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| ID | Type | Description | Link |
|---|---|---|---|
| 20-389 | Other Grant/Funding Number | China Medical Board | |
| 2022B1515020094 | Other Grant/Funding Number | Guangdong Outstanding Youth Fund |
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The goal of this clinical trial is to learn if the adapted mhGAP intervention guide (mhGAP-IG) can improve quality of child mental and behavioral disorders (CMBDs) services in China. It will also learn about the implementation of the mhGAP-IG delivered by kindergarten teachers. The main questions it aims to answer are:
Researchers will compare the adapted mhGAP-IG to child healthcare as usual to see if the adapted mhGAP-IG can improve quality of child mental and behavioral disorders services in China.
Participants (kindergarten teachers) will:
Participants (children/caregivers) will:
Background: Globally, child mental and behavioral disorders (CMBDs) have a high disease burden. The quality of CMBDs services in China, and in many low- and middle-income countries (LMICs), is limited due to the shortage of mental health providers trained to deliver evidence-based clinical care for this population. The WHO Mental Health Gap Action Program Intervention Guide (mhGAP-IG)is an evidence-based training for non-specialist mental health providers in LMICs.
Overall goal: Using a hybrid Type I trial design, To evaluate the effectiveness and implementation of the adapted mhGAP-IG at kindergartens in Guangdong province, China.
Methods: The effectiveness and implementation of the adapted mhGAP-IG will be tested in a stepped-wedge cluster randomized controlled trial. The trail will recruit 20 kindergartens and 375 children in Zhongshan City. Kindergartens will be randomly and subsequently enrolled at regular intervals (steps). At each step, kindergarten teachers will receive the mhGAP-IG training and then cross over from the control condition (providing child mental and behavioral disorders services as usual) to the intervention condition (providing child mental and behavioral disorders services under the adapted mhGAP-IG).
Outcome measures:Symptom severity of CMBDs measured by the Strengths and Difficulties Questionnaire is set as the primary outcome. Implementation measurements will cover the five domains of the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework.
Implications: This project will provide additional evidence of the effectiveness of the mhGAP-IG in improving quality of CMBDs services. The lessons learned from this project can aid in scaling the training to other regions of China and LMICs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the adapted mhGAP-IG | Experimental | mhGAP-IG-based CMBDs mental health services (including screening, management and follow-up) delivered by trained kindergarten teachers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mental health gap action program intervention guide (mhGAP-IG) | Behavioral | The mhGAP-IG is an evidence-based intervention developed by WHO. It was designed for non-specialists to scale up high quality mental health services. Although more than 90 countries worldwide have implemented mhGAP-IG, this study is the first to evaluated if it works for scaling up CMBDs services in China. Investigators have cultrually adapted the mhGAP-IG according Chinese context. |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom severity of CMBDs assessed by Strengths and Difficulties Questionnaire (SDQ) | A total score ranges from 0 (lowest distress) to 60 (highest distress) and higher scores of SDQ indicate the worse symptom. | baseline and 3-, 6- and 12- months of intervention |
| Developmental domain scores measured by Ages and Stages Questionnaire (ASQ) | Developmental domain scores derived from ASQ. The ASQ consists of a series of questionnaires specifically designed for children at different months of age. The total score range varies depending on the questionnaire for each age group, but higher scores consistently indicate better development within a particular domain. | baseline and 3-, 6- and 12- months of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Caregivers' psychological distress assessed by the Parenting Stress Index-Short Form (PSI-SF) | A total score ranges from 7 (lowest distress) to 28 (highest distress). | baseline and 3-, 6- and 12- months of intervention |
| Mental health action competence among kindergarten teachers measured by the Chinese version of Mental Health Action Competence (MHAC) Scale. |
| Measure | Description | Time Frame |
|---|---|---|
| Adoption and maintainance of the intervention measured by the proportion of targeted teahcers who attended the mhGAP trainings, the screenings rate in each class/kindergarten, the referal rate and follow-up rate in each kindergarten. | One teacher in each class will be recruited, so that the number of targeted teacher equals to the number of classes in a kindergarten. The screening rate in class will be calculated as the number of children screened in a class divided by the total number of children in the class. The screening rate in class will be calculated as the number of children screened in a kindergarten divided by the total number of children in the kindergarten. The referal rate equals to the number of children be refered divided by the number of children screened positive. The follow-up rate equals to the number of children be followed divided by the number of children screened positive. |
Eligibility criteria for children/caregivers
Inclusion Criteria:
Exclusion Criteria:
Eligibility criteria for kindergarten teachers
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wen Chen, Professor | Contact | +86 13580520052 | chenw43@mail.sysu.edu.cn | |
| Meng Zheng | Contact | +86 18089525995 | zhengm29@mail2.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Wen Chen, PhD | Medical statistics, School of public health, Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Zhengfa Kindergarten | Recruiting | Zhongshan | Guangdong | 528403 | China |
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This study use a stepped wedge design. Participants in the same kindergarten are defined as a cluster. The study includes four sequence, each sequence includes five clusters. Each Sequeces will transform into mhGAP-IG intervention as predominated order. Thus the study includes 20 clusters totally.
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A total score ranges from 4 (lowest self-reported competence) to 64 (highest lowest self-reported competence). |
| baseline and 3-, 6-, 9-, and 12- months of intervention |
| Kownledge level on providing CMBDs services among kindergarten teachers measured by the knowledge questionnaire form the mhGAP-IG | The questionnaire consists of a series of multiple-choice questions regarding the assessment, management, and follow-up of CMBD. Each correct answer is awarded one point, while incorrect answers receive no points. A higher total score indicates a greater level of knowledge. | baseline and 3-, 6-, 9-, and 12- months of intervention |
| Efficacy score among kindergarten teachers measured by the Chinese short form Teacher Efficacy Scale (TSE). | The TSE consists of measures for efficacy for instructional strategies, for classroom management, and for student engagement. Both total score or subscale score can derived from TSE, and higher score indicates a greater level of efficacy. | baseline and 3-, 6-, 9- and 12- months of intervention |
| baseline, 3-, 6-, 9-, 12-months of intervention. |
| Number of children who are referred to hospital and diagnosed with CMBDs | The diagnosis will be made by clinical professionals in CMBDs | From enrollment to 12 months of intervention |
| Zhongshan Xiaolan Huasheng Kindergarten | Recruiting | Zhongshan | Guangdong | 528415 | China |
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| Zhongshan Dongfeng Deshan Kindergarten | Recruiting | Zhongshan | Guangdong | 528425 | China |
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| Zhongshan Huangpu Boya Oriental Pearl Kindergarten | Recruiting | Zhongshan | Guangdong | 528429 | China |
|
| First Kindergarten in Zhongshan Torch High-Tech Industrial Development Zone | Active, not recruiting | Zhongshan | Guangdong | 528437 | China |
| Third Kindergarten in Zhongshan Torch High-Tech Industrial Development Zone | Active, not recruiting | Zhongshan | Guangdong | 528437 | China |
| Xiao Yin Kindergarten in Zhongshan Torch High-Tech Industrial Development Zone | Active, not recruiting | Zhongshan | Guangdong | 528437 | China |
| Zhangjiabian Kindergarten in Zhongshan Torch High-Tech Industrial Development Zone | Active, not recruiting | Zhongshan | Guangdong | 528437 | China |
| Shaxi Xin Shimen Kindergarten in Zhongshan City. | Active, not recruiting | Zhongshan | Guangdong | 528471 | China |
| ID | Term |
|---|---|
| D065886 | Neurodevelopmental Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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