School-Based Mental Health Effectiveness Study

Child Development Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04383327
• Other study ID #: 20-00117
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: October 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2444
• Est. completion date: June 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Child Development

Intervention

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.
• 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).

Locations

Country	Name	City	State
Uganda	Hoima School	Hoima
Uganda	Kampala School	Kampala

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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