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Mental Health Support Interventions for Mothers of Infants and Young Children

31 de mayo de 2026 actualizado por: Yuyin Xiao, Stanford University

Integrating Maternal Mental Health Support Into Child Healthcare System in China: A Randomized Trial

The goal of this clinical trial is to learn whether a maternal mental health support program can improve maternal mental health and child development when delivered through routine child healthcare services in community health centers in China. The study will also examine how the program works and whether it can be successfully integrated into the child healthcare system.

The main questions it aims to answer are:

  • Does the maternal mental health support program improve maternal mental health and well-being?
  • Does the program improve child development outcomes?
  • Through what pathways does the program influence maternal mental health and child development?
  • Can the program be successfully integrated and delivered within the child healthcare system?

Researchers will compare the maternal mental health support program with usual child healthcare services.

Participants will:

  • Receive either the maternal mental health support program or usual child healthcare services
  • Attend program sessions delivered in community health centers
  • Complete questionnaires and assessments related to maternal well-being, parenting, and child development
  • Participate in follow-up assessments during the study period

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

440

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Porcelana
      • Shanghai, Porcelana
        • 5 Community Health Centers in Pudong District, Shanghai
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • Mothers aged 18 years or older with an infant aged 0 to 12 months
  • Living in or near the study area and planning to remain in the area for the next 12 months
  • Screen positive for mild to moderate depressive symptoms based on the study screening assessment
  • Able and willing to provide informed consent

Exclusion Criteria:

  • Mothers or infants with serious medical conditions that would prevent participation in the study
  • Mothers or infants with severe congenital disorders, infectious diseases, genetic or metabolic disorders, or severe disabilities

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: THEP
Participants attend group-based sessions twice a month.
Conductual: Thinking Healthy Extended Program
The Thinking Healthy Extended Programme (THEP) is a group-based psychosocial intervention developed for caregivers of children aged 0-3 years in China. Building on the core principles of the World Health Organization's Thinking Healthy Programme (THP), THEP adapts simplified cognitive behavioral therapy strategies to support caregiver mental health and parenting well-being. THEP aims to improve mental health through three core mechanisms: promoting healthy thinking patterns, encouraging positive and rewarding daily activities, and strengthening peer support through group discussion, shared experiences, and mutual support among participants.
Sin intervención: Control
Participants will receive usual care, defined as the routine services currently available through the public health service system.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Depressive symptoms measured by the Patient Health Questionnaire-8 (PHQ-8)
Periodo de tiempo: Baseline, 6 months, and 12 months (2 months for pilot study)
The PHQ-8 is an 8-item self-report measure of depressive symptoms. Scores range from 0 to 24, with higher scores indicating more severe depressive symptoms.
Baseline, 6 months, and 12 months (2 months for pilot study)
Parenting stress measured by the Parenting Stress Index (PSI)
Periodo de tiempo: Baseline, 6 months, and 12 months (2 months for pilot study)
The PSI assesses stress related to parenting and caregiver-child interactions. Higher scores indicate greater parenting stress.
Baseline, 6 months, and 12 months (2 months for pilot study)
Depressive symptoms measured by the Hamilton Depression Rating Scale (HAMD)
Periodo de tiempo: 12 months (2 months for pilot study)
The Hamilton Depression Rating Scale (HAMD) is a clinician-administered measure of depressive symptoms. Higher scores indicate more severe depressive symptoms.
12 months (2 months for pilot study)
Depressive symptoms measured by the Center for Epidemiological Studies Depression Scale (CES-D)
Periodo de tiempo: Baseline, 6 months, 12 months (2 months for pilot study)
The CES-D is a self-report measure of depressive symptoms. Higher scores indicate more severe depressive symptoms.
Baseline, 6 months, 12 months (2 months for pilot study)
Child social-emotional development measured by the Brief Infant-Toddler Social and Emotional Assessment (BITSEA)
Periodo de tiempo: Baseline, 6 months, 12 months ( 2 months for pilot study)
The BITSEA assesses social-emotional competencies and behavioral problems in young children.
Baseline, 6 months, 12 months ( 2 months for pilot study)
Child cognitive development measured by the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III)
Periodo de tiempo: Baseline, 6 months, 12 months ( 2 months for pilot study)
The Bayley-III assesses cognitive, language, and motor development in infants and young children.
Baseline, 6 months, 12 months ( 2 months for pilot study)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Mental health literacy measured by the Mental Health Literacy Scale, Chinese version (MHLS-C)
Periodo de tiempo: Baseline, 6 months, 12 months ( 2 months for pilot study)
The Mental Health Literacy Scale, Chinese version (MHLS-C), is a self-report measure assessing knowledge and understanding of mental health conditions, their recognition, management, and help-seeking. Higher scores indicate greater mental health literacy.
Baseline, 6 months, 12 months ( 2 months for pilot study)
Stimulative parenting practices measured by the Family Care Indicators (FCI)
Periodo de tiempo: Baseline, 6 months, 12 months ( 2 months for pilot study)
Baseline, 6 months, 12 months ( 2 months for pilot study)
Caregiver-child relationship measured by the Mother's Object Relations Scale-Short Form (MORS-SF)
Periodo de tiempo: Baseline, 6 months, 12 months ( 2 months for pilot study)
Baseline, 6 months, 12 months ( 2 months for pilot study)
Parenting self-efficacy measured by the Brief Parenting Self-Efficacy Scale (BPSES)
Periodo de tiempo: Baseline, 6 months, 12 months ( 2 months for pilot study)
Baseline, 6 months, 12 months ( 2 months for pilot study)
Perceived social support measured by the Multidimensional Scale of Perceived Social Support (MSPSS)
Periodo de tiempo: Baseline, 6 months, 12 months ( 2 months for pilot study)
Baseline, 6 months, 12 months ( 2 months for pilot study)
Anxiety symptoms measured by the Anxiety Subscale of the Depression Anxiety Stress Scales-21 (DASS-A)
Periodo de tiempo: Baseline, 6 months, 12 months ( 2 months for pilot study)
Baseline, 6 months, 12 months ( 2 months for pilot study)
Health-related quality of life measured by the EuroQol 5-Dimension questionnaire (EQ-5D)
Periodo de tiempo: Baseline, 6 months, 12 months ( 2 months for pilot study)
Baseline, 6 months, 12 months ( 2 months for pilot study)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Stanford University

Colaboradores

Shanghai Children's Medical Center

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de julio de 2026

Finalización primaria (Estimado)

31 de octubre de 2027

Finalización del estudio (Estimado)

31 de octubre de 2027

Fechas de registro del estudio

Enviado por primera vez

31 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

31 de mayo de 2026

Publicado por primera vez (Actual)

4 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

4 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

31 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 83406

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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