WHO Mental Health Gap Action Program (mhGAP) for Improving Child Mental and Behavioral Disorder Service Quality in China (mhGAP)

WHO Mental Health Gap Action Program (mhGAP) Delivered by Primary Care Workers for Improving Quality of Child Mental and Behavioral Disorders Services: A Hybrid Effectiveness-implementation Cluster Randomized Controlled Trial

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:

• Does the adapted mhGAP-IG reduce the symptom severity among children with CMBDs between two and sis years old?
• Does the adapted mhGAP-IG reduce psychological distress among caregivers of children with CMBDs?
• Does the adapted mhGAP-IG improve mental and behavioral health serivces capacity among kindergarten teachers in China?
• How is the feasibility, acceptablity, and what are barriers and facilitators of implementation?

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:

• Complete questionnaires and scales at baseline and at 3-, 6-, 9- and 12- months of intervention;
• Receive mhGAP-based trainings;
• Deliver long-term child mental and behavioral disorders services (including screenings, referals, follow-up, and physcosocial interventions) to children with CMBDs.

Participants (children/caregivers) will:

• Complete questionnaires and scales at baseline and at 3-, 6- and 12- months of intervention.
• Accept long-term CMBDs management (including screenings, referals, follow-up management, and physcosocial interventions) from mhGAP-trained kindergarten teachers.

Study Overview

• Status: Recruiting
• Conditions: Neurodevelopmental Disorders
• Intervention / Treatment: Behavioral: mental health gap action program intervention guide (mhGAP-IG)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 375
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wen Chen, Professor; Phone Number: +86 13580520052; Email: chenw43@mail.sysu.edu.cn
• Study Contact Backup: Name: Meng Zheng; Phone Number: +86 18089525995; Email: zhengm29@mail2.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Zhongshan, Guangdong, China, 528403
      • Recruiting
      • Zhongshan Zhengfa Kindergarten
      • Contact: Xin-yan Bu; Phone Number: 86 15918808828; Email: buxy3@mail2.sysu.edu.cn
    • Zhongshan, Guangdong, China, 528415
      • Recruiting
      • Zhongshan Xiaolan Huasheng Kindergarten
      • Contact: Xue-zhi Liang; Phone Number: 86 13265386106
    • Zhongshan, Guangdong, China, 528425
      • Recruiting
      • Zhongshan Dongfeng Deshan Kindergarten
      • Contact: Ming-lu Yuan; Phone Number: 86 17770917041
    • Zhongshan, Guangdong, China, 528429
      • Recruiting
      • Zhongshan Huangpu Boya Oriental Pearl Kindergarten
      • Contact: Q Zou; Email: zouq25@mail2.sysu.edu.cn
    • Zhongshan, Guangdong, China, 528437
      • Active, not recruiting
      • First Kindergarten in Zhongshan Torch High-Tech Industrial Development Zone
    • Zhongshan, Guangdong, China, 528437
      • Active, not recruiting
      • Third Kindergarten in Zhongshan Torch High-Tech Industrial Development Zone
    • Zhongshan, Guangdong, China, 528437
      • Active, not recruiting
      • Xiao Yin Kindergarten in Zhongshan Torch High-Tech Industrial Development Zone
    • Zhongshan, Guangdong, China, 528437
      • Active, not recruiting
      • Zhangjiabian Kindergarten in Zhongshan Torch High-Tech Industrial Development Zone
    • Zhongshan, Guangdong, China, 528471
      • Active, not recruiting
      • Shaxi Xin Shimen Kindergarten in Zhongshan City.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

1. Eligibility criteria for children/caregivers

   Inclusion Criteria:

   • Aged 2-6 years;
   • Screened positive by the mhGAP-IG screening tool;
   • Will stay in Zhongshan City for the next one year.

   Exclusion Criteria:

   • Co-morbid physical or mental conditions requiring inpatient hospitalization;
   • Currently or in the past six months received CMBDs services provided by specialized mental health workers;
   • Deafness or blindness in the child or caregivers;
   • Not available or unwilling to participate in the trial.
2. Eligibility criteria for kindergarten teachers

Inclusion Criteria:

• Have one or more years of work experience in the selected kindergartens
• Be available to participate in the mhGAP training.

Exclusion Criteria:

• Have received the mhGAP training before;
• Have arrangements requiring long-term leave from work in the next one year;
• Unwilling to participate in the trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: the adapted mhGAP-IG; mhGAP-IG-based CMBDs mental health services (including screening, management and follow-up) delivered by trained kindergarten teachers

Behavioral: mental health gap action program intervention guide (mhGAP-IG); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.	baseline, 3-, 6-, 9-, 12-months of intervention.

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Collaborators: Zhongshan Boai Hospital
• Investigators: Principal Investigator: Wen Chen, PhD, Medical statistics, School of public health, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2024
• Primary Completion (Estimated): February 20, 2026
• Study Completion (Estimated): February 20, 2026

Study Registration Dates

• First Submitted: November 20, 2024
• First Submitted That Met QC Criteria: November 20, 2024
• First Posted (Actual): November 25, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2025
• Last Update Submitted That Met QC Criteria: May 13, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: implementation science; task shifting; stepped wedge trial; evidence-based practice; neurodevelopmental disorders
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders
• Other Study ID Numbers: 2020-089; 20-389 (Other Grant/Funding Number: China Medical Board); 2022B1515020094 (Other Grant/Funding Number: Guangdong Outstanding Youth Fund)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No