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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-21

Study Completion Date

2025-08-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Social Cognition Training in Schizophrenia

NCT01206842

Schizophrenia Social Cognition

COMPLETED NA

Efficacy of Social Cognition Training in Schizophrenia

NCT00587561

Schizophrenia

COMPLETED NA

A Trial of Cognitive Training in Schizophrenia

NCT02478827

Schizophrenia

COMPLETED NA

An Evaluation of a Psychoeducation Program in Individuals Diagnosed With Schizophrenia

NCT03865186

Schizophrenia

COMPLETED NA

A Study of a Remediation Program of Social Cognition in Schizophrenia

NCT01077791

Schizophrenia

TERMINATED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Schizophrenia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Emotion Recognition Training

Group Type EXPERIMENTAL

Emotion Recognition Training

Intervention Type 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) .

Control Training

Control

Group Type OTHER

Control Training

Intervention Type 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) .

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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) .

Intervention Type 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) .

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

15 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes