Clinical Research Directory

Real World Outcomes of Intranasal MuSE Exosomes and Stem Cells in Neurological Regenerative Therapy

This prospective observational study collects real world data on participants receiving regenerative therapies administered internationally and delivered intranasally via the Kurve Therapeutics ViaNase device. The study does not assign treatment. Participants are enrolled after receiving, or electing to receive, therapy as part of routine clinical care outside the study. Participants are observed in one of three cohorts based on the therapy received: MuSE cell derived exosomes, MuSE stem cells, or combination therapy. The objective is to evaluate safety, tolerability, and changes in inflammatory biomarkers and clinical outcomes over time in a real world setting. The study also evaluates changes in inflammatory biomarkers, including serum tumor necrosis factor alpha (TNF-α), to better understand the biological effects of these therapies.

Spanish-language Executive Function Intervention for Children With Autism and/or ADHD

The goal of this clinical trial is to learn whether the Spanish-language version of Unstuck and On Target (SL-Unstuck), an executive functioning (EF) intervention, is feasible, acceptable, and effective for Spanish-speaking caregivers and their neurodivergent children (ages 8-11) in the U.S.. The main questions it aims to answer are: * Is SL-Unstuck acceptable to Spanish-speaking caregivers and children? * Does SL-Unstuck improve child EF, caregiver EF knowledge, and caregiver strain? Researchers will compare families randomly assigned to immediate SL-Unstuck versus waitlist control to see if participating in the intervention improves EF and family outcomes. Participants will: * Attend 8 weekly SL-Unstuck sessions at a clinic (parallel child and caregiver groups) * Complete pre- and post-intervention assessments on child EF, caregiver strain, and satisfaction * Participate in a focus group to share feedback on the intervention

Safety Planning Intervention for Autistic Youth: A Randomized Controlled Trial With Providers in Developmental-Behavioral Pediatric Clinics

The goal of this clinical trial is to examine the initial feasibility, acceptability, and effectiveness of Crisis Interventions for Pediatric Providers - Autism version (CIPP-A) for providers serving autistic youth in outpatient settings. The main question aims to answer: * Assess whether CIPP-A is feasible and acceptable to providers in development behavioral pediatric clinics? * Assess whether CIPP-A shows initial effectiveness in increasing providers confidence in managing suicide risk in autistic youth? If there is a comparison group: Researchers will compare CIPP-A to general safety planning intervention (SPI) on feasibility, acceptability, and initial effectiveness. Participants will be randomized to receive training in SPI or CIPP-A and complete online surveys and interviews over 6-months to measure feasibility, acceptability, and initial effectiveness.

Improving Caregiver Engagement in Early Interventions

The goal of this study is to test the effectiveness of the FANS-EI program in supporting caregiver engagement in caregiver-mediated early interventions for young children with autism. This study also examines caregiver-perceived social support and self-efficacy and FANS-EI implementation outcomes (feasibility, acceptability, appropriateness).

Trial of Suvorexant for Sleep in Children With Autism

The purpose of this study is to examine the effect of suvorexant on sleep in children and adolescents with Autism Spectrum Disorder (ASD). Suvorexant is a selective, dual orexin receptor antagonist (DORA) used for the treatment of sleep onset difficulties and/or sleep maintenance. To accomplish this, the investigators will use a randomized double-blind placebo-controlled crossover 8-week study design to examine the effect of suvorexant on sleep physiology as assessed by polysomnography (PSG), actigraphy, circadian rhythm, and clinical measures.

Trial of Zolpidem for Sleep in Children With Autism

The purpose of this study is to examine the effect of zolpidem on sleep in children and adolescents with Autism Spectrum Disorder (ASD). Zolpidem is a nonbenzodiazepine GABAa receptor agonist drug that acts as a hypnotic. To accomplish this, the investigators will use a randomized double-blind placebo-controlled crossover 8-week study design to examine the effect of zolpidem on sleep physiology as assessed by polysomnography (PSG), actigraphy, circadian rhythm, and clinical measures.

CFT Guided Self-help Intervention: Parents of Autistic Children

This research will aim to test how practical, achievable and effective a brief, guided, self-help compassion focused intervention is for parents of autistic children aged 6-17 years old. The demands of parenting can be rewarding but also challenging, and it is known that parents of autistic children experience additional pressures. As a result of this, parents of autistic children may be more likely to experience increased stress, anxiety, low mood and lower quality of life, compared to those parenting children who are not autistic. There has been only a small amount of research so far regarding whether interventions that focus on building compassion, would be beneficial to parents of autistic children. The purpose of this study is to test whether a short, self-guided compassion-focused intervention is practical, achievable and effective for parents of autistic children. The intervention is based on Compassion Focused Therapy (CFT) and involves reading workbook material and listening to audio tracks. There will also be some questionnaires to complete and 30-minute weekly support calls with the lead researcher. This intervention was adapted previously, from an intervention for parents in general, to be more suitable and focused on the needs of parents of autistic children. This study will be the first time the adapted intervention has been used by parents. The intervention will be tested by 6-8 parents and will be about 13 weeks long. We will collect some demographic data at the start of the study, and there will be the opportunity to complete an evaluation questionnaire.

Milieu Teaching-AV: Adaptation of Milieu Teaching That Encourages Looking to the Mouth

This project will look at Milieu Teaching (i.e., a language intervention) that encourages looking to audiovisual speech cues (Milieu Teaching-AV) for infants with autistic older siblings (Baby Sibs), who are highly likely be diagnosed with autism or developmental language disorder (DLD), compared to Milieu Teaching alone (Milieu Teaching-NoAV). This study will specifically look at whether Milieu Teaching-AV (compared to Milieu Teaching-NoAV) results in (a) increased looking towards caregivers' faces, (b) increased communicative behaviors and language skill, and (c) increased engagement with the caregiver during play. We will also look at caregiver factors, such as their use of strategies and their attitudes toward the intervention they received.

Trial of Diphenhydramine for Sleep in Children With Autism

The purpose of this study is to examine the effect of diphenhydramine on sleep in children and adolescents with Autism Spectrum Disorder (ASD). Diphenhydramine is an anti-histaminergic agent with strong hypnotic properties. To accomplish this, the investigators will use a randomized double-blind placebo-controlled crossover 8-week study design to examine the effect of diphenhydramine on sleep physiology as assessed by polysomnography (PSG), actigraphy, circadian rhythm, and clinical measures.

Differences in Rest, Emotion, and Arousal Modulation in Youth

The goal of this study is to examine the relationship between sensory responsivity, bedtime arousal levels, sleep disturbances, and daytime emotion dysregulation for autistic children (ages 6-10). In a subset of children with elevated sensory responsivity, a sensory-based bedtime manipulation targeting bedtime arousal levels will be tested.

Magnetoencephalography in Children

This study is a single-center observational clinical study, which evaluates the diagnostic value of magnetoencephalography (MEG) in the diagnosis of neurodevelopmental diseases in children, such as the localization of epileptic foci and brain functional areas, intracranial tumors, cerebrovascular diseases, autism, mental retardation, and neuropsychiatric disorders.

TF-CBT for Autistic Youth Pilot Implementation - Open Pilot

Compared to the general population, autistic youth are at increased risk for both exposure to potentially traumatic events and trauma-related symptoms following trauma exposure. Autistic people identify approaches to effectively addressing trauma as a top mental health research priority, yet providers in community settings often report inadequate training in trauma treatment. The purpose of this study is to conduct an open pilot to evaluate the feasibility and acceptability of an evidence-based intervention for youth affected by trauma, Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), that has been modified for autistic youth served in Community Mental Health Centers.

Telehealth Parent-Implemented Intervention for Young Children With Autism Spectrum Disorder (ASD)

The primary objective of this research study is to improve outcomes involving core social-communication symptoms for young children with ASD or social communication delays by increasing access to clinically validated early behavioral intervention through a telehealth parent coaching model. The investigators will test the hypothesis that telehealth-delivered Naturalistic Developmental Behavioral Intervention parent coaching (TC) is non-inferior to in-person coaching (IPC) for the treatment of core social-communication symptoms in toddlers with either a social communication delay or ASD.

Prednisone in Adults With an Immune-Mediated Subtype of Autism Spectrum Disorder

The goal of this clinical trial is to learn how prednisone affects adults with autism spectrum disorder (ASD). It will also learn about the safety of prednisone. The main questions it aims to answer are: * How does prednisone affect the core features and associated target symptoms of ASD in adults with an immune-mediated subtype of ASD? * Is prednisone safe for autistic adults without causing too many side effects? * Does this study warrant larger trials studying anti-inflammatory drugs in this subject population? Researchers will compare the drug prednisone to a placebo (a look-alike substance that contains no drug) to see how prednisone affects autistic adult males. Participants will: * Visit the clinic 2 times for a screening and baseline visit. * Take prednisone or a placebo every day for 16 weeks. * Visit the clinic 2 times for checkups, tests, questionnaires, and dose changes, and 1 time for a follow-up visit 4 weeks after stopping the study drug. * Provide blood and urine samples for testing up to 4 times. * Complete 8 remote calls every 1-2 weeks for checkups and dose changes. * Keep a diary of the dose and times they take the study drug every day and any symptoms or side effects they experience.

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.

Self-inspired & Tailored Autism Movement With Phystic App

The goal of this clinical trial is to learn if watching instructions for daily exercises with three different contents (the patients themselves, other children, or children dressed as rabbits in addition to their physiotherapist, could increase physical activity among children with autism. The main questions it aims to answer are: Are children with autism motivated to engage in daily exercise by seeing themselves in a mobile application? Researchers will compare instructions with the children themselves with instructions containing other children and children in rabbit suits. Parents and their children will use the mobile application once daily for 8 weeks, and 5-10 minutes per day. Parents will fill out questionnaires before, during and after the 8-week intervention, and write about their experiences in the mobile application 2-3 days per week.

An Open Label Study of CM-AT for the Treatment of Children With Autism

This is a Phase III, open label extension study evaluating the continued safety and efficacy of CM-AT in pediatric patients with autism with all levels of fecal chymotrypsin.

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.

Using ChatGPT as a Job Coach for Adults With Autism Spectrum Disorder

The goal of this clinical trial is to examine the effectiveness of the ChatGPT-based job coach in helping ASD individuals prepare for job application, job interview, and interpersonal skills in workplaces. The main questions aim to answer are: How can we develop a ChatGPT-based job coach system to assist individuals with autism spectrum disorder (ASD) in job applications, job interviews, and interpersonal skills in workplaces? How effective is the ChatGPT-based job coach in helping ASD individuals (n=30) prepare for job applications, job interviews, and interpersonal skills in workplaces? What clinical correlates are associated with better effectiveness, and what are the interaction patterns between ASD adults and the ChatGPT platform? Participants will complete assessment questionnaires (evaluating autism traits and empathy, approximately 30 minutes) and a one-hour job interview practice. Please follow the recommendations to use ChatGPT for completing your job resume, job type discussions, job interview preparation and practice, explanation of Asperger's traits for the workplace, and workplace social discussions. After one week of practice, you will fill out the assessment questionnaires and complete the job interview practice again.

Family-Centered Implementation of Parent Training for Autistic Toddlers in Early Intervention

Early Intervention (EI) systems are ill-equipped to serve the many children 12 to 36 months with early signs or a diagnosis of autism spectrum disorder (ASD). EI funded by Part C of the Individuals with Disabilities Education Act (IDEA) uses home-based service delivery, emphasizes family-centered care, and prioritizes family-defined concerns (i.e., patient-centered outcomes). The Part C system is ideally situated to provide family-based intervention to children aged birth to three. However, Part C EI providers receive little training in ASD or the challenges characterizing ASD in toddlerhood, most notably emotion regulation. This study introduces Parent Training for emotion regulation for autistic toddlers into the Part C EI system, determines its feasibility and preliminary efficacy in this setting, and assesses what family, provider, and system-level factors may facilitate the uptake of parent training in the Part C EI system.

Randomized Clinical Trial of TUNE In 3.0: A Social/Emotional Program for Adults With Autism Spectrum Disorder

The purpose of this study is to test a novel, cognitive behavioral treatment strategy to improve social functioning in adults with autism spectrum disorder. The treatment, named TUNE In (Training to Understand and Navigate Emotions and Interactions), includes components to address the many behavioral domains involved in social functioning, including social motivation, social anxiety, social cognition, social skills, and generalization of the skills to community settings. The Investigators will test the efficacy of TUNE In to improve social functioning in adults with autism spectrum disorder (ASD), using a randomized controlled trial using the SRS-2 as the primary outcome measure.

Testing a Measurement Feedback App to Improve Data Quality, Supervision & Outcomes in Behavioral Health

The goal of this clinical trial is to test whether a smartphone-based data collection and feedback application ("Footsteps") improves the quality of behavioral data collected by one-to-one aides and leads to better youth mental health outcomes in school-aged youth (ages 4-17) who receive one-to-one support in schools. The main questions it aims to answer are: 1. Does the Footsteps app improve aides' data collection quality (i.e., consistency, timeliness, and completeness)? 2. Does Footsteps use lead to improved youth behavioral health outcomes (e.g., SDQ, YTP, GAS scores)? 3. Does Footsteps improve communication and supervision processes between aides and clinical supervisors? Researchers will compare aides using Footsteps to those using a "data collection only" control app to see if Footsteps leads to higher quality data collection, enhanced supervisory communication, and better youth outcomes. Participants will: * Use either Footsteps or a control app to record de-identified data on one client's behaviors and skills over 12 weeks * Complete biweekly online surveys about data collection experiences, youth progress, and aide-supervisor communication * Participate in a virtual intake and post-trial meeting * (For a subset) Participate in a 30-45 minute qualitative interview about their experience using the app

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.

SenseToKnow Autism Screening Device Validation Study

This is a pivotal, prospective, double-blind, study to evaluate the sensitivity and specificity of the SenseToKnow device for the detection of autism spectrum disorder in children 16-36 months of age.