Mental Health Support Interventions for Mothers of Infants and Young Children
2026년 5월 31일 업데이트: 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
연구 개요
연구 유형
중재적
등록 (추정된)
440
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
-
Shanghai, 중국
- 5 Community Health Centers in Pudong District, Shanghai
-
연락하다:
- Study Team
- 전화번호: 6505099006
- 이메일: yuyinx@stanford.edu
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: THEP
Participants attend group-based sessions twice a month.
|
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.
|
|
간섭 없음: Control
Participants will receive usual care, defined as the routine services currently available through the public health service system.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Depressive symptoms measured by the Patient Health Questionnaire-8 (PHQ-8)
기간: 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.
|
Baseline, 6 months, and 12 months (2 months for pilot study)
|
|
Parenting stress measured by the Parenting Stress Index (PSI)
기간: 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.
|
Baseline, 6 months, and 12 months (2 months for pilot study)
|
|
Depressive symptoms measured by the Hamilton Depression Rating Scale (HAMD)
기간: 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.
|
12 months (2 months for pilot study)
|
|
Depressive symptoms measured by the Center for Epidemiological Studies Depression Scale (CES-D)
기간: 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.
|
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)
기간: Baseline, 6 months, 12 months ( 2 months for pilot study)
|
The BITSEA assesses social-emotional competencies and behavioral problems in young children.
|
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)
기간: Baseline, 6 months, 12 months ( 2 months for pilot study)
|
The Bayley-III assesses cognitive, language, and motor development in infants and young children.
|
Baseline, 6 months, 12 months ( 2 months for pilot study)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Mental health literacy measured by the Mental Health Literacy Scale, Chinese version (MHLS-C)
기간: Baseline, 6 months, 12 months ( 2 months for pilot study)
|
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.
|
Baseline, 6 months, 12 months ( 2 months for pilot study)
|
|
Stimulative parenting practices measured by the Family Care Indicators (FCI)
기간: Baseline, 6 months, 12 months ( 2 months for pilot study)
|
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)
기간: Baseline, 6 months, 12 months ( 2 months for pilot study)
|
Baseline, 6 months, 12 months ( 2 months for pilot study)
|
|
|
Parenting self-efficacy measured by the Brief Parenting Self-Efficacy Scale (BPSES)
기간: Baseline, 6 months, 12 months ( 2 months for pilot study)
|
Baseline, 6 months, 12 months ( 2 months for pilot study)
|
|
|
Perceived social support measured by the Multidimensional Scale of Perceived Social Support (MSPSS)
기간: Baseline, 6 months, 12 months ( 2 months for pilot study)
|
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)
기간: Baseline, 6 months, 12 months ( 2 months for pilot study)
|
Baseline, 6 months, 12 months ( 2 months for pilot study)
|
|
|
Health-related quality of life measured by the EuroQol 5-Dimension questionnaire (EQ-5D)
기간: Baseline, 6 months, 12 months ( 2 months for pilot study)
|
Baseline, 6 months, 12 months ( 2 months for pilot study)
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 7월 1일
기본 완료 (추정된)
2027년 10월 31일
연구 완료 (추정된)
2027년 10월 31일
연구 등록 날짜
최초 제출
2026년 5월 31일
QC 기준을 충족하는 최초 제출
2026년 5월 31일
처음 게시됨 (실제)
2026년 6월 4일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 4일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 31일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .