Clinical Research Directory

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....

Sensory Habituation in Autism Spectrum Disorders

Autism spectrum disorder (ASD) is one of the most common developmental disabilities and often people with ASD have sensory processing disorders. These sensory processing disorders are often associated with problem behaviors and, more recently, have been connected to anxiety disorders in people with ASD. While it has been suggested that sensory processing responses in ASD could be malleable, current treatment strategies for sensory processing disorders in ASD have inconsistent results or lack large-sample sized data. This investigation will explore changes in neurophysiological activity in people with ASD and neurotypical peers after they are exposed to an unpleasant visual stimulus through a virtual reality systematic desensitization protocol. 30 people with ASD and 30 neurotypical people between the ages 7 - 35 will be recruited. The study have, 1) a practice magnetic resonance imaging (MRI) visit with questionnaires, 2) a per-exposure MRI with structural and functional MRI collections, 3) a virtual reality systematic desensitization session where we will record the participant's physiological response using an Emotibit device, and 4) a post-exposure MRI session with structural and functional MRI collections. This investigation aims to quantify changes in neurophysiological responses in order to determine the effect of systematic desensitization.

Effects of Neuralli® MP on Self-Defined Outcomes in Adults With Autistic Traits

To evaluate the efficacy of Neuralli® MP in improving participant-defined outcomes in adults with autistic traits.

The Alama Project: Autism Outcomes and Neurobehavioral Markers in Young Children Born to Mothers With HIV in Kenya

The study will use a non-invasive remote eye-tracking system (Eyelink Portable Duo) to acquire a short series of eye-tracking measures to determine whether these can predict autism diagnoses in both children exposed to HIV and uninfected (CHEU) and children not exposed to HIV and uninfected (CHUU).

Reciprocal Imitation Training and Musical Rhythm Sensitivity in Autistic Toddlers

The primary goal of this study is to examine rhythm sensitivity as a predictor of response to naturalistic developmental behavioral intervention (NDBIs) in autistic toddlers. Toddlers receive either Reciprocal Imitation Training (RIT), an evidence-based NDBI that supports children's imitation and social communication skills, or a music-enhanced version of RIT. Throughout their participation in the intervention, toddlers will complete study procedures of viewing naturalistic videos of infant-directed singing and other social scenes while eye gaze data is collected.

Online Pivotal Response Treatment Training in Autism Spectrum Disorder

This is a research study that will assess the effects of a Pivotal Response Treatment Online Training Course (PRT-O) for training parents of children with Autism Spectrum Disorder (ASD). The study will specifically investigate whether participants can learn to deliver PRT effectively following participation in the Online training.

Evaluating Georgia Part C Implementation Outcomes

This study aims to answer the question: What is the best way to help Early Intervention (EI) providers deliver high-quality services to children with communication delays for autism? The primary goal of this project is to examine the outcomes associated with delivering Project ImPACT, an evidence-based autism intervention that is delivered as part of routine training within Georgia's EI system. Providers in the study will receive one of two Project ImPACT training models to help us understand which training model helps providers learn Project ImPACT better. Specifically, this study will examine the: 1) the process and quality by which Project ImPACT is implemented and adapted by EI providers across the two training conditions; 2) factors that impact how well Project ImPACT is implemented; and 3) the child (i.e., social communication) and family (i.e., parent empowerment and fidelity) outcomes associated with receiving Project ImPACT.

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.

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.

Cognitive-Behavioral Therapy for Irritability in Children With Autism Spectrum Disorder and Intellectual Disability

In addition to the core symptoms, children and adolescents with Autism Spectrum Disorder (ASD) often exhibit disruptive behavior problems including irritability, tantrums, noncompliance, and aggression. The purpose of this study is to investigate cognitive-behavioral therapy (CBT) for disruptive behavior in children with autism spectrum disorders and intellectual disability. This pilot study will include children with ASD and IQ between 55 and 85 in an open study of CBT. CBT is modified in this study to reduce complexity of activities during therapy sessions but retains all key elements and principles of CBT. Assessments of irritability and disruptive behavior will include clinical interviews, parent ratings and child self-report measures. Study participants will be asked to complete functional magnetic resonance imaging (fMRI) to evaluate biomarkers of social perception and emotion regulation before and after CBT.

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 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

Project VOICES: Vocal Optimization in Children Elevating the Spectrum

Thirty percent of children with autism barely talk or do not talk at all despite years of intervention. This study aims to address this important and long-standing challenge by developing a novel intervention to increase the quantity and quality of vocalizations (i.e., sounds children make before words) and expressive language in young children with autism (aged 2 to 5 years) with minimal verbal skills. The intervention includes contingent responses to the child's vocalizations and vocal elicitation strategies. We also collect social validity information from parents about how they perceive the novel intervention.

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.

Work Chat: An Interactive Virtual Workday

Nearly 50,000 youth with autism spectrum disorder (ASD) transition from high school to adult life each year with only 25% of these transition-age youth with ASD (TAY-ASD) getting jobs within 2 years of graduation. TAY-ASD's ability to sustain employment is even more challenging due in part to their social cognitive deficits (e.g., poorly reading social cues) that disrupt communicating with customers, coworkers, and supervisors. Research shows nearly 90% of job dismissals among TAY-ASD are attributed to poor work-based social functioning (e.g., poorly communicating with upset customers). The subsequent unemployment has damaging effects on their mental, physical, and economic health. A critical gap in federally-mandated services to support youth with ASD as they transition from school-to-adult life is the lack of evidence-based practice to enhance work-based social functioning. Given that TAY-ASD report computerized training tools (developed by the investigators and others) are highly acceptable and improve their real-world outcomes, the investigators propose to address this critical barrier to sustained employment by developing and evaluating a novel and scalable computerized training tool to enhance participant conversations with customers, coworkers and supervisors at work. The investigators propose to develop and test the effectiveness of Social Cognitive and Affective Learning for Work (Work Chat: An Interactive Virtual Workday), a computerized training tool. Work Chat will have three tiers of instruction designed to help TAY-ASD prepare for effective workplace communication. Tier 1 will adapt existing evidence-based practices to design an e-learning curriculum that trains social cognitive strategies to help guide work-related conversations (e.g., reading social cues or regulating emotions during supervisor feedback). In Tier 2, SIMmersion's PeopleSim® technology will enable TAY-ASD to apply social cognitive strategies learned in Tier 1 to repetitively practice simulated conversations with a fictional customer, coworker, or supervisor. In Tier 3, SIMmersion will innovate PeopleSim to exist in an interactive 3-D environment to create a virtual workday with interconnected activities were the actions made early in the day influence conversations later in the day (e.g., a poor customer interaction may result in constructive feedback from a supervisor). Phase I (Feasibility) was completed with application HUM00177878. Phase II (Efficacy) Aims: Aim 1) Complete Work Chat development using an iterative process that includes initial and ongoing individual-level feedback from Phase I participants and the community and scientific advisory boards to complete the product that will be evaluated in Aims 2-3. Aim 2) Conduct a Randomized Controlled Effectiveness-Implementation hybrid trial in a school setting to evaluate Work Chat. The investigators will recruit and randomly assign n=338 TAY-ASD (90% of sample frame) enrolled in school-based standard transition services (STS) to the Work Chat group (STS+SW) or a STS group (STS). The hypothesis is that STS+SW, compared to STS, will show greater gains in: (H1) social cognition and (H2) work-based social functioning; as well as (H3) reduced anxiety about work-based social encounters, and (H4) greater sustained employment by 9-month follow-up. The investigators will test mechanistic hypotheses (H5a-b) that social cognitive ability (H5a) and work-based social functioning (H5b) mediate the effect of treatment (STS+SW vs. STS) on sustained employment. For the implementation evaluation, the investigators will conduct a multilevel, mixed-method process evaluation of Work Chat's acceptability, appropriateness, and feasibility. Aim 3) Use community participatory research methods to prepare for commercialization. The investigators will conduct a parallel multilevel, mixed method implementation evaluation that focuses on the Work Chat delivery system regarding its feasibility, sustainability, scalability, and generalizability by conduct focus groups with delivery staff and administrators. These groups will discuss potential facilitators and barriers to Work Chat implementation, adoption, and sustainability.

Neural Correlates of Autistic Individuals With Anorexia Nervosa

Masking is a behaviour or strategy used by many Autistic people to appear non-Autistic and blend in with a neurotypical society. The goal of this observational study is to understand the relationship between masking, anorexia nervosa symptoms and brain structure in Autistic people. The main questions this study aims to answer are: * Do Autistic individuals with anorexia nervosa show differences in structure or function of the brain relation to Autistic individuals without anorexia nervosa? * Do Autistic individuals with anorexia nervosa display higher levels of masking than Autistic individuals without anorexia nervosa? * Are there indeed relationships between levels of masking, anorexia nervosa symptoms and brain structure in Autistic people? Researchers will compare Autistic people without anorexia nervosa to Autistic people with anorexia nervosa to see if there are differences between groups. Participants will: * Complete a series of questionnaires focused on eating disorder symptoms, autistic traits, autistic masking and psychological well-being * Undergo an MRI scan at the Aberdeen Royal Infirmary

Adapting BA for Minimally Verbal Autistic Adults

The present study aims to adapt and evaluate the feasibility of the BeatIt-2 behavioral activation intervention for people with intellectual disabilities and low mood to be implemented with minimally verbal autistic individuals.

Adia MED of Winter Park LLC Autism Spectrum Disorder Research Study

This 24-month study is testing whether adding AdiaVita, an umbilical cord blood-derived stem cell and exosome product, to glutathione therapy helps improve autism symptoms in children ages 3-12 more than glutathione alone. Children will be randomly placed into one of two groups for the first three months: one group receives glutathione only, and the other receives glutathione plus monthly intravenous AdiaVita infusions. Both groups also use topical glutathione cream twice daily at home. Autism symptoms will be tracked over two years using the Autism Treatment Evaluation Checklist (ATEC) filled out by parents and by therapists or teachers. Safety, side effects, quality of life, and overall well-being will be closely monitored through regular clinic visits, physical exams, blood tests, and adverse event reporting. After the initial three-month phase, children who received glutathione alone may cross over to receive AdiaVita infusions at no additional cost if safety checks at month 6 are satisfactory. Approximately 100 children with a confirmed autism diagnosis from the Central Florida area will take part. Participation is completely voluntary, and families may withdraw at any time.

Family, Responsibility, Education, Support, and Health for Families With a Child With Autism

The objective of this proposed study is to collect initial efficacy data on a telehealth parent-based behavioral program for children with autism and overweight or obesity (PBT-A), compared with health education (HE).

Promoting Emotional and Autonomic Control Through Guided Breathing Exercises for Emerging Adults With Autism

This study examines the impact of guided breathing exercises on stress and heart rate variability (HRV) in autistic young adults. It explores how daily movement behavior (sleep, physical activity and sedentary behavior) influences HRV and to what extent two guided breathing exercises can affect HRV. Additionally, the study investigates how participants perceive the exercises in terms of usability and usefulness.

The Feasibility of a Remote Problem-Solving Intervention for Autistic Adolescents or Young Adults and a Caregiver

This project seeks to evaluate the feasibility and acceptability of a remote metacognitive strategy training intervention in transition-age autistic adolescents and young adults and a primary caregiver. We will also conduct limited efficacy testing.

Cognitive Control and Metacognition Training

95 autistic children (ages 8-11yrs) will be randomly assigned to a novel computer-based Cognitive Control Training combined with Metacognition Coaching or to a comparison group that receives the intervention after a delay. Before and after intervention, electroencephalography (EEG) will be used to examine engagement of the target neural responses.

Piloting the Competence in Romance and Understanding Sexual Health Curriculum

The goal of this clinical trial is to learn whether the CRUSH curriculum is possible (feasible), whether it fits the needs of the adults it is designed for (acceptable), and shows initial signs of being helpful (efficacious). CRUSH is a group-based behavioral intervention plus 1-1 coaching designed to provide sexual education and improve the skills of autistic adults for intimate relationships. The main goals of the project are to: * Evaluate the feasibility and acceptability of the CRUSH curriculum in the context of a clinical trial with a waitlist control condition. * Initial exploration of how the CRUSH curriculum works and whether it is helpful. Participants will complete: * A screening call. * Confirmation of clinical characteristics (autism features, language ability, cognitive ability). * 3 visits to assess knowledge and behaviors related to dating and sexual health at each point throughout the training curriculum (before beginning, midway, and after finishing). * 20 sessions of the CRUSH curriculum plus 1-1 coaching sessions. After each session, provide feedback about the session.

Biomarkers Research in Anxiety for Validation and Efficacy

A within-subjects design will be used for this preliminary investigation of four biomarkers across two contexts of use: prediction of treatment response (i.e., stratification) and quantification of response (i.e., change).

Use of Eye Tracking to Aid in Autism Risk Detection

The study will use a non-invasive remote eye-tracking system (Eyelink Portable Duo) to acquire a short series of eye-tracking measures.