Survey on the Reproductive and Child-Rearing Situations of Patients With Severe Mental Disorders

NCT07005245 | Completed

• 1 other identifier: 2021-1-13-7
• Study Type: observational
• Target: 77,145
• Locations: 1 country
• Sites: 1

Brief Summary

Severe mental disorders represent a major public health concern, imposing substantial disease burden and adversely affecting multiple dimensions of patients' lives, while also creating intergenerational impacts on their offspring and families. Existing evidence suggests that children of affected patients demonstrate elevated vulnerability to various physical and psychological challenges during developmental stages. Currently, China lacks systematic data regarding reproductive patterns and child-rearing practices among patients with severe mental disorders. To address this knowledge gap, investigators are conducting a multicenter epidemiological survey across ten representative cities and regions nationwide. This study aims to comprehensively examine the reproductive history, child-rearing circumstances, and family socioeconomic status of this population. The findings will establish a crucial foundation for subsequent analytical epidemiological investigations and intervention studies, while informing evidence-based mental health policy formulation. The study population consists of registered patients (aged 18-59 years) in the national severe mental disorder management system who meet diagnostic criteria for: schizophrenia, bipolar disorder, paranoid personality disorder, schizoaffective disorder, epilepsy-induced mental disorders, or intellectual disability-associated mental disorders. Eligible participants must have documented childbirth history (including miscarriage, preterm, and term deliveries).

Conditions

Schizophrenia and Schizoaffective Disorder; Bipolar Disorder (BD)

Outcome Measures

Primary Outcomes (1)

• Participants' fertility data

  Baseline

Secondary Outcomes (1)

• Somatic/psychiatric morbidity history in participants' offspring

  Baseline

Other Outcomes (1)

• Participants' demographics, their offspring's education level, and family caregiving situation

  Baseline

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Peking University Sixth Hospital, 51 Huayuan North Road, Haidian District, Beijing.

You may qualify if:

• Patients who meet the diagnostic criteria for schizophrenia, bipolar disorder, paranoid personality disorder, schizoaffective disorder, mental disorders caused by epilepsy, or mental disorders associated with intellectual disabilities, and are registered in the management system for severe mental disorders
• Aged 18-60 years
• Patients who had a history of childbirth (childbirth history includes miscarriage, preterm birth, and full-term birth).

You may not qualify if:

• Do not agree to participate in the survey.

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Peking University Sixth Hospital

Beijing, Haidian District, 100083, China

Location

Related Publications (1)

• Sheng Z, Zhou T, Du C, Wu T, Wen L, Yang X, Chen W, Ma X, Deng H, Ge L, Zhang C, Hong X, He R, Du X, Zhu L, Xiang H, Chen S, Liu J, Ding Y, Liang G, Pan Y, Ji S, Chang Z, Yuan N, Chen W, Lv X, Ma H, Guan L, Yu X. Sex-differences in the intergenerational transmission of mental disorders among schizophrenia probands: familial risk and protective factors in a population-based study. Lancet Reg Health West Pac. 2025 Nov 20;65:101750. doi: 10.1016/j.lanwpc.2025.101750. eCollection 2025 Dec.

  PMID: 41362421 DERIVED

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Bipolar Disorder

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: June 5, 2025
• Study Start: June 7, 2021
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: June 5, 2025

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)