing the severity of social communication deficits in preschool children with ASD. Despite even high-quality evidence, real-world translation to clinical practice remains challenging, especially for children from lower-income families, for two reasons. First, the treatment outcome is highly variable despite study-level efficacy data, most likely due to unique child and parent factors that make treatment response uneven across individual children. Second, the cost of intervention with the largest effect sizes remains high due to its one-on-one format. With the overarching goal to reduce cost and to increase treatment effectiveness at the individual-child level, this project will conduct a randomized controlled trial (RCT) to compare the effectiveness of two options for intervention to address two specific objectives. The investigators will first ascertain whether parent-implemented communication treatment taught by a speech therapist in an Individual (one-on-one) format is more effective than treatment taught in a Group format (up to 8 families learning together) at the study level. The Individual format is at least 4 times more expensive than the Group format; its relative treatment effect must be empirically ascertained to justify its cost. The investigators will then evaluate what combinations of parent and child behavioral and neural factors determine which format of intervention is likely to be more effective at the individual-child level. It is likely that not all families require the more costly Individual format of intervention. Machine-learning analytics with cross-validation will be used in constructing predictive models of treatment response, which will increase the likelihood of these models being generalizable to new patients. This study will be among the first examples of fulfilling the promise of Precision Medicine in providing guidance to patients and families with developmental disorders not about whether to receive intervention but which option for intervention to receive in the context of multiple options. This predict-to-prescribe approach of ASD intervention will likely lead to a paradigm shift in clinical practice and ultimately result in lowering the overall cost and increasing the effectiveness of intervention for children with ASD as individuals.

QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)

BRIEF SUMMARY A. "What is the purpose of this study?" BACKGROUND. The QAIAx clinical trial (Quantum SI/SGI Public Health Agency), known operationally as the "AI City Hall Project," represents a landmark intergovernmental research initiative examining the viability of AI-governed residential ecosystems for behavioral and mental health intervention. Authorized under 10 U.S.C. 4001 (Defense Sector Research Projects, RDT\&E) and supported by pending USPTO applications (Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360), this non-medicinal program investigates whether quantum AI-managed public administration, AI/SI humanoid robotics, holographic holoportation (AI-119 Kikkeri Holo-Suit / "AI Wat Beam Bot"; AI-119 Vulcan QM-Ware or "Quasi-Mind Ware"), and advanced AGI learning machines can reduce housing and care costs while improving mental health outcomes-particularly for persons with addiction and co-occurring psychiatric disorders. SCOPE \& JURISDICTION. The trial operates across a network of self-contained, geodesic dome-enclosed "Microcities" (1,500-15,000 occupants per site) within an affiliate network of 300 communities, spanning North America, South America, Europe, Africa, Oceania, Asia, and the Middle East. Participating host nations are U.S.-allied member states party to the Status of Forces Agreement (SOFA), the Vienna Convention on Diplomatic Relations, and the Hague Convention, alongside related bilateral treaties with the U.S. government. INTERVENTION \& POPULATION: Eligible adults (18+) reside in these Microcities for up to 36 months. Daily life-including housing, utilities, and healthcare-is administered by the ISAC SI/SGI system and robots with minimal human oversight. CLINICAL TRIAL GOAL(S): The clinical trial program goals are to exemplify a sustainable SGI-managed public administration supported by AI robotics and AGI trans-human and omni-AI machines (e.g., "Q-Men"; "AI-Me"; Beam Bot", "QM-Ware", "AVK Suit") to improve mental health outcomes-especially for those with addiction disorders-and create a financially sustainable model for people on fixed incomes or public assistance. B. "What conditions does the study focus on?" The study focuses on adults with: * Autism spectrum disorders (Asperger's, autism, ADHD, ASD) * Substance use disorders (alcohol, opioids, marijuana, cocaine, MDMA/ecstasy, tobacco/nicotine) * Psychiatric conditions (personality disorders, narcissism, gender dysphoria, eating disorders) * Behavioral addictions (gambling, sex addiction) and related issues (sex offence history). C. "What does the study involve?" Eligible volunteers live in an omni AI-managed Microcity for up to 24 months. The community is housed in a geodesic dome that contains all daily necessities: housing, food, utilities, healthcare, and public services. Daily life is managed by an SI system (ISAC) and AI humanoid robots, with only occasional human oversight. Participants receive free mental-health treatment that may include AI-driven counselling, virtual-reality therapy (holo-suits), and non-invasive digital "attitude inoculation" protocols designed to reduce stress and addiction cravings. All participants also take AI-technology courses as a condition of enrolment. The study does not use any FDA-regulated drug, device, or biologic. \*\*Who can participate?\*\* You may be able to join if you: * Are an adult (18 years or older) * Have a diagnosis of one of the listed mental-health or addiction disorders * Are referred by a licensed health professional (e.g., RN, NP, PhD, MD), a non-profit organization (e.g., 501(c)(3), university, church), or a public agency (e.g., case manager, social worker, parole/probation officer, judge) * Are willing to live in a closed, AI-managed community for up to one year and complete AI educational courses. Participants who are veterans, receive public assistance (e.g., VA disability, SSDI/SSI, Medicaid, Medicare), or are experiencing homelessness may be prioritized. \*\*Where is the study taking place?\*\* The study will be conducted at Microcity sites in the United States and internationally. The first administrative site is in Richmond, Virginia, USA. Additional sites are planned in partner nations, including tribal lands, military installations, and special economic zones. \*\*Who is sponsoring the study?\*\* The study is sponsored by Veterans Recovery Network Inc., a SCDV-owned non-profit organization, in collaboration with AI-119 Vulcan Project Research \& Educational Technology Co. (PRETCO). The study is conducted under U.S. federal research and development authorities (28 U.S.C. §1498; 10 U.S.C. §§§§ 4001, 4021, 4022, and 4023) and is part of a Cooperative Research and Development Agreement (CRADA) with participating segments or RDT\&E programming missions of the United States Defense Department (DoW). This summary describes a planned clinical study. Not all details may be final. Information may change as the study progresses.

Word Learning From Parentese in Autistic Children

The overall objective of this research is to determine whether parentese delivered in the video format (Aim 1) and in live interaction (Aim 2) facilitates novel word learning in autistic children and to investigate if there are factors that influence the effect of parentese on word learning (Aim 3).

COMPASS Across Settings (CAST) for Improving Transition Outcomes for Students With ASD

Purpose: The purpose of this project is to develop and test the COMPASS \[Collaborative Model for Competence and Success\] Across Settings (CAST) intervention to enhance the goal setting and attainment skills of autistic youth. Despite federal education law mandating transition services as part of the Individualized Education Program (IEP) for ensuring good outcomes for students with disabilities, current educational practices have been unable to demonstrate that autistic students experience positive postsecondary outcomes. There are existing, evidence-based interventions aimed at supporting positive outcomes for these students. However, these interventions have not systematically provided coaching support to the caregivers, students, and employment specialists. To address these issues, CAST will integrate three evidence-based interventions for supporting student transitions while providing this critical coaching support. By doing so, CAST aims to align the priorities and goals of interventions across home, school, and community settings to better support positive postsecondary outcomes for autistic students.

The Effectiveness of Community Autism Peer Specialist (CAPS) Program

The number of autistic adults reached 5.4 million in the United States in 2017 and is projected to continue to rise, but evidence-based practices to optimize their health and well-being are limited and poor outcomes are common. This study will leverage existing infrastructure to finalize the development of a novel support service provided by peers with lived experience, incorporating input from autistic peer specialists, autism researchers, peer support researchers, and experts in peer support training. Investigators will then conduct a pilot randomized controlled trial to examine the effectiveness of the service while also examining the feasibility, acceptability, and implementation procedures in preparation for future large-scale testing and dissemination.

Theta Burst Stimulation for Refractory Depression in Autism Spectrum Disorder

Evaluate the efficacy of accelerated theta burst stimulation (aTBS) in reducing depressive symptoms in autism spectrum disorder (ASD)

Adapting the Sensory Environment to Reduce Stress in Children With Autism During Dental Visits

This study aims to evaluate the impact of a sensory-adapted dental environment (SADE) on the stress levels and behavioral responses of children with autism spectrum disorder (ASD) during dental visits. Children with ASD often experience sensory sensitivities, making traditional dental care challenging and stressful. In this study, 40 children aged 8 to 12 diagnosed with ASD, along with their parents or legal guardians, will participate in two standard dental visits spaced 30 days apart. The first visit will take place under standard clinical conditions, while the second visit will utilize a sensory-adapted dental environment featuring modified visual elements (such as dark protective glasses), auditory (noise-canceling headphones or relaxing music), taste (unflavored toothpaste), smell (sweet orange essential oil) and tactile adjustments (a weighted blanket). The study will measure stress using objective tools, including continuous digital biomarkers of stress recorded via wristbands (such as heart rate, electrodermal activity, accelerometer data, actigraphy, movement intensity, step count, metabolic equivalent of task, skin temperature, and peripheral body orientation) and the analysis of salivary lysozyme and cortisol levels in both children and parents. Additionally, standardized psychological questionnaires will be used to assess the child's sensory profile, as well as parental stress and coping strategies. The findings will help determine whether modifying the sensory environment can effectively reduce anxiety and improve the dental care experience for children with autism.

Safety of Cultured Allogeneic Adult Umbilical Cord or Placental Derived Mesenchymal Stem Cell Intravenous Infusion for Autism

This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cells for the treatment of Autism

Improving Academic and Social Functioning in Middle-Schoolers With Autism

The goal of this study is to test how well two group interventions work for middle-school children with Autism Spectrum Disorder (ASD). One of the interventions focuses on teaching parents and adolescent skills to help improve their social functioning and the other focuses on teaching parents and adolescents skills to improve organization, planning, and study skills. Eligible participants will be randomly (like a coin flip) assigned to attend one of the two interventions.

Optimizing Outcomes for Young Autistic Children

The overarching goal of the proposed study is to: (a) determine how best to sequence two parent-mediated interventions: a social communication intervention (Project ImPACT, Improving Parents as Communication Teachers) and a disruptive behavior intervention (Parent Training for Disruptive Behavior) and (b) examine moderators and mediators of intervention outcomes.

Parent-Mediated Social Cognition Intervention for Young Children With Autism Spectrum Disorder

This study evaluates the efficacy of the Companion Mind-Drawing Cooperative Game Program, a parent-mediated, home-based structured play intervention targeting social cognitive development in young children with autism spectrum disorder (ASD). Children with ASD in the intervention group will receive a structured program in which parents attend an in-person training session (approximately 2.5 hours) at the hospital, where parents are taught to administer a series of researcher-designed cooperative game paradigms at home. Parents then deliver the intervention daily for at least 30 minutes per session over a period of six months. Monthly online video reviews by a clinician provide parents with individualized feedback and guidance to ensure program fidelity and quality. Children with ASD in the comparison group will continue to receive usual care and will not receive the program during the study period. Social cognitive outcomes - including emotion recognition, theory of mind, empathy, joint attention, self-perception, and social communication - will be assessed at baseline and at 12-month follow-up using behavioral experimental tasks and eye-tracking paradigms. This study aims to provide evidence for the efficacy of a scalable, family-implemented social cognition intervention for young children with ASD.

Interactive Massage Intervention in Toddlers With Autism Spectrum Disorder

This randomized controlled trial aims to evaluate the efficacy of a 3-month maternal interactive massage intervention in toddlers aged 18-24 months with autism spectrum disorder (ASD). A total of 120 toddlers with ASD will be randomly assigned in a 1:1 ratio to either an intervention group or a usual care group. Participants in the intervention group will receive standardized maternal interactive massage in addition to usual care and ASD parenting guidance, whereas participants in the usual care group will receive usual care and ASD parenting guidance only. The interactive massage will be performed by the child's mother for 15 minutes per session, three sessions per day, six days per week, for three months. The primary outcome is parent-child interaction quality. Secondary outcomes include salivary oxytocin levels and brain responses to social versus non-social stimuli measured using functional near-infrared spectroscopy (fNIRS). Outcomes will be assessed at baseline, immediately after the 3-month intervention, and at a 1-month post-intervention follow-up.

Testing the Efficacy of 100mg Vitamin-B6 Daily for Sensory Reactivity in Autism

This clinical trial aims to explore the effect of Vitamin B6 supplementation on anxiety sensory hyperreactivity in autistic adults. Researchers will compare a placebo group to high-dose Vitamin-B6 to see if vitamin B6 reduce anxiety and sensory reactivity differences in autism.

Effectiveness of Interactive Techniques on Oral Hygiene Skills in a Group of Autistic Egyptian Children

The present study will be performed to evaluate the effectiveness of peer modeling and audiovisual peer modeling video on toothbrushing skills in comparison to the visual pedagogical method at home. To monitor the improvement of teeth brushing skills in children with ASD using plaque and gingival indices.

To Share or Not To Share: Navigating Disclosure and Stigma Among Family Caregivers of Autistic Young Adults_Group Intervention

This study is a caregiver support program for family caregivers of autistic young adults (ages 18 to 26) as their family members navigate young adulthood. The program includes six 60-minute virtual sessions focused on making sense of caregiving roles during young adulthood, reflecting on everyday family experiences, supporting decision-making within families, deciding when and how to share experiences with others, and thinking about the future.

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.

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.

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.

The Neurodevelopmental and Behavioral Phenotyping Screening Protocol

The purpose of this protocol is to allow for the careful evaluation of healthy volunteers and individuals with risk for psychiatric disorders or neurodevelopmental disorders, such as autism spectrum disorder for specific protocols at NIH.

Tailored and Transdiagnostic Internetbased Intervention for Autistic Adults

The number of individuals receiving an autism diagnosis is increasing, particularly among individuals without co-occurring intellectual disability. This group does not always present with stereotypically autistic characteristics. Instead, the cognitive mechanisms underlying autistic functioning often manifest in less apparent difficulties, such as difficulties with self-acceptance, low self-esteem, stress-related problems, low energy, or anxiety. At the same time, this group is highly heterogeneous in terms of abilities and difficulties, and consequently, their needs also vary. Over the past decades, it has become increasingly evident that autistic adults have substantial needs for support for psychological distress, while healthcare services have difficulties meeting these needs. This is likely due to a combination of limited resources and a lack of adapted and accessible interventions. Providing psychological treatment via the internet may be one way of increasing access to healthcare for this population. Internet-based interventions have been shown to be effective in treating mental health problems in other patient populations, and the internet-based format may be well suited to the needs and preferences commonly reported by autistic individuals. Within this project, we are developing an internet-based treatment for autistic adults aimed at increasing individuals' understanding of themselves and their difficulties, as well as improving self-esteem and self-acceptance. In the longer term, we hope that the treatment may also contribute to improved quality of life and sense of coherence, as well as reduced levels of anxiety and depression. The treatment is intended for autistic adults experiencing some form of psychological distress. It consists of text-based modules, and participants complete exercises with the support of an individual therapist who guides them through the treatment. If the treatment proves to be effective, our hope is that it can be implemented within Swedish habilitation services as an alternative to face-to-face psychological treatment.

Examining the Effects of Group Versus Individual Based Exercise Program on Balance and Coordination in Children With Autism

This study compared the effects of group-based versus individual-based exercise programs on balance and coordination in children aged 3-12 years who were diagnosed with Autism Spectrum Disorder (ASD) Level 1. A total of 16 children were recruited and randomly allocated into two groups (n=8 each): Group A (individual-based) and Group B (group-based). Both groups received 40-minute exercise sessions, 3 days per week, for 6 weeks. Outcomes were assessed at baseline and after 6 weeks using the Pediatric Balance Scale (PBS) and neurological coordination tests (Finger-to-Nose, Heel-to-Shin, Past-Pointing).

Enhancing Emotion Regulation in Children With Autism Through Extended Reality

Pilot study on the development of an Extended Reality (XR) application to support emotion regulation in children with Autism Spectrum Disorder (ASD) (random assignment to an experimental group, N = 10, and a control group, N = 10). The matched control group with autistic children of the same age receives emotion regulation coaching without the use of virtual reality. Few studies systematically captured the transfer of XR-supported learning into real life. One study investigated the transfer of breathing techniques into everyday life, where children with ASD successfully transferred these techniques to daily life and applied learned breathing patterns in anxiety-inducing situations. The use of XR systems is considered as low-risk. Primary Hypotheses: * Feasibility analysis of the described XR-supported coaching * Reduced Emotional Dysregulation between T1 and T2 Secondary Hypotheses: * Reduced Parental stress between T1 and T2 * Reduced internalising/externalising behaviors between T1 and T2 * Exploratory analyses of physiological parameter changes during intervention period

Transdiagnostic Behavioral Therapy for Anxiety and Depression in Autistic Adolescents

This study tests the effectiveness of a transdiagnostic cognitive behavioral therapy for autistic youth with anxiety and/or depression.