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

July 21, 2026 updated by: NYU Langone Health

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1536

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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:

  • Inability to provide informed consent
  • Teachers who are not teaching students in the selected schools or not within the TTC service region.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: EBI Implementation
Schools will implement the mental health evidence-based interventions (EBIs).
Behavioral: Mental Health Evidence-Based Interventions (EBIs).
EBIs addressing mental health.
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).
EBIs addressing mental health.
Behavioral: EBI Support
Technical assistance and continuous learning strategies to support sustainable EBI implementation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline (T1); After Training (T2, 4-5 month after T1)
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.
Baseline (T1); After Training (T2, 4-5 month after T1), Follow-up (T3, 12 months after T1)
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.
aseline (T1); After Training (T2, 4-5 month after T1), Follow-up (T3, 12 months after T1)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Teacher Engagement in EBI
Time Frame: After training (T2, 5-6 months after T1)
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.
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)
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.
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)
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.
After training (T2, 5-6 months after T1); Follow-up (T3, 12 months after T1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NYU Langone Health

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Keng-Yen Huang, MPH, PhD, NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 3, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 24-00477

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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