Mental Health Support Interventions for Mothers of Infants and Young Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Thinking Healthy Extended Program.
- Who it may be relevant to
- Registry conditions: Maternal Mental Health, Early Child Development, Depressive Symptoms, Postpartum. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Integrating Maternal Mental Health Support Into Child Healthcare System in China: A Randomized Trial
Overview
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
- Behavioral 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
Primary outcome measures
- Depressive symptoms measured by the Patient Health Questionnaire-8 (PHQ-8) [Time frame: Baseline, 6 months, and 12 months (2 months for pilot study)]
- Parenting stress measured by the Parenting Stress Index (PSI) [Time frame: Baseline, 6 months, and 12 months (2 months for pilot study)]
- Depressive symptoms measured by the Hamilton Depression Rating Scale (HAMD) [Time frame: 12 months (2 months for pilot study)]
- Depressive symptoms measured by the Center for Epidemiological Studies Depression Scale (CES-D) [Time frame: 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) [Time frame: 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) [Time frame: Baseline, 6 months, 12 months ( 2 months for pilot study)]
Secondary outcome measures (7)
- Mental health literacy measured by the Mental Health Literacy Scale, Chinese version (MHLS-C) [Time frame: Baseline, 6 months, 12 months ( 2 months for pilot study)]
- Stimulative parenting practices measured by the Family Care Indicators (FCI) [Time frame: 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) [Time frame: Baseline, 6 months, 12 months ( 2 months for pilot study)]
- Parenting self-efficacy measured by the Brief Parenting Self-Efficacy Scale (BPSES) [Time frame: Baseline, 6 months, 12 months ( 2 months for pilot study)]
- Perceived social support measured by the Multidimensional Scale of Perceived Social Support (MSPSS) [Time frame: 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) [Time frame: Baseline, 6 months, 12 months ( 2 months for pilot study)]
- Health-related quality of life measured by the EuroQol 5-Dimension questionnaire (EQ-5D) [Time frame: Baseline, 6 months, 12 months ( 2 months for pilot study)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- 5 Community Health Centers in Pudong District, Shanghai — Shanghai
Identifiers
NCT: NCT07627373 · 83406