Improving Autism Screening With Brain-Related miRNA

Status Completed

Clinical Trial Summary

The goal of this project is to identify specific miRNAs that are increased or decreased in the saliva of children with developmental delay and are useful for screening toddlers for ASD. Such a screening tool would improve the specificity of diagnosis, streamline referrals to developmental specialists, and expedite the arrangement of early intervention services.

Clinical Trial Description

The central aim of this project is to characterize the expression of exosomal microRNA (miRNA) in children with autism spectrum disorder (ASD). Currently, the CDC estimates the prevalence of ASD in U.S. children to be 1 in 68. Yet, the biological causes, diagnosis, and treatment of this disease remain ambiguous. Growing evidence implicates a genetic role in ASD. miRNAs regulate genetic expression and are altered in lymphocytes, neurons and serum of patients with ASD. Recent studies of miRNAs have shown that they can be packaged into exosomal vessels and extruded from neurons as extracellular signaling tools. This knowledge provides a novel approach for examining the genetic regulation of the central nervous system.

We propose to measure the expression of extracellular miRNA in children with ASD. Expression levels of miRNA from blood and saliva will be compared between children with autism and normally developing controls. The goal of this study will be to identify genetic regulatory mechanisms involved in ASD and provide potential biomarkers for diagnostic screening.

The primary endpoints of this study are as follows:

1. Characterization of brain-related miRNA in the saliva of children with ASD and typically developing control children between the ages of two and five years.

2. Identification of sets of miRNAs in saliva and plasma that are predictive of both ASD diagnosis and severity of ASD symptoms. This aim will enroll ASD and control children age 12-24 months (inclusive).

Secondary endpoints include the identification of miRNA expression patterns that correlate with ASD symptom severity measured with standardized neuropsychologic testing and to characterize parental knowledge and attitudes towards epigenetic testing in the context of ASD.. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02712853
Study type	Observational
Source	Milton S. Hershey Medical Center
Contact
Status	Completed
Phase
Start date	November 2015
Completion date	August 2018

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05207956` - App for Strengthening Services In Specialized Therapeutic Support	N/A
Completed	`NCT03286621` - Development of Eye-tracking Based Markers for Autism in Young Children
Completed	`NCT02608333` - Efficiency of Early Intervention for Autism Spectrum Disorder	N/A
Recruiting	`NCT05935722` - Evaluation of a Home-based Parenting Support Program: Parenting Young Children	N/A
Active, not recruiting	`NCT06259539` - A YouTube Curriculum for Children With Autism and Obesity	N/A
Active, not recruiting	`NCT06303791` - Digital-based Psychosocial Intervention for Parents of Children With Neurodevelopmental Disorders	N/A
Enrolling by invitation	`NCT05017779` - A Hybrid Effectiveness-implementation Trial of a High School-based Executive Function Treatment for Autistic Youth	N/A
Completed	`NCT04772898` - Effectiveness of a 6-week Hippotherapy Program in Children With Autism Spectrum Disorder	N/A
Recruiting	`NCT04987541` - The Therapeutic Effect of TBS Stimulation on Emotion Regulation in Autism Spectrum Disorder	N/A
Completed	`NCT04308915` - Mobile-based Games for Cognitive Training in Children With Neurodevelopmental Disorders	N/A
Completed	`NCT06038435` - The Effect of Cognitive Orientation Approach on Daily Occupational Performance With Autism Spectrum Disorder	N/A
Terminated	`NCT04049981` - Investigation of Mechanisms of Action in Superpower Glass	Phase 1/Phase 2
Completed	`NCT03693313` - The Effect of CrossFit Kids on Social Skills in Children With Autism Spectrum Disorder (CrossFit KAMP)	N/A
Recruiting	`NCT04107064` - Achieving Steady Work Among Adults With Autism Through Specialized Employment Program	N/A
Recruiting	`NCT03812068` - Parent-mediated Developmental Behavioral Intervention	N/A
Completed	`NCT03206996` - Exposure Therapy for Auditory Sensitivity in Autism	N/A
Completed	`NCT02299700` - Study to Evaluate the Janssen Autism Knowledge Engine in Children and Adults With Autism Spectrum Disorder	N/A
Completed	`NCT03422016` - Electroretinogram in Autistic Spectrum Disorders
Active, not recruiting	`NCT03548779` - North Carolina Genomic Evaluation by Next-generation Exome Sequencing, 2	N/A
Recruiting	`NCT05114538` - Improving the Part C Early Intervention Service Delivery System for Children With ASD	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.