Mental Health Support Interventions for Mothers of Infants and Young Children

N/ANot Yet RecruitingNCT07627373

Stanford University440 enrolled

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

440

Conditions

Maternal Mental Health Early Child Development

Interventions

Thinking Healthy Extended ProgramBEHAVIORAL

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

5 Community Health Centers in Pudong District, Shanghai

Shanghai, China

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

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)

The BITSEA assesses social-emotional competencies and behavioral problems in young children.