Research Studies

Currently Recruiting or Active Research Studies

 Study Title

Study Description

Age Range

Language Treatment Trial for Children with Autism

Researchers at Stanford University are currently recruiting children with autism spectrum disorder to identify MRI-based markers of response to treatment with Pivotal Response Treatment (PRT) targeting language abilities. Children with autism spectrum disorder between the ages of 2 and 4 years 11 months are invited to participate. This study involves up to a 5 month time commitment. The participant must be willing to complete cognitive and behavioral assessments (such as IQ and language testing) and be able to either sleep (young children) or lie still in the scanner during an MRI. After a successful MRI, the participant will be randomized into the PRT trial or DTG (Delayed Treatment Group). PRT will consist of 16 weekly, 60-90 minute sessions of parent training in PRT over a 16 week time period. DTG will consist of your child’s treatments as usual in the community and measurements and questionnaires will need to be filled out on three study visits over the course of the 16 weeks. After completion of the DTG, the participant will be offered PRT parent training sessions similar to the PRT group. There is no cost to participate in the study. If you would like to participate or if you have any questions please call (650) 736-1235 or email: autismdd@stanford.edu to discuss the study in more detail. 

2 and 4 years,11 months


Vasopressin Treatment Trial for Children with Autism

Vasopressin Treatment Trial for Children with Autism

The purpose of this clinical trial is to investigate the effectiveness of vasopressin nasal spray for treating symptoms associated with autism. Vasopressin is a hormone that is produced naturally within the body and has been implicated in regulating social behaviors. It has been proposed that administration of the hormone may also help improve social functioning in individuals with autism.

 

Link to study at clinicaltrials.gov

6 to 17 years


SPARK (Simons Powering Autism Research) Study

If you or your child has a professional diagnosis of autism, Stanford University invites you to learn more about SPARK, a new online research study sponsored by the Simons Foundation Autism Research Initiative. The mission of SPARK is clear: speed up research and advance understanding of autism by creating the nation’s largest autism study. Joining SPARK is simple – register online and provide a DNA sample via a saliva collection kit in the comfort of your own home. Together, we can help spark a better future for all individuals and families affected by autism.

Register in person at Stanford University by contacting us at sparkstudy@stanford.edu or online at www.sparkforautism.org/stanford.

 

All Ages


A Center Based Randomized Controlled Trial of Pivotal Response Treatment for Preschoolers With Autism

Researchers at Stanford University are currently recruiting children with autism and their parents to participate in a study examining the effectiveness of a center-based Pivotal Response Treatment (PRT) program in targeting social communication abilities in young children with autism. We are currently recruiting children diagnosed with ASD and social communication deficits, aged 2:0 to 3:11 years. Children who are eligible based on behavioral screening assessments will be randomly assigned to either an immediate treatment (PRT) group or a delayed treatment group (DTG). If randomized into the PRT group, the 12-week treatment will consist of a combination of one weekly 60-minute individual parent training session and 12 weekly hours (approximately 3 hours per day for 4 days per week) with your child in a center-based group preschool environment at Stanford University. If randomized into the delayed treatment group, the children will wait 12 weeks to receive the PRT treatment and continue any treatment they are receiving as usual in the community. The cost of clinic-based services varies based on individual family health insurance plans.

For more information, please call (650) 736-1235 or email autismdd@stanford.edu to discuss the study in more detail. 

 

2 to 3 years, 11 months


Targeting the Neurobiology of Restricted and Repetitive Behaviors in Children with Autism Using N-acetylcysteine

We are recruiting children autism to participate in a study examining the treatment effects of an over-the-counter dietary supplement on the brain.   

 

Eligibility: Children with autism spectrum disorder who -

·    are aged between 3 and 12 years old

·    exhibit restricted and repetitive behaviors

·    will drink N-acetyl cysteine dissolved in water

·    will undergo brain scanning (asleep or awake) with magnetic resonance                 imaging (MRI)

·    will undergo brain scanning with electroencephalography (EEG)

The study will take place over 3 to 6 visits (some remotely over Zoom) and the approximate time required is about 10 to 12 hours. Individuals that are able to complete both of the MRI/EEG sessions will be compensated $50.

To help determine if your child might be eligible, please complete a screening questionnaire at https://redcap.link/autismresearch

If you have any questions please call 650-736-1235 or email: autismresearch@stanford.edu.

3 to 12 years


Transcranial Magnetic Stimulation (TMS) for Restricted & Repetitive Behavior in Autism

Stanford University researchers are recruiting individuals with an autism spectrum disorder diagnosis between 12-45 years old for a research study to examine the efficacy of TMS for restricted and repetitive behavior in ASD.

Participants must:

  1. Be willing to receive TMS sessions for up to 6 weeks
  2. Be willing to participate in behavioral and cognitive testing
  3. Have no history of epilepsy, no implanted metal and no active medical problems

There is no cost to participate in this study. Visit https://redcap.link/tms_asd to express your interest in the study

For more information, visit clinicaltrials.gov or contact the protocol director at ecole@stanford.edu

 

12 to 45 years


Pregnenolone Randomized Controlled Trial

Neurosteroid Pregnenolone Treatment for Irritability in Adolescents with Autism

Medication treatments for core symptoms of autism spectrum disorder (ASD) continue to be unmet medical needs. The only medications approved by the U.S. Food and Drug Administration (FDA) for the treatment of individuals with ASD are effective in treating irritability and associated aggressive behaviors, but these medications can also cause severe long-term side effects such as diabetes and involuntary motor movements. Therefore, effective medications with more tolerable side effect profiles are highly desirable. This profile is consistent with pregnenolone (PREG). PREG belongs to a new class of hormones known as neurosteroids, which have been shown to be effective in treating various psychiatric conditions including bipolar depression and schizophrenia. As compared to currently FDA-approved medications, our preliminary data suggested that PREG may represent a potentially effective and well-tolerated agent for treating irritability in individuals with ASD. In addition, our experience suggests that PREG might be helpful in improving selected core symptoms such as social deficits and sensory abnormalities of ASD. This study provides the opportunity to further explore the usefulness of PREG in the treatment of irritability and some core symptoms of ASD. We are performing a 12-week randomized double-blind controlled pilot trial to examine the effectiveness of orally administered PREG in reducing irritability and associated behaviors in adolescents with ASD. In this study, we also aim to examine the usefulness of biomarkers (blood levels of neurosteroids, eyetracking and brain wave recording) in predicting treatment response and assessing biologic changes with PREG treatment.

Link to study in Stanford's Clinical Trials Directory

14 to 25 years


Improving Access to Pivotal Response Treatment (PRT) via Telehealth Parent Training

There is an urgent need for improved access to effective autism treatments. With advances in technology, distance learning models have particular promise for families who cannot access evidence-based parent training locally or may be on long wait-lists for behavioral treatments. Pivotal Response Treatment (PRT) is an established treatment for autism spectrum disorder (ASD); however, a telehealth PRT model has not yet been evaluated in a controlled trial. This study will examine the effects of training parents in PRT via secure video conferencing and investigate 1) whether parents can learn via telehealth to deliver PRT in the home setting (PRT-T) and 2) whether their children will show greater improvement in functional communication skills compared to children in a waitlist control group. Participants will include 40 children age 2 to 5 years with ASD and significant language delay. Eligible children will be randomly assigned to either PRT-T or waiting list. Weekly 60-minute parent training sessions will be delivered for 12 weeks via secure video conferencing software by a PRT-trained study therapist. Link: https://clinicaltrials.gov/ct2/show/NCT04042337

2 to 5 years


Natural History Study of Individuals with Autism and Germline Heterozygous PTEN Mutations

The goal of this study is to gain a better understanding of PTEN mutation syndromes to identify early markers and ultimately effective interventions for autism spectrum disorder. Individuals 18 months or older are eligible to participate if they have been diagnosed with PTEN hamartoma tumor syndrome. The study involves five visits over a two year period. Three of the visits occur on-site at a study location. The other two visits occur as phone calls. The on-site visits include a blood draw, physical/neurological exams and behavioral testing.

Study Webpage    

18 months and older

Active Studies, not Recruiting

Multi-Site Validation Study of Eye Tracking-Based Measure if Autism Symptom Severity

Help us test fun and quick tools for assessing eye gaze!

For your time, you will receive $60 - $120!

If this tool works it can:

  • Make early diagnosis of autism easier
  • Reduce wait times for diagnosis
  • Increase access to early intervention

You are eligible to take part if:

  • Your child is between 2 and 17 years old
  • Your child will or has been seen at Stanford University for a question of Autism Spectrum Disorder (ASD) or another concern about their development

The study will involve:

  • Filling out some questionnaires about your child
  • Your child will experience a fun, quick, and child-friendly eye gaze activity that will involve looking at some pictures on a screen
  • Your child may complete some measures on their development and behavior
  • You and your child may be asked to participate in 2 follow-up visits 2 weeks and 16 weeks later

For more information, please call (650) 736-1235 or email autismdd@stanford.edu to discuss the study in more detail. 

2 to 17 years


An Open-Label Pilot Study of Esomeprazole in Children with Autism

Researchers at Stanford University are currently examining the effectiveness of esomeprazole in improving social communication deficits in children with Autism Spectrum Disorder (ASD). Esomeprazole is currently FDA-approved for children ages 1 and up for gastroesophageal reflux disease (GERD) and has been identified as a potential treatment for improving social communication in children with ASD. Children with ASD ages 2 through 6 years are invited to participate. The child must be willing to take esomeprazole orally for at least 8 weeks, complete diagnostic and behavioral assessments, and be free of serious medical problems. There is also an optional research blood draw. The study will require visits to Stanford University and the parent/caregiver will be required to complete questionnaires for each visit.

For more information, please go to https://is.gd/ASDstudy,  call (650) 736-1235, or email autismdd@stanford.edu.

2 to 6 years


Effectiveness of a Developmental Reciprocity Treatment Program in Autism

This is a research study examining the effectiveness of a Developmental Reciprocity Treatment Program in treating social deficits in children with Autism Spectrum Disorders. Developmental Reciprocity Treatment is an early intervention that applies developmentally-informed teaching methods in naturalistic settings in order to target social and communication deficits.

Researchers have begun to develop strategies to investigate the effectiveness of combining a parent training program teaching parents how to implement  Developmental Reciprocity Treatment with in-home, therapist-implemented treatment. To determine the effectiveness of theDevelopmental Reciprocity Treatment Program, it will be compared to a delayed treatment group by conducting a randomized controlled 24-week trial. This research will allow us to help in the development of therapeutic approaches that can meet the increasing service demands for families. We hope that investigating interventions that aim to improve core deficits will aid in providing better care for children with autism.

2 to 5 years