Mental Health Support Interventions for Mothers of Infants and Young Children

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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

Eligibility

Primary outcome measure(s)

• Depressive symptoms measured by the Patient Health Questionnaire-8 (PHQ-8) — 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.
• Parenting stress measured by the Parenting Stress Index (PSI) — 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.
• Depressive symptoms measured by the Hamilton Depression Rating Scale (HAMD) — 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.
• Depressive symptoms measured by the Center for Epidemiological Studies Depression Scale (CES-D) — 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.
• Child social-emotional development measured by the Brief Infant-Toddler Social and Emotional Assessment (BITSEA) — Baseline, 6 months, 12 months ( 2 months for pilot study)
  The BITSEA assesses social-emotional competencies and behavioral problems in young children.
• Child cognitive development measured by the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III) — Baseline, 6 months, 12 months ( 2 months for pilot study)
  The Bayley-III assesses cognitive, language, and motor development in infants and young children.

Trial sites (1)

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