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Completed

NCT Number: NCT04383327

School-Based Mental Health Effectiveness Study

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hoima School, Hoima, Uganda

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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.

Treatment and study plan

ParentCorps-Professional Development (PD)

Behavioral

Multi-component school-based intervention that promotes early childhood mental health and development. Teachers (pre-primary to 4th grade) will participate in a 3-day ParentCorps-PD training during the school term. They will also receive 8 sessions (8 hours) of face-to-face group-based coaching during after the training. Coaching sessions are to help teachers apply EBI strategies in their classrooms, engage families, and develop competencies.

T-Wellness

Behavioral

A brief teacher stress management psychoeducation package, adapted from EBIs including one-day workshop for common stress management and stress management, and three follow-up group support sessions (3 additional monthly 1-hr wellness sessions for teachers as a group that were integrated into the 3 of the 8 PD coaching sessions. A total 3 hours of coaching were included.

Primary outcomes

  1. Teacher Knowledge of Evidence-Based Practice (Knowledge Score)

    Time frame: Baseline

    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.

  2. Teacher Knowledge of Evidence-Based Practice (Knowledge Score)

    Time frame: 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.

  3. Teacher EBI Practice Score-Emotion Support Strategies Use

    Time frame: Baseline

    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.

  4. Teacher EBI Practice Score-Emotion Support Strategies Use

    Time frame: Month 6

    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.

  5. Teacher EBI Practice Score-Emotion Support Strategies Use

    Time frame: 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.

  6. Teacher Stress Score

    Time frame: Baseline

    Teachers complete a 5-item assessment of stress over the past month. Each item is rated on a scale from 1 to 4. The total score is the average of responses and ranges from 1-4. Higher scores indicate greater stress.

  7. Teacher Stress Score

    Time frame: Month 6

    Teachers complete a 5-item assessment of stress over the past month. Each item is rated on a scale from 1 to 4. The total score is the average of responses and ranges from 1-4. Higher scores indicate greater stress.

  8. Teacher Stress Score

    Time frame: Month 18

    Teachers complete a 5-item assessment of stress over the past month. Each item is rated on a scale from 1 to 4. The total score is the average of responses and ranges from 1-4. Higher scores indicate greater stress.

  9. Child's Emotion Regulation Score

    Time frame: Baseline

    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.

  10. Child's Emotion Regulation Score

    Time frame: Month 6

    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.

  11. Child's Emotion Regulation Score

    Time frame: 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.

Secondary outcomes

  1. Teacher Mental Health

    Time frame: Baseline

    Teachers complete Kessler Psychological Distress Scale (K10), which assesses anxiety and depressive symptoms that teacher experiencing over the past month. Each item is rated on a scale from 0 to 4. The total score is the sum of responses and ranges from 0 to 40, where higher scores indicate greater psychological distress.

  2. Teacher Mental Health

    Time frame: Month 6

    Teachers complete Kessler Psychological Distress Scale (K10), which assesses anxiety and depressive symptoms that teacher experiencing over the past month. Each item is rated on a scale from 0 to 4. The total score is the sum of responses and ranges from 0 to 40, where higher scores indicate greater psychological distress.

  3. Teacher Mental Health

    Time frame: Month 18

    Teachers complete Kessler Psychological Distress Scale (K10), which assesses anxiety and depressive symptoms that teacher experiencing over the past month. Each item is rated on a scale from 0 to 4. The total score is the sum of responses and ranges from 0 to 40, where higher scores indicate greater psychological distress.

  4. Child Mental Health- Conduct Problem

    Time frame: Baseline

    Conduct problem items (5 items) from the Strengths and Difficulties Questionnaire (SDQ) are rated by parents, which assesses child's conduct and non-compliant behaviors over the last six months. 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 0-10; higher scores indicate greater difficulties.

  5. Child Mental Health- Conduct Problem

    Time frame: Month 6

    Conduct problem items (5 items) from the Strengths and Difficulties Questionnaire (SDQ) are rated by parents, which assesses child's conduct and non-compliant behaviors over the last six months. 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 0-10; higher scores indicate greater difficulties.

  6. Child Mental Health- Conduct Problem

    Time frame: Month 18

    Conduct problem items (5 items) from the Strengths and Difficulties Questionnaire (SDQ) are rated by parents, which assesses child's conduct and non-compliant behaviors over the last six months. 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 0-10; higher scores indicate greater difficulties.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

Effectiveness and Implementation of an Early Childhood School-Based Mental Health Intervention in Low-Resource Communities

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
May 12, 2020
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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