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

Primary Purpose

Schizophrenia

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Emotion Recognition Training
Active Control Training
Sponsored by
The Royal Ottawa Mental Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

15 Years - 25 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Between (or equal to) 15-25 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:

  • Diagnosis of mental health 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)

Sites / Locations

  • The Royal Ottawa Mental Health CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Emotion Recognition Training

Active Control Training

Arm Description

Outcomes

Primary Outcome Measures

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
Change in brain activity during emotion recognition tasks from baseline
Brain activity as measured using task-based functional magnetic resonance imaging (fMRI).

Secondary Outcome Measures

Full Information

First Posted
December 18, 2020
Last Updated
April 27, 2022
Sponsor
The Royal Ottawa Mental Health Centre
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1. Study Identification

Unique Protocol Identification Number
NCT04681807
Brief Title
Social Cognition in Youth Who Have a First Degree Relative With Schizophrenia
Official Title
Social Cognition in Youth Who Have a First Degree Relative With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 21, 2021 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Royal Ottawa Mental Health Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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 an active control training program on iPad that includes commercial games and control emotional attention bias training.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Emotion Recognition Training
Arm Type
Experimental
Arm Title
Active Control Training
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Emotion Recognition Training
Intervention Description
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) .
Intervention Type
Behavioral
Intervention Name(s)
Active Control Training
Intervention Description
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) .
Primary Outcome Measure Information:
Title
Change in emotion recognition performance from baseline - PENN Emotion Recognition Test
Description
Penn Emotion Recognition test - tests the participant's ability to recognize emotion from facial expressions
Time Frame
baseline and post treatment (1 month)
Title
Change in brain activity during emotion recognition tasks from baseline
Description
Brain activity as measured using task-based functional magnetic resonance imaging (fMRI).
Time Frame
baseline and post treatment (1 month)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Between (or equal to) 15-25 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: Diagnosis of mental health 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Synthia Guimond
Phone
6137226521
Ext
6586
Email
Synthia.Guimond@theroyal.ca
Facility Information:
Facility Name
The Royal Ottawa Mental Health Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Z 7K4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Synthia Guimond, PhD
Phone
6137226521
Ext
6586
Email
Synthia.Guimond@theroyal.ca

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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).

Learn more about this trial

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

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