Depressive Symptoms, Postpartum, Early Child Development, Maternal Mental Health
Conditions
Brief summary
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
Interventions
BEHAVIORALThinking 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.
Sponsors
Stanford University
Shanghai Children's Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depressive symptoms measured by the Patient Health Questionnaire-8 (PHQ-8) | 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. |
| Parenting stress measured by the Parenting Stress Index (PSI) | 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. |
| Depressive symptoms measured by the Hamilton Depression Rating Scale (HAMD) | 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. |
| Depressive symptoms measured by the Center for Epidemiological Studies Depression Scale (CES-D) | 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. |
| Child social-emotional development measured by the Brief Infant-Toddler Social and Emotional Assessment (BITSEA) | Baseline, 6 months, 12 months ( 2 months for pilot study) | The BITSEA assesses social-emotional competencies and behavioral problems in young children. |
| Child cognitive development measured by the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III) | Baseline, 6 months, 12 months ( 2 months for pilot study) | The Bayley-III assesses cognitive, language, and motor development in infants and young children. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mental health literacy measured by the Mental Health Literacy Scale, Chinese version (MHLS-C) | 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. |
| Stimulative parenting practices measured by the Family Care Indicators (FCI) | 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) | Baseline, 6 months, 12 months ( 2 months for pilot study) | — |
| Parenting self-efficacy measured by the Brief Parenting Self-Efficacy Scale (BPSES) | Baseline, 6 months, 12 months ( 2 months for pilot study) | — |
| Perceived social support measured by the Multidimensional Scale of Perceived Social Support (MSPSS) | 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) | Baseline, 6 months, 12 months ( 2 months for pilot study) | — |
| Health-related quality of life measured by the EuroQol 5-Dimension questionnaire (EQ-5D) | Baseline, 6 months, 12 months ( 2 months for pilot study) | — |
Countries
China
Outcome results
None listed