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| Name | Class |
|---|---|
| Shanghai Children's Medical Center | OTHER |
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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:
Researchers will compare the maternal mental health support program with usual child healthcare services.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| THEP | Experimental | Participants attend group-based sessions twice a month. |
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| Control | No Intervention | Participants will receive usual care, defined as the routine services currently available through the public health service system. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thinking Healthy Extended Program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Depressive symptoms measured by the Patient Health Questionnaire-8 (PHQ-8) | 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) | 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) | 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) | 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) | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Mental health literacy measured by the Mental Health Literacy Scale, Chinese version (MHLS-C) | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 5 Community Health Centers in Pudong District, Shanghai | Shanghai | China |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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The Bayley-III assesses cognitive, language, and motor development in infants and young children.
| Baseline, 6 months, 12 months ( 2 months for pilot study) |
| 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) |