Mental HealthNCT07466563
Testing Multi-level Scale-Up Strategies: Ugandan School System
A study testing Mental Health Evidence-Based Interventions (EBIs). and EBI Support in people with Mental Health, run by NYU Langone Health at 2 sites in Uganda.
Trial summary
The overall objective of the project is to address the school mental health evidence-based interventions (EBIs) scale-up and sustainability challenges in low-and-middle-income countries (LMICs) by studying "system level intervention" strategies. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health
- What is being tested?
- Mental Health Evidence-Based Interventions (EBIs). and EBI Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,536 participants
- Where
- 2 sitesUganda
- Study dates
- 3 Mar 2026to 31 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- TTCs and tutors:
- 12 TTCs (out of a total 26 TTCs) will be selected.
- All tutors will be aged 18-65, and currently employed under the educational system.
- Tutors from each TTC will be recruited and trained in EBI implementation and management
- Schools:
- 10 public schools (5 match pairs, match in size) under each TTC will be selected, and Principals of public schools will be invited to attend information sessions.
Show all 10Show fewer
- All principals will be aged 18-65, and currently employed under the educational system.
- PTTs and teachers:
- All pre-primary teachers serving students between the ages of 3 and 12 years at the 120 study schools will be eligible to participate.
- All teachers will be aged 18-65, and currently employed under the educational system.
Who cannot join
- Inability to provide informed consent
- Teachers who are not teaching students in the selected schools or not within the TTC service region.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sabrina Cheng contact
Uganda2 sites, 2 recruiting
- Recruiting
Uganda Ministry of Education (MOE)/District Education Office (DEO) Schools
Kampala Region, Kampala, 25601
- Recruiting
Ministry of Education (MOE)/District Education Office (DEO)
Nakaseke
About this study
Official title: TESTING MULTI-LEVEL SCALE-UP STRATEGIES TO IMPLEMENT A SCHOOL-BASED POPULATION APPROACH OF MENTAL HEALTH PREVENTIVE INTERVENTION: UGANDA
The overall objective of the project is to address the school mental health evidence-based interventions (EBIs) scale-up and sustainability challenges in low-and-middle-income countries (LMICs) by studying "system level intervention" strategies. The project tests a scale-up model utilizing a two-level train-the-trainer model to support the expansion of an evidence-based intervention (mWEL -Teacher Professional Development; PD) in one LMIC (Uganda). mWEL-PD is the abbreviation of "Promoting Mental Wellbeing \& Empowering Lives of the School Community". mWEL -PD is a teacher intervention that trains teachers to apply evidence-based strategies to engage parents and to promote student's mental health in classroom, as well as to promote teachers' own mental wellbeing. PD has been adapted and tested in Uganda and has demonstrated effectiveness in promoting Ugandan teachers' practices, teacher wellbeing, and students' mental health. Previous studies only applied one-level of the train-the-trainer model. This new study will test a new two-level of the train-the-trainer model that include a digital-learning system to scale PD, so that more teachers can be trained on PD, and more students can benefit from teachers' training and practice changes. Investigators will also test the new EBI/PD scale-up model with and without including additional sustainability strategies (including technical assistance and continuing education strategies). Investigators will carry out an evaluation study (using a cluster-randomized trial design) to understand the impacts of the new two-level training model. The participants of the study will be the trainers and trainees, and the outcomes will be their implementation and practice outcomes.
- Conditions
- Mental Health
- Being tested
- Mental Health Evidence-Based Interventions (EBIs)., EBI Support
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental Health Evidence-Based Interventions (EBIs).Behavioural
EBIs addressing mental health.
EBI SupportBehavioural
Technical assistance and continuous learning strategies to support sustainable EBI implementation.
| Study group | Role | What they receive |
|---|---|---|
| EBI Implementation | Experimental | Schools will implement the mental health evidence-based interventions (EBIs). Receives: Behavioral: Mental Health Evidence-Based Interventions (EBIs). |
| EBI Implementation + Technical Assistance + Continuous Learning | Experimental | Schools will implement the mental health evidence-based interventions (EBIs); they will also receive technical assistance and continuous learning strategies to support sustainable EBI implementation. Receives: Behavioral: Mental Health Evidence-Based Interventions (EBIs).; Behavioral: EBI Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Teacher Knowledge of Evidence-Based Practice: Teacher Self-Report.
A % correct score from 0-100 will be created.
Measured: Baseline (T1); After Training (T2, 4-5 month after T1)
Teacher Practice Using EBI Strategies
A composite score will be created from four measures, including (i) Practice of EBI strategies (applied a range of evidence-based behavioral management strategies); (ii) Mindfulness (awareness of own action and consideration of student's situation when interacting or disciplining students); (iv) Emotion socialization-Supporting Negative Emotion; (v) Family engagement ; The composite score will be range from 1-100; higher scores indicate a more positive practice.
Measured: Baseline (T1); After Training (T2, 4-5 month after T1), Follow-up (T3, 12 months after T1)
Teacher Stress Management
A composite score will be created from (i) cognitive regulation (ability to redirect negative to positive thinking; (ii) emotion regulation; (iii) support from work. The composite score will be range from 1-100. Higher scores indicate better stress management.
Measured: aseline (T1); After Training (T2, 4-5 month after T1), Follow-up (T3, 12 months after T1)
Secondary outcomes (3)
Teacher Engagement in EBI
A composite score will be created from (i) completion of e-Learning modules, (ii) attendance of PD group sessions; (iii) attendance of post-PD activities. The composite score will range from 1-100.
Measured: After training (T2, 5-6 months after T1)
Teacher-Rated Program Acceptability and Usefulness
Measured using a questionnaire. Teacher will rate content relevance, usefulness of E-Learning and coaching when mWEL-PD is implemented by educators. . Each item is rated on a scale from 1-5; the total score is the mean of responses and ranges from 1-5; higher scores indicate greater acceptability.
Measured: After training (T2, 5-6 months after T1); Follow-up (T3, 12 months after T1)
Teacher-Rated Facilitator Competency
Facilitator competency is measured using a feedback questionnaire. Teachers will rate PD facilitators' (non-mental health professionals) competence in providing mWEL-PD. . Each item is rated on a scale from 1-5; the total score is the mean of responses and ranges from 1-5; higher scores indicate greater appropriateness.
Measured: After training (T2, 5-6 months after T1); Follow-up (T3, 12 months after T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start3 Mar 2026
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,536 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Keng-Yen Huang, MPH, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07466563
- Sponsor's protocol ID
- 24-00477
- Status last verified
- Jul 2026
- First submitted
- 9 Mar 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Keng-Yen.Huang@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TESTING MULTI-LEVEL SCALE-UP STRATEGIES TO IMPLEMENT A SCHOOL-BASED POPULATION APPROACH OF MENTAL HEALTH PREVENTIVE INTERVENTION: UGANDA
- ClinicalTrials.gov ID
- NCT07466563
- Acronym / sponsor ID
- 24-00477
- Conditions
- Mental Health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,536 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 3 Mar 2026 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objective of the project is to address the school mental health evidence-based interventions (EBIs) scale-up and sustainability challenges in low-and-middle-income countries (LMICs) by studying "system level intervention" strategies. The project tests a scale-up model utilizing a two-level train-the-trainer model to support the expansion of an evidence-based intervention (mWEL -Teacher Professional Development; PD) in one LMIC (Uganda). mWEL-PD is the abbreviation of "Promoting Mental Wellbeing \& Empowering Lives of the School Community". mWEL -PD is a teacher intervention that trains teachers to apply evidence-based strategies to engage parents and to promote student's mental health in classroom, as well as to promote teachers' own mental wellbeing. PD has been adapted and tested in Uganda and has demonstrated effectiveness in promoting Ugandan teachers' practices, teacher wellbeing, and students' mental health. Previous studies only applied one-level of the train-the-trainer model. This new study will test a new two-level of the train-the-trainer model that include a digital-learning system to scale PD, so that more teachers can be trained on PD, and more students can benefit from teachers' training and practice changes. Investigators will also test the new EBI/PD scale-up model with and without including additional sustainability strategies (including technical assistance and continuing education strategies). Investigators will carry out an evaluation study (using a cluster-randomized trial design) to understand the impacts of the new two-level training model. The participants of the study will be the trainers and trainees, and the outcomes will be their implementation and practice outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EBI Implementation | Experimental | Behavioral: Mental Health Evidence-Based Interventions (EBIs).Schools will implement the mental health evidence-based interventions (EBIs). |
| EBI Implementation + Technical Assistance + Continuous Learning | Experimental | Behavioral: Mental Health Evidence-Based Interventions (EBIs)., Behavioral: EBI SupportSchools will implement the mental health evidence-based interventions (EBIs); they will also receive technical assistance and continuous learning strategies to support sustainable EBI implementation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 12 TTCs (out of a total 26 TTCs) will be selected.
- All tutors will be aged 18-65, and currently employed under the educational system.
- Tutors from each TTC will be recruited and trained in EBI implementation and management
- 10 public schools (5 match pairs, match in size) under each TTC will be selected, and Principals of public schools will be invited to attend information sessions.
- All principals will be aged 18-65, and currently employed under the educational system.
Key exclusion criteria (2 listed)
- Inability to provide informed consent
- Teachers who are not teaching students in the selected schools or not within the TTC service region.
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 |
|---|---|---|
| Mental Health Evidence-Based Interventions (EBIs).EBIs addressing mental health. | Behavioural | EBI Implementation, EBI Implementation + Technical Assistance + Continuous Learning |
| EBI SupportTechnical assistance and continuous learning strategies to support sustainable EBI implementation. | Behavioural | EBI Implementation + Technical Assistance + Continuous Learning |
Primary outcome
Teacher Knowledge of Evidence-Based Practice: Teacher Self-Report.
Time frame: Baseline (T1); After Training (T2, 4-5 month after T1)
A % correct score from 0-100 will be created.
Teacher Practice Using EBI Strategies
Time frame: Baseline (T1); After Training (T2, 4-5 month after T1), Follow-up (T3, 12 months after T1)
A composite score will be created from four measures, including (i) Practice of EBI strategies (applied a range of evidence-based behavioral management strategies); (ii) Mindfulness (awareness of own action and consideration of student's situation when interacting or disciplining students); (iv) Emotion socialization-Supporting Negative Emotion; (v) Family engagement ; The composite score will be range from 1-100; higher scores indicate a more positive practice.
Teacher Stress Management
Time frame: aseline (T1); After Training (T2, 4-5 month after T1), Follow-up (T3, 12 months after T1)
A composite score will be created from (i) cognitive regulation (ability to redirect negative to positive thinking; (ii) emotion regulation; (iii) support from work. The composite score will be range from 1-100. Higher scores indicate better stress management.
3 secondary outcomes
Teacher Engagement in EBI
Time frame: After training (T2, 5-6 months after T1)
Teacher-Rated Program Acceptability and Usefulness
Time frame: After training (T2, 5-6 months after T1); Follow-up (T3, 12 months after T1)
Teacher-Rated Facilitator Competency
Time frame: After training (T2, 5-6 months after T1); Follow-up (T3, 12 months after T1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Keng-Yen.Huang@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
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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.
Sabrina Cheng contact
Keng-Yen Huang, MPH, PhD 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 Mental Health Evidence-Based Interventions (EBIs). and EBI Support in people with Mental Health, 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 10 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 22 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Keng-Yen Huang, MPH, PhD (646-501-2879, Keng-yen.huang@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Teacher Knowledge of Evidence-Based Practice: Teacher Self-Report. (time frame: Baseline (T1); After Training (T2, 4-5 month after T1)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jul 2026.