Social Cognition in Youth Who Have a First Degree Relative With Schizophrenia

Social cognition is an individual's ability to perceive, process, understand, and react to other individuals in a social situation. Social cognition is impaired in individuals with schizophrenia, including difficulty recognizing others' emotions. A promising treatment avenue for emotion recognition problems in individuals with schizophrenia is continued practice with various facial expression recognition training programs. First degree relatives of someone with schizophrenia are considered at familial high risk (FHR) for the illness, because of its high level of heritability. It is therefore critical to explore if these emotion recognition training programs could also benefit people at FHR. In this current study, the investigators aim to explore the social-cognitive profiles and their neural correlates in FHR individuals. The investigators also aim to explore the potential efficacy of an emotion recognition intervention to improve this ability in FHR individuals.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Behavioral: Emotion Recognition Training; Behavioral: Control Training

Detailed Description

All participants will complete a battery of social cognitive tests as well as an fMRI scan to explore the neuronal correlates underlying lower social cognitive functioning observed in FHR individuals. FHR youth will be randomized into either a 4-session emotion recognition training exercise program on iPad or a control training program on iPad that includes commercial games and control emotional attention bias training.

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1Z 7K4
      • The Royal Ottawa Mental Health Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Between (or equal to) 15-35 years of age
• Ability to read/speak fluent English
• Diagnosis of SZ, schizoaffective disorder or schizophreniform confirmed for 1st degree relative by referring psychiatrist or two reliable informants (using the adapted FIGS questionnaire).

Exclusion Criteria:

• No diagnosis of psychosis related disorder
• Significant neurological or medical disorders that may produce cognitive impairment
• Current epilepsy or previous history of seizures
• Previous head injury with current continuing symptoms (i.e., cognitive ability, dizziness, etc.)
• Recent history of substance abuse or dependence (within past 3 months)
• MRI contraindication (e.g. metallic head implant, history of seizure, pacemaker, pregnancy, etc.)
• Current IQ < 70 as measured by the Wechsler Abbreviated Scale of Intelligence Scale (WASI)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Emotion Recognition Training	Behavioral: Emotion Recognition Training; Participants will undergo 2 fMRI scans, one before and one after the training sessions. There will be 4 visits consisting of an emotion recognition training exercise on iPad, lasting for a period of ~1 hour each. (More details about each condition will be added after study completion to protect the blinding of participants) .
Other: Control Training; Control	Behavioral: Control Training; Participants will undergo 2 fMRI scans, one before and one after the training sessions. There will be 4 visits consisting of a control training exercise on iPad, lasting for a period of ~1 hour each. (More details about each condition will be added after study completion to protect the blinding of participants) .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in emotion recognition performance from baseline - PENN Emotion Recognition Test	Penn Emotion Recognition test - tests the participant's ability to recognize emotion from facial expressions	baseline and post treatment (1 month)
Change in brain activity during emotion recognition tasks from baseline	Brain activity as measured using task-based functional magnetic resonance imaging (fMRI).	baseline and post treatment (1 month)

Collaborators and Investigators

• Sponsor: The Royal Ottawa Mental Health Centre

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2021
• Primary Completion (Actual): August 22, 2025
• Study Completion (Actual): August 22, 2025

Study Registration Dates

• First Submitted: December 18, 2020
• First Submitted That Met QC Criteria: December 18, 2020
• First Posted (Actual): December 23, 2020

Study Record Updates

• Last Update Posted (Estimated): January 2, 2026
• Last Update Submitted That Met QC Criteria: December 29, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Schizophrenia
• Other Study ID Numbers: 2019033

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data collected from this study may be shared with other researchers at the Royal's Institute of Mental Health Research for analyses and re-analyses. Variables of the study and scripts used for analyses will be made available to the public. De-identified data will also be shared with the general public upon request. Data that can connect with participants' identity will NOT be used or shared for analyses.
• IPD Sharing Time Frame: De-identified data will become available upon completion of the study and once results have been published in an academic journal (anticipated time frame: the year of 2026).
• IPD Sharing Supporting Information Type: SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No