Reviewed by Michael Gill, B. Sc.
Image of The University of Texas/Callier Center for Communication Disorders in Dallas, United States.
Phase-Based Progress Estimates
1
Effectiveness
1
Safety

Pathways Interventionfor Autism Spectrum Disorders

< 18
All Sexes
The goal of this clinical trial is to compare the efficacy of Pathways parent-mediated early autism intervention (Pathways) and a parent education intervention (PEI) delivered to culturally and linguistically diverse families with children 12-42 months of age suspected of or diagnosed with autism. Question 1: Is Pathways more effective than a PEI at (a) fostering the development of social orienting, joint attention, and social communication and language in children with a research diagnosis of autism and (b) relieving their parents' stress? Question 2: Is the magnitude of the relationship between early and later developing attention greater in children whose parents receive Pathways compared to children whose parents receive PEI? Question 3: Is the magnitude of the relationship between joint attention and social communication and language greater in children whose parents receive Pathways compared to children whose parents receive PEI? Participants will be randomized into 24 weeks of Pathways or PEI. Participants will receive a battery of assessments to evaluate the child's cognitive, social attention, social communication, language, and adaptive functioning, and parental stress at four different time points spaced every 12 weeks from baseline to three-month follow-up.
Recruiting
Has No Placebo
The University of Texas/Callier Center for Communication DisordersPamela R Rollins, Ed.D
25 Autism Clinical Trials Near Me
Top Hospitals for Autism Clinical Trials
Image of Vanderbilt University Medical Center in Tennessee.
Vanderbilt University Medical Center
Nashville
7Active Trials
15All Time Trials for Autism
2012First Autism Trial
Top Cities for Autism Clinical Trials
Autism Clinical Trials by Phase of Trial
Phase < 1 Autism Clinical Trials
2Active Autism Clinical Trials
2Number of Unique Treatments
2Number of Active Locations
ASD-EXP and NT-EXPFlore
Autism Clinical Trials by Age Group
< 18 Autism Clinical Trials
118Active Autism Clinical Trials
Pathways InterventionTreatment as Usual OnlyEarly Diagnostic Response Model (EDRM)Telehealth Parent Coaching (TC)Treatment with RisperidoneAutism ALERTOverheard Speechclinician-mediated JASPER
Top Treatments for Autism Clinical Trials
Treatment Name
Active Autism Clinical Trials
All Time Trials for Autism
First Recorded Autism Trial
Overheard Speech
3
3
2020
Intranasal Oxytocin
2
7
2009
Levoleucovorin Calcium
2
2
2020
JASPER
2
3
2020
SENSE Theatre
2
3
2014
Recently Completed Studies with FDA Approved Treatments for Autism
Treatment
Year
Sponsor
STP1
2020
Stalicla SA
Gabapentin
2017
University of Massachusetts, Worcester

What is Autism?

Autism is a developmental disorder that affects the way a person communicates, interacts with others, and processes information. People with autism have difficulty communicating or understanding social cues, which can make it hard for them to form relationships and participate in activities that require social interaction.

It is a spectrum disorder—that is, it can be milder or more severe depending on the individual's ability to communicate effectively. Autistic people may have trouble understanding body language or facial expressions, or they may have difficulty processing sensory input like sound or touch. There are many different types of autism that exist today, including Asperger Syndrome (AS), Rett syndrome (RTT), Pervasive Developmental Disorder-Not Otherwise Specified (PDD-NOS), Childhood Disintegrative Disorder (CDD), and Pervasive Developmental Disorder-Not Otherwise Specified (PDD-NOS).

Why is Autism Being Studied in Clinical Trials?

The reason is simple: there are no drugs to treat autism, and there's no way to predict who will respond to treatment. According to the National Institute of Mental Health, 1 out of 44 children has autism spectrum disorder. The condition results in difficulty with social interactions, verbal and nonverbal communication, and repetitive behaviors. So, researchers have been trying to find out what makes people respond to treatment for autism to come up with new and better treatments.

In clinical trials, people with autism are given medications that are designed to help them function better in their daily lives. These medications don't cure autism or make it go away—they just enable people who take them to function better than they would otherwise be able to do, which means they can return home and live independently after taking the medication for a certain period. Some people with autism may also have sensory processing difficulties or problems with motor coordination. These symptoms can make it difficult for them to communicate effectively, which means they may need more time to complete certain tasks or work through situations that are familiar to others.

How Do Autism Clinical Trials Work?

Autism clinical trials are conducted by pharmaceutical companies and research institutes. The goal of a clinical trial is to test whether a drug will help people with autism. Although modern medicine is still at its earliest stages in providing an effective pharmaceutical solution to Autism, researchers are still driven to develop such drugs.

One example is this clinical trial that uses participants who have been diagnosed with autism or who have symptoms of autism to test the effectiveness of drugs. Clinical trials typically last about six months and involve multiple visits at a medical center. Each participant receives a different drug treatment during the trial period and is monitored closely by doctors and nurses in order to make sure that they do not develop side effects from taking the drug.

The purpose of a clinical trial is to determine whether the drug is safe and effective for people with autism. If the results show that it is safe, then other companies may start their own clinical trials as well. If it does not work, no one should be afraid to use this medication since it has already been tested in an environment where there are no side effects caused by it.

What are Some Key Breakthrough Clinical Trials Involving Autism?

2006: In one clinical trial, researchers found that a new treatment may be more effective than others in treating autism than currently used drugs. The study involved 40 patients between the ages of 2 and 9 who had previously been diagnosed with a moderate-to-severe autism spectrum disorder. 20 of these children received doses of the drug Risperdal (risperidone) once per day for six months. Afterward, they were compared with another group of 20 patients who received placebos. This study is significant because risperidone paved the way to improved social responsiveness and global functioning and reduced hyperactivity and aggression in children with autism.

Who are the Key Opinion Leaders in Autism Clinical Trial Research?

There are many key opinion leaders on autism clinical trial research, but here are a few:

Dr. David Amaral is the research director of the University of California’s MIND Institute (Davis Campus). He is primarily focused on the biological origin of autism.

Dr. Young-Shin Kim is a pediatric psychiatrist and epidemiologist at the University of California (San Francisco Campus), who has written about the occurrence of Autism in her home country of South Korea. Without her work, any kind of studies or clinical trials in the country would be non-existent.

Dr. Rebecca Landa is the director and founder of the Center for Autism and Related Disorders (CARD) and a professor at John Hopkins University. Her studies are of an innovative direction, as she intensively researched the development of the younger siblings of those who are diagnosed with autism. She was handed a National Institute of Mental Health (NIMH) Shannon Award for her novel research work.

Top Hospitals for Autism Clinical Trials

After looking at the top hospitals in the world that conducts autism clinical trials, The Massachusetts General Hospital has been found as the leader in such research. It is the largest hospital in Boston, Massachusetts, and one of the world's oldest and most respected hospitals. It was founded in 1811, making it one of the oldest medical centers in the United States. The hospital is a teaching affiliate of Harvard Medical School, and its research arm is the largest in New England. Massachusetts General Hospital has more than 1,300 beds and employs more than 10,000 people. It has been ranked as one of the best hospitals in the United States by U.S. News & World Report since 1990, and it is consistently ranked among the top 10 hospitals in the nation. In 2021, U.S. News & World Report ranked MGH as #1 in New England, #2 in the nation for both diabetes/endocrinology and Ear, Nose, and Throat, and #3 in psychiatry. Check out more top hospitals conducting autism clinical trials below.

Top Cities for Autism Clinical Trials

The city of Boston, Massachusetts, is listed to be the most popular city for autism clinical trials, with a record of 17 total active cases. This may be caused by it being the home to the top hospital for such purpose: the Massachusetts General Hospital. The city of Boston has a reputation for being one of the most modern, sophisticated, and progressive cities in America. It is home to one of the oldest universities in the United States and a liberal arts college where you can study anything from art to law at Harvard University. This city is home to many historic sites, such as the Fenway Park baseball stadium, where the Boston Red Sox play their games. Other cities listed as top cities for autism clinical trials can be seen below.

Top Treatments for Autism Clinical Trials

According to Power’s database, overheard speech is the top-rated treatment technique that is used for autism clinical trials, with a total of 3 active cases. Overheard speech is an effective clinical trial for the diagnosis of autism because it has the greatest number of positive characteristics. Overhearing is a more objective test than observation because it does not rely on a caregiver report. It provides information about function with no inference about causality, patients' compliance with testing procedures may improve as they become more familiar with them, and over-reporting by parents will reduce their child's detection rates. More treatments for autism clinical trials are found below.

How Many Autism Clinical Trials are Open to Youth and/or Seniors?

According to Power’s data, there are a total of 115 active clinical trials for autism patients aged 18 or below. This is due to the fact that children lack the ability to understand conflicts between their actions and the reactions of others. In children, this conflict is due to the fact that they do not understand why people react in certain ways or what actions might produce different reactions. Children may not realize how their behavior can affect others until they experience it firsthand. Occurrences regarding other age groups can be explored below.

About The Author

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 12th, 2021

Last Reviewed: October 22nd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.