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

NCT06702410 | Recruiting

• 3 other identifiers: 2020-08920-3892022B1515020094
• Study Type: interventional
• Target: 375
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

Neurodevelopmental Disorders

Keywords

neurodevelopmental disorders; task shifting; evidence-based practice; implementation science; stepped wedge trial

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Caregivers' psychological distress assessed by the Parenting Stress Index-Short Form (PSI-SF)

  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.

  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

  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).

  baseline and 3-, 6-, 9- and 12- months of intervention

Other Outcomes (2)

• 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.

  baseline, 3-, 6-, 9-, 12-months of intervention.

• Number of children who are referred to hospital and diagnosed with CMBDs

  From enrollment to 12 months of intervention

Study Arms (1)

the adapted mhGAP-IG

EXPERIMENTAL

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)

Interventions

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.

the adapted mhGAP-IG

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (9)

Zhongshan Zhengfa Kindergarten

Zhongshan, Guangdong, 528403, China

RECRUITING

Zhongshan Xiaolan Huasheng Kindergarten

Zhongshan, Guangdong, 528415, China

RECRUITING

Zhongshan Dongfeng Deshan Kindergarten

Zhongshan, Guangdong, 528425, China

RECRUITING

Zhongshan Huangpu Boya Oriental Pearl Kindergarten

Zhongshan, Guangdong, 528429, China

RECRUITING

First Kindergarten in Zhongshan Torch High-Tech Industrial Development Zone

Zhongshan, Guangdong, 528437, China

ACTIVE NOT RECRUITING

Third Kindergarten in Zhongshan Torch High-Tech Industrial Development Zone

Zhongshan, Guangdong, 528437, China

ACTIVE NOT RECRUITING

Xiao Yin Kindergarten in Zhongshan Torch High-Tech Industrial Development Zone

Zhongshan, Guangdong, 528437, China

ACTIVE NOT RECRUITING

Zhangjiabian Kindergarten in Zhongshan Torch High-Tech Industrial Development Zone

Zhongshan, Guangdong, 528437, China

ACTIVE NOT RECRUITING

Shaxi Xin Shimen Kindergarten in Zhongshan City.

Zhongshan, Guangdong, 528471, China

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Wen Chen, PhD

  Medical statistics, School of public health, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wen Chen, Professor

CONTACT

+86 13580520052; chenw43@mail.sysu.edu.cn

Meng Zheng

CONTACT

+86 18089525995; zhengm29@mail2.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: November 25, 2024
• Study Start: November 20, 2024
• Primary Completion: February 20, 2026
• Study Completion: February 20, 2026
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (9)