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NCT Number: NCT07627373

Mental Health Support Interventions for Mothers of Infants and Young Children

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

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Key information

Conditions

Maternal Mental Health Behavior Behavioral Symptoms Depression Depressive Symptoms, Postpartum Early Child Development

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. 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.

  2. Stimulative parenting practices measured by the Family Care Indicators (FCI)

    Time frame: Baseline, 6 months, 12 months ( 2 months for pilot study)

  3. 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)

  4. Parenting self-efficacy measured by the Brief Parenting Self-Efficacy Scale (BPSES)

    Time frame: Baseline, 6 months, 12 months ( 2 months for pilot study)

  5. 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)

  6. 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)

  7. 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)

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Shanghai Children's Medical Center

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 4, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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