Effectiveness and Implementation of an Early Childhood School-Based Mental Health Intervention in Low-Resource Communities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,444
- 试验地点
- 2
- 主要终点
- Teacher Knowledge of Evidence-Based Practice (Knowledge Score)
研究概览
简要总结
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.
详细描述
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 (mWEL-Professional Development (PD), adapted from the US ParentCorps-Professional Development) 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Research staff performing outcome assessment will be blind to the study conditions.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- •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.
- •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.
- •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
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Evidence of psychopathology or cognitive impairment severe enough to preclude giving consent, or completing the survey instruments or the focus group of the study.
- •Minors (age <18) will also be excluded. Additional criteria should be included as appropriate for the study design and risk.
研究组 & 干预措施
ParentCorps-Professional Development (PD)
n = 6 Schools in Kampala, Uganda (Urban) - 89 Teachers, 325 Parent-Child Pairs
+ n = 10 Schools in Hoima, Uganda (Rural) - 98 Teachers, 344 Parent-Child Pairs
干预措施: ParentCorps-Professional Development (PD) (Behavioral)
ParentCorps-Professional Development (PD) + T-Wellness
n = 6 Schools in Kampala, Uganda (Urban) - 77 Teachers, 300 Parent-Child Pairs
+ n = 10 Schools in Hoima, Uganda (Rural) - 80 Teachers, 329 Parent-Child Pairs
干预措施: ParentCorps-Professional Development (PD) (Behavioral)
ParentCorps-Professional Development (PD) + T-Wellness
n = 6 Schools in Kampala, Uganda (Urban) - 77 Teachers, 300 Parent-Child Pairs
+ n = 10 Schools in Hoima, Uganda (Rural) - 80 Teachers, 329 Parent-Child Pairs
干预措施: T-Wellness (Behavioral)
Control
n = 6 Schools in Kampala, Uganda (Urban) - 73 Teachers, 316 Parent-Child Pairs
+ n = 9 Schools in Hoima, Uganda (Rural) - 92 Teachers, 321 Parent-Child Pairs
结局指标
主要结局
Teacher Knowledge of Evidence-Based Practice (Knowledge Score)
时间窗: Month 6
Teachers will complete a 10-item quiz assessing EBI knowledge. The total score is the number of correct responses and ranges from 0-100; higher scores indicate greater knowledge.
Teacher EBI Practice Score-Emotion Support Strategies Use
时间窗: Month 18
The Emotion Socialization Scale assesses teachers' practice in supporting students' management of negative emotions. Each of the scale items (6 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 lower adherence to EBI practice.
Child's Emotion Regulation Score
时间窗: Month 18
Parents answer 6 questions about their child's emotion regulation 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 to 4; higher scores indicate greater emotion regulation.
Teacher Stress Score
时间窗: Month 18
Teacher Stress was assessed using four measures: (i) Work Burnout (level of emotional and physical exhaustion from work) (9 items, 1-7 point scale), (ii) Family Stress (relationship stress) (5 items, 1-4 point scale); (iii) Kessler Psychological Distress Scale (K10) (anxiety and depressive symptoms) (10 items, 1-5 point scale); and (iv) Organization/ School Staff Stress (teachers' perception of level of stress in school) (5 items, 1-5 point scale). The total score is a mean composite of these four measures and ranges from 1-5; higher scores indicate higher stress levels.
Teacher Stress Score
时间窗: Baseline
Teacher Stress was assessed using four measures: (i) Work Burnout (level of emotional and physical exhaustion from work) (9 items, 1-7 point scale), (ii) Family Stress (relationship stress) (5 items, 1-4 point scale); (iii) Kessler Psychological Distress Scale (K10) (anxiety and depressive symptoms) (10 items, 1-5 point scale); and (iv) Organization/ School Staff Stress (teachers' perception of level of stress in school) (5 items, 1-5 point scale). The total score is a mean composite of these four measures and ranges from 1-5; higher scores indicate higher stress levels.
Teacher Stress Score
时间窗: Month 6
Teacher Stress was assessed using four measures: (i) Work Burnout (level of emotional and physical exhaustion from work) (9 items, 1-7 point scale), (ii) Family Stress (relationship stress) (5 items, 1-4 point scale); (iii) Kessler Psychological Distress Scale (K10) (anxiety and depressive symptoms) (10 items, 1-5 point scale); and (iv) Organization/ School Staff Stress (teachers' perception of level of stress in school) (5 items, 1-5 point scale). The total score is a mean composite of these four measures and ranges from 1-5; higher scores indicate higher stress levels.
Teacher EBI Practice Score
时间窗: Baseline
Use of Evidence-Based Practices was assessed with six measures: (i) Practice of evidence-based strategies (applied a range of evidence-based behavioral management strategies such as praise and proactive strategies) (9 items, 1-5 point scale); (ii) Non-harsh discipline (4 items, 1-5 point scale); (iii) Mindfulness (awareness of own actions and consideration of student's situations when interacting or disciplining students) (10 items, 1-4 point scale); (iv) Emotion socialization-supporting negative emotion (practice used to support students in managing negative emotions) (6 items, 1-5 point scale); (v) Family engagement (frequency in interacting with families) (2 items, 1-5 point scale); and (vi) Teacher-Student Interaction (5 items, 1-5 point scale). The final score is a mean composite of these six measures and ranges from 1-5; where higher scores indicate greater use of EBI practices.
Teacher EBI Practice Score
时间窗: Month 6
Use of Evidence-Based Practices was assessed with six measures: (i) Practice of evidence-based strategies (applied a range of evidence-based behavioral management strategies such as praise and proactive strategies) (9 items, 1-5 point scale); (ii) Non-harsh discipline (4 items, 1-5 point scale); (iii) Mindfulness (awareness of own actions and consideration of student's situations when interacting or disciplining students) (10 items, 1-4 point scale); (iv) Emotion socialization-supporting negative emotion (practice used to support students in managing negative emotions) (6 items, 1-5 point scale); (v) Family engagement (frequency in interacting with families) (2 items, 1-5 point scale); and (vi) Teacher-Student Interaction (5 items, 1-5 point scale). The final score is a mean composite of these six measures and ranges from 1-5; where higher scores indicate greater use of EBI practices.
Teacher EBI Practice Score
时间窗: Month 18
Use of Evidence-Based Practices was assessed with six measures: (i) Practice of evidence-based strategies (applied a range of evidence-based behavioral management strategies such as praise and proactive strategies) (9 items, 1-5 point scale); (ii) Non-harsh discipline (4 items, 1-5 point scale); (iii) Mindfulness (awareness of own actions and consideration of student's situations when interacting or disciplining students) (10 items, 1-4 point scale); (iv) Emotion socialization-supporting negative emotion (practice used to support students in managing negative emotions) (6 items, 1-5 point scale); (v) Family engagement (frequency in interacting with families) (2 items, 1-5 point scale); and (vi) Teacher-Student Interaction (5 items, 1-5 point scale). The final score is a mean composite of these six measures and ranges from 1-5; where higher scores indicate greater use of EBI practices.
Teacher Stress Management
时间窗: Baseline
Teacher Stress Management was assessed using four measures: (i) Cognitive regulation (ability to redirect negative thinking to positive thinking when distressed) (3 items, 1-5 point scale); (ii) Emotion Expression (ability to express emotion) (4 items, 1-5 point scale); (iii) Emotion Acceptance (ability to accept negative emotion) (3 items, 1-5 point scale); and (iv) Support from Work (getting support from school staff) (5 items, 1-5 point scale). The total score is a mean composite of these four measures and ranges from 1-5; higher scores indicate greater management of stress.
Teacher Stress Management
时间窗: Month 6
Teacher Stress Management was assessed using four measures: (i) Cognitive regulation (ability to redirect negative thinking to positive thinking when distressed) (3 items, 1-5 point scale); (ii) Emotion Expression (ability to express emotion) (4 items, 1-5 point scale); (iii) Emotion Acceptance (ability to accept negative emotion) (3 items, 1-5 point scale); and (iv) Support from Work (getting support from school staff) (5 items, 1-5 point scale). The total score is a mean composite of these four measures and ranges from 1-5; higher scores indicate greater management of stress.
Teacher Stress Management
时间窗: Month 18
Teacher Stress Management was assessed using four measures: (i) Cognitive regulation (ability to redirect negative thinking to positive thinking when distressed) (3 items, 1-5 point scale); (ii) Emotion Expression (ability to express emotion) (4 items, 1-5 point scale); (iii) Emotion Acceptance (ability to accept negative emotion) (3 items, 1-5 point scale); and (iv) Support from Work (getting support from school staff) (5 items, 1-5 point scale). The total score is a mean composite of these four measures and ranges from 1-5; higher scores indicate greater management of stress.
次要结局
- Teacher Mental Health(Month 18)
- Child Mental Health- Conduct Problem(Month 18)