Early Identification and Predictive Parsing for High Risk Group of Schizophrenia

Sponsor
Wuhan Mental Health Centre (Other)
Overall Status
Completed
CT.gov ID
NCT05042739
Collaborator
Health Commission of Hubei Province (Other)
189
1
47
4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: CAARMS;SIPS; BSABS;

Study Design

Study Type:
Observational
Actual Enrollment :
189 participants
Observational Model:
Family-Based
Time Perspective:
Prospective
Official Title:
Early Identification and Predictive Parsing for High Risk Group of Schizophr
Actual Study Start Date :
May 1, 2017
Actual Primary Completion Date :
Jan 1, 2019
Actual Study Completion Date :
Apr 1, 2021

Outcome Measures

Primary Outcome Measures

  1. The overall agreement percent [2 years]

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

  2. the inter-rater reliability [2 years]

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

  3. the transition rates of UHR+ to psychosis within 2 years [2 years]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • all are immediate family and three-generation blood kinship of patients with schizophrenia
Exclusion Criteria:

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dept. of Psychological Rehabilitation, Affiliated Wuhan Mental Health Center, Tongji Medical College of Huazhong University of Science & Technology Wuhan Hubei China 430022

Sponsors and Collaborators

  • Wuhan Mental Health Centre
  • Health Commission of Hubei Province

Investigators

  • Principal Investigator: Peng Wang, Master, Dept. of Psychological Rehabilitation, Affiliated Wuhan Mental Health Center, Tongji Medical College of Huazhong University of Science & Technology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Wuhan Mental Health Centre
ClinicalTrials.gov Identifier:
NCT05042739
Other Study ID Numbers:
  • ky2018.45
First Posted:
Sep 13, 2021
Last Update Posted:
Sep 13, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Wuhan Mental Health Centre
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 13, 2021