School-Based Mental Health Effectiveness Study

Not Applicable

Completed

• Conditions: Child Development
• Interventions: Behavioral: ParentCorps-Professional Development (PD); Behavioral: T-Wellness

• Registration Number: NCT04383327
• Lead Sponsor: NYU Langone Health

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.

Study Timeline

• Study First Submitted: 2020-04-16
• Study First Submitted QC: 2020-05-07
• Study First Posted: 2020-05-12
• Study Start: 2021-08-01
• Primary Completion: 2024-06-30
• Study Completion: 2025-02-28
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2444

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ParentCorps-Professional Development (PD) + T-Wellness	T-Wellness	n = 6 Schools in Kampala, Uganda (Urban) - 90 Teachers, 6 PTAs, 330 Parent-Child Pairs + n = 6 Schools in Hoima, Uganda (Rural) - 90 Teachers, 6 PTAs, 330 Parent-Child Pairs
ParentCorps-Professional Development (PD)	ParentCorps-Professional Development (PD)	n = 6 Schools in Kampala, Uganda (Urban) - 90 Teachers, 6 PTAs, 330 Parent-Child Pairs + n = 6 Schools in Hoima, Uganda (Rural) - 90 Teachers, 6 PTAs, 330 Parent-Child Pairs
ParentCorps-Professional Development (PD) + T-Wellness	ParentCorps-Professional Development (PD)	n = 6 Schools in Kampala, Uganda (Urban) - 90 Teachers, 6 PTAs, 330 Parent-Child Pairs + n = 6 Schools in Hoima, Uganda (Rural) - 90 Teachers, 6 PTAs, 330 Parent-Child Pairs

Primary Outcome Measures

Name	Time	Method
Child's Strengths and Difficulties Questionnaire (SDQ) Score	Baseline	Completed by parents; the SDQ is a 25-item assessment of a child's behavior over the last six months/school year. The Externalizing subscale provides Each item is rated on a Likert scale from 0 (not true) to 2 (certainly true). The total score is the sum of responses and ranges from 0-50; higher scores indicate greater difficulties.
Child's SDQ Score	Month 18	Completed by parents; the SDQ is a 25-item assessment of a child's behavior over the last six months/school year. The Externalizing subscale provides Each item is rated on a Likert scale from 0 (not true) to 2 (certainly true). The total score is the sum of responses and ranges from 0-50; higher scores indicate greater difficulties.
EBI Classroom Practice Score	Month 18	Blind raters will observe participating teachers and assess classroom disruptive behaviors and emotion atmosphere. Each of the scales 7 items are rated on a scale from 1 to 5; the total score is the average of responses and ranges from 1-5; lower scores indicate greater adherence to EBI practices.
EBI Knowledge Questionnaire Score	Month 18	Teachers will complete a 10-item quiz assessing EBI knowledge. The total score is the number of correct responses and ranges from 0-10; higher scores indicate greater knowledge.
Perceived Stress Scale (PSS-4) - General Stress Score	Baseline	Teachers will complete the PSS-4, a 4-item assessment of stress over the past month. Each item is rated on a scale from 1 (Never) to 5 (Very Often). The total score is the sum of responses and ranges from 4-20; higher scores indicate greater stress.
Stress Response Style Score	Month 18	Teachers will complete a 45-item assessment of practices to manage social stress. Each item is rated on a scale from 1 (not at all) to 4 (a lot). The total score is the sum of responses and ranges from 45-180; higher scores indicate healthier coping strategies.
PSS-4 - General Stress Score	Month 18	Teachers will complete the PSS-4, a 4-item assessment of stress over the past month. Each item is rated on a scale from 1 (Never) to 5 (Very Often). The total score is the sum of responses and ranges from 4-20; higher scores indicate greater stress.

Secondary Outcome Measures

Name	Time	Method
Family - Teacher Relationship Quality Score	Month 18	Completed by parents; 4-item assessment of family-teacher relationships. Each item is rated on a scale from 1-5; higher scores indicate more positive relationships between teachers and families.
Child's Relationship with Teacher Score	Month 18	Children answer 8 questions related to their relationship with their teacher. Each item is rated on a Likert scale from 0 (never) to 4 (almost always). The total score is the sum of responses and ranges from 0-32; lower scores indicate more positive child-teacher relationships.
Child's Social Competence Score	Month 18	Parents answer 12 questions about their child's behavior over the past 7 days. Each item is rated on a Likert scale from 0 (not at all) to 4 (very well). The total score ranges from 0-48; higher scores indicate greater social competence.

Trial Locations

Locations (2)

Hoima School; 🇺🇬 Hoima, Uganda

Kampala School; 🇺🇬 Kampala, Uganda