Mental Health Support Interventions for Mothers of Infants and Young Children
2026年5月31日 更新者：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
調査の概要
研究の種類
介入
入学 (推定)
440
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Shanghai、中国
- 5 Community Health Centers in Pudong District, Shanghai
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コンタクト：
- Study Team
- 電話番号：6505099006
- メール：yuyinx@stanford.edu
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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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介入なし：Control
Participants will receive usual care, defined as the routine services currently available through the public health service system.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Depressive symptoms measured by the Patient Health Questionnaire-8 (PHQ-8)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Mental health literacy measured by the Mental Health Literacy Scale, Chinese version (MHLS-C)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年7月1日
一次修了 (推定)
2027年10月31日
研究の完了 (推定)
2027年10月31日
試験登録日
最初に提出
2026年5月31日
QC基準を満たした最初の提出物
2026年5月31日
最初の投稿 (実際)
2026年6月4日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月4日
QC基準を満たした最後の更新が送信されました
2026年5月31日
最終確認日
2026年5月1日
詳しくは
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