Recruiting

PEERS

Sponsor:

Loma Linda University

Code:

NCT05185128

Conditions

Autism Spectrum Disorder

Psychosis

Social Communication

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

Interventions

PEERS social skills intervention

Study Details

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

Study ID

NCT05185128

Start date

Feb 1, 2022

Status verified date

Feb, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

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.

Exclusion Criteria:

Exclusion criteria will include history of significant medical/neurologic conditions that would affect neuroimaging interpretation (e.g., epilepsy, tumor), and any psychiatric history for TD controls. Participants with any MRI contraindications (e.g., history of metal fragment injury or metal implants, current orthodontic braces or nonremovable retainers) will also be excluded in compliance with scanner safety standards.

Study Design

Enrollment

90 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Control arm

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

experimental: Patient arm

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

Interventions

PEERS social skills intervention

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.

Primary outcome measure

  • The Awareness of Social Inference Test (TASIT) [ Time Frame: Change between baseline and final visit at week 16 ]
  • The Social Attribution Task - Multiple Choice (SAT-MC, SAT-MC-II) [ Time Frame: Change between baseline and final visit at week 16 ]
  • The computerized Penn Emotion Identification Task (PennCNB) [ Time Frame: Change between baseline and final visit at week 16 ]

Central Contacts and Locations

Central contacts

Locations

Loma Linda U

Recruiting

Loma Linda, California, United States, 92354

Contacts

More Information

Sponsor

Loma Linda University

Last update posted

Feb 4, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Loma Linda University on 2026-02-04.