Maternal Mental HealthNCT07627373
Mental Health Support Interventions for Mothers of Infants and Young Children
A study testing Thinking Healthy Extended Program in people with Maternal Mental Health and Early Child Development, run by Stanford University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Maternal Mental Health, Early Child Development, Depressive Symptoms, Postpartum
- What is being tested?
- Thinking Healthy Extended Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2026to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
5 Community Health Centers in Pudong District, Shanghai
Shanghai
Study Team, 6505099006, yuyinx@stanford.edu
About this study
Official title: 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:
Read more
- 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
- Being tested
- Thinking Healthy Extended Program
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thinking Healthy Extended ProgramBehavioural
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 group | Role | What they receive |
|---|---|---|
| THEP | Experimental | Participants attend group-based sessions twice a month. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
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.
Measured: Baseline, 6 months, 12 months ( 2 months for pilot study)
Stimulative parenting practices measured by the Family Care Indicators (FCI)
Measured: 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)
Measured: Baseline, 6 months, 12 months ( 2 months for pilot study)
Parenting self-efficacy measured by the Brief Parenting Self-Efficacy Scale (BPSES)
Measured: Baseline, 6 months, 12 months ( 2 months for pilot study)
Perceived social support measured by the Multidimensional Scale of Perceived Social Support (MSPSS)
Measured: 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)
Measured: Baseline, 6 months, 12 months ( 2 months for pilot study)
Health-related quality of life measured by the EuroQol 5-Dimension questionnaire (EQ-5D)
Measured: Baseline, 6 months, 12 months ( 2 months for pilot study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal Mental HealthStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Children's Medical Center
- Responsible party
- Principal investigator, Yuyin Xiao, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07627373
- Sponsor's protocol ID
- 83406
- Status last verified
- May 2026
- First submitted
- 31 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Maternal Mental Health Support Into Child Healthcare System in China: A Randomized Trial
- ClinicalTrials.gov ID
- NCT07627373
- Acronym / sponsor ID
- 83406
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Shanghai Children's Medical Center
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| THEP | Experimental | Behavioral: Thinking Healthy Extended ProgramParticipants attend group-based sessions twice a month. |
| Control | No intervention | –Participants will receive usual care, defined as the routine services currently available through the public health service system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thinking Healthy Extended ProgramThe 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. | Behavioural | THEP |
Primary outcome
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.
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.
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.
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.
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.
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.
7 secondary outcomes
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)
Stimulative parenting practices measured by the Family Care Indicators (FCI)
Time frame: 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)
Parenting self-efficacy measured by the Brief Parenting Self-Efficacy Scale (BPSES)
Time frame: 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)
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thinking Healthy Extended Program in people with Maternal Mental Health and Early Child Development, run by Stanford University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.