School-Based Mental Health Effectiveness Study

NCT04383327 | Completed Results DMC

• 1 other identifier: 20-00117
• Study Type: interventional
• Target: 2,444
• Locations: 1 country
• Sites: 2

Brief Summary

This study involves efforts to advance the science of prevention in early childhood mental health in low-resource communities. Investigators will assess the effectiveness, practical implementation strategies, and underlying mechanisms of the evidence-based intervention, ParentCorps-Professional Development, in urban and rural Uganda. Two implementation approaches, with and without the teacher stress management package, T-Wellness, will be compared for efficacy.

Conditions

Child Development

Outcome Measures

Primary Outcomes (11)

• Teacher Knowledge of Evidence-Based Practice (Knowledge Score)

  Teachers will complete a 10-item quiz assessing EBI knowledge. The total score is the number of correct responses and ranges from 0-100; higher scores indicate greater knowledge.

  Baseline

• Teacher Knowledge of Evidence-Based Practice (Knowledge Score)

  Teachers will complete a 10-item quiz assessing EBI knowledge. The total score is the number of correct responses and ranges from 0-100; higher scores indicate greater knowledge.

  Month 6

• Teacher EBI Practice Score-Emotion Support Strategies Use

  The Emotion Socialization Scale assesses teachers' practice in supporting students' management of negative emotions. Each of the scale items (6 items) are rated on a scale from 1 to 5. The total score is the average of responses and ranges from 1-5; lower scores indicate lower adherence to EBI practice.

  Baseline

• Teacher EBI Practice Score-Emotion Support Strategies Use

  The Emotion Socialization Scale assesses teachers' practice in supporting students' management of negative emotions. Each of the scale items (6 items) are rated on a scale from 1 to 5. The total score is the average of responses and ranges from 1-5; lower scores indicate lower adherence to EBI practice.

  Month 6

• Teacher EBI Practice Score-Emotion Support Strategies Use

  The Emotion Socialization Scale assesses teachers' practice in supporting students' management of negative emotions. Each of the scale items (6 items) are rated on a scale from 1 to 5. The total score is the average of responses and ranges from 1-5; lower scores indicate lower adherence to EBI practice.

  Month 18

• Teacher Stress Score

  Teachers complete a 5-item assessment of stress over the past month. Each item is rated on a scale from 1 to 4. The total score is the average of responses and ranges from 1-4. Higher scores indicate greater stress.

  Baseline

• Teacher Stress Score

  Teachers complete a 5-item assessment of stress over the past month. Each item is rated on a scale from 1 to 4. The total score is the average of responses and ranges from 1-4. Higher scores indicate greater stress.

  Month 6

• Teacher Stress Score

  Teachers complete a 5-item assessment of stress over the past month. Each item is rated on a scale from 1 to 4. The total score is the average of responses and ranges from 1-4. Higher scores indicate greater stress.

  Month 18

• Child's Emotion Regulation Score

  Parents answer 6 questions about their child's emotion regulation behavior over the past 7 days. Each item is rated on a Likert scale from 0 (not at all) to 4 (very well). The total score ranges from 0 to 4; higher scores indicate greater emotion regulation.

  Baseline

• Child's Emotion Regulation Score

  Parents answer 6 questions about their child's emotion regulation behavior over the past 7 days. Each item is rated on a Likert scale from 0 (not at all) to 4 (very well). The total score ranges from 0 to 4; higher scores indicate greater emotion regulation.

  Month 6

• Child's Emotion Regulation Score

  Parents answer 6 questions about their child's emotion regulation behavior over the past 7 days. Each item is rated on a Likert scale from 0 (not at all) to 4 (very well). The total score ranges from 0 to 4; higher scores indicate greater emotion regulation.

  Month 18

Secondary Outcomes (6)

• Teacher Mental Health

  Baseline

• Teacher Mental Health

  Month 6

• Teacher Mental Health

  Month 18

• Child Mental Health- Conduct Problem

  Baseline

• Child Mental Health- Conduct Problem

  Month 6

Study Arms (3)

ParentCorps-Professional Development (PD)

EXPERIMENTAL

n = 6 Schools in Kampala, Uganda (Urban) - 89 Teachers, 325 Parent-Child Pairs \+ n = 10 Schools in Hoima, Uganda (Rural) - 98 Teachers, 344 Parent-Child Pairs

Behavioral: ParentCorps-Professional Development (PD)

ParentCorps-Professional Development (PD) + T-Wellness

EXPERIMENTAL

n = 6 Schools in Kampala, Uganda (Urban) - 77 Teachers, 300 Parent-Child Pairs \+ n = 10 Schools in Hoima, Uganda (Rural) - 80 Teachers, 329 Parent-Child Pairs

Behavioral: ParentCorps-Professional Development (PD); Behavioral: T-Wellness

Control

NO INTERVENTION

n = 6 Schools in Kampala, Uganda (Urban) - 73 Teachers, 316 Parent-Child Pairs \+ n = 9 Schools in Hoima, Uganda (Rural) - 92 Teachers, 321 Parent-Child Pairs

Interventions

ParentCorps-Professional Development (PD) BEHAVIORAL

Multi-component school-based intervention that promotes early childhood mental health and development. Teachers (pre-primary to 4th grade) will participate in a 3-day ParentCorps-PD training during the school term. They will also receive 8 sessions (8 hours) of face-to-face group-based coaching during after the training. Coaching sessions are to help teachers apply EBI strategies in their classrooms, engage families, and develop competencies.

ParentCorps-Professional Development (PD); ParentCorps-Professional Development (PD) + T-Wellness

T-Wellness BEHAVIORAL

A brief teacher stress management psychoeducation package, adapted from EBIs including one-day workshop for common stress management and stress management, and three follow-up group support sessions (3 additional monthly 1-hr wellness sessions for teachers as a group that were integrated into the 3 of the 8 PD coaching sessions. A total 3 hours of coaching were included.

ParentCorps-Professional Development (PD) + T-Wellness

Eligibility Criteria

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

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Evidence of psychopathology or cognitive impairment severe enough to preclude giving consent, or completing the survey instruments or the focus group of the study.
• Minors (age \<18) will also be excluded. Additional criteria should be included as appropriate for the study design and risk.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (2)

Hoima School

Hoima, Uganda

Location

Kampala School

Kampala, Uganda

Location

Related Publications (1)

• Huang KY, Nakigudde J, Kisakye EN, Sentongo H, Dennis-Tiwary TA, Tozan Y, Park H, Brotman LM. Advancing scalability and impacts of a teacher training program for promoting child mental health in Ugandan primary schools: protocol for a hybrid-type II effectiveness-implementation cluster randomized trial. Int J Ment Health Syst. 2022 Jun 20;16(1):28. doi: 10.1186/s13033-022-00538-7.

  PMID: 35718782 DERIVED

Results Point of Contact

• Title: Keng-Yen Huang, PhD, MPH
• Organization: NYU Langone Health

Keng-Yen.Huang@nyulangone.org

646-501-2879

Study Officials

• Keng-Yen Huang, MD, MPH

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research staff performing outcome assessment will be blind to the study conditions.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A cluster randomized controlled trial (cRCT), single blind and mixed-methods design will be applied

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: May 12, 2020
• Study Start: August 1, 2021
• Primary Completion: June 30, 2024
• Study Completion: February 28, 2025
• Last Updated: August 8, 2025
• Results First Posted: August 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Analyzed data file and final trial data will be share at the end of the study via the National Databased of Clinical Trials (NDCT) related to Mental Illness (the NIMH recommended format). There will be no end date for data sharing.
• Access Criteria: Requests should be directed to PI Keng-Yen Huang at huangk01@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

UG (2)