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

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: Recruiting
• Conditions: Mental Health
• Intervention / Treatment: Behavioral: Mental Health Evidence-Based Interventions (EBIs).; Behavioral: EBI Support

• Study Type: Interventional
• Enrollment (Estimated): 1556
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Keng-Yen Huang, MPH, PhD; Phone Number: 646-501-2879; Email: Keng-yen.huang@nyulangone.org
• Study Contact Backup: Name: Sabrina Cheng; Email: Sabrina.Cheng@nyulangone.org

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Teacher Knowledge of Evidence-Based Practice: Teacher Self-Report.	A % correct score from 0-100 will be created.	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.	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.	aseline (T1); After Training (T2, 4-5 month after T1), Follow-up (T3, 12 months after T1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	After training (T2, 5-6 months after T1); Follow-up (T3, 12 months after T1)

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Keng-Yen Huang, MPH, PhD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): March 31, 2029

Study Registration Dates

• First Submitted: March 9, 2026
• First Submitted That Met QC Criteria: March 9, 2026
• First Posted (Actual): March 12, 2026

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Personal Satisfaction; Psychological Well-Being; ethylenebis(isothiocyanate)
• Other Study ID 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