Neurodevelopmental DisordersmhGAPNCT06702410
WHO Mental Health Gap Action Program (mhGAP) for Improving Child Mental and Behavioral Disorder Service Quality in China
A study testing mental health gap action program intervention guide (mhGAP-IG) in people with Neurodevelopmental Disorders, run by Sun Yat-sen University at 9 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurodevelopmental Disorders
- What is being tested?
- mental health gap action program intervention guide (mhGAP-IG)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 375 participants
- Where
- 9 sitesChina
- Study dates
- 20 Nov 2024to 20 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged 2-6 years;
- Screened positive by the mhGAP-IG screening tool;
- Will stay in Zhongshan City for the next one year.
- Have one or more years of work experience in the selected kindergartens
- Be available to participate in the mhGAP training.
Who cannot join
- 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 received the mhGAP training before;
- Have arrangements requiring long-term leave from work in the next one year;
- Unwilling to participate in the trial.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
China9 sites, 4 recruiting
- Recruiting
Zhongshan Zhengfa Kindergarten
Zhongshan, Guangdong, 528403
Xin-yan Bu, 86 15918808828, buxy3@mail2.sysu.edu.cn
- Recruiting
Zhongshan Xiaolan Huasheng Kindergarten
Zhongshan, Guangdong, 528415
Xue-zhi Liang, 86 13265386106
- Recruiting
Zhongshan Dongfeng Deshan Kindergarten
Zhongshan, Guangdong, 528425
Ming-lu Yuan, 86 17770917041
- Recruiting
Zhongshan Huangpu Boya Oriental Pearl Kindergarten
Zhongshan, Guangdong, 528429
Q Zou, zouq25@mail2.sysu.edu.cn
- Active, not recruiting
First Kindergarten in Zhongshan Torch High-Tech Industrial Development Zone
Zhongshan, Guangdong, 528437
- Active, not recruiting
Third Kindergarten in Zhongshan Torch High-Tech Industrial Development Zone
Zhongshan, Guangdong, 528437
- Active, not recruiting
Xiao Yin Kindergarten in Zhongshan Torch High-Tech Industrial Development Zone
Zhongshan, Guangdong, 528437
- Active, not recruiting
Zhangjiabian Kindergarten in Zhongshan Torch High-Tech Industrial Development Zone
Zhongshan, Guangdong, 528437
- Active, not recruiting
Shaxi Xin Shimen Kindergarten in Zhongshan City.
Zhongshan, Guangdong, 528471
About this study
Official title: 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?
Read more
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.
Read the 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.
- Conditions
- Neurodevelopmental Disorders
- Being tested
- mental health gap action program intervention guide (mhGAP-IG)
- Keywords
- neurodevelopmental disorders, task shifting, evidence-based practice, implementation science, stepped wedge trial
- Medical subject headings
- Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mental health gap action program intervention guide (mhGAP-IG)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| the adapted mhGAP-IG | Experimental | mhGAP-IG-based CMBDs mental health services (including screening, management and follow-up) delivered by trained kindergarten teachers Receives: Behavioral: mental health gap action program intervention guide (mhGAP-IG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
A total score ranges from 7 (lowest distress) to 28 (highest distress).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: baseline and 3-, 6-, 9- and 12- months of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start20 Nov 2024
- Primary completion20 Feb 2026 (estimated)
- Study completion20 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodevelopmental DisordersStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 375 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen Chen, Sun Yat-sen University
- Investigators
- Wen Chen, PhD, Principal investigator, Medical statistics, School of public health, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06702410
- Sponsor's protocol ID
- 2020-089
- Other IDs
- 20-389, 2022B1515020094
- Acronym
- mhGAP
- Status last verified
- May 2025
- First submitted
- 20 Nov 2024
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06702410
- Acronym / sponsor ID
- mhGAP / 2020-089
- Conditions
- Neurodevelopmental Disorders
- Keywords
- neurodevelopmental disorders, task shifting, evidence-based practice, implementation science, stepped wedge trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 375 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 20 Feb 2026 (estimated)
- Study completion
- 20 Feb 2026 (estimated)
- First posted
- 25 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| the adapted mhGAP-IG | Experimental | Behavioral: mental health gap action program intervention guide (mhGAP-IG)mhGAP-IG-based CMBDs mental health services (including screening, management and follow-up) delivered by trained kindergarten teachers |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Have one or more years of work experience in the selected kindergartens
- Be available to participate in the mhGAP training.
Key exclusion criteria (8 listed)
- Eligibility criteria for kindergarten teachers
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | the adapted mhGAP-IG |
Primary outcome
Symptom severity of CMBDs assessed by Strengths and Difficulties Questionnaire (SDQ)
Time frame: baseline and 3-, 6- and 12- months of intervention
A total score ranges from 0 (lowest distress) to 60 (highest distress) and higher scores of SDQ indicate the worse symptom.
Developmental domain scores measured by Ages and Stages Questionnaire (ASQ)
Time frame: baseline and 3-, 6- and 12- months of intervention
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.
4 secondary outcomes
Caregivers' psychological distress assessed by the Parenting Stress Index-Short Form (PSI-SF)
Time frame: 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.
Time frame: 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
Time frame: 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).
Time frame: baseline and 3-, 6-, 9- and 12- months of intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wen Chen, PhD principal investigator
Medical statistics, School of public health, Sun Yat-sen University
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mental health gap action program intervention guide (mhGAP-IG) in people with Neurodevelopmental Disorders, run by Sun Yat-sen University at 9 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wen Chen, Professor (+86 13580520052, chenw43@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom severity of CMBDs assessed by Strengths and Difficulties Questionnaire (SDQ) (time frame: baseline and 3-, 6- and 12- months of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.