Mapping brain function in children with autism spectrum disorder with diffuse optical tomography

Dr. Eggebrecht and researchers at Washington University in St. Louis are mapping brain function in children with autism spectrum disorder with diffuse optical tomography.

What are the goals of the study?

Dr. Eggebrecht and researchers at Washington University in St. Louis aim to investigate brain function underlying development in children who have or are at risk for developing Autism Spectrum Disorder.

What will happen during the visit or online?

Children will complete a 1-hour brain imaging scan and developmental testing at Washington University School of Medicine in St. Louis. Parents will complete online and phone surveys from home. Families will be compensated $25/hour for their participation.

How will this help families?

We hope that, in the future, society may benefit from study results which increase our understanding of typical and altered development of brain function. We hope that in the future, optical imaging will complement the current brain imaging technologies in the management of a variety of patient populations.

In our international study, we want to find out how Selective Mutism differs from Autism Spectrum Disorder. We are particularly interested in whether the situation has an influence on certain symptoms, for example, whether symptoms occur just as frequently at home in a familiar environment as in an unfamiliar environment. A symptom could be described as a sign by which a particular mental illness can be identified. In general, mental illnesses are associated with various symptoms. Therefore, in order to recognize a mental illness, it is essential to know as many symptoms as possible and to know how often and when they occur. This is particularly important for diagnostics, but also when it comes to providing the affected children with the best possible therapeutic support. We are also interested in surveying parents of neurotypical children without mental illness to determine possible differences. The study involves six questionnaires (approximately 40 minutes) that are completed online.

What are the goals of the study?

To gain knowledge on symptoms of selective mutism and autism and whether those are context-dependent.

What will happen during the visit or online?

Fill out questionnaire

How will this help families?

There are several hints that selective mutism is comorbid in a significant portion of autistic children. This research will enhance our understanding of selective mutism and autism and will help differentiate between the two conditions.

This study is being conducted by Dr. Lee Mason and Alexis Bolds of Cook Children’s Health Care System and Texas Christian University’s Burnett School of Medicine in Fort Worth, Texas. Our research is designed to assess your child’s language development over the course of two years. Every six months we will ask you and your child to take part in a telehealth-based functional language assessment that will last approximately one hour. At the completion of this project, we will compare the different language profiles of all participants.

What are the goals of the study?

We are asking you to take part in this research because your child’s language skills are still developing, and we are trying to learn more about how functional language develops over time. The purpose of this research is to determine whether we can accurately conduct language assessments via telehealth, and to better understand the differences in language development between children with and without autism spectrum disorder.

What will happen during the visit or online?

A language assessment called a “verbal operant experimental (VOX) analysis” will be conducted every six months as part of this research. The VOX is a functional analysis of language that has been carefully designed to assess four language domains: conversing, labeling, echoing, and requesting. Across each of these conditions, we will assess your child’s ability to say the same words. Caregivers will also be asked to complete a brief demographic survey at the time of each assessment to identify potential factors that may be related to language development. We expect each assessment to take approximately 45-60 minutes of your time.

How will this help families?

After each VOX analysis, you will receive an assessment report that describes strengths and weaknesses of your functional language skills. The report provides recommendations for helping to remediate any deficit areas identified by the assessment.

This pediatric autism clinical research study is currently testing the drug, pimavanserin, to see if it is safe and effective in treating irritability and other behaviors in children and adolescents with autism spectrum disorder (ASD). Study participation will last for up to 14 weeks, with a 6-week treatment period. Children who enroll in this study will receive either the study drug or placebo. A placebo looks like the study drug but has no impact on the person taking it. There will be no cost for the study drug or any study-related procedures. You may be compensated for your time and travel. If your child completes the 6-week treatment period, they may be able to enroll in a 52-week, open-label extension study if they qualify. During this open-label study, there is no placebo. Children who enroll will receive the study drug, pimavanserin.

What are the goals of the study?

The overall goal of this study is to evaluate whether an investigational drug might help relieve irritable behaviors associated with Pediatric Autism Spectrum Disorder that make social interactions and everyday functioning challenging.

What will happen during the visit or online?

Study participation will last for up to 14 weeks, with a 6-week treatment period. Children who enroll in this study will receive either the study drug or placebo. A placebo looks like the study drug but has no impact on the person taking it. There will be no cost for the study drug or any study-related procedures. You may be compensated for your time and travel.
If your child completes the 6-week treatment period, they may be able to enroll in a 52-week, open-label extension study if they qualify. During this open-label study, there is no placebo. Children who enroll will receive the study drug, pimavanserin.

How will this help families?

The evaluation of this investigational drug may help relieve irritable behaviors associated with Pediatric Autism Spectrum Disorder that make social interactions and everyday functioning challenging.

Research has shown that certain bacteria in the gut produce substances that may enter the bloodstream and reach the brain, which my contribute to some characteristics often co-occurring with autism, such as irritability. Reducing these substances in the gut before they enter the bloodstream is a potential new approach to treating irritability associated with ASD. AB-2004, with its gut-targeted mechanism of action has the potential to fill this unmet need.

What are the goals of the study?

The study medication AB-2004 is designed to adsorb specific substances produced by bacteria in the gut and reduce their levels circulation in the bloodstream. The purpose of this study is to learn if AB-2004 may help improve irritability in adolescents compared to placebo by lowering the levels of these substances. The study seeks to determine if there is an effective dose of AB-2004 in 13 to 17 year olds with ASD.

What will happen during the visit or online?

Participants will be examined by the study doctor for any changes to their health, complete a behavioral questionnaire, and participate in blood, urine, and other testing. Blood samples will be collected only 3 times during the study. Participants will take the study medication for 8 weeks and attend 6 clinic visits (lasting 2-3 hours) over 14-16 weeks. Formulated as a tasteless odorless powder, the medication is to be taken 3x/day mixed with any soft food your child may like such as yogurt or apple sauce. You will also be asked to collect urine and stool samples.

How will this help families?

Physicians have reported that irritability impacts a majority of pediatric ASD patients. The presentation of ASD-associated irritability can very with autism severity and age and can be caused by a broad array of different factors including lack of sleep, the inability to communicate pain, and mental health conditions. Currently, there are limited treatment options available for irritability associated with ASD and those that are approved can have significant side effects. AB-2004 offers potential hope of a new therapeutic option for autism-related irritability that might improve patients’ daily lives by avoiding the side effects and risks of currently available medications for irritability of autism.

What are the goals of the study?

We are carrying out an interview research study in the US and Canada which will involve interviews with autistic adolescents and supporters of autistic children and adolescents.
The aim of the study is to understand everyday life with autism and to understand the most important characteristics and impacts of autism that should be measured in future clinical studies. We will use this information to develop a new questionnaire and a personalised goal setting approach in order to measure what matters to autistic people.

What will happen during the visit or online?

● Speak to a researcher during two one-to-one interviews, which should last around 60-75 minutes each
● Talk about the experience/their child’s experience of living with autism
● Give honest feedback about some questionnaires
● In appreciation of your time, you will be reimbursed after each interview (two interviews in total).

How will this help families?

There is no direct medical benefit from being in this study. The information learnt from this study may help researchers and doctors learn more about autism in general. Your child and others with autism may benefit from the results of such research in the future, as we seek to develop a new questionnaire and a personalised goal setting approach in order to measure what matters to autistic people.

Children with ASD experience a wide range of outcomes, and not all children respond effectively to behavioral interventions. There is accumulating evidence of tDCS (mild brain stimulation) being effective in treating the comorbidities as well as the core symptoms of ASD. tDCS is most effective when used simultaneously with behavior intervention. In this study, we will isolate the effects of tDCS alone and in combination with ABA on the executive functioning skills and the core symptoms of ASD and monitor the results using an objective neurophysiological test (EEG).

What are the goals of the study?

The goal of this study is to see if transcranial direct current stimulation (tDCS) when used during ABA therapy improves learning in children with ASD. If your child takes part in the research, s/he will receive tDCS while receiving her/his ABA therapy.

What will happen during the visit or online?

Your child will participate in the study for a total of five months. S/he will receive 20 sessions of tDCS as well as 20 sessions sham (fake) tDCS. Each session is 20-mins long. A resting electroencephalogram (EEG) using a portable headset will be obtained about one time per month. Most study procedures will be done remotely but several in-person visits are required.

How will this help families?

Potential benefits of tDCS are improvements in executive function skills, decrease in the core symptoms of ASD, and/or greater learning acquisition during ABA therapy in study participants. However, there may not be any benefit at all – that is why we are conducting this study.

The genetic changes we study in TIGER3 have been connected with autism and developmental disabilities, but we are just beginning to learn how those changes might affect each person and family differently, and what effects might be shared versus unique across those genetic variants. By learning more about the shared and unique effects of these rare variants, we aim to contribute to (1) better understanding of co-occurring medical and behavioral conditions, and (2) development of individualized supports for affected individuals and their families.

What are the goals of the study?

In the TIGER research study, we are learning more about individuals with genetic events associated with autism spectrum disorder (ASD), intellectual disability (ID), and/or developmental delay (DD). We hope to better understand and describe how different gene changes influence the development, behavior, and experiences of children and adults. Individuals with these genetic changes may have neurodevelopmental differences that we would like to better understand.

What will happen during the visit or online?

Eligible families participate in a consent phone call, and are then invited to complete a series of video- or phone calls to assess for autism-associated features, adaptive skills, cognitive skills, and medical history. Caregivers are also invited to complete a variety of online questionnaires, including measures of adaptive behavior, treatment history, sleep habits, gastrointestinal symptoms, social-emotional functioning, and executive function. Biospecimen (blood or saliva) collection is completed remotely. Finally, families are offered a feedback session with a clinician and a written report of standardized measures and recommendations.

How will this help families?

Families will be compensated $100 for their participation. Participants may receive feedback about their family’s genetic event(s). Families will also receive written and/or verbal feedback regarding adaptive behavior, social communication skills, language skills, and cognitive skills as available from completed study activities.

Autistic children frequently engage in repetitive and inflexible behaviors, and sometimes these behaviors can significantly interfere with child learning, are associated with long-term functional impairment, and co-occurring psychiatric conditions (e.g., anxiety). However, there is a significant gap in effective interventions that address repetitive and inflexible behaviors. The FITBI Study partners caregivers of autistic children with trained therapists to provide coaching for inflexible or repetitive behaviors that are interfering with parent or child quality of life.

What are the goals of the study?

Researchers at the University of Kansas are currently recruiting for a study that provides parent coaching to address the repetitive or inflexible behaviors of autistic children between the ages of 3 to 9 years old. The Family-Implemented Treatment for Behavioral Inflexibility (FITBI) project partners eligible participants with a trained coach to receive individualized support via telehealth.

What will happen during the visit or online?

If you and your child qualify to participate, you will be partnered with a trained coach to receive free, individualized support. Here are a few important details about the research study:
• The study will primarily take place via a secure telehealth video meeting system. Depending on family proximity, there could be home visits to collect data.
• Caregiver participation includes attending weekly telehealth sessions with a trained coach and completing online surveys and brief interviews about yourself and your child.
• Participants can receive up to $120 in compensation for participating.
• Eligible participants will be randomly assigned to one of two groups.
• Participants will be recruited from the states of Kansas and Missouri.

How will this help families?

The overall goal of the FITBI Study is to determine whether a new form of family-based intervention for repetitive and inflexible behaviors, delivered using videoconferencing technology, can counter any negative effects of those behaviors and improve positive outcomes for young autistic children. Results from this study could have substantial implications for remotely delivered interventions that address the repetitive and inflexible behaviors of autistic children.

What are the goals of the study?

We are interested to explore how both neurotypical and autistic adolescents and adults initially perceive people in conversations. To explore whether perceptions of the adolescent in the video are different depending on a participants age or diagnosis. Furthermore, the second part of the survey will state if the adolescents in the video has autism or not, we would like to discover whether this will alter participants initial perception and or judgement of the conversation.

What will happen during the visit or online?

Participants will watch videos (without sound) of an adolescent having a conversation with two people you can’t see in the video, then state their initial perceptions of the adolescent using slider bar questions.

How will this help families?

Could provide insight for families into how their autistic adolescents may perceive social situations, how they interpret other peoples conversations. Similarly if Adults with autism participate the research highlights how communication is expressed differently, promoting a non judgmental mindset or potentially a deeper understanding of how people can be perceived no matter the social situation.

Social communication and language skills are important intervention targets for children with autism, but we lack easy-to-use tools to monitor children’s progress in this developmental area. This study aims to develop a new tool, the Early Communication Indicator for Autism (ECI-A), to monitor children’s progress over time. Participation consists of completing online surveys and in-person developmental and play-based assessments with your child and eligible participants will receive at least $100 for participating ($50 to $150 additional compensation depending on the number of activities completed).

What are the goals of the study?

The goal of this study is to adapt an existing tool to monitor the social-communication skills, or the way that children interact with and communicate with others, of children with or at elevated likelihood for autism (ages 12 – 60 months).

What will happen during the visit or online?

If you agree to participate in this study, you will be asked to complete:
• Online surveys related to your child’s development, information about your family, and services your child receives
• University of Kansas or University of North Carolina-Chapel Hill clinic or home visits, based on family preference, for play-based assessments
• Video recordings of in-home play-based assessments with you and your child
Eligible participants will receive $100 for participating. You may be asked to participate in additional research activities, and you will receive between $50 and $150 in additional compensation depending on the number of activities.

How will this help families?

The ultimate goal of this tool is to provide families’ and other caregivers’ access to meaningful and actionable data about their children’s social-communication and language progress over time. Data generated from the ECI-A could be used to make a case for the need for early intervention or be used to determine if an intervention is working as intended.

There is a clear unmet need for new medicines to treat irritability in children with ASD that do not have the metabolic and weight adverse event profiles of the currently approved treatments. Cannabidivarin (CBDV), a nonpsychoactive phytocannabinoid with no appreciable tetrahydrocannabinol (THC), has potential therapeutic effects on irritability and disruptive behaviors, repetitive behaviors, sociability, and quality of life, as well as the capacity to reduce inflammation.

What are the goals of the study?

This study aims to examine the efficacy and safety of CBDV, with a primary aim of studying its effect on irritability in children with ASD.

What will happen during the visit or online?

It will take about 16 weeks to complete this study. During this time, we will ask you to come to Albert Einstein College of Medicine 4 times for study visits. (Baseline, Week 4, Week 8, and Week 12). In addition, we will ask you to complete 5 remote visits. Two out of these 5 remote visits will involve assessments performed over the phone, as well as a visit to your local QUEST diagnostic center (at no cost to you, at Screening and Week 2 ) The other 3 remote visits will only involve assessments performed over the phone (Weeks 6, 10, and 14). On-site visits include a physical and neurological exam, measuring vital signs, lab work, and completion of assessments/questionnaires. An ECG will be completed at Baseline and Week 12.

How will this help families?

The goal of this study is to see if CBDV can improve irritability and disruptive behaviors in children with autism spectrum disorder, without the weight gain and metabolic side effects of the FDA approved antipsychotics aripiprazole and risperidone.