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113 Autism Spectrum Disorder Trials Near You
Power is an online platform that helps thousands of Autism Spectrum Disorder patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Learn More About PowerThis study is a pragmatic clinical trial examining the comparative effectiveness of two stimulant medications (methylphenidate and amphetamine) in the treatment of ADHD in children and adolescents with autism. Using a sequential, multiple assignment randomization trial (SMART) design the study will not only assess these two medications but also the role of an increasingly popular class of ADHD medication, the alpha-2 agonists. Findings from this study will help improve clinicians' approach to medication selection and reduce the repeated trials of multiple medications that are current standard care.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:4 - 17
Key Eligibility Criteria
Disqualifiers:Unstable Medications, Others
Must Not Be Taking:ADHD Medications
500 Participants Needed
ML-004 for Autism
Columbus, Ohio
This trial is testing the safety of a treatment called ML-004 in adolescents and adults with Autism Spectrum Disorder (ASD). The main goal is to ensure that the treatment does not cause any harmful side effects.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Phase 2
Age:12 - 46
Key Eligibility Criteria
Disqualifiers:Rett Syndrome, Epilepsy, Hypertension, Others
120 Participants Needed
ML-004 for Autism Spectrum Disorder
Columbus, Ohio
This trial is testing a treatment called ML-004 to see if it can help improve social communication skills in adolescents and adults with Autism Spectrum Disorder (ASD). The study will involve about 150 participants to determine its effectiveness.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:12 - 45
Key Eligibility Criteria
Disqualifiers:Rett Syndrome, Epilepsy, Hypertension, Others
150 Participants Needed
Suicide Prevention Interventions for Autism
Columbus, Ohio
This trial is testing two methods to prevent suicide in autistic youth aged 12-24. One method involves creating a personalized safety plan, while the other adds ongoing support through periodic check-ins. The safety plan helps individuals recognize warning signs and use coping strategies, and the check-ins provide continuous support.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:12 - 99
Key Eligibility Criteria
Disqualifiers:Acute Psychosis, Intoxication, Mania, Others
1665 Participants Needed
Cariprazine for Pediatric Schizophrenia
West Chester, Ohio
This trial is testing the safety and effectiveness of cariprazine in children and teens with schizophrenia, bipolar I disorder, or autism. The goal is to see if the medication is safe and beneficial for use in these young patients.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:5 - 17
Key Eligibility Criteria
Disqualifiers:Major Depressive, Schizoaffective, Intellectual Disability, Others
310 Participants Needed
Lumateperone for Schizophrenia and Bipolar Disorder
Cincinnati, Ohio
This is a multicenter, global, 26-week, open-label study to assess the safety and tolerability of lumateperone in pediatric patients with schizophrenia, bipolar disorder or autism spectrum disorder.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:5 - 17
Key Eligibility Criteria
Disqualifiers:Suicidal Risk, Catatonia, Psychotic Features, Others
Must Be Taking:Psychostimulants
500 Participants Needed
Lumateperone for Irritability in Autism
Cincinnati, Ohio
This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients aged 5 to 17 years with a primary diagnosis of irritability associated with Autism Spectrum Disorder (ASD) based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) and confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia Present and Lifetime Version (K-SADS-PL).
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:5 - 17
Key Eligibility Criteria
Disqualifiers:Rett Syndrome, Fragile X, Others
Must Be Taking:ADHD Medications
174 Participants Needed
Therapy Dogs + Behavioral Treatment for Autism
Cincinnati, Ohio
This trial is testing if having a dog in therapy sessions can help children with autism manage their emotions better. It targets kids aged 8 to 15 who struggle with emotional control. The idea is that dogs can make therapy more enjoyable and less stressful, aiding in emotional learning. Using dogs in therapy is a growing practice in autism therapy, often involving dogs to help improve emotional and behavioral outcomes.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:8 - 15
Key Eligibility Criteria
Disqualifiers:Canine Phobia/allergy, Animal Aggression, Recent Child Aggression, Major Neuropsychiatric Illness, Major Sensory Impairment, Others
240 Participants Needed
Autism Doula Program for Autism
Cincinnati, Ohio
Background: Findings from a group level assessment with caregivers of Black children with autism revealed barriers to equitable care and services (e.g., a lack of cultural representation among their child's care team, caregiver stress, stigma, and uncertainty about services needed). The Autism Doula program was identified by the community to address the aforementioned barriers and provide culturally matched family navigation and social-emotional support while also acknowledging the unique experiences and values of caregivers of Black children with autism.
Impact: The current project aims to assess the acceptability, feasibility, and preliminary effectiveness of the Autism Doula program and promote equitable care for Black children with autism and their families.
Methods: Fifty-six Black families of children 18 months to five years of age who recently received a new diagnosis of autism spectrum disorder from CCHMC will be recruited to the current study. Twenty-six families will be randomly assigned to either the control group (i.e., care as usual including DDBP Family Navigation) or the intervention group (i.e., Autism Doula services). Feasibility and acceptability data will be gathered, including satisfaction of both groups, how many families approached agree to be in the study, how many sessions with the doula were successfully completed, and was the intervention content delivered as intended. Additionally, preliminary effectiveness will be evaluated by examining completion of recommended next steps, caregivers' perceived stress, and self-efficacy.
Implications: Data from this project will provide evidence that the Autism Doula program is feasible, acceptable, and effective, ultimately demonstrating it as an equitable care approach for Black children with autism and their families.
Future Directions: Findings from this pilot project will highlight the need for growth of the Autism Doula program to promote culturally competent care and health equity for Black children with autism and their families.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Non-Black Caregivers, Children Without Autism
52 Participants Needed
Social and Academic Interventions for Autism Spectrum Disorder
Cincinnati, Ohio
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.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:10 - 15
Key Eligibility Criteria
Disqualifiers:Home Schooled, Severe Psychopathology, Others
224 Participants Needed
Theta Burst Stimulation for Depression and Autism
Cincinnati, Ohio
Evaluate the efficacy of accelerated theta burst stimulation (aTBS) in reducing depressive symptoms in autism spectrum disorder (ASD)
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:13 - 26
Key Eligibility Criteria
Disqualifiers:Substance Use Disorder, Epilepsy, Others
Must Not Be Taking:Anticonvulsants, Barbiturates, Lithium, Benzodiazepines
24 Participants Needed
Telehealth Programs for Autism
Cincinnati, Ohio
The current study seeks to compare outcomes of a telehealth intervention targeting daily living skills (Surviving and Thriving in the Real World - Telehealth, or STRW-T) intervention to a control group telehealth intervention targeting social skills (Program for the Education and Enrichment of Relational Skills- Telehealth, or PEERS-T). The key endpoint will be change in daily living skills on primary and secondary outcome measures at the end of treatment.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:15 - 21
Key Eligibility Criteria
Disqualifiers:Aggressive Behaviors, Mental Health Issues, Others
192 Participants Needed
Alpha Auditory Entrainment for Fragile X Syndrome
Cincinnati, Ohio
Fragile X Syndrome (FXS) is a complex neurodevelopmental disorder caused by a mutation on the X chromosome. Scientists have investigated FXS extensively in both humans and animals. Thus far, phenotypic rescue in animal models has not resulted in treatment breakthroughs in humans, though some important discoveries have been made. Research has shown that individuals with FXS process sounds differently than those in the typical population, and they also show baseline differences in brain activity, including high gamma activity, increased theta activity, and decreased alpha activity. The investigators' central hypothesis is that these alterations in brain activity (specifically alpha and gamma activity) impair the brain's ability to process new information, thereby impeding cognitive functioning and increasing sensory sensitivity. The investigators propose that auditory entrainment, a technique that involves playing special sounds through headphones, will normalize brain activity in individuals with FXS and lead to increased cognitive function and decreased sensory hypersensitivity.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:5 - 10
Key Eligibility Criteria
Disqualifiers:Auditory Impairments, Visual Impairments, Substance Abuse, Others
180 Participants Needed
Speech Perception for Autism and Fragile X Syndrome
Cincinnati, Ohio
The goal of this study is to identify which brain regions are active during speech-in-noise perception, as well as how those regions interact. The investigators are studying brain activation during speech-in-noise in autism and controls as well as individuals with Fragile X Syndrome. The main question\[s\] it aims to answer are: 1) How does the brain's response to background noise affect a person's ability to understand speech? 2) Can visual cues improve hearing in background noise?
Participants will complete the following:
* hearing tests
* cognitive and behavioral measures
* questionnaires about their symptoms
* both passive and active hearing tasks while brain activity is recorded with a neuroimaging cap Results will be compared between individuals with autism with and without Fragile X Syndrome as well as individuals without autism.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:15 - 35
Key Eligibility Criteria
Disqualifiers:Hearing Loss, Uncorrected Vision, Others
Must Not Be Taking:EEG-affecting Medications
60 Participants Needed
Regulating Together for Autism
Cincinnati, Ohio
This trial tests a program called Regulating Together, which helps children with autism manage their emotions. It targets kids aged 8-12 who struggle with emotional regulation. The program teaches them to recognize and control their feelings.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:8 - 12
Key Eligibility Criteria
Disqualifiers:Major Neuropsychiatric Illness, Sensory Impairment, Others
144 Participants Needed
Mobile Early Social Interaction Coaching for Toddler Autism
Cincinnati, Ohio
The goal of this collaborative R01 is to demonstrate the therapeutic value and community-wide implementability of an early intervention (EI) platform for toddlers with autism spectrum disorder (ASD) that is completely virtual, from recruitment through intervention. This platform-Early Social Interaction Mobile Coaching (ESI-MC) deploys individual telehealth sessions with coaching and feedback to help families embed intervention in everyday activities. Specifically, the investigators will conduct an effectiveness trial of ESI-MC to address the important question of whether starting evidence-based intervention earlier leads to better outcomes than starting later. The investigators will address this question by using a modified stepped wedge design and blended implementation research to analyze data obtained with ESI-MC start at 18, 24, or 30 months. The investigators will diagnostically ascertain 240 children from a pool of 360 18-month-olds with early signs of autism, 30 in each of 8 US regions (Central and SW Florida; Atlanta, GA; suburbs of Philadelphia, PA; New York City, NY; Cincinnati, OH; Chicago, IL; Seattle, WA; and Los Angeles, CA). Research participants will be recruited using a new virtual platform-My Baby Navigator-linking a new surveillance and screening tool, an app to upload video-recorded home observations and telehealth intervention sessions, and a package of educational resources. The 240 children will be randomly assigned to one of three ESI-MC timing groups. ESI-MC will be delivered by community-based early intervention providers (EIPs) currently working within the the early intervention system in the recruitment regions. The investigators will measure child active engagement and social communication change every 6 months as the primary outcome variables. Outcome measures of developmental level, autism symptoms, and adaptive behavior will be examined to measure differential treatment effects. Maximizing the use of mobile technology, ESI-MC offers the prospect of a community-viable, scalable and sustainable treatment to improve EI services for toddlers with ASD, particularly among minority and low-resource communities.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:15 - 20
Key Eligibility Criteria
Disqualifiers:No Autism, Motor Impairments, Others
240 Participants Needed
Pimavanserin for Autism Spectrum Disorder
Cincinnati, Ohio
This trial is testing pimavanserin, a medication that may help reduce irritability in children and teenagers with autism. The study focuses on kids aged 5 to 17 who have this symptom. Pimavanserin works by balancing brain chemicals to help them feel calmer. The goal is to see if the medication is safe and effective over time.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Age:5 - 18
Key Eligibility Criteria
Disqualifiers:Not Listed
209 Participants Needed
Medical Cannabis for Chronic Pain
Sandusky, Ohio
This trial will investigate if medical cannabis can effectively reduce pain and improve quality of life for patients with chronic conditions. The study will gather data through an online questionnaire about patients' use of cannabis and its effects. Medical cannabis interacts with the body's natural system to help manage pain and other symptoms. Medical cannabis has been increasingly studied and used as an alternative treatment for managing chronic pain, with numerous studies supporting its potential benefits.
Stay on current meds
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:7+
Key Eligibility Criteria
Disqualifiers:Pregnancy, Breastfeeding, Suicidality, Psychosis, Others
200000 Participants Needed
Lumateperone for Autism
Avon Lake, Ohio
This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients aged 5 to 17 years with a primary diagnosis of irritability associated with Autism Spectrum Disorder (ASD) based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) and confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia Present and Lifetime Version (K-SADS-PL).
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:5 - 17
Key Eligibility Criteria
Disqualifiers:Rett Syndrome, Fragile X, Suicidal Risk, Others
Must Be Taking:ADHD Medications
174 Participants Needed
CM-AT for Autism
Cleveland, Ohio
This trial is testing a special enzyme powder called CM-AT to help children with autism digest protein better.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:3 - 17
Key Eligibility Criteria
Disqualifiers:Seizures, Severe Trauma, Systemic Disease, Others
Must Not Be Taking:Stimulants, Non-stimulants, ADHD Meds
405 Participants Needed
Why Other Patients Applied
"As a healthy volunteer, I like to participate in as many trials as I'm able to. It's a good way to help research and earn money."
IZ
Healthy Volunteer PatientAge: 38
"I have dealt with voice and vocal fold issues related to paralysis for over 12 years. This problem has negatively impacted virtually every facet of my life. I am an otherwise healthy 48 year old married father of 3 living. My youngest daughter is 12 and has never heard my real voice. I am now having breathing issues related to the paralysis as well as trouble swallowing some liquids. In my research I have seen some recent trials focused on helping people like me."
AG
Paralysis PatientAge: 50
"I changed my diet in 2020 and I’ve lost 95 pounds from my highest weight (283). I am 5’3”, female, and now 188. I still have a 33 BMI. I've been doing research on alternative approaches to continue my progress, which brought me here to consider clinical trials."
WR
Obesity PatientAge: 58
"I've tried several different SSRIs over the past 23 years with no luck. Some of these new treatments seem interesting... haven't tried anything like them before. I really hope that one could work."
ZS
Depression PatientAge: 51
"My orthopedist recommended a half replacement of my right knee. I have had both hips replaced. Currently have arthritis in knee, shoulder, and thumb. I want to avoid surgery, and I'm open-minded about trying a trial before using surgery as a last resort."
HZ
Arthritis PatientAge: 78
CAST for Autism Spectrum Disorder
Muncie, Indiana
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.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:16 - 99
Key Eligibility Criteria
Disqualifiers:Moving, Job Change, Others
297 Participants Needed
Virtual Interview Training for Autism
Lincoln Park, Michigan
The purpose of the study is to see if an internet job interview training program can help people that have autism improve interview skills and access to jobs.
Participants will be randomized to use Virtual Interview Training (VIT) or continue services as usual (active control group).
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Age:16 - 26
Key Eligibility Criteria
Disqualifiers:Not In Transition Services
200 Participants Needed
Emotion Regulation Therapies for Autism
Pittsburgh, Pennsylvania
Too few clinicians are able and willing to help autistic patients. A recent review identified challenges to mental health service delivery in autism, including a lack of interventions designed for community implementation and limited workforce capacity. It has been argued that improving impairment in emotion regulation has the potential to improve a range of mental health difficulties in autistic people. In this clinical trial, the investigators are comparing two evidence-based interventions for emotion regulation, to determine if one created specifically for autistic people is clinically superior. The interventions will be implemented in the community, through partnering agencies.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:10 - 30
Key Eligibility Criteria
Disqualifiers:Acute Psychosis, Suicide Threat, Intoxication, Mania
470 Participants Needed
Online Work Chat Program for Autism
Ann Arbor, Michigan
This study is aiming to see if it is feasible for the intervention Work Chat to be delivered in a completely online setting to adults with autism spectrum disorder.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
90 Participants Needed
Eye Tracking for Autism Detection
Indianapolis, Indiana
The study will use a non-invasive remote eye-tracking system (Eyelink Portable Duo) to acquire a short series of eye-tracking measures.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:12 - 48
Key Eligibility Criteria
Disqualifiers:Age, Language, Others
100 Participants Needed
Cognitive Enhancement Therapy for Autism
Pittsburgh, Pennsylvania
This trial will test two therapies for adults with autism. One therapy aims to improve thinking and planning through mental exercises. The other provides support to help manage emotions and social skills. The study focuses on adults because there are few treatments available for them.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Age:16 - 45
Key Eligibility Criteria
Disqualifiers:Not Listed
86 Participants Needed
Bedtime Routine for Autism
Pittsburgh, Pennsylvania
The goal of this pilot intervention study is to examine the feasibility and acceptability of a novel bedtime manipulation protocol called "The Power Down" for autistic youth, ages 6-10. The main questions it aims to answer are:
1. Is the Power Down feasible for caregivers to do each night?
2. Do the families find the Power Down an acceptable intervention to address their child's difficulties settling down to fall asleep?
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:6 - 10
Key Eligibility Criteria
Disqualifiers:Non-English Speakers, Trauma History, Others
10 Participants Needed
Simplified Language for Autism
East Lansing, Michigan
The long-term study goal is to experimentally evaluate the components (and likely active ingredients) of early language interventions for young children with ASD. The overall objective is to determine how single-word and telegraphic simplification affects real-time language processing and word learning in young children with ASD (relative to full, grammatical utterances). The proposed project will investigate three specific aims: 1) Determine how single-word and telegraphic simplification affects language processing. 2) Determine how single-word and telegraphic simplification affects word learning. 3) Evaluate child characteristics that may moderate the effects of linguistic simplification on language processing and word learning. Aim 1 will test the hypothesis that children with ASD will process full, grammatical utterances faster and more accurately than single-word or telegraphic utterances. Aim 2 will test the hypothesis that full, grammatical utterances will support word learning better than telegraphic or single-word utterances. Aim 3 will test the hypothesis that language and cognitive skills significantly moderate the effects of linguistic simplification on language processing and word learning in young children with ASD.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:1 - 4
Key Eligibility Criteria
Disqualifiers:Genetic Conditions, Cerebral Palsy, Brain Injury, Others
104 Participants Needed
Reciprocal Imitation Training for Autism
East Lansing, Michigan
This study is evaluating whether a parent-mediated intervention can improve outcomes for children with autism.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:16 - 33
Key Eligibility Criteria
Disqualifiers:Visual, Hearing, Motor Conditions
440 Participants Needed
Interactive Virtual Workday Training for Autism
Plainwell, Michigan
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.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Age:16+
Key Eligibility Criteria
Disqualifiers:Traumatic Brain Injury, Vision, Hearing, Others
300 Participants Needed
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We started Power when my dad was diagnosed with multiple myeloma, and I struggled to help him access the latest immunotherapy. Hopefully Power makes it simpler for you to explore promising new treatments, during what is probably a difficult time.
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Frequently Asked Questions
How much do Autism Spectrum Disorder clinical trials pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do Autism Spectrum Disorder clinical trials work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Autism Spectrum Disorder trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length for Autism Spectrum Disorder is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a Autism Spectrum Disorder medical study?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest Autism Spectrum Disorder clinical trials?
Most recently, we added Bedtime Routine for Autism, Caregiver Training for Autism Spectrum Disorder and Cognitive Behavioral Therapy for Anxiety in Autism to the Power online platform.
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