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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04681807
Enrollment
82
Registered
2020-12-23
Start date
2021-07-21
Completion date
2025-08-22
Last updated
2026-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

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

Interventions

BEHAVIORALEmotion 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) .

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) .

Sponsors

The Royal Ottawa Mental Health Centre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes 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.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
15 Years to 35 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026