Child DevelopmentNCT04383327
School-Based Mental Health Effectiveness Study
A study testing ParentCorps-Professional Development (PD) and T-Wellness in people with Child Development, run by NYU Langone Health at 2 sites in Uganda.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Development
- What is being tested?
- ParentCorps-Professional Development (PD) and T-Wellness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,444 participants
- Where
- 2 sitesUganda
- Study dates
- 1 Aug 2021to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Effectiveness and Implementation of an Early Childhood School-Based Mental Health Intervention in Low-Resource Communities
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.
- Conditions
- Child Development
- Being tested
- ParentCorps-Professional Development (PD), T-Wellness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParentCorps-Professional Development (PD)Behavioural
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-WellnessBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| ParentCorps-Professional Development (PD) | Experimental | 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 Receives: Behavioral: ParentCorps-Professional Development (PD) |
| ParentCorps-Professional Development (PD) + T-Wellness | Experimental | 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 Receives: Behavioral: ParentCorps-Professional Development (PD); Behavioral: T-Wellness |
| Control | No intervention | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
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.
Measured: Month 6
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.
Measured: Baseline
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.
Measured: Month 6
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.
Measured: Month 18
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.
Measured: Baseline
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.
Measured: Month 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.
Measured: Month 18
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.
Measured: Baseline
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.
Measured: Month 6
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.
Measured: Month 18
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.
Measured: Baseline
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.
Measured: Month 6
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.
Measured: Month 18
Secondary outcomes (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.
Measured: Baseline
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.
Measured: Month 6
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.
Measured: Month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start1 Aug 2021
- Primary completion30 Jun 2024
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A cluster randomized controlled trial (cRCT), single blind and mixed-methods design will be applied
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,444 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Keng-Yen Huang, MD, MPH, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04383327
- Sponsor's protocol ID
- 20-00117
- Status last verified
- Aug 2026
- First submitted
- 16 Apr 2020
- Last updated
- 14 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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 at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Implementation of an Early Childhood School-Based Mental Health Intervention in Low-Resource Communities
- ClinicalTrials.gov ID
- NCT04383327
- Acronym / sponsor ID
- 20-00117
- Conditions
- Child Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,444 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 12 May 2020 (actual)
- Results
- Posted 8 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- A cluster randomized controlled trial (cRCT), single blind and mixed-methods design will be applied
| Arm | Type | Receives |
|---|---|---|
| ParentCorps-Professional Development (PD) | Experimental | Behavioral: 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 |
| ParentCorps-Professional Development (PD) + T-Wellness | Experimental | Behavioral: ParentCorps-Professional Development (PD), Behavioral: T-Wellnessn = 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 |
| Control | No intervention | –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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ParentCorps-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. | Behavioural | ParentCorps-Professional Development (PD), ParentCorps-Professional Development (PD) + T-Wellness |
| T-WellnessA 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. | Behavioural | ParentCorps-Professional Development (PD) + T-Wellness |
Primary outcome
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.
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.
Teacher EBI Practice Score
Time frame: 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
Time frame: 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
Time frame: 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 Score
Time frame: 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
Time frame: 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 Stress Score
Time frame: 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 Management
Time frame: 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
Time frame: 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
Time frame: 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.
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.
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.
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.
3 secondary outcomes
Child Mental Health- Conduct Problem
Time frame: Baseline
Child Mental Health- Conduct Problem
Time frame: Month 6
Child Mental Health- Conduct Problem
Time frame: Month 18
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35718782Huang 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keng-Yen Huang, MD, MPH principal investigator
NYU Langone Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ParentCorps-Professional Development (PD) and T-Wellness in people with Child Development, run by NYU Langone Health at 2 sites in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Teacher Knowledge of Evidence-Based Practice (Knowledge Score) (time frame: Baseline). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04383327, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.