NCT Number: NCT06702410
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.
Interested in participating?
Request Info2 year–6 year
All sexes
Interventional
Not applicable
First Kindergarten in Zhongshan Torch High-Tech Industrial Development Zone, Zhongshan, Guangdong, China
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Inclusion criteria
Exclusion criteria
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.
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.
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.
Time frame: baseline and 3-, 6- and 12- months of intervention
A total score ranges from 7 (lowest distress) to 28 (highest distress).
Time frame: baseline and 3-, 6-, 9-, and 12- months of intervention
A total score ranges from 4 (lowest self-reported competence) to 64 (highest lowest self-reported competence).
Time frame: baseline and 3-, 6-, 9-, and 12- months of intervention
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.
Time frame: baseline and 3-, 6-, 9- and 12- months of intervention
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.
Time frame: baseline, 3-, 6-, 9-, 12-months of intervention.
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.
Time frame: From enrollment to 12 months of intervention
The diagnosis will be made by clinical professionals in CMBDs
Contact information is provided by the study sponsor or research team.
Meng Zheng
CONTACT
Wen Chen, Professor
CONTACT
Sun Yat-sen University
Other
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
Acronym: mhGAP
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