Autism

Boston, MA

126 Autism Trials near Boston, MA

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No Placebo
Highly Paid
Stay on Current Meds
Pivotal Trials (Near Approval)
Breakthrough Medication

Adderall XR for ADHD

Boston, Massachusetts
The investigators are conducting a 10-week brain imaging and medication study. They are doing the research to study the response of Attention-Deficit/ Hyperactivity Disorder (ADHD) in youth with Autism Spectrum Disorder (ASD) on extended-release formulation of mixed amphetamine salts (MAS) (also know as Adderall XR). The investigators also want to find out if taking MAS has any effect on the brains of children and adolescents with ADHD and ASD. This study will help researchers better understand how the use of MAS to treat ADHD effects children and adolescents with ASD. The investigators will compare MAS to a placebo. The placebo will look exactly like the MAS capsules but will contain no MAS. During this study, participants may get a placebo instead of MAS. Placebos are used in research studies to see if the study results are due to the study drug or due to other reasons. Participants with ASD and ADHD will complete 4-weeks of treatment with the study medication or placebo. They will complete bi-weekly study visits virtually via a telemedicine platform with the study doctor and complete questionnaires. On alternating weeks, they will meet with a Massachusetts General Hospital (MGH) study team member to discuss medication adherence and potential side effects. Participants will have the option to attend all study visits in-person if participants prefer. They will also complete baseline and endpoint Magnetic Resonance (MR) scan visits at Massachusetts Institute of Technology (MIT). During the MR Scan visits, they will complete a series of tasks to measure inattention, impulsivity, reward sensitivity, decision-making, and working memory. Participants without ADHD or ASD will complete eligibility screening with MGH. If eligible, they will be invited to baseline and endpoint MR scan visits at MIT. During the MR Scan visits, they will complete a series of tasks to measure inattention, impulsivity, reward sensitivity, decision-making, and working memory.

Trial Details

Trial Status:Not Yet Recruiting
Trial Phase:Phase 4
Age:8 - 18

196 Participants Needed

Stimulant Medications for ADHD in Autism Spectrum Disorder

Boston, Massachusetts
This 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

500 Participants Needed

ML-004 for Autism Spectrum Disorder

Boston, Massachusetts
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:Active Not Recruiting
Trial Phase:Phase 2
Age:12 - 45

150 Participants Needed

Family Support Program for Autism

Boston, Massachusetts
A randomized controlled trial will be conducted to determine the effects of an adapted family-centered autism transition intervention called Transitioning Together/Juntos en la Transición on meaningful outcomes for families. The study will occur in a safety net hospital setting. The adapted version of this multi-family group psychoeducation intervention is delivered across one individual family joining session and four 2.5 hour multi-family group sessions. The parent and youth groups are held in separately, at the same time.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:14 - 21

48 Participants Needed

Speech Treatment for Minimally Verbal Children with Autism

Boston, Massachusetts
Comorbid Childhood Apraxia of Speech (CAS) may be one factor that limits speech development in some minimally verbal children with autism. CAS is a disorder affecting speech movement planning. This study tests whether CAS-specific treatment, appropriately modified for minimally verbal children with autism, improves their speech.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:5 - 18

20 Participants Needed

JASPER Intervention for Autism

Boston, Massachusetts
This trial is testing JASPER, a play-based therapy, on young children with autism who have limited verbal skills. The therapy uses guided play to help these children improve their social and communication abilities. JASPER (Joint Attention, Symbolic Play, Engagement, and Regulation) is a naturalistic developmental behavioral intervention that has been found effective for promoting social communication in young children with autism.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 5

90 Participants Needed

HEARTS Classes for Autism

Boston, Massachusetts
The goal of this randomized clinical trial is to test whether the 6 sessions HEARTS Healthy Relationships classes increases the satisfaction that autistic adults feel about their friendships and dating relationships compared to a 6 weeks online discussion group. The 6 HEARTS sessions cover: healthy and unhealthy relationships, launching new relationships, neurohealth, meeting and reconnecting, boundaries, and healthy endings. Participants who take part in this research study will be in this research study for three months. During this time, participants will be asked to complete two 30-minute and six 10-minute online surveys, and participate in two 20-minute interviews over Zoom.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting

95 Participants Needed

Learning Strategies for Autism

Boston, Massachusetts
The goal of this research is to explore abilities to learn word meanings from overheard conversations in children with ASD (and, as a control, typically developing children). Specific Aim 3 (Experiment 3): Determine whether children with ASD can learn verbs and pronouns by overhearing. Most prior work on learning from overheard speech has focused on learning nouns that label objects. This experiment extends this work to study other kinds of words.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Age:24 - 71

179 Participants Needed

Overheard Speech Learning for Autism

Boston, Massachusetts
This trial studies if children with ASD can learn new words from video calls, either by being spoken to directly or by overhearing conversations. It aims to improve educational methods for these children.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting

295 Participants Needed

Speech Exposure for Autism

Boston, Massachusetts
The goal of this research is to explore abilities to learn word meanings from overheard conversations in children with ASD (and, as a control, typically developing children). Specific Aim 1 (Experiment 1): Subaim 1a: Identify child characteristics associated with learning from overhearing. In a prior study, the investigators found that 13 children with ASD were able to learn the meanings of novel words that they heard used in a conversation involving two adults. In the current study, the investigators aim to study a larger sample to identify what child characteristics are associated with good learning in an overhearing situation as compared to a situation in which the child is directly taught the new word. Subaim 1b: Assess retention and generalization of words learned from overhearing. The investigators will re-test children on their knowledge of the word meanings after a 10-minute delay to see if they both retain the word meanings and can generalize the new words to new situations.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting

155 Participants Needed

Lumateperone for Autism

Boston, Massachusetts
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

174 Participants Needed

Lumateperone for Irritability in Autism

Boston, Massachusetts
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

174 Participants Needed

Oxytocin Nasal Spray for Autism

Boston, Massachusetts
This trial tests if giving oxytocin through a nasal spray can improve bone health in children with autism. Children with autism often have weaker bones and lower levels of oxytocin. The study aims to see if oxytocin can help make their bones stronger. Oxytocin has been investigated for its potential to treat social deficits in autism spectrum disorders, with various studies exploring its effects on social behavior and brain function.

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 2
Age:6 - 18

96 Participants Needed

Behavior Analytic Support for Autism

Boston, Massachusetts
The purpose of this study is to evaluate the effectiveness of the behavior analytic intervention in reducing the number of challenging behaviors exhibited by patients with Autism Spectrum Disorder (ASD) while increasing compliance with needle-related simulations and procedures. A second purpose is to assess the social validity of this study as evidenced by patient and/or caregiver acceptability. The study wil take place at Boston Medical Center (BMC). A Single Subject Design (SSD) wil be utilized as it allows for detailed, individualized assessment of how interventions affect behavior over time in this type of behavior analytic research. By focusing on each participant as an individual and having each participant act as their own control, it demonstrates clear cause-and-effect relationships, showing how behavior changes with the introduction or withdrawal of an intervention. This method is flexible, enabling ongoing adjustments to treatments based on real-time data, making it particularly useful in personalized interventions and ensuring effectiveness for patients with unique needs such as those who would be eligible to enroll and participate in this study.
No Placebo Group

Trial Details

Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:3+

10 Participants Needed

Being Brave for Anxiety

Brookline, Massachusetts
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).
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:3 - 6

25 Participants Needed

Melatonin for Autism

Boston, Massachusetts
Sleep disturbances and sensory sensitivities are common disabling features of autism, but their underlying causes are not clear. We hypothesize that both of these difficulties reflect disrupted communication between a deep brain structure, the thalamus, and the brain's outer layer, the cortex. This communication is mediated by the thalamic reticular nucleus (TRN). Due to its small size and location deep in the brain, we cannot assess TRN function without invasive techniques. Fortunately, sleep spindles, a specific brain rhythm provide a noninvasive read-out of TRN function. In Aim 1 we will examine whether reduced sleep spindles are related to worse sleep quality, impaired selective attention during wake, and sensory sensitivities in children with autism. In Aim 2, we will determine whether melatonin, which is commonly used to improve sleep, also increases sleep spindles in autism. If successful, this study will introduce TRN as a target for treatment of sleep disruption and guide larger home-based sleep studies.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:12 - 18

30 Participants Needed

Reciprocal Imitation Training for Autism

Boston, Massachusetts
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

440 Participants Needed

Prednisone for Autism

Lexington, Massachusetts
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.

Trial Details

Trial Status:Not Yet Recruiting
Trial Phase:Early Phase 1
Age:18 - 50
Sex:Male

32 Participants Needed

Folinic Acid for Language Impairment in Autism Spectrum Disorder

Lexington, Massachusetts
This trial is testing folinic acid, a vitamin, to see if it can help children with autism who have language problems. The study focuses on whether this vitamin can improve brain function and language skills. Children with moderate language issues will participate. Folinic acid has been studied for its potential to improve verbal communication in children with autism and language impairment.

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:5 - 17

56 Participants Needed

Virtual Reality for Autism

Dedham, Massachusetts
The goal of this randomized clinical trial is to compare and learn about Virtual Reality (VR) in children with autism/Autistic children. The main question it aims to answer is: • Does the Floreo VR clinical product show clinical improvement in autism symptoms? Participants will engage the VR product for twice a week for twelve weeks. They will be randomized to either the Floreo Clinical Product or a VR Control group experience. Researchers will compare the two groups to see if there is an effect on learning specific skills and behaviors.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:5 - 18

100 Participants Needed

Why Other Patients Applied

"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 been struggling with ADHD and anxiety since I was 9 years old. I'm currently 30. I really don't like how numb the medications make me feel. And especially now, that I've lost my grandma and my aunt 8 days apart, my anxiety has been even worse. So I'm trying to find something new."

FF
ADHD PatientAge: 31

"I was diagnosed with stage 4 pancreatic cancer three months ago, metastatic to my liver, and I have been receiving and responding well to chemotherapy. My blood work revealed that my tumor markers have gone from 2600 in the beginning to 173 as of now, even with the delay in treatment, they are not going up. CT Scans reveal they have been shrinking as well. However, chemo is seriously deteriorating my body. I have 4 more treatments to go in this 12 treatment cycle. I am just interested in learning about my other options, if any are available to me."

ID
Pancreatic Cancer PatientAge: 40

"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

"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

Online Sexual Health Program for Fathers and Teens

Wellesley, Massachusetts
This study proposes to pilot an online intervention to support father-teen health-promoting talk about sex and relationships using Social Cognitive Theory, and to evaluate this intervention's acceptability, feasibility, and preliminary efficacy, using an Intervention Mapping approach. This study involves conducting a pilot intervention with 50 pairs of fathers and their high-school aged teens. Feasibility and acceptability will be assessed through program data such as participants' pilot enrollment, lesson feedback, and program retention, survey data and member checks through debrief interviews (5 father, 5 teens). Preliminary assessment of directionality of change in participants' health-related knowledge, self-efficacy, and outcome expectations over the course of the pilot intervention (pre- and post-intervention surveys) to determine whether a full-scale R01 is warranted.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:14+

100 Participants Needed

Gabapentin for Autism

Worcester, Massachusetts
This trial tests whether gabapentin can improve social skills in adolescents with autism by increasing levels of a calming brain chemical called GABA. The study involves 40 adolescents and aims to see if this treatment can correct brain chemical imbalances and improve social interactions.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 4
Age:13 - 17

40 Participants Needed

Early Intervention Coaching for Infants at Risk of Autism

Worcester, Massachusetts
The proposed study (PETAL: Promoting Early intervention Timing and Attention to Language) aims to determine the timing of intervention among infants with Increased Likelihood for Autism (ILA; at risk for autism by virtue of having an older sibling with autism) on communication and language outcomes at 24 months. Results of this study will determine when (9 vs 12 vs 15 months), and based on which measures (brain, language, or their combination) to augment parental support with a specialized parent-mediated coaching intervention for optimal outcomes on communication and language at 24 months. Children will be recruited at 6-8 months of age and will begin with entry assessments. All children will first begin with the MONITOR condition (using Ages \& Stages Questionnaire (ASQ-3) and activity cards. Then when the child is 9 months, they will be randomized to continue with MONITOR condition or COACH condition (incorporates JASPER intervention and Babble Bootcamp) after second set of assessments. There are a total of 6 assessment timepoints (6-8 months of age, 9 months of age, 12 months of age, 15 months of age, 18 months of age, and 24 months of age). At time points of 9months and 12 months, the child will be randomized to COACH or MONITOR conditions. Once the child is randomized to COACH condition, they will continue with that condition until they terminate the study at 24 months. At the 15 months timepoint, there will no longer be a randomization. Children that were in the MONITOR condition will change to the COACH condition until they terminate the study.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:6 - 8

140 Participants Needed

CM-AT for Autism

Warwick, Rhode Island
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

405 Participants Needed

OPT-In-Early for Autism Spectrum Disorder

Hartford, Connecticut
Latinx and Rural-living children with diagnosed or suspected autism have especially long wait times for diagnoses and intervention, up to a year or even more. This delayed access to intervention is likely to prevent children from reaching their full potential in skills and adaptive functioning. A comprehensive, online mobile device-based, free intervention that can be used by parents while on these wait lists may optimize their child's development. The investigators have developed such a program, the Online Parent Training in Early Intervention (OPT-In-Early) program. It teaches parents the fundamental principles of both applied behavior analysis and naturalistic interventions, uses non-technical language, video demonstrations, guidance in selecting appropriate skills to teach, embedding teaching into daily routines, and reducing interfering behaviors. It is a self-paced, individualized platform giving parents strategies to strengthen the parent-child relationship, to teach basic skills, such as simple communication, to reduce interfering behaviors, and to establish helpful routines. In pilot the RCT, parents (half of whom were self-identified as Latinx) rated the program very highly and showed positive changes in behavior and knowledge. The goal of the current project is to develop, and pilot test a bilingual Spanish/English culturally tailored version of OPT-In-Early for Latinx families in the US, as well as tailoring and testing the program for rural communities of Oregon. First, the investigators will obtain detailed, iterative feedback from bilingual Latinx parents with an autistic child regarding OPT-In-Early. Similar feedback will also be obtained from participants from rural communities of Oregon who also have an autistic child. The investigators will use this feedback to culturally adapt the program content and format. Next, the adapted program will be modified via user testing with Spanish speaking parents and English speaking parents. Finally, the bilingual version will be tested in a six-month pilot RCT, in preparation for a fully powered R01 trial. The investigators will use a wait-list control design: the Intervention Now arm will be given the online program and the Intervention Later arm (controls) will be given educational material about autism. All children will receive a baseline and 6-month follow-up assessment, which will measure parent fidelity in using the intervention principles (the primary outcome), child social communication, level of autism symptoms, impact of autism symptoms, and degree of developmental delays. The Intervention Now group will have two subgroups. One will test the online program with an emphasis placed on the Spanish version, while the other will focus on the English version and complete the program through a rural lens. At the conclusion of this research, the investigators will have developed an evidence-based, comprehensive, freely available, parent-delivered intervention that can be used by US Latinx and rural families on their mobile devices as they await diagnosis and intervention. This will increase parent efficacy and reduce their stress, accelerate children's skills, reduce interfering behavior, and enhance PCPs' willingness to implement universal autism screening.
No Placebo Group

Trial Details

Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:15+

120 Participants Needed

Therapeutic Horseback Riding for Autism Spectrum Disorder

Portland, Maine
This randomized control trial (RCT) seeks to assess the mechanisms underlying Therapeutic Horseback Riding's (THR) previously observed significant positive effects on ASD youth, particularly those with co-occurring psychiatric disorders, and to refine information on the durability, dose and sub-population effects of the intervention.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Age:6 - 17

250 Participants Needed

Transcranial Magnetic Stimulation for Autism Spectrum Disorder

Hartford, Connecticut
The goal of this observational study is to test the modulation effect of different transcranial magnetic stimulation (TMS) on the neural network supporting our ability to create mental representations of others (also known as mentalizing) in young adults with autism. The main question it aims to answers is can stimulation of the right temporoparietal junction can change brain activity related to mentalizing during social interaction in the stimulation area and other brain areas connected to it. Researchers will compare results to a group of individuals without autism to see if the patterns of neural activity change are similar between the groups. Participants will undergo assessment of their clinical traits and social skills and baseline MRI scan. They will attend three additional visits that include TMS session and functional MRI scans before and right after TMS.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 35

80 Participants Needed

Mindfulness Intervention for Stress and Anxiety

Portland, Maine
The purpose of this clinical trial is to investigate the effectiveness of a mobile app-based mindfulness program in improving the mental well-being of caregivers with a child diagnosed with autism spectrum disorder (ASD) who live in rural areas of Maine. The primary question the investigators aim to answer is whether this mindfulness intervention can reduce stress and anxiety in these rural caregivers of children with ASD. Participants in the trial will engage in a 30-day mindfulness program that they can complete over a maximum of 60 days. During this time, they will practice short daily mindfulness lessons and respond to a set of brief questions regarding their anxiety levels. Ultimately, the investigators want to assess whether this intervention helps these caregivers feel less stressed and anxious.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased

40 Participants Needed

Behavioral Therapy for Autism

New Haven, Connecticut
This trial tests a new therapy called BTIA, which helps teens with autism manage their emotions and behaviors. The therapy involves regular sessions where therapists teach both the teens and their parents how to handle frustration and improve daily functioning. The study aims to see if BTIA can reduce disruptive behaviors and help these teens function better in their everyday lives.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:12 - 19

65 Participants Needed

TMS for Autism

New Haven, Connecticut
This is a randomized interventional study designed to evaluate the effects of repetitive Transcranial Magnetic Stimulation (rTMS) on neural and behavioral facets of social cognition in adults with autism spectrum disorder (ASD).

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 40

60 Participants Needed

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