A Salivary miRNA Diagnostic Test for Autism

NCT02832557 | Completed DMC

• 3 other identifiers: 346301R41MH111347R42MH111347
• Study Type: observational
• Target: 998
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to validate a panel of miRNAs that distinguish children with autism spectrum disorder (ASD) from their non-ASD peers with a positive MCHAT-R. These biomarkers may allow earlier diagnosis of autism, allowing earlier service, and also help us to understand some of the changes in the brains of autistic children.

Conditions

Autism Spectrum Disorder; Developmental Delay

Keywords

Autism; Asperger's Syndrome; microRNA; epigenetic; biomarker

Outcome Measures

Primary Outcomes (1)

• Salivary miRNA profile

  Measures of miRNA abundance in saliva

  at the time of collect (from 18m to 6 years of age)

Secondary Outcomes (3)

• Measures of adaptive function

  At time of enrollment (from 18m to 6 years of age)

• Measures of early intellectual development

  At time of enrollment (from 18m to 6 years of age)

• Measure of autistic behavior

  At time of enrollment (from 18m to 6 years of age)

Study Arms (1)

MCHAT-R Positive

Children identified at risk for the development of autism spectrum disorder (ASD) by scoring a 3 or higher on the MCHAT-R. Participants should not have a history of extreme pre-term birth or underlying neurological disorders such as seizures or cerebral palsy.

Other: Salivary collection; Other: Vineland Adaptive Behavior Scale-III Assessment; Other: Medical history questionaire; Other: Autism Diagnostic Observation Schedule -2nd edition (ADOS-2); Other: Mullen Scales of Early Learning

Interventions

Salivary collection OTHER

Collection of saliva via swab for miRNA processing

MCHAT-R Positive

Vineland Adaptive Behavior Scale-III Assessment OTHER

MCHAT-R Positive

Medical history questionaire OTHER

MCHAT-R Positive

Autism Diagnostic Observation Schedule -2nd edition (ADOS-2) OTHER

MCHAT-R Positive

Mullen Scales of Early Learning OTHER

MCHAT-R Positive

Eligibility Criteria

• Age: 24 Months - 48 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study will compare salivary miRNA in children between the ages of 24 months and 48 months of age who are considered at risk for the development of autism spectrum disorder as identified by a score of 3 or greater on the MCHAT-R.

You may qualify if:

• Age at enrollment: 24 months to 48 months (inclusive)
• MCHAT-R score of 3 or greater
• Parent/guardian must be fluent in spoken English (required to complete study specific questionnaires etc)

You may not qualify if:

• confounding neurological (i.e. cerebral palsy, epilepsy), sensory (i.e. auditory or visual) impairments, and feeding tube dependence.
• history of extreme pre-term birth (\< 32 weeks gestation)
• wards of the state
• Autistic subjects with known syndromic autism (attributed to a known genetic mutation)

Sponsors & Collaborators

• State University of New York - Upstate Medical University: lead
• National Institute of Mental Health (NIMH): collaborator
• Quadrant Biosciences Inc.: collaborator
• Milton S. Hershey Medical Center: collaborator
• University of Missouri-Columbia: collaborator
• Children's Hospital Medical Center, Cincinnati: collaborator
• Baylor College of Medicine: collaborator

Study Sites (1)

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Related Publications (3)

• Hicks SD, Ignacio C, Gentile K, Middleton FA. Salivary miRNA profiles identify children with autism spectrum disorder, correlate with adaptive behavior, and implicate ASD candidate genes involved in neurodevelopment. BMC Pediatr. 2016 Apr 22;16:52. doi: 10.1186/s12887-016-0586-x.

  PMID: 27105825 BACKGROUND

• Hicks SD, Rajan AT, Wagner KE, Barns S, Carpenter RL, Middleton FA. Validation of a Salivary RNA Test for Childhood Autism Spectrum Disorder. Front Genet. 2018 Nov 9;9:534. doi: 10.3389/fgene.2018.00534. eCollection 2018.

  PMID: 30473705 BACKGROUND

• Hicks SD, Carpenter RL, Wagner KE, Pauley R, Barros M, Tierney-Aves C, Barns S, Greene CD, Middleton FA. Saliva MicroRNA Differentiates Children With Autism From Peers With Typical and Atypical Development. J Am Acad Child Adolesc Psychiatry. 2020 Feb;59(2):296-308. doi: 10.1016/j.jaac.2019.03.017. Epub 2019 Mar 27.

  PMID: 30926572 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Salivary RNA

MeSH Terms

Conditions

Autism Spectrum Disorder; Learning Disabilities; Autistic Disorder; Asperger Syndrome

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator/Associate Professor

Study Record Dates

• First Submitted: July 12, 2016
• First Posted: July 14, 2016
• Study Start: November 1, 2015
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: June 5, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)