Health TrialsbyHealthPanel

Mental Health Support Interventions for Mothers of Infants and Young Children

ConditionsMaternal Mental HealthEarly Child DevelopmentDepressive Symptoms, Postpartum
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorStanford University

About this 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

440 Participants
are divided into 2 treatment groups
Group A: THEPExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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)
2

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)
3

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)
4

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)

Secondary outcomes

1

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

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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stanford University

Lead sponsor

Shanghai Children's Medical Center

Collaborator

Source ClinicalTrials.gov

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