Mental Health Support Interventions for Mothers of Infants and Young Children

NCT07627373 | Not Yet Recruiting

• 1 other identifier: 83406
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 1

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

Conditions

Maternal Mental Health; Early Child Development; Depressive Symptoms, Postpartum

Outcome Measures

Primary Outcomes (6)

• 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)

  The Bayley-III assesses cognitive, language, and motor development in infants and young children.

  Baseline, 6 months, 12 months ( 2 months for pilot study)

Secondary Outcomes (7)

• Mental health literacy measured by the Mental Health Literacy Scale, Chinese version (MHLS-C)

  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)

Study Arms (2)

THEP

EXPERIMENTAL

Participants attend group-based sessions twice a month.

Behavioral: Thinking Healthy Extended Program

Control

NO INTERVENTION

Participants will receive usual care, defined as the routine services currently available through the public health service system.

Interventions

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.

THEP

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• Shanghai Children's Medical Center: collaborator

Study Sites (1)

5 Community Health Centers in Pudong District, Shanghai

Shanghai, China

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Scholar

Study Record Dates

• First Submitted: May 31, 2026
• First Posted: June 4, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: June 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)