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Completed

NCT Number: NCT07005245

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

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).

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Key information

Age range

15 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University Sixth Hospital

Beijing, Haidian District, 100083, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • Do not agree to participate in the survey.

Treatment and study plan

Primary outcomes

  1. Participants' fertility data

    Time frame: Baseline

Secondary outcomes

  1. Somatic/psychiatric morbidity history in participants' offspring

    Time frame: Baseline

Other outcomes

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

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Peking University

Other

Registry information

Official study title

The Demand for Psychological and Social Services Related to COVID-19 Pandemic in Families of Patients With Severe Mental Disorders

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 5, 2025
Registry last updated
Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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