N/A
N=4,379
School-Based Mental Health Effectiveness Study
Child Development
Bottom Line
View on ClinicalTrials.gov: NCT04383327 ↗Enrolled (actual)
4,379
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Teacher Knowledge of Evidence-Based Practice (Knowledge Score) — 36.68; 36.41; 35.18 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ParentCorps-Professional Development (PD) (Behavioral); T-Wellness (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Teacher Knowledge of Evidence-Based Practice (Knowledge Score) |
41.91; 45.12; 36.75 | — |
| PRIMARY Teacher Knowledge of Evidence-Based Practice (Knowledge Score) |
41.91; 45.12; 36.75 | — |
| PRIMARY Teacher EBI Practice Score-Emotion Support Strategies Use |
4.14; 4.19; 3.98 | — |
| PRIMARY Teacher EBI Practice Score-Emotion Support Strategies Use |
4.14; 4.19; 3.98 | — |
| PRIMARY Teacher EBI Practice Score-Emotion Support Strategies Use |
4.14; 4.19; 3.98 | — |
| PRIMARY Teacher Stress Score |
1.84; 1.83; 1.83 | — |
| PRIMARY Teacher Stress Score |
1.84; 1.83; 1.83 | — |
| PRIMARY Teacher Stress Score |
1.84; 1.83; 1.83 | — |
| PRIMARY Child's Emotion Regulation Score |
2.56; 2.47; 2.53 | — |
| PRIMARY Child's Emotion Regulation Score |
2.56; 2.47; 2.53 | — |
| PRIMARY Child's Emotion Regulation Score |
2.56; 2.47; 2.53 | — |
| SECONDARY Teacher Mental Health |
18.79; 18.82; 19.32 | — |
| SECONDARY Teacher Mental Health |
18.79; 18.82; 19.32 | — |
| SECONDARY Teacher Mental Health |
18.79; 18.82; 19.32 | — |
| SECONDARY Child Mental Health- Conduct Problem |
1.76; 1.71; 1.77 | — |
| SECONDARY Child Mental Health- Conduct Problem |
1.76; 1.71; 1.77 | — |
| SECONDARY Child Mental Health- Conduct Problem |
1.76; 1.71; 1.77 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04383327). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.