Neural Basis of Social Cognition Deficits

Part of paid clinical trials in Loma Linda, California.

Sponsor
Loma Linda University
Study ID
NCT05185128
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 18 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Feb 1, 2022
Status verified
Feb 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
90 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

Primary Outcome Measure

The Awareness of Social Inference Test (TASIT) [ Time Frame: Change between baseline and final visit at week 16 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Loma Linda ULoma LindaCalifornia92354
Aarti Nair, Ph.D
909-558-8707

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