Clinical trial NCT04383327: School-Based Mental Health Effectiveness Study
Official title: Effectiveness and Implementation of an Early Childhood School-Based Mental Health Intervention in Low-Resource Communities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Development
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2020-05-12
Enrollment: 2444
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A cluster randomized controlled trial (cRCT), single blind and mixed-methods design will be applied
Primary purpose: OTHER

Brief summary: This study involves efforts to advance the science of prevention in early childhood mental health in low-resource communities. Investigators will assess the effectiveness, practical implementation strategies, and underlying mechanisms of the evidence-based intervention, ParentCorps-Professional Development, in urban and rural Uganda. Two implementation approaches, with and without the teacher stress management package, T-Wellness, will be compared for efficacy.

Detailed description: Promoting child mental health in low-resource or low-income country settings faces numerous challenges in global health research. Although efforts have been made to improve mental health interventions and services for young children, evidence-based interventions (EBIs) for children in low-and middle-income countries (LMICs) are limited. Most mental health EBIs in LMICs have not been scaled widely, and do not focus on early childhood. Mechanisms of action and effectiveness are not well understood. Additionally, most EBIs in LMICs rely on community health workers (CHWs) or a task-shifting approach of implementation because of resource barriers and shortage of mental health professionals (MHPs). However, challenges related to task-shifting (e.g., CHW stress and job burnout) have rarely been studied. For task-shifting to be successful, strategies to overcome challenges faced by CHWs and understanding mechanisms to conduct effective task-shifting are paramount. The overall goal of this study is to address these EBI effectiveness and implementation knowledge gaps by providing a preventive EBI (ParentCorps-Professional Development; PD) that utilizes a task-shifting and a scalable implementation model to promote early childhood students' mental health in a LMIC-Uganda. PD is a school-based EBI and preventive mental health service provision model that supports teachers and school personnel to apply EBI strategies to promote young children's mental health. The PD approach represents a task-shifting model of mental healthcare by shifting mental health preventive duties from professionals to teachers to optimize school children's mental health. Therefore, teachers are considered as CHWs. This study examines impacts and cost-effectiveness of the EBI/PD on teachers and students, as well as examines underlying mechanisms (or theories of change) that contribute to intervention effect. In addition, considering most Ugandan teachers (or CHWs) experience occupational stress that threatens PD uptake, effectiveness, and sustainment, this study will also test a teacher stress management package (T-Wellness, adapted from EBIs) as an enhancement to PD. This study will investigate whether PD + T-Wellness (PDT) is more effective for CHWs/teachers than PD alone.

Eligibility criteria: Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. The inclusion criteria for the school staff (teachers, head teachers) are: they must be in the recruited study schools and teaching in Pre-Primary to Primary 4 classrooms or holding the head teachers/administration leadership position in school. The inclusion criteria for Parent Leaders are: they must be at least 18 years old and have served as a Parent-Teacher-Association member or Parent Leader in the school for at least 1 year.
2. The inclusion criteria for the PD/PDT program implementers are: they must have current employment with eligible partners (i.e., medical/mental health institutions, Teacher Training Colleges), with professional experiences in teacher training or mental health training.
3. The inclusion criteria for parents are: caregivers must be at least 18 years old, their children must be enrolled in Pre-Primary or Primary 1 to 4 classes (or between 3 to 10 years old) in the recruited schools, and willing to have their child to be assessed by research staff. Parents and children will have diverse characteristics (e.g., randomly selected from school student lists). About 10% families will be randomly selected from the student lists. The proposed study will be open to both men and women caregivers

Exclusion Criteria

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Evidence of psychopathology or cognitive impairment severe enough to preclude giving consent, or completing the survey instruments or the focus group of the study.
2. Minors (age \<18) will also be excluded. Additional criteria should be included as appropriate for the study design and risk.

Primary outcomes:
measure: Child's Strengths and Difficulties Questionnaire (SDQ) Score
timeFrame: Baseline
measure: Child's SDQ Score
timeFrame: Month 6
measure: Child's SDQ Score
timeFrame: Month 18
measure: EBI Classroom Practice Score
timeFrame: Baseline
measure: EBI Classroom Practice Score
timeFrame: Month 6
measure: EBI Classroom Practice Score
timeFrame: Month 18
measure: EBI Knowledge Questionnaire Score
timeFrame: Baseline
measure: EBI Knowledge Questionnaire Score
timeFrame: Month 6
measure: EBI Knowledge Questionnaire Score
timeFrame: Month 18
measure: Perceived Stress Scale (PSS-4) - General Stress Score
timeFrame: Baseline
measure: PSS-4 - General Stress Score
timeFrame: Month 6
measure: PSS-4 - General Stress Score
timeFrame: Month 18
measure: Stress Response Style Score
timeFrame: Baseline
measure: Stress Response Style Score
timeFrame: Month 6
measure: Stress Response Style Score
timeFrame: Month 18
Secondary outcomes:
measure: Child's Social Competence Score
timeFrame: Baseline
measure: Child's Social Competence Score
timeFrame: Month 6
measure: Child's Social Competence Score
timeFrame: Month 18
measure: Child's Relationship with Teacher Score
timeFrame: Baseline
measure: Child's Relationship with Teacher Score
timeFrame: Month 6
measure: Child's Relationship with Teacher Score
timeFrame: Month 18
measure: Family - Teacher Relationship Quality Score
timeFrame: Baseline
measure: Family - Teacher Relationship Quality Score
timeFrame: Month 6
measure: Family - Teacher Relationship Quality Score
timeFrame: Month 18
Other outcomes:
Locations:
city: Hoima
country: Uganda
facility: Hoima School
city: Kampala
country: Uganda
facility: Kampala School
Study officials:
affiliation: NYU Langone Health
name: Keng-Yen Huang, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Huang KY, Nakigudde J, Kisakye EN, Sentongo H, Dennis-Tiwary TA, Tozan Y, Park H, Brotman LM. Advancing scalability and impacts of a teacher training program for promoting child mental health in Ugandan primary schools: protocol for a hybrid-type II effectiveness-implementation cluster randomized trial. Int J Ment Health Syst. 2022 Jun 20;16(1):28. doi: 10.1186/s13033-022-00538-7.