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

Sun Yat-sen University

Status: Enrolling

Conditions: Neurodevelopmental Disorders

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06702410

20-389 (Other Grant/Funding Number)

2020-089

2022B1515020094 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 375 estimated patients

Sex: All

Ages: 2 to 6 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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375 participants in 1 patient group

the adapted mhGAP-IG

Experimental group

Description:

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

Treatment:

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