Neural Basis of Social Cognition Deficits

NCT05185128 | Recruiting DMC

• 1 other identifier: 5200189
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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-treatment in ASD and SSD groups, (2) examining inter-group changes in connectivity patterns, activation levels, and neurometabolite concentrations in key social brain regions in response to treatment in ASD and SSD groups, and, (3) dimensionally identifying intra-group differences in brain responses and how they relate to real-world treatment outcomes.

Conditions

Autism Spectrum Disorder; Psychosis; Social Communication

Outcome Measures

Primary Outcomes (3)

• The Awareness of Social Inference Test (TASIT)

  This is a Theory of Mind (ToM) measure containing 16 videotaped scenes. After each scene, subjects respond to questions about the characters' intentions, beliefs about the situation, and emotional state.

  Change between baseline and final visit at week 16

• The Social Attribution Task - Multiple Choice (SAT-MC, SAT-MC-II)

  his test uses a 64- second video of geometric shapes set in motion to portray themes of social relatedness and intentions. Considered a test of "Theory of Mind," the SAT-MC and its alternative form SAT-MC-II assesses implicit social attribution formation while reducing verbal and basic cognitive demands.

  Change between baseline and final visit at week 16

• The computerized Penn Emotion Identification Task (PennCNB)

  The PennCNB Emotion Identification Test (EMI) measures the ability to correctly identify facial expressions of emotion. Participants are shown 40 faces one at a time on the computer, and must identify the emotion expressed by the actors face from multiple choice options provided.

  Change between baseline and final visit at week 16

Secondary Outcomes (1)

• Functional MRI

  Change between baseline and final visit at week 16

Study Arms (2)

Control arm

NO INTERVENTION

Typically developing control participants will undergo cognitive assessments and MRI imaging 16 weeks apart with no intervention in between.

Patient arm

EXPERIMENTAL

Both ASD and SSD participants will undergo cognitive assessments and MRI imaging pre- and post- the 16-week PEERS social skills intervention.

Behavioral: PEERS social skills intervention

Interventions

PEERS social skills intervention BEHAVIORAL

The PEERS treatment program consists of 90-minute sessions, delivered once a week over the course of 16- weeks. Parents and children/adolescents attend separate concurrent sessions that instruct them on key elements about making and keeping friends. Among others, this parent-assisted, social skills intervention provides explicit instruction to target verbal and nonverbal communication skills, appropriate use of humor and resolving peer conflict, as well as expanding and developing friendship networks38. The candidate, Dr. Nair, has been trained on the PEERS social skills intervention extensively for the past five years, and is a certified provider for the adolescent program. The PEERS program will be provided by Dr. Nair's research team (consisting of Dr. Nair, lab co-ordinators, and clinical psychology doctoral students) through the LLU Department of Psychology.

Patient arm

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Participants in this study will be 30 ASD adolescents and 30 demographically matched adolescents with SSD who undergo the PEERS social skills training program. Participants will be between the ages of 12-18 years, and mostly male reflecting the higher prevalence in the population of ASD, and to a lesser extent, SSD. The ASD adolescents will be recruited through the Loma Linda University Behavioral Health Institute (LLU BHI), LLU Behavior Medicine Center (BMC), and LLU Department of Psychology Child and Family Center (CFC). The SSD adolescents will be recruited from the BMC inpatient, partial hospitalization, intensive outpatient, and standard outpatient programs for youth with psychosis. Thirty demographically comparable typically developing (TD) controls will be recruited through community samples, and in compliance with the LLU Institutional Review Board (IRB) standards. Before enrolling in the proposed MRI studies, prospective ASD participants will undergo testing with experienced assessors. Clinical diagnosis will be confirmed using both the Autism Diagnostic Interview- Revised, and the Autism Diagnostic Observation Schedule, 2nd edition. SSD participants will be screened using the Structured Clinical Interview for DSM-IV (SCID) Axis I diagnoses, with additional modules for assessment of childhood disorders. SSD participants must meet criteria for schizophrenia, schizophreniform, schizoaffective disorder, or unspecified schizophrenia spectrum and other psychotic disorder. All study participants will have verbal IQ as well as Full Scale IQ of 70 or higher on the Wechsler Abbreviated Scale of Intelligence (WASI-II) to ensure they will have the language and cognitive ability to participate in an MRI scan.

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda U

Loma Linda, California, 92354, United States

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder; Psychotic Disorders; Communication

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Behavior

Study Officials

• Aarti Nair, PhD

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aarti Nair, PhD

CONTACT

9095588707; anair@llu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The PEERS treatment program consists of 90-minute sessions, delivered once a week over the course of 16- weeks. Parents and children/adolescents attend separate concurrent sessions that instruct them on key elements about making and keeping friends. Participants in both the ASD and SSD groups will engage in approximately three hours of diagnostic, behavioral, and social cognition testing and one hour of MRI scanning both pre- and post-treatment. Additionally, TD participants will undergo two MRI scanning and behavioral assessment sessions approximately 16-weeks apart without enrolling in the PEERS program, to serve as controls.

Study Record Dates

• First Submitted: December 23, 2021
• First Posted: January 11, 2022
• Study Start: February 1, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)