Research Studies

Currently Recruiting or Active Research Studies

 Study Title

Study Description

Age Range

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

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

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

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

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

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


oRBiting Study

oRBiting Study

We know that no two people with autism are the same. And of course we wouldn’t want them  to be. But people with autism often have behaviors that they repeat, known as repetitive and restricted behaviors, or RRBs. So we are conducting the oRBiting study to better understand the different scales that have been developed to measure RRBs in autism, and to explore the use of wearable technologies for gaining important insights into daily behaviors.

oRBiting is a non-drug observational study which we hope will help to inform later studies as to whether investigational drugs could make life with autism a little easier.  We’re looking for children and adults with autism to join the  oRBiting study who are aged 5–45 years and have someone they see and speak to regularly who can be their study partner and accompany them to all clinic visits (for example, a parent or close friend).

 

For more information, please contact Rachel Schuck at 650-736-1235 or autismdd@stanford.edu

5 to 45 years


Multi-Modal Neuroimaging of the Cerebellum in Autism Spectrum Disorder

Stanford University researchers are currently recruiting children and adolescents with autism (i.e. typically developing) to participate in a research study. The study compares individuals with Autism Spectrum Disorder to typically developing individuals so we can better understand the causes of autism.

2 to 21 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 between the ages of 3 and 21 years are eligible to participate if they have been diagnosed with PTEN hamartoma tumor syndrome or autism spectrum disorder with macrocephaly. 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    

3 to 21 years


Clinical Trial of Everolimus in Children and Adolescents with PTEN Mutations

Phosphatase and TENsin homolog (PTEN) gene mutations (mistakes in the gene) are associated with neurocognitive deficits, intellectual disability, autism symptoms, skin lesions, macrocephaly (large head size), overgrowth of tissues, and an increased risk of cancers. Investigators are conducting research to evaluate the potential safety and efficacy (effectiveness) of the drug, RAD001 (everolimus), in patients with PTEN Hamartoma Tumor Syndrome, and the potential neurocognitive benefits from treatment with RAD001 or placebo for a six month period. The investigators hope this trial will lead to a better understanding of PTEN and to new forms of treatment that may benefit children and adults with PTEN in the future.

Clinical Trials Website  

Study Webpage

5 to 45 years


ICATS - Imaging California Autism Twin Study

Stanford University researchers are currently recruiting same-sex twin pairs with autism and twin pairs without autism (i.e. typically developing) to participate in a research study. The study compares twins with Autism Spectrum Disorder to typically developing twins so we can better understand the causes of autism.

3 to 14 years


Parent Training to Enhance Social Success for Children with Autism Spectrum Disorder

Children with autism spectrum disorder (ASD) exhibit characteristic deficits in social initiation and there are few empirically validated treatments specifically for this core deficit. While parent training is known to be a critical intervention component, few social skills programs involve parents. This study will capitalize on an existing social skills group already established at the community agency Abilities United, with the goal of enhancing the program’s effectiveness by adding a parent component. Specifically, the proposed study will investigate whether a novel parent-mediated social skills program (Social SUCCESS), which provides parent training in conjunction with a social skills group intervention, will result in more frequent initiations during play with typically developing peers. We are currently recruiting verbal children with Autism Spectrum Disorder, aged 4:0 to 6:11 years, who have average to above average cognitive ability. Children will be randomly assigned to either Social SUCCESS or waiting list. Treatment will be provided for 12 weeks and include participation in a social skills group and a separate parent training group. The study will evaluate the effects of Social SUCCESS on areas of core social deficit including frequency of peer initiations using parent ratings, observational

measures, standardized questionnaires, and a social eyetracking task. Outcomes will be compared to a waiting list control group. Findings will aid clinicians in providing more effective social skills treatment for children with ASD and enhance the scientific knowledge-base related to evidence-based social skills treatments

4 to 6 years


Resilience Training for Parents of Children with Autism Spectrum Disorder

The goal of this study is to examine the effectiveness of a novel resilience training program for parents of children with Autism Spectrum Disorder (ASD), the AMOR Method. The program is designed to teach parents of children with ASD (4-10 years old) various resilience techniques including mindfulness, optimism, and acceptance. This treatment approach is based on several principles of resilience training, mindfulness practice, Grief and Loss Processing Therapy (GLPT), Acceptance and Commitment Therapy (ACT), and optimism training. Specifically, we are looking to see the different parent factors that may contribute to resilience development. 

The 8-week program includes both a parent group and an individual component. Parents will be asked to participate in weekly group parent training sessions at Stanford University to learn the science, foundation, and skills of the treatment from study staff as well as receive feedback on weekly homework assignments of practicing the skills outside of group. In addition, parents will enroll in three individual sessions with research staff on specific treatment content including grief and loss processing, optimistic thinking strategies, and resilience maintenance over time. We hope that by investigating what treatments are most effective in improving resilience it will aid clinicians in providing better care for parents of children with ASD

 

4 to 10 years

Active Studies, not Recruiting

 

GABA Neurophysiology

GABAergic Neurophysiology in Autism Spectrum Disorder

In current clinical practice, diagnosis of autism spectrum disorder (ASD) is performed by identification of behavioral and cognitive symptoms, and treatments for ASD are completely empirical. Identification of specific molecular abnormalities (related to a the major inhibitory neurotransmitter GABA) in targeted brain networks, as is proposed, would allow for better assessments of abnormalities of brain circuits associated with the cognitive-behavioral deficits, and more rational and effective development of interventions that are based on molecular abnormalities in specific brain networks. Therefore, the proposed work in molecular neuroimaging in individuals with ASD will help the field to depart from the symptom-clustering approach in diagnosis and empirical approach in treatments, and move toward more mechanism- and biomarker-based diagnostic and intervention strategies.

18 to 45 years

Analysis of the Glutathione Cycle in Children with Autism

Stanford University researchers are recruiting children with autism to participate in a research study to examine the levels of certain biomarkers (antioxidant) in children with autism in an effort to better understand autism spectrum disorder and help develop future treatments.

4 to 12 years

Sensory Processing in Developmental Disorders

Stanford Psychology and the Autism and Developmental Disorders Research Program are working together to better understand how children with developmental disorders process sensory information. We expect that this work will provide clues about developmental disorders and will help the design of diagnostic and therapeutic tools. Our study involves two or three visits to our lab on campus. We will show participants pictures (stripes, patterns, objects, or faces) on a computer monitor and present sounds while we measure brain-waves. Parent interviews and clinical assessments will also be part of the study. The entire procedure is non-invasive and safe, and all participants’ information will be kept confidential. We are currently recruiting children with ASD, ADHD and typical developing children between 4 and 9 years of age.

4 to 9 years

Pivotal Response Treatment Package for Young Children with Autism

This is a research study examining the effectiveness of pivotal response treatment in targeting language skills in young children with autism.

1.5 to 5 years

The Role of Vasopressin in the Social Deficits of Autism

Researchers at the Stanford University School of Medicine are seeking participants for a study examining the effectiveness of vasopressin, a neuropeptide, in treating children with autism spectrum disorder.

Link to study in Stanford's Clinical Trial Directory

Press Release

6 to 12 years

Social Motivation Intervention for Children with Autism Spectrum Disorder: Improving Initiations to Peers

4 to 6 years