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

NCT04681807 | Completed

• 1 other identifier: 2019033
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (2)

Emotion Recognition Training

EXPERIMENTAL

Behavioral: Emotion Recognition Training

Control Training

OTHER

Control

Behavioral: Control Training

Interventions

Emotion Recognition Training BEHAVIORAL

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) .

Emotion Recognition Training

Control Training BEHAVIORAL

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) .

Control Training

Eligibility Criteria

• Age: 15 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Royal Ottawa Mental Health Centre: lead

Study Sites (1)

The Royal Ottawa Mental Health Centre

Ottawa, Ontario, K1Z 7K4, Canada

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, treatment administrators will not be able to remain blind to group assignment; however, assessment staff, investigators, and participants will be blind to group assignment. Assessment staff and investigators will never be involved in the randomization or treatment procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients will be randomized to either 7 visits over a period of 1 month of an emotion recognition training condition or 7 visits over a period of one month of active control training condition.

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: December 23, 2020
• Study Start: July 21, 2021
• Primary Completion: August 22, 2025
• Study Completion: August 22, 2025
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE
• 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).

Locations

CA (1)