School-Based Mental Health Effectiveness Study

Effectiveness and Implementation of an Early Childhood School-Based Mental Health Intervention in Low-Resource Communities

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Child Development
• Intervention / Treatment: Behavioral: ParentCorps-Professional Development (PD); Behavioral: T-Wellness

Detailed Description

Promoting child mental health in low-resource or low-income country settings faces numerous challenges in global health research. Although efforts have been made to improve mental health interventions and services for young children, evidence-based interventions (EBIs) for children in low-and middle-income countries (LMICs) are limited. Most mental health EBIs in LMICs have not been scaled widely, and do not focus on early childhood. Mechanisms of action and effectiveness are not well understood. Additionally, most EBIs in LMICs rely on community health workers (CHWs) or a task-shifting approach of implementation because of resource barriers and shortage of mental health professionals (MHPs). However, challenges related to task-shifting (e.g., CHW stress and job burnout) have rarely been studied. For task-shifting to be successful, strategies to overcome challenges faced by CHWs and understanding mechanisms to conduct effective task-shifting are paramount. The overall goal of this study is to address these EBI effectiveness and implementation knowledge gaps by providing a preventive EBI (ParentCorps-Professional Development; PD) that utilizes a task-shifting and a scalable implementation model to promote early childhood students' mental health in a LMIC-Uganda. PD is a school-based EBI and preventive mental health service provision model that supports teachers and school personnel to apply EBI strategies to promote young children's mental health. The PD approach represents a task-shifting model of mental healthcare by shifting mental health preventive duties from professionals to teachers to optimize school children's mental health. Therefore, teachers are considered as CHWs. This study examines impacts and cost-effectiveness of the EBI/PD on teachers and students, as well as examines underlying mechanisms (or theories of change) that contribute to intervention effect. In addition, considering most Ugandan teachers (or CHWs) experience occupational stress that threatens PD uptake, effectiveness, and sustainment, this study will also test a teacher stress management package (T-Wellness, adapted from EBIs) as an enhancement to PD. This study will investigate whether PD + T-Wellness (PDT) is more effective for CHWs/teachers than PD alone.

• Study Type: Interventional
• Enrollment (Actual): 2444
• Phase: Not Applicable

Contacts and Locations

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

Study Locations

• Uganda
  • Hoima, Uganda
    • Hoima School
  • Kampala, Uganda
    • Kampala School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

1. The inclusion criteria for the school staff (teachers, head teachers) are: they must be in the recruited study schools and teaching in Pre-Primary to Primary 4 classrooms or holding the head teachers/administration leadership position in school. The inclusion criteria for Parent Leaders are: they must be at least 18 years old and have served as a Parent-Teacher-Association member or Parent Leader in the school for at least 1 year.
2. The inclusion criteria for the PD/PDT program implementers are: they must have current employment with eligible partners (i.e., medical/mental health institutions, Teacher Training Colleges), with professional experiences in teacher training or mental health training.
3. The inclusion criteria for parents are: caregivers must be at least 18 years old, their children must be enrolled in Pre-Primary or Primary 1 to 4 classes (or between 3 to 10 years old) in the recruited schools, and willing to have their child to be assessed by research staff. Parents and children will have diverse characteristics (e.g., randomly selected from school student lists). About 10% families will be randomly selected from the student lists. The proposed study will be open to both men and women caregivers

Exclusion Criteria

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Evidence of psychopathology or cognitive impairment severe enough to preclude giving consent, or completing the survey instruments or the focus group of the study.
2. Minors (age <18) will also be excluded. Additional criteria should be included as appropriate for the study design and risk.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ParentCorps-Professional Development (PD); n = 6 Schools in Kampala, Uganda (Urban) - 90 Teachers, 6 PTAs, 330 Parent-Child Pairs + n = 6 Schools in Hoima, Uganda (Rural) - 90 Teachers, 6 PTAs, 330 Parent-Child Pairs	Behavioral: ParentCorps-Professional Development (PD); Multi-component school-based intervention that promotes early childhood mental health and development. Teachers and PTAs (pre-primary to 4th grade) will participate in a 3-day ParentCorps-PD training before the 1st school term. They will also receive 8 sessions (12 hours) of face-to-face group-based coaching during the 1st and 2nd terms. Coaching sessions are to help teachers apply EBI strategies in their classrooms, engage families, and develop competencies.
Experimental: ParentCorps-Professional Development (PD) + T-Wellness; n = 6 Schools in Kampala, Uganda (Urban) - 90 Teachers, 6 PTAs, 330 Parent-Child Pairs + n = 6 Schools in Hoima, Uganda (Rural) - 90 Teachers, 6 PTAs, 330 Parent-Child Pairs	Behavioral: ParentCorps-Professional Development (PD); Multi-component school-based intervention that promotes early childhood mental health and development. Teachers and PTAs (pre-primary to 4th grade) will participate in a 3-day ParentCorps-PD training before the 1st school term. They will also receive 8 sessions (12 hours) of face-to-face group-based coaching during the 1st and 2nd terms. Coaching sessions are to help teachers apply EBI strategies in their classrooms, engage families, and develop competencies.; Behavioral: T-Wellness; A brief teacher stress management psychoeducation package, adapted from EBIs including a half-day workshop for common stress management and a half-day for burnout management, and three follow-up group support sessions (3 additional monthly 1-hr wellness sessions for teachers as a group in each school, a total 15 hours of coaching).
No Intervention: Control; n = 6 Schools in Kampala, Uganda (Urban) - 90 Teachers, 6 PTAs, 330 Parent-Child Pairs + n = 6 Schools in Hoima, Uganda (Rural) - 90 Teachers, 6 PTAs, 330 Parent-Child Pairs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Child Mental Health	Two continuous composite scales will be created: Child externalizing (composite of i, iii, vi scales) and internalizing problems (composite of ii, iv, v, vii scales). A higher score indicates more mental health problems. Strength and Difficulty Questionnaire/SDQ (Parent). i) Conduct Problem/ Externalizing Range 0-10 ii) Emotion Symptom/ Internalizing. Range 0-10. PROMIS- Anger (Parent) iii) Anger scale/Externalizing. Range 0-20. PROMIS- Anxiety (Parent). iv) Anxiety scale/ Internalizing. Range 0-32. PROMIS- Depression (Parent). v) Depression Scale/Internalizing. Range 0-24. Pictorial pediatric Symptom Checklist-17 (Child). vi) Externalizing Problem. Range 0-10. vii) Internalizing Problem. Range 0-14.	Baseline, 6 months, 18 months
Change in Teacher EBI practices	Primary intermediate outcome to study underlying mechanisms. Continuous scale, based on observation and teacher report. A higher score indicates more EBI strategies used. EBI Strategies Classroom Practice (Observation by Research Staff) Positive Environment & High EBI Practice Range 1-4 EBI Strategy Practice Questionnaire (Teacher) EBI Practice Composite (e.g., positive strategies, praise/ incentive, low harsh, encourage emotion) Range 1-5	Baseline, 6 months, 18 months
Change in Teacher Stress Management	Primary intermediate outcomes to study underlying mechanisms (for PD enhancement group that also receive Teacher-Wellness Intervention/T-Wellness). One continuous Teacher Response to Stress composite score will be created (composite of i) & ii)). Continuous scale, based on teacher-report. A higher score indicates poor stress management. Perceived Stress Scale (Teacher) i)Perceive Stress Range 1-5 Difficulties in Emotion Regulation (Teacher) ii) Emotion Regulation Difficulty Composite Range 1-5	Baseline, 6 months, 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Research Domain Criteria (RDoC) Mental Health Behavioral Domains	Secondary child effectiveness outcomes in three RDoC domains: negative valence (emotion disregulation), social processes (student-teacher relationship), executive functioning composite (hearts & flower and DCCS), and cognitive system (cognitive functioning). All on Continuous scale based on Parent-report and child-report. A higher score indicates more optimal outcome. Social Competence Scale (Parent) Emotion regulation (reverse dysregulation/negative valence) Range 0-4 Student-Teacher Relationship Scale (Child) Student-Teacher Social Process Range 0-4 Hearts and Flower (Child) Executive Function Range 0-100 Dimensional Change Card Sort/DCCS (Child) Executive Function Range 0-3 Neuro-QOL Item Bank v2.0 -Pediatric Cognitive Function - Short Form (Child) Cognitive function Range 1-5	Baseline, 6 months, 18 months

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Keng-Yen Huang, MD, MPH, NYU Langone Health

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Estimated): May 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: April 16, 2020
• First Submitted That Met QC Criteria: May 7, 2020
• First Posted (Actual): May 12, 2020

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 20-00117

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 datasets (defined below) will be shared via the National Databased of Clinical Trials (NDCT) related to Mental Illness. The proposed cluster RCT study will be carried out in Uganda. It will collect data on 540 school staff (i.e., teachers), and 1,980 parent-child pairs from 36 schools. Child and teacher/school effectiveness outcome data and demographic data collected from teachers, schools, and families across all three assessment time points will be released for sharing. In addition, implementation context data will also be released. These data will be share via the NDCT related to Mental Illness. Implementation fidelity data will not be shared through NDCT, but can be requested from the PI Keng-Yen Huang directly beginning 9 months following article publication or at the end of the study.
• IPD Sharing 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.
• IPD 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.
• 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