Clinical trial NCT07005245: Survey on the Reproductive and Child-Rearing Situations of Patients With Severe Mental Disorders
Official title: The Demand for Psychological and Social Services Related to COVID-19 Pandemic in Families of Patients With Severe Mental Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia and Schizoaffective Disorder
Bipolar Disorder (BD)
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2025-06-05
Enrollment: 77145
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Peking University Sixth Hospital, 51 Huayuan North Road, Haidian District, Beijing.

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Participants' fertility data
timeFrame: Baseline
Secondary outcomes:
measure: Somatic/psychiatric morbidity history in participants' offspring
timeFrame: Baseline
Other outcomes:
measure: Participants' demographics, their offspring's education level, and family caregiving situation
timeFrame: Baseline
Locations:
city: Beijing
country: China
facility: Peking University Sixth Hospital
state: Haidian District
Study officials:
References: