A pilot study of vagus nerve stimulation (VNS) for autonomic dysregulation in individuals with the developmental disabilities

This study is examining whether a non-invasive device called vagus nerve stimulator (VNS) improves symptoms related to intellectual and developmental disability (IDD) and/or autism spectrum disorder (ASD). VNS involves applying mild electrical stimulation through the skin around the neck. The vagus nerve sends communications between the brain and many parts of the body. It regulates many cognitive, emotional and bodily functions. VNS is FDA-approved for headaches in people 12-years and older.

What are the goals of the study?

The purpose of the study is to examine whether a device called vagus nerve stimulator (VNS) can help with autonomic symptoms commonly seen in developmental disabilities, including autism.

What will happen during the visit or online?

The participant will undergo several behavioral, neurocognitive, and EEG tests and attend regularly scheduled study appointments. The study duration will be between 9-11 months, which includes 1, 3, 6-month follow-up appointments.

How will this help families?

Possible improvements in some symptoms related to developmental disabilities and ASD with the use of VNS.

Emotion dysregulation (ED) in autism spectrum disorder (ASD) exacerbates social impairment, increases risk for psychiatric and behavioral problems, and often leads to polypharmacy, crisis interventions, and high rates of suicidality. Effective treatment of ED could greatly reduce morbidity and costs and significantly improve quality of life for individuals with ASD. The Emotion Dysregulation Inventory (EDI) is a caregiver report for children ages 6-17 years old that measures rapidly escalating, intense, and poorly regulated negative emotion and dysphoria. However, there are no existing self-report measures of ED validated in adolescents and adults with ASD. Currently, best practice for assessment of emotional and behavioral constructs in ASD is the use of multiple reporters, but this approach is more challenging for adults with ASD when a parent is no longer available or as involved in daily life. Although adults are the fastest growing segment of the ASD population, there has been limited treatment research focused on adults. The EDI-SR would be the first self-report of ED in ASD. It will be developed through a systematic item refinement process to ensure validity, thereby generating a new opportunity to incorporate patient-reported experiences and outcomes in an overlooked and growing group of adults with ASD. The availability of validated self-report of ED is particularly crucial to address gaps in evidence-based treatment for adults with ASD. Dr. Carla A. Mazefsky at the University of Pittsburgh is conducting this research study.

What are the goals of the study?

With this project, we aim to develop and validate a change-sensitive self-report measure of ED for adolescents and adults with ASD, called the Emotion Dysregulation Inventory-Self-Report (EDI-SR).

What will happen during the visit or online?

This study will occur entirely online and will take less than an hour for participants to complete. Participants will be able to pause and resume the questionnaires at any point. They will be paid $75 for completion of surveys. There are no travel requirements. Overall, it is low burden study. Participants may be invited back 4 weeks later for a single survey re-test for an additional $10.

How will this help families?

Although adults are the fastest growing segment of the ASD population, there has been limited treatment research focused on adults. Support for ED is a major unaddressed need for adults with ASD. Studies consistently identify ED as one of the top barriers in college, and adults with ASD and their parents identify mental health as a top priority for research. Therefore, the availability of validated self-report of ED is particularly crucial to address gaps in evidence-based treatment for adults with ASD.

We are a team of researchers located at the MGH Institute of Health Professions (MGH IHP) in Boston, MA. We are completing a study about speech therapy treatment for children with the motor speech disorder childhood apraxia of speech and autism. Instead of being primarily drill-based, therapy will be embedded in a social, play-based context to provide ecologically valid feedback and help children generalize their skills as much as possible.

What are the goals of the study?

The main aim of this study is to test whether treatment for the motor speech disorder childhood apraxia of speech, appropriately modified for minimally verbal autistic children, does in fact improve speech production in minimally verbal children with both conditions.

What will happen during the visit or online?

Prospective participants will be assessed in our lab in Charlestown with a variety of measures that document their speech, language, social, and nonverbal IQ skills. During the speech tasks only (estimated to last approximately 30 minutes), children will wear reflective markers, 2-3 millimeters in size, on their faces. Our multiple camera system will track the movements of these markers as children attempt to repeat a series of syllables and simple words. Baseline assessments are conservatively estimated to last approximately 4 hours, scheduled as two 2-hour visits. All assessments will be audio- and videotaped for later analysis.

During the baseline visits, children’s parents will also be asked to complete a series of questionnaires that document demographics, developmental history, and current levels of community functioning.

After analysis of baseline data (documenting that participants meet criteria for ASD, minimally verbal status, and CAS), children who meet inclusion criteria will be invited to receive treatment. A set of 6 one- or two-syllable words will be selected for each child, identified from their baseline tests to specifically involve the speech movements that are found to be disordered in their speech (i.e., stimuli will consist of words that the child can attempt to say but which are not pronounced perfectly).

Treatment will consist of 15 hour-long sessions over 3 weeks and may take place in our lab or at a child’s home or school, and will be video- and audio-recorded for later analysis.

During treatment sessions, children will practice each target multiple times, divided into separate practice blocks and interspersed with practice on the other targets. A “scaffolding” hierarchy will be employed to help children learn the correct speech movements for each target. Specific scaffolding activities that the therapist will provide include (1) producing the target slowly, (2) producing it in unison with the therapist, (3) gradually fading out this assistance as the child learns to produce the targets correctly on their own, and (4) providing tactile or visual cues to help children remember the correct oral movements for each target.

Practice will occur in a naturalistic, developmentally-informed framework, which involves embedding speech tasks within social interactions organized around play or social activities that are matched to the child’s developmental level and that incorporate the child’s target words. For example, if a child has difficulty saying the consonant /k/, the word “cookie” might be selected as a target. This word could be practiced during an activity where therapist and child pretend to feed a stuffed animal cookies or where they actually decorate and eat cookies as a snack. The aim is for children to learn correct speech production at the same time that they engage in positive and rewarding social interactions that promote skill generalization, rather than for them to simply respond to therapist prompts.

After treatment is completed, children will be invited back to the lab to have their speech production analyzed, using the same procedures as at baseline. They may also re-enroll to receive an additional series of 15 treatment sessions if desired.

For their time, participants will receive $50 for completion of the baseline testing and $100 upon completion of the post-treatment testing. Parking compensation will be provided for each visit to our Charlestown lab location.

How will this help families?

In our research, we are interested in understanding why many children with autism don’t learn to talk on their own. Our ultimate goal is to improve communication outcomes for children at risk for being minimally verbal. In this study, participants will be contributing to the advancement and development of evidence-based speech treatment approaches for children with autism and childhood apraxia of speech.

This study is being completed by a team of health researchers from the SPAN (Speech in Autism and Neurodevelopmental Disorders) Lab at the MGH Institute of Health Professions (MGH IHP) in Boston, MA. In this study, we want to understand how minimally and low-verbal autistic children perceive speech sounds, and then to see if that is related to their own speech production and expressive language abilities.

What are the goals of the study?

We hypothesize that, if some kids can’t hear the difference between similar-sounding words like “ball” and “doll”, maybe they can’t learn to pronounce words accurately and this interferes with their being able to learn spoken language.

What will happen during the visit or online?

We created a tablet-based video game to help us answer these questions, where children sort pictures into categories. It includes a purely visual version of the task as well as an auditory version, so that we can tell if children have auditory processing issues only or whether their challenges also extend to visual stimuli.

Prospective participants will be assessed in our lab in Charlestown, MA with a variety of measures that document their speech, language, social, and nonverbal IQ skills. They will then be given the tablet game to play. The visits will be broken down into two 2-hour visits. All assessments and game play will be audio-and videotaped for later analysis.

During the visits, children’s parents will also be asked to complete a series of questionnaires that document demographics, developmental history, and current levels of community functioning. Parents will also be asked to participate in an hour-long interview either in person or by zoom, whichever is most convenient for the parent.

For their time, participants will receive $25 for completion of the assessments and will get an additional sum of $50 once they have completed the whole study. Parking compensation will be provided for each visit to our Charlestown lab location.

How will this help families?

In our studies, we are interested in understanding why many children with autism don’t learn to talk on their own. Participation in this study would help our researchers better understand auditory perception in children with autism with the ultimate goal being to improve communication outcomes for children with autism at risk for being minimally verbal.

We are conducting a study to better understand autistic girls and how/why autism characteristics are masked in high school. If you are the mother of a high school autistic female in inclusion for at least 80% of the school day, we would love to hear the perspectives of both you and your daughter via a virtual interview and questionnaire! Compensation is available for qualified participants. 

What are the goals of the study?

The goal of this study is to investigate high school aged autistic females who try and “mask” their autistic characteristics as they navigate through everyday high-school life.

What will happen during the visit or online?

An online questionnaire and a zoom interview.

How will this help families?

This study will help empower autistic females as the navigate their high school years.

Researchers at the Ohio State University are currently looking for children and caregivers to participate in a study examining child report of depressive symptoms, anxiety symptoms and social support. If your child is between the ages of 10 and 17 years and has a diagnosis of autism spectrum disorder, you may be eligible to participate in this study. This study aims to examine self-report measures of internalizing symptoms and social support to improving screening and intervention outcome measures.

What are the goals of the study?

The primary objective is to examine psychometric properties of measures of anxiety, depression and social support in youth with ASD age 10-17. The secondary aim is to examine the relationship between peer, parental, and teacher social support and internalizing disorders in ASD.

What will happen during the visit or online?

The child participant and an accompanying parent will participate in two zoom visits. The duration of the first visit would be about 1 hour. The second visit would occur two weeks after the first and would be about 30 minutes long. The visits would consist of interview and survey questions. Participants would be emailed a $10 Amazon gift card after completion of the first visit, and a $20 gift card after completion of the second.

How will this help families?

Having validated self-report measures on internalizing symptoms and social support in ASD will help us better screen for youth that may need intervention, as well as measure how effective interventions are. As youth with ASD often have a fewer number of friendships, understanding how social support from different people (parents, teachers, friends) relate to mental health symptoms will help inform target areas of intervention.

In this study, we will present a series of validated eye tracking paradigms (e.g., images of faces, videos of social interactions) while we monitor eye movements and physiological arousal. Two research assistants will also collect behavioral reports of ASD and ADHD symptoms from 8-12 years old participants. These data will allow us to examine how and if eye movements, arousal, and questionnaire outcomes differ between children with ASD and ADHD. By combining eye tracking/arousal measures and behavioral assessments, we will then draft a map of how these social cognitive traits manifest in eye movements.

What are the goals of the study?

The primary aim of this study is to test the utility of a social cognitive battery incorporating psychophysiological measures to differentiate between autism spectrum disorder (ASD) and attention-deficit/hyperactivity disorder (ADHD).

What will happen during the visit or online?

A brief telephone screening will be conducted to determine if the child and family are interested in the study. Then, a research team member will schedule a time for the family to come into the lab for approximately 90 minutes. Prior to the visit, parents will be asked to send a copy of a recent diagnostic assessment to confirm diagnosis. During the visit, the participant will come to our lab with their parent. Upon completion of the consent and assent, cognitive screener will be conducted first to the child and then the eye tracking tasks will be administered using the Eyelink 1000. We will ask the child to sit in front of a computer screen, and we will be showing the child some videos and images while the computer will track the child’s physiological response and their eye movements. Parent and caregivers will complete a few questionnaires by the time. Upon completion of all measures, the participant will be given a $20 gift card for their time.

How will this help families?

Families will receive a feedback summary compiling information regarding their responses on questionnaires, including the Conners, SRS, and CBCL. Families will learn about their children’s current condition in behavior performances and cognitive development. If requested by contacting the lab via phone or email (or indicating during the study visit), a 15 minute phone feedback session will be scheduled for the parents with the PI, clinical psychologist, to discuss the results from the questionnaires. This will also offer the PI a chance to address any other questions the parents may have. Participants will also be compensated $20 for their time.

This project will evaluate the effectiveness of MINDful TIME, an 8-week mindfulness-based program designed to improve mental health in adolescents with autism spectrum disorder and their caregivers. MINDful TIME includes weekly psychoeducational group meetings conducted through videoconferencing and use of a commercially available mindfulness meditation app. We will also explore whether caregivers in the treatment group demonstrate improvements in quality of life.

This project is a collaboration between researchers at the Southwest Autism Research & Resource Center (SARRC) and the Autism Brain Aging Lab at Arizona State University.

Why this study is important: At least half of individuals with ASD experience clinically significant anxiety or depression. Mood symptoms increase significantly from childhood to adolescence and remain elevated during adulthood. Additionally, parents of children with ASD report higher levels of stress than parents of typically developing children or children with other disabilities and may experience higher stress once their children enter adolescence due to increased social-emotional difficulties. Notably, research from our group and others indicates increases in stress and anxiety during the COVID-19 pandemic in both adolescents with ASD and their parents. This project aims to improve mental health among teens with ASD and their parents through a telehealth mindfulness intervention.

What are the goals of the study?

This project will evaluate the effectiveness of MINDful TIME, an 8-week mindfulness-based program designed to improve mental health in adolescents with autism spectrum disorder and their caregivers. MINDful TIME includes weekly psychoeducational group meetings conducted through videoconferencing and use of a commercially available mindfulness meditation app. We will also explore whether caregivers in the treatment group demonstrate improvements in quality of life.

What will happen during the visit or online?

Participation involves: 1-2 hour virtual intake visit to determine eligibility; Virtual group intervention sessions (2-hour sessions that meet weekly for 8 weeks); Up to 4 virtual data collection visits before and after participating in the intervention (1-2 hours each).

Teens and caregivers will: Attend an 8-week group telehealth intervention*; Learn strategies that may help with management of stress, anxiety or depression; Receive free access to a mindful meditation app (Ten Percent Happier) and asked to regularly use it throughout the study period.

*If you do not have access to the internet, our team will provide assistance for those who qualify.

How will this help families?

This project aims to improve mental health among teens with ASD and their parents through a telehealth mindfulness intervention.

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.

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 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 5 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.

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.