CClinicalTrials.gg
CompletedNCT04383327Updated Sep 14, 2026Results posted

School-Based Mental Health Effectiveness Study

An interventional study of ParentCorps-Professional Development (PD) and T-Wellness in Child Development, sponsored by NYU Langone Health. Completed at 2 sites in Uganda. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-14.

Sponsored by NYU Langone Health · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
2,444
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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 (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.

02

Conditions studied

  • Child Development
03

In context

Lead sponsor

NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.

Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
2,444 participants (actual)

Study arms

  • Experimental
    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

    Behavioral: ParentCorps-Professional Development (PD)

  • Experimental
    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

    Behavioral: ParentCorps-Professional Development (PD) · Behavioral: T-Wellness

  • No intervention
    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

Interventions

  • BehavioralParentCorps-Professional Development (PD)

    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.

  • BehavioralT-Wellness

    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.

06

What researchers measure

Primary outcomes

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

    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.

    Time frame: Baseline

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

    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.

    Time frame: Month 6

  3. Teacher EBI Practice Score

    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.

    Time frame: Baseline

  4. Teacher EBI Practice Score

    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.

    Time frame: Month 6

  5. Teacher EBI Practice Score

    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.

    Time frame: Month 18

  6. Teacher Stress Score

    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.

    Time frame: Baseline

  7. Teacher Stress Score

    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.

    Time frame: Month 6

  8. Teacher Stress Score

    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.

    Time frame: Month 18

  9. Teacher Stress Management

    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.

    Time frame: Baseline

  10. Teacher Stress Management

    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.

    Time frame: Month 6

  11. Teacher Stress Management

    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.

    Time frame: Month 18

  12. Child's Emotion Regulation Score

    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.

    Time frame: Baseline

  13. Child's Emotion Regulation Score

    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.

    Time frame: Month 6

  14. Child's Emotion Regulation Score

    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.

    Time frame: Month 18

Secondary outcomes

  1. Child Mental Health- Conduct Problem

    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.

    Time frame: Baseline

  2. Child Mental Health- Conduct Problem

    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.

    Time frame: Month 6

  3. Child Mental Health- Conduct Problem

    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.

    Time frame: Month 18

07

Results

Posted Aug 8, 2025

Participant flow

Participant flow — Overall Study
MilestoneParentCorps-Professional Development (PD) - Parent + Child: UrbanParentCorps-Professional Development (PD) - Teachers: UrbanParentCorps-Professional Development (PD) + T-Wellness - Parent + Child: UrbanParentCorps-Professional Development (PD) + T-Wellness - Teachers: UrbanControl - Parent + Child: UrbanControl - Teacher: UrbanParentCorps-Professional Development (PD) - Parent + Child: RuralParentCorps-Professional Development (PD) - Teachers: RuralParentCorps-Professional Development (PD) + T-Wellness - Parent + Child: RuralParentCorps-Professional Development (PD) + T-Wellness - Teachers: RuralControl - Parent + Child: RuralControl - Teacher: Rural
Started650896007763273688986588064292
Completed538755226452260614855807048279
Not completed112147813110137413781016013
Withdrew: Lost to follow-up112147813110137413781016013

Outcome measures

PrimaryTeacher Knowledge of Evidence-Based Practice (Knowledge Score)

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.

Time frame:
Baseline
Reported as:
Mean · score on a scale
Teacher Knowledge of Evidence-Based Practice (Knowledge Score)
score on a scaleParentCorps-Professional Development (PD) - Teachers: Urban and RuralParentCorps-Professional Development (PD) + T-Wellness - Teachers: Urban and RuralControl - Teacher: Urban and Rural
Teacher Knowledge of Evidence-Based Practice (Knowledge Score)36.68 ± 14.4636.41 ± 13.9635.18 ± 11.75
PrimaryTeacher Knowledge of Evidence-Based Practice (Knowledge Score)

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.

Time frame:
Month 6
Reported as:
Mean · score on a scale
Teacher Knowledge of Evidence-Based Practice (Knowledge Score)
score on a scaleParentCorps-Professional Development (PD) - Teachers: Urban and RuralParentCorps-Professional Development (PD) + T-Wellness - Teachers: Urban and RuralControl - Teacher: Urban and Rural
Teacher Knowledge of Evidence-Based Practice (Knowledge Score)41.91 ± 15.8545.12 ± 14.1236.75 ± 13.64
PrimaryTeacher EBI Practice Score

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.

Time frame:
Baseline
Reported as:
Mean · score on a scale
Teacher EBI Practice Score
score on a scaleParentCorps-Professional Development (PD) - Teachers: Urban and RuralParentCorps-Professional Development (PD) + T-Wellness - Teachers: Urban and RuralControl - Teacher: Urban and Rural
Teacher EBI Practice Score3.82 ± 0.363.80 ± 0.363.74 ± 0.37
PrimaryTeacher EBI Practice Score

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.

Time frame:
Month 6
Reported as:
Mean · score on a scale
Teacher EBI Practice Score
score on a scaleParentCorps-Professional Development (PD) - Teachers: Urban and RuralParentCorps-Professional Development (PD) + T-Wellness - Teachers: Urban and RuralControl - Teacher: Urban and Rural
Teacher EBI Practice Score3.83 ± 0.383.87 ± 0.363.71 ± 0.41
PrimaryTeacher EBI Practice Score

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.

Time frame:
Month 18
Reported as:
Mean · score on a scale
Teacher EBI Practice Score
score on a scaleParentCorps-Professional Development (PD) - Teachers: Urban and RuralParentCorps-Professional Development (PD) + T-Wellness - Teachers: Urban and RuralControl - Teacher: Urban and Rural
Teacher EBI Practice Score3.93 ± 0.363.93 ± 0.353.98 ± 0.77
PrimaryTeacher Stress Score

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.

Time frame:
Baseline
Reported as:
Mean · score on a scale
Teacher Stress Score
score on a scaleParentCorps-Professional Development (PD) - Teachers: Urban and RuralParentCorps-Professional Development (PD) + T-Wellness - Teachers: Urban and RuralControl - Teacher: Urban and Rural
Teacher Stress Score2.23 ± 0.522.45 ± 0.612.29 ± 0.55
PrimaryTeacher Stress Score

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.

Time frame:
Month 6
Reported as:
Mean · score on a scale
Teacher Stress Score
score on a scaleParentCorps-Professional Development (PD) - Teachers: Urban and RuralParentCorps-Professional Development (PD) + T-Wellness - Teachers: Urban and RuralControl - Teacher: Urban and Rural
Teacher Stress Score2.16 ± 0.582.18 ± 0.542.29 ± 0.62
PrimaryTeacher Stress Score

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.

Time frame:
Month 18
Reported as:
Mean · score on a scale
Teacher Stress Score
score on a scaleParentCorps-Professional Development (PD) - Teachers: Urban and RuralParentCorps-Professional Development (PD) + T-Wellness - Teachers: Urban and RuralControl - Teacher: Urban and Rural
Teacher Stress Score2.08 ± 0.532.12 ± 0.562.11 ± 0.53
PrimaryTeacher Stress Management

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.

Time frame:
Baseline
Reported as:
Mean · score on a scale
Teacher Stress Management
score on a scaleParentCorps-Professional Development (PD) - Teachers: Urban and RuralParentCorps-Professional Development (PD) + T-Wellness - Teachers: Urban and RuralControl - Teacher: Urban and Rural
Teacher Stress Management3.09 ± 0.403.04 ± 0.393.05 ± 0.35
PrimaryTeacher Stress Management

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.

Time frame:
Month 6
Reported as:
Mean · score on a scale
Teacher Stress Management
score on a scaleParentCorps-Professional Development (PD) - Teachers: Urban and RuralParentCorps-Professional Development (PD) + T-Wellness - Teachers: Urban and RuralControl - Teacher: Urban and Rural
Teacher Stress Management3.10 ± 0.373.08 ± 0.343.01 ± 0.36
PrimaryTeacher Stress Management

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.

Time frame:
Month 18
Reported as:
Mean · score on a scale
Teacher Stress Management
score on a scaleParentCorps-Professional Development (PD) - Teachers: Urban and RuralParentCorps-Professional Development (PD) + T-Wellness - Teachers: Urban and RuralControl - Teacher: Urban and Rural
Teacher Stress Management3.39 ± 0.413.37 ± 0.393.26 ± 0.37
PrimaryChild's Emotion Regulation Score

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.

Time frame:
Baseline
Reported as:
Mean · score on a scale
Child's Emotion Regulation Score
score on a scaleParentCorps-Professional Development (PD) - Parents: Urban and RuralParentCorps-Professional Development (PD) + T-Wellness - Parents: Urban and RuralControl - Parents: Urban and Rural
Child's Emotion Regulation Score2.33 ± 0.772.42 ± 0.732.39 ± 0.75
PrimaryChild's Emotion Regulation Score

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.

Time frame:
Month 6
Reported as:
Mean · score on a scale
Child's Emotion Regulation Score
score on a scaleParentCorps-Professional Development (PD) - Parents: Urban and RuralParentCorps-Professional Development (PD) + T-Wellness - Parents: Urban and RuralControl - Parents: Urban and Rural
Child's Emotion Regulation Score2.71 ± 0.652.75 ± 0.682.58 ± 0.7
PrimaryChild's Emotion Regulation Score

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.

Time frame:
Month 18
Reported as:
Mean · score on a scale
Child's Emotion Regulation Score
score on a scaleParentCorps-Professional Development (PD) - Parents: Urban and RuralParentCorps-Professional Development (PD) + T-Wellness - Parents: Urban and RuralControl - Parents: Urban and Rural
Child's Emotion Regulation Score2.56 ± 0.642.47 ± 0.632.53 ± 0.64
SecondaryChild Mental Health- Conduct Problem

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.

Time frame:
Baseline
Reported as:
Mean · score on a scale
Child Mental Health- Conduct Problem
score on a scaleParentCorps-Professional Development (PD) - Parents: Urban and RuralParentCorps-Professional Development (PD) + T-Wellness - Parents: Urban and RuralControl - Parents: Urban and Rural
Child Mental Health- Conduct Problem2.39 ± 2.052.41 ± 1.982.44 ± 2.09
SecondaryChild Mental Health- Conduct Problem

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.

Time frame:
Month 6
Reported as:
Mean · score on a scale
Child Mental Health- Conduct Problem
score on a scaleParentCorps-Professional Development (PD) - Parents: Urban and RuralParentCorps-Professional Development (PD) + T-Wellness - Parents: Urban and RuralControl - Parents: Urban and Rural
Child Mental Health- Conduct Problem1.96 ± 1.812.23 ± 1.902.13 ± 1.95
SecondaryChild Mental Health- Conduct Problem

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.

Time frame:
Month 18
Reported as:
Mean · score on a scale
Child Mental Health- Conduct Problem
score on a scaleParentCorps-Professional Development (PD) - Parents: Urban and RuralParentCorps-Professional Development (PD) + T-Wellness - Parents: Urban and RuralControl - Parents: Urban and Rural
Child Mental Health- Conduct Problem1.76 ± 1.761.71 ± 1.691.77 ± 1.64

Adverse events

Collected over Two years.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
ParentCorps-Professional Development (PD)0/1,525 (0%)0/1,525 (0%)0/1,525 (0%)
ParentCorps-Professional Development (PD) + T-Wellness0/1,415 (0%)0/1,415 (0%)0/1,415 (0%)
Control0/1,439 (0%)0/1,439 (0%)0/1,439 (0%)

Baseline characteristics

Note that only parent participants in the parent + child dyads were consented and had baseline characteristic data collected.

Age, Continuous
Age, Continuous(years)ParentCorps-Professional Development (PD) - Parents UrbanParentCorps-Professional Development (PD) - Teachers: UrbanParentCorps-Professional Development (PD) + T-Wellness - Parents: UrbanParentCorps-Professional Development (PD) + T-Wellness - Teachers: UrbanControl - Parents: UrbanControl - Teacher: UrbanParentCorps-Professional Development (PD) - Parents: RuralParentCorps-Professional Development (PD) - Teachers: RuralParentCorps-Professional Development (PD) + T-Wellness - Parents: RuralParentCorps-Professional Development (PD) + T-Wellness - Teachers: RuralControl - Parents: RuralControl - Teacher: RuralTotal
Mean36.04 ± 9.6540.9 ± 11.836.54 ± 10.1740.2 ± 12.335.83 ± 8.8642.7 ± 11.338.07 ± 10.6340.8 ± 9.738.05 ± 9.4640.8 ± 11.838.33 ± 11.4938.4 ± 9.938.88 ± 10.59
Sex: Female, Male
Sex: Female, Male(Participants)ParentCorps-Professional Development (PD) - Parents UrbanParentCorps-Professional Development (PD) - Teachers: UrbanParentCorps-Professional Development (PD) + T-Wellness - Parents: UrbanParentCorps-Professional Development (PD) + T-Wellness - Teachers: UrbanControl - Parents: UrbanControl - Teacher: UrbanParentCorps-Professional Development (PD) - Parents: RuralParentCorps-Professional Development (PD) - Teachers: RuralParentCorps-Professional Development (PD) + T-Wellness - Parents: RuralParentCorps-Professional Development (PD) + T-Wellness - Teachers: RuralControl - Parents: RuralControl - Teacher: RuralTotal
Female2456825049237502327423964211631782
Male80215028792311224901611029662
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)ParentCorps-Professional Development (PD) - Parents UrbanParentCorps-Professional Development (PD) - Teachers: UrbanParentCorps-Professional Development (PD) + T-Wellness - Parents: UrbanParentCorps-Professional Development (PD) + T-Wellness - Teachers: UrbanControl - Parents: UrbanControl - Teacher: UrbanParentCorps-Professional Development (PD) - Parents: RuralParentCorps-Professional Development (PD) - Teachers: RuralParentCorps-Professional Development (PD) + T-Wellness - Parents: RuralParentCorps-Professional Development (PD) + T-Wellness - Teachers: RuralControl - Parents: RuralControl - Teacher: RuralTotal
Hispanic or Latino0000000000000
Not Hispanic or Latino0000000000000
Unknown or Not Reported3258930077316733449832980321922444
Race (NIH/OMB)
Race (NIH/OMB)(Participants)ParentCorps-Professional Development (PD) - Parents UrbanParentCorps-Professional Development (PD) - Teachers: UrbanParentCorps-Professional Development (PD) + T-Wellness - Parents: UrbanParentCorps-Professional Development (PD) + T-Wellness - Teachers: UrbanControl - Parents: UrbanControl - Teacher: UrbanParentCorps-Professional Development (PD) - Parents: RuralParentCorps-Professional Development (PD) - Teachers: RuralParentCorps-Professional Development (PD) + T-Wellness - Parents: RuralParentCorps-Professional Development (PD) + T-Wellness - Teachers: RuralControl - Parents: RuralControl - Teacher: RuralTotal
American Indian or Alaska Native0000000000000
Asian0000000000000
Native Hawaiian or Other Pacific Islander0000000000000
Black or African American3258930077316733449832980321922444
White0000000000000
More than one race0000000000000
Unknown or Not Reported0000000000000
Region of Enrollment
Region of Enrollment(participants)ParentCorps-Professional Development (PD) - Parents UrbanParentCorps-Professional Development (PD) - Teachers: UrbanParentCorps-Professional Development (PD) + T-Wellness - Parents: UrbanParentCorps-Professional Development (PD) + T-Wellness - Teachers: UrbanControl - Parents: UrbanControl - Teacher: UrbanParentCorps-Professional Development (PD) - Parents: RuralParentCorps-Professional Development (PD) - Teachers: RuralParentCorps-Professional Development (PD) + T-Wellness - Parents: RuralParentCorps-Professional Development (PD) + T-Wellness - Teachers: RuralControl - Parents: RuralControl - Teacher: RuralTotal
Uganda3258930077316733449832980321922444
08

Study locations

2 sites
  • Hoima School
    Hoima, Uganda
  • Kampala School
    Kampala, Uganda
09

References and documents

Publications

  • 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. PubMed 35718782 ↗

Study documents

  • Protocol and statistical analysis plan · Aug 10, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — The de-identified participant data from the final research datasets (defined below) will be shared via the National Databased of Clinical Trials (NDCT) related to Mental Illness. The proposed cluster RCT study will be carried out in Uganda. It will collect data on 540 school staff (i.e., teachers), and 1,980 parent-child pairs from 36 schools. Child and teacher/school effectiveness outcome data and demographic data collected from teachers, schools, and families across all three assessment time points will be released for sharing. In addition, implementation context data will also be released. These data will be share via the NDCT related to Mental Illness. Implementation fidelity data will not be shared through NDCT, but can be requested from the PI Keng-Yen Huang directly beginning 9 months following article publication or at the end of the study.

Supporting information: Study protocol, Sap

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04383327
Lead sponsor
NYU Langone Health
Responsible party
Sponsor
First posted
May 12, 2020
Start date
Aug 1, 2021
Primary completion
Jun 30, 2024
Completion
Feb 28, 2025
Results posted
Aug 8, 2025
Last update
Sep 14, 2026

Study contacts

Keng-Yen Huang, MD, MPH
principal investigator · NYU Langone Health

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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