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NCT05185128 · ClinicalTrials.gov registry record · NA

Neural Basis of Social Cognition Deficits

A NA study of Autism Spectrum Disorder and Psychosis, sponsored by Loma Linda University.

Recruiting
Registry status
NA
Development phase
90
Enrollment target
1
Study location

NCT05185128 is a NA study of Autism Spectrum Disorder and Psychosis that is actively recruiting participants, run by Loma Linda University. The registered enrollment target is 90 participants, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (33% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05185128, a NA study of Autism Spectrum Disorder and Psychosis, is actively recruiting participants, sponsored by Loma Linda University.

RECRUITING
Registry status
NA
Development phase
90 participants
Enrollment target
1
Study location

Study Summary

Difficulties in reciprocal social interaction are hallmark features of several neuropsychiatric disorders, most notably autism spectrum disorder (ASD) and schizophrenia spectrum disorder (SSD). While recent studies have demonstrated substantial overlap in genetic etiology between ASD and SSD, little is known about common versus unique neural mechanisms that may underlie these downstream social deficits that cross diagnostic boundaries. Thus, a comprehensive imaging study examining social deficits in youth with ASD and adolescent- onset SSD at the neurochemical, connectivity, as well as functional activation level will be crucial in furthering our understanding of these underlying neural mechanisms. Specifically, the current project aims to examine how targeted social skills interventions may impact the organization of large-scale functional brain networks implicated in social cognition in these disorders, leading to improved outcomes. Thirty adolescents with ASD and 30 adolescents with SSD will undergo the Program for the Education and Enrichment of Relational Skills (PEERS), which is a 16-week parent-assisted social skills intervention that aims to improve friendship quality and social skills in teens with social difficulties. All participants will receive pre- and post-treatment MRI scans including functional MRI and magnetic resonance spectroscopy to quantify neural changes resulting from the intervention. All participants will also receive behavioral and social cognition assessments pre- and post-intervention to quantify real- world gains in social behaviors resulting from the intervention. Additionally, 30 typically developing adolescents will be recruited to serve as control participants and undergo two MRI and behavioral assessment sessions 16-weeks apart with no intervention in between. Specific aims include (1) examining inter-group disruptions in connectivity patterns, activation levels, and neurometabolite concentrations in key social brain regions pre-tr

Interventions

  • BEHAVIORAL PEERS social skills intervention

Study Locations (1)

California

  • Loma Linda U - Loma Linda

Trial Details

FieldValue
Enrollment Target 90 participants
Start Date 2022-02-01
Est. Completion 2026-12
Phase NA

Sponsor

Loma Linda University

237 total trials

What the Registry Record Tells You About NCT05185128

The ClinicalTrials.gov registry entry for NCT05185128 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (33% lower). The listed sponsor is Loma Linda University, which has 237 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 1 intervention - of which PEERS social skills intervention is the first listed.

NCT05185128 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT05185128 about?

NCT05185128 is a clinical study titled "Neural Basis of Social Cognition Deficits". Difficulties in reciprocal social interaction are hallmark features of several neuropsychiatric disorders, most notably autism spectrum disorder (ASD) and schizophrenia spectrum disorder (SSD). While recent studies have demonstrated substantial overlap in genetic etiology between ASD and SSD, little...

What is the current status of trial NCT05185128?

This trial is currently recruiting. It is a NA study. The enrollment target is 90 participants. The study started on 2022-02-01. Estimated completion is 2026-12.

What conditions does trial NCT05185128 study?

This clinical trial studies the following conditions: Autism Spectrum Disorder, Psychosis, Social Communication.

What interventions are being tested in trial NCT05185128?

The interventions under investigation include: PEERS social skills intervention (BEHAVIORAL).

Who is sponsoring clinical trial NCT05185128?

This trial is sponsored by Loma Linda University, which has 237 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05185128 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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