ClinicalTrials.gg
RecruitingNCT07466563Updated Jul 22, 2026

Testing Multi-level Scale-Up Strategies: Ugandan School System

An interventional study of Mental Health Evidence-Based Interventions (EBIs). and EBI Support in Mental Health, sponsored by NYU Langone Health. Recruiting at 2 sites in Uganda. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-22.

Sponsored by NYU Langone Health · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Mar 2026; still recruiting 8 months later.

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Phase
Not applicable
Study type
Interventional
Enrollment
1,536
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 10 studies in Psychological Well-Being with a site in Uganda — 3 open to participants now, 6 under way, none of them phase 3. Psychological Well-Being · Uganda.

Planned enrollment
2nd of 10
1,536 · median 900
Started
2026
with 3 others
No phase
10 of 10
3 open now
Registered
7th of 10
by date
Lead sponsor
2 of 10
NYU Langone Health

Among the 10 studies in Psychological Well-Being with a site in Uganda, this one is the 2nd largest by planned enrollment, is one of 4 that started in 2026, is one of 10 with no phase, and was the 7th registered.

Psychological Well-Being

2,195 studies on the registry are indexed under Psychological Well-Being; 728 are open to participants now.

Browse Psychological Well-Being studies →

Open to participants now

3 of the 10 studies in Psychological Well-Being with a site in Uganda are open now. Recruiting first, the newest first:

All 3 open studies →

A study can be open while its sites in Uganda have not opened yet or have stopped. Only those recruiting at a site in Uganda →

Who these studies take

Of the 401 Psychological Well-Being studies recruiting now, 218 (54%) set no upper age limit and 157 (39%) stop at 75 or younger; 120 take children under 18; 204 take healthy volunteers.

This study: 18 Years to 65 Years · all sexes · healthy volunteers too.

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02

Study 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. 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.

03

Conditions studied

  • Mental Health
04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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.
  • 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.

Exclusion criteria

Exclusion Criteria:

  • Inability to provide
  • Teachers who are not teaching students in the selected schools or not within the TTC service region.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
1,536 participants (estimated)

Study arms

  • Experimental
    EBI Implementation

    Schools will implement the mental health evidence-based interventions (EBIs).

    Behavioral: Mental Health Evidence-Based Interventions (EBIs).

  • Experimental
    EBI Implementation + Technical Assistance + Continuous Learning

    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.

    Behavioral: Mental Health Evidence-Based Interventions (EBIs). · Behavioral: EBI Support

Interventions

  • BehavioralMental Health Evidence-Based Interventions (EBIs).

    EBIs addressing mental health.

  • BehavioralEBI Support

    Technical assistance and continuous learning strategies to support sustainable EBI implementation.

06

What researchers measure

Primary outcomes

  1. Teacher Knowledge of Evidence-Based Practice: Teacher Self-Report.

    A % correct score from 0-100 will be created.

    Time frame: Baseline (T1); After Training (T2, 4-5 month after T1)

  2. 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.

    Time frame: Baseline (T1); After Training (T2, 4-5 month after T1), Follow-up (T3, 12 months after T1)

  3. 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.

    Time frame: aseline (T1); After Training (T2, 4-5 month after T1), Follow-up (T3, 12 months after T1)

Secondary outcomes

  1. 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.

    Time frame: After training (T2, 5-6 months after T1)

  2. 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.

    Time frame: After training (T2, 5-6 months after T1); Follow-up (T3, 12 months after T1)

  3. 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.

    Time frame: After training (T2, 5-6 months after T1); Follow-up (T3, 12 months after T1)

07

Study locations

2 of 2 sites recruiting
  • Uganda Ministry of Education (MOE)/District Education Office (DEO) Schools
    Kampala Region, Kampala 25601, Uganda
    Recruiting
  • Ministry of Education (MOE)/District Education Office (DEO)
    Nakaseke, Uganda
    Recruiting
08

References and documents

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Statistical analysis plan

Time frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.

Access criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Keng-Yen.Huang@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2026 (actual). Primary completion is estimated for Aug 2028, 29 months after the start.

Of 1,261 non-industry interventional studies with no phase under Psychological Well-Being, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 34. This study's planned 29 months is above that.

Counting every sponsor, half of 1,304 studies reached it within 16 months; a quarter within 7 and three quarters within 34.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 9, 2026
First posted
Mar 12, 2026
StartActual
Mar 3, 2026
Primary completionEst.
Aug 31, 2028
CompletionEst.
Mar 31, 2029
Last update
Jul 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07466563
Lead sponsor
NYU Langone Health
Responsible party
Sponsor
First posted
Mar 12, 2026
Start date
Mar 3, 2026
Primary completion
Aug 31, 2028 (estimated)
Completion
Mar 31, 2029 (estimated)
Last update
Jul 22, 2026

Study contacts

Keng-Yen Huang, MPH, PhD
Contact
Keng-yen.huang@nyulangone.org
646-501-2879
Sabrina Cheng
Contact
Sabrina.Cheng@nyulangone.org
Keng-Yen Huang, MPH, PhD
principal investigator · NYU Langone Health

Oversight

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

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