Mental Health Support Interventions for Mothers of Infants and Young Children

Официальное название

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

Обзор

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

Вмешательства

• Поведенческое 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

Первичные конечные точки

• Depressive symptoms measured by the Patient Health Questionnaire-8 (PHQ-8) [Срок оценки: Baseline, 6 months, and 12 months (2 months for pilot study)]
• Parenting stress measured by the Parenting Stress Index (PSI) [Срок оценки: Baseline, 6 months, and 12 months (2 months for pilot study)]
• Depressive symptoms measured by the Hamilton Depression Rating Scale (HAMD) [Срок оценки: 12 months (2 months for pilot study)]
• Depressive symptoms measured by the Center for Epidemiological Studies Depression Scale (CES-D) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Baseline, 6 months, 12 months ( 2 months for pilot study)]

Вторичные конечные точки (7)

• Mental health literacy measured by the Mental Health Literacy Scale, Chinese version (MHLS-C) [Срок оценки: Baseline, 6 months, 12 months ( 2 months for pilot study)]
• Stimulative parenting practices measured by the Family Care Indicators (FCI) [Срок оценки: 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) [Срок оценки: Baseline, 6 months, 12 months ( 2 months for pilot study)]
• Parenting self-efficacy measured by the Brief Parenting Self-Efficacy Scale (BPSES) [Срок оценки: Baseline, 6 months, 12 months ( 2 months for pilot study)]
• Perceived social support measured by the Multidimensional Scale of Perceived Social Support (MSPSS) [Срок оценки: 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) [Срок оценки: Baseline, 6 months, 12 months ( 2 months for pilot study)]
• Health-related quality of life measured by the EuroQol 5-Dimension questionnaire (EQ-5D) [Срок оценки: Baseline, 6 months, 12 months ( 2 months for pilot study)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• 5 Community Health Centers in Pudong District, Shanghai — Шанхай

Идентификаторы

NCT: NCT07627373 · 83406

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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