Mental Health Support Interventions for Mothers of Infants and Young Children
31 mei 2026 bijgewerkt door: 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
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
440
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Shanghai, China
- 5 Community Health Centers in Pudong District, Shanghai
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Contact:
- Study Team
- Telefoonnummer: 6505099006
- E-mail: yuyinx@stanford.edu
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: THEP
Participants attend group-based sessions twice a month.
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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.
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Geen tussenkomst: Control
Participants will receive usual care, defined as the routine services currently available through the public health service system.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Depressive symptoms measured by the Patient Health Questionnaire-8 (PHQ-8)
Tijdsspanne: Baseline, 6 months, and 12 months (2 months for pilot study)
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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.
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Baseline, 6 months, and 12 months (2 months for pilot study)
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Parenting stress measured by the Parenting Stress Index (PSI)
Tijdsspanne: Baseline, 6 months, and 12 months (2 months for pilot study)
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The PSI assesses stress related to parenting and caregiver-child interactions.
Higher scores indicate greater parenting stress.
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Baseline, 6 months, and 12 months (2 months for pilot study)
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Depressive symptoms measured by the Hamilton Depression Rating Scale (HAMD)
Tijdsspanne: 12 months (2 months for pilot study)
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The Hamilton Depression Rating Scale (HAMD) is a clinician-administered measure of depressive symptoms.
Higher scores indicate more severe depressive symptoms.
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12 months (2 months for pilot study)
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Depressive symptoms measured by the Center for Epidemiological Studies Depression Scale (CES-D)
Tijdsspanne: Baseline, 6 months, 12 months (2 months for pilot study)
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The CES-D is a self-report measure of depressive symptoms.
Higher scores indicate more severe depressive symptoms.
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Baseline, 6 months, 12 months (2 months for pilot study)
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Child social-emotional development measured by the Brief Infant-Toddler Social and Emotional Assessment (BITSEA)
Tijdsspanne: Baseline, 6 months, 12 months ( 2 months for pilot study)
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The BITSEA assesses social-emotional competencies and behavioral problems in young children.
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Baseline, 6 months, 12 months ( 2 months for pilot study)
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Child cognitive development measured by the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III)
Tijdsspanne: Baseline, 6 months, 12 months ( 2 months for pilot study)
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The Bayley-III assesses cognitive, language, and motor development in infants and young children.
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Baseline, 6 months, 12 months ( 2 months for pilot study)
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Mental health literacy measured by the Mental Health Literacy Scale, Chinese version (MHLS-C)
Tijdsspanne: Baseline, 6 months, 12 months ( 2 months for pilot study)
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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.
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Baseline, 6 months, 12 months ( 2 months for pilot study)
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Stimulative parenting practices measured by the Family Care Indicators (FCI)
Tijdsspanne: Baseline, 6 months, 12 months ( 2 months for pilot study)
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Baseline, 6 months, 12 months ( 2 months for pilot study)
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Caregiver-child relationship measured by the Mother's Object Relations Scale-Short Form (MORS-SF)
Tijdsspanne: Baseline, 6 months, 12 months ( 2 months for pilot study)
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Baseline, 6 months, 12 months ( 2 months for pilot study)
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Parenting self-efficacy measured by the Brief Parenting Self-Efficacy Scale (BPSES)
Tijdsspanne: Baseline, 6 months, 12 months ( 2 months for pilot study)
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Baseline, 6 months, 12 months ( 2 months for pilot study)
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Perceived social support measured by the Multidimensional Scale of Perceived Social Support (MSPSS)
Tijdsspanne: Baseline, 6 months, 12 months ( 2 months for pilot study)
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Baseline, 6 months, 12 months ( 2 months for pilot study)
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Anxiety symptoms measured by the Anxiety Subscale of the Depression Anxiety Stress Scales-21 (DASS-A)
Tijdsspanne: Baseline, 6 months, 12 months ( 2 months for pilot study)
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Baseline, 6 months, 12 months ( 2 months for pilot study)
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Health-related quality of life measured by the EuroQol 5-Dimension questionnaire (EQ-5D)
Tijdsspanne: Baseline, 6 months, 12 months ( 2 months for pilot study)
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Baseline, 6 months, 12 months ( 2 months for pilot study)
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 juli 2026
Primaire voltooiing (Geschat)
31 oktober 2027
Studie voltooiing (Geschat)
31 oktober 2027
Studieregistratiedata
Eerst ingediend
31 mei 2026
Eerst ingediend dat voldeed aan de QC-criteria
31 mei 2026
Eerst geplaatst (Werkelijk)
4 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
4 juni 2026
Laatste update ingediend die voldeed aan QC-criteria
31 mei 2026
Laatst geverifieerd
1 mei 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 83406
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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