School-Based Mental Health Effectiveness Study

Sponsor
NYU Langone Health (Other)
Overall Status
Recruiting
CT.gov ID
NCT04383327
Collaborator
(none)
2,556
Enrollment
2
Locations
3
Arms
42.8
Anticipated Duration (Months)
1278
Patients Per Site
29.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Behavioral: ParentCorps-Professional Development (PD)
  • Behavioral: T-Wellness
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
2556 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
A cluster randomized controlled trial (cRCT), single blind and mixed-methods design will be appliedA cluster randomized controlled trial (cRCT), single blind and mixed-methods design will be applied
Masking:
Single (Outcomes Assessor)
Masking Description:
Research staff performing outcome assessment will be blind to the study conditions.
Primary Purpose:
Other
Official Title:
Effectiveness and Implementation of an Early Childhood School-Based Mental Health Intervention in Low-Resource Communities
Actual Study Start Date :
Aug 4, 2021
Anticipated Primary Completion Date :
Feb 28, 2024
Anticipated Study Completion Date :
Feb 28, 2025

Arms and Interventions

ArmIntervention/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

Outcome Measures

Primary Outcome Measures

  1. Change in Child Mental Health [Baseline, 6 months, 18 months]

    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.

  2. Change in Teacher EBI practices [Baseline, 6 months, 18 months]

    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

  3. Change in Teacher Stress Management [Baseline, 6 months, 18 months]

    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

Secondary Outcome Measures

  1. Change in Research Domain Criteria (RDoC) Mental Health Behavioral Domains [Baseline, 6 months, 18 months]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Hoima SchoolHoimaUganda
2Kampala SchoolKampalaUganda

Sponsors and Collaborators

  • NYU Langone Health

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NYU Langone Health
ClinicalTrials.gov Identifier:
NCT04383327
Other Study ID Numbers:
  • 20-00117
First Posted:
May 12, 2020
Last Update Posted:
Feb 18, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Feb 18, 2022