Mental Health Support Interventions for Mothers of Infants and Young Children
31. mai 2026 oppdatert av: 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
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
440
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Shanghai, Kina
- 5 Community Health Centers in Pudong District, Shanghai
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Ta kontakt med:
- Study Team
- Telefonnummer: 6505099006
- E-post: yuyinx@stanford.edu
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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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Ingen inngripen: Control
Participants will receive usual care, defined as the routine services currently available through the public health service system.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Depressive symptoms measured by the Patient Health Questionnaire-8 (PHQ-8)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Mental health literacy measured by the Mental Health Literacy Scale, Chinese version (MHLS-C)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Studierekorddatoer
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Studer hoveddatoer
Studiestart (Antatt)
1. juli 2026
Primær fullføring (Antatt)
31. oktober 2027
Studiet fullført (Antatt)
31. oktober 2027
Datoer for studieregistrering
Først innsendt
31. mai 2026
Først innsendt som oppfylte QC-kriteriene
31. mai 2026
Først lagt ut (Faktiske)
4. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
4. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
31. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 83406
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