Clinical trial NCT06702410: WHO Mental Health Gap Action Program (mhGAP) for Improving Child Mental and Behavioral Disorder Service Quality in China
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neurodevelopmental Disorders
Keywords: neurodevelopmental disorders
task shifting
evidence-based practice
implementation science
stepped wedge trial
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-11-25
Enrollment: 375
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility 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.

Primary outcomes:
measure: Symptom severity of CMBDs assessed by Strengths and Difficulties Questionnaire (SDQ)
timeFrame: baseline and 3-, 6- and 12- months of intervention
measure: Developmental domain scores measured by Ages and Stages Questionnaire (ASQ)
timeFrame: baseline and 3-, 6- and 12- months of intervention
Secondary outcomes:
measure: Caregivers' psychological distress assessed by the Parenting Stress Index-Short Form (PSI-SF)
timeFrame: baseline and 3-, 6- and 12- months of intervention
measure: Mental health action competence among kindergarten teachers measured by the Chinese version of Mental Health Action Competence (MHAC) Scale.
timeFrame: baseline and 3-, 6-, 9-, and 12- months of intervention
measure: Kownledge level on providing CMBDs services among kindergarten teachers measured by the knowledge questionnaire form the mhGAP-IG
timeFrame: baseline and 3-, 6-, 9-, and 12- months of intervention
measure: Efficacy score among kindergarten teachers measured by the Chinese short form Teacher Efficacy Scale (TSE).
timeFrame: baseline and 3-, 6-, 9- and 12- months of intervention
Other outcomes:
measure: 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.
timeFrame: baseline, 3-, 6-, 9-, 12-months of intervention.
measure: Number of children who are referred to hospital and diagnosed with CMBDs
timeFrame: From enrollment to 12 months of intervention
Locations:
city: Zhongshan
country: China
facility: Zhongshan Zhengfa Kindergarten
state: Guangdong
city: Zhongshan
country: China
facility: Zhongshan Xiaolan Huasheng Kindergarten
state: Guangdong
city: Zhongshan
country: China
facility: Zhongshan Dongfeng Deshan Kindergarten
state: Guangdong
city: Zhongshan
country: China
facility: Zhongshan Huangpu Boya Oriental Pearl Kindergarten
state: Guangdong
city: Zhongshan
country: China
facility: First Kindergarten in Zhongshan Torch High-Tech Industrial Development Zone
state: Guangdong
city: Zhongshan
country: China
facility: Third Kindergarten in Zhongshan Torch High-Tech Industrial Development Zone
state: Guangdong
city: Zhongshan
country: China
facility: Xiao Yin Kindergarten in Zhongshan Torch High-Tech Industrial Development Zone
state: Guangdong
city: Zhongshan
country: China
facility: Zhangjiabian Kindergarten in Zhongshan Torch High-Tech Industrial Development Zone
state: Guangdong
city: Zhongshan
country: China
facility: Shaxi Xin Shimen Kindergarten in Zhongshan City.
state: Guangdong
Study officials:
affiliation: Medical statistics, School of public health, Sun Yat-sen University
name: Wen Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References: