Mental Health Support Interventions for Mothers of Infants and Young Children
31 mai 2026 mis à jour par: 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
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
440
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Shanghai, Chine
- 5 Community Health Centers in Pudong District, Shanghai
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Contact:
- Study Team
- Numéro de téléphone: 6505099006
- E-mail: yuyinx@stanford.edu
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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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Aucune intervention: Control
Participants will receive usual care, defined as the routine services currently available through the public health service system.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Depressive symptoms measured by the Patient Health Questionnaire-8 (PHQ-8)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Mental health literacy measured by the Mental Health Literacy Scale, Chinese version (MHLS-C)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 juillet 2026
Achèvement primaire (Estimé)
31 octobre 2027
Achèvement de l'étude (Estimé)
31 octobre 2027
Dates d'inscription aux études
Première soumission
31 mai 2026
Première soumission répondant aux critères de contrôle qualité
31 mai 2026
Première publication (Réel)
4 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
4 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
31 mai 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 83406
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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