Mental Health Support Interventions for Mothers of Infants and Young Children

May 31, 2026 updated by: Yuyin Xiao, Stanford University

Integrating Maternal Mental Health Support Into Child Healthcare System in China: A Randomized Trial

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

440

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • 5 Community Health Centers in Pudong District, Shanghai
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: THEP
Participants attend group-based sessions twice a month.
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 and rewarding daily activities, and strengthening peer support through group discussion, shared experiences, and mutual support among participants.
No Intervention: Control
Participants will receive usual care, defined as the routine services currently available through the public health service system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depressive symptoms measured by the Patient Health Questionnaire-8 (PHQ-8)
Time Frame: 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.
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)
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)
Time Frame: 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.
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)
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)
Time Frame: Baseline, 6 months, 12 months ( 2 months for pilot study)
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)
Time Frame: Baseline, 6 months, 12 months ( 2 months for pilot study)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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)
Stimulative parenting practices measured by the Family Care Indicators (FCI)
Time Frame: Baseline, 6 months, 12 months ( 2 months for pilot study)
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)
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)
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)
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)
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)
Baseline, 6 months, 12 months ( 2 months for pilot study)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

Shanghai Children's Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

October 31, 2027

Study Registration Dates

First Submitted

May 31, 2026

First Submitted That Met QC Criteria

May 31, 2026

First Posted (Actual)

June 4, 2026

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

May 31, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 83406

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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