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

NCT07466563 | Recruiting

• 1 other identifier: 24-00477
• Study Type: interventional
• Target: 1,556
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Mental Health

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Teacher Engagement in EBI

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

• Teacher-Rated Program Acceptability and Usefulness

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

• Teacher-Rated Facilitator Competency

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

Study Arms (2)

EBI Implementation

EXPERIMENTAL

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

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.

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

Interventions

Mental Health Evidence-Based Interventions (EBIs). BEHAVIORAL

EBIs addressing mental health.

EBI Implementation; EBI Implementation + Technical Assistance + Continuous Learning

EBI Support BEHAVIORAL

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

EBI Implementation + Technical Assistance + Continuous Learning

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• TTCs and tutors:
• 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:
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

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

MeSH Terms

Conditions

Psychological Well-Being

Interventions

ethylenebis(isothiocyanate)

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Keng-Yen Huang, MPH, PhD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Keng-Yen Huang, MPH, PhD

CONTACT

646-501-2879; Keng-yen.huang@nyulangone.org

Sabrina Cheng

CONTACT

Sabrina.Cheng@nyulangone.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 12, 2026
• Study Start: March 2, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): March 31, 2029
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.

Locations

UG (2)