Early Identification and Predictive Parsing for High Risk Group of Schizophrenia

NCT05042739 | Completed DMC

• 1 other identifier: ky2018.45
• Study Type: observational
• Target: 189
• Locations: 1 country
• Sites: 1

Brief Summary

An accurate identification of individuals at ultra-high risk (UHR) based on psychometric tools to prospectively identify psychosis as early as possible is required for indicated preventive intervention. The diagnostic comparability of several psychometric tools is unknown. To address the psychometric comparability of the CAARMS, SIPS and BSABS for subjects who are the immediate family and three-generation blood kinship of patients with schizophrenia. To verify the viability and reliability of the three instruments for these subjects. subjects who all are immediate family and three-generation blood kinship of patients with schizophreniawere interviewed. All the subjects were assessed for a UHR state by three psychometric tools including CAARMS, SIPS and BSABS. The psychometric diagnosis results including at risk of psychosis (UHR+), not at risk of psychosis (UHR-), and Psychosis. Demographic and clinical characteristics interviewed by these three instruments were also measured. The inter-rater agreement was assessed for evaluation of the coherence of the three scales. Transition rates of CAARMS, SIPS and BSABS for UCH+ subjects within 2 years were also recorded.There is good diagnostic agreement between the CAARMS, SIPS and BSABS towards identification of UHR subjects who are immediate family and three-generation blood kinship of patients with schizophrenia. Also, these three instruments are reliable and valid for assessing and detecting at risk mental states in these subjects.

Conditions

High Risk Group of Schizophrenia

Keywords

Psychosis; UHR; CAARMS;SIPS; BSABS

Outcome Measures

Primary Outcomes (3)

• The overall agreement percent

  diagnostic comparison of CAARMS and SIPS, SIPS and BSABS, CAARMS and BSABS.

  2 years

• the inter-rater reliability

  Inter-rater correlation (ICC) coefficients of CAARMS, SIPS and BSABS subscales.

  2 years

• the transition rates of UHR+ to psychosis within 2 years

  Transition rates of CAARMS, SIPS and BSABS for UCH+ subjects within 2 years follow-up.

  2 years

Interventions

CAARMS;SIPS; BSABS; DIAGNOSTIC_TEST

Comprehensive Assessment of At Risk Mental State (CAARMS); Structured Interview for Psychosis-Risk Syndrome (SIPS); Bonn Scale for the Assessment of Basic Symptoms (BSABS);

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All are immediate family and three-generation blood kinship of patients with schizophrenia diagnosed in Affiliated Wuhan Mental Health Center, Tongji Medical College of Huazhong University of Science \& Technology. Subjects are recruited from Wuhan Mental Health Center who can be contacted by telephone or an internet homepage.

You may qualify if:

• all are immediate family and three-generation blood kinship of patients with schizophrenia

Sponsors & Collaborators

• Wuhan Mental Health Centre: lead
• Health Commission of Hubei Province: collaborator

Study Sites (1)

Dept. of Psychological Rehabilitation, Affiliated Wuhan Mental Health Center, Tongji Medical College of Huazhong University of Science & Technology

Wuhan, Hubei, 430022, China

Location

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Peng Wang, Master

  Dept. of Psychological Rehabilitation, Affiliated Wuhan Mental Health Center, Tongji Medical College of Huazhong University of Science & Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: September 13, 2021
• Study Start: May 1, 2017
• Primary Completion: January 1, 2019
• Study Completion: April 1, 2021
• Last Updated: September 13, 2021

Record last verified: 2021-08

Locations

CN (1)