- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07666542
Psychosocial Support Program for Public School Teachers (PSP)
Evaluation of the Effectiveness and Feasibility of Different Formats of a School-Based Psychosocial Support Program for Public School Teachers: A Randomized Clinical Trial
The goal of this clinical trial is to learn if different formats of a school-based psychosocial support training program can improve teachers' ability to recognize and respond to students' mental health needs. The study will include teachers working in public schools in Brazil.
The main questions it aims to answer are:
- Do teachers who receive the training improve their knowledge on how to better to identify and support students with mental health difficulties?
- Do different formats of training (in-person, online, or self-paced) and the presence of supervision lead to different levels of improvement in this knowledge, in attitudes related to mental health, and helping behaviors?
Researchers will compare five versions of the program (in-person, online, and asynchronous formats, with or without supervision) to see which approach is more effective, acceptable, and feasible.
Participants will:
- Take part in a training program delivered either in-person, online, or through self-paced materials;
- In some groups, attend additional supervision sessions to discuss real-life cases;
- Receive brief follow-up materials through mobile messages after the training
- Complete online questionnaires at multiple time points (before the training, during the program, after completion, and at follow-up).
The study will measure changes in teachers' knowledge, attitudes, and behaviors related to supporting students' mental health, as well as satisfaction with the program and its feasibility for large-scale implementation.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Giovanni A. Salum, MD, PhD
- Phone Number: (+55) 51 3359 8094
- Email: gsalum @hcpa.edu.br
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
School-level inclusion criteria:
- Public schools from the state education system of Rio Grande do Sul, Brazil, serving students in "Ensino Fundamental" and "Ensino Médio" (equivalent to grades 1-12), and belonging to "Polo 1", an administrative grouping defined by the Rio Grande do Sul State Department of Education that includes the following Regional Education Coordinators (Coordenadorias Regionais de Educação [CREs]): 1st, 2nd, 11th, 12th, 27th, and 28th CREs;
- Schools with 10 or more teachers on staff;
- Schools with a complete school management team, defined as having all three core management roles in place.
Participant-level inclusion criteria (teacher level)
Participating teachers must meet all of the following criteria:
- Teachers currently working in participating public schools;
- Able and willing to participate in all stages of the intervention and scheduled assessments;
- Provide informed consent prior to participation
Exclusion Criteria:
School-level exclusion criteria:
- Schools with fewer than 10 teachers on staff;
- Schools without a complete school management team;
- Youth and Adult Education Centers (Núcleos de Educação de Jovens e Adultos [EJA]);
- Schools that began operating as full-time schools in 2026;
- Schools not belonging to Polo 1 of the state education system of Rio Grande do Sul;
- Schools that do not serve students in grades 1-12
Participant-level exclusion criteria
- Not currently working as a teacher in a participating public school;
- Unable to participate in the training in the planned date for the specific school the teacher works at;
- Decline or are unable to provide informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm 1: In-Person Training + Supervision
Participants receive two in-person training sessions on school-based psychosocial support, followed by two supervision sessions (audio-based, small group) focused on case discussion and practical application.
Participants also receive brief follow-up materials via mobile messages.
|
A structured training program designed to improve teachers' ability to recognize and respond to students' mental health needs.
The intervention includes evidence-based content on mental health literacy, identification of emotional and behavioral difficulties, and appropriate support and referral strategies.
The training is delivered in-person in two weekly sessions.
Structured small-group supervision sessions conducted via audio calls, focused on discussion of real-life cases, clarification of concepts, and support for practical application of the training content.
Brief follow-up materials delivered via mobile messaging to reinforce key concepts covered in the training sessions.
|
|
Experimental: Arm 2: In-Person Training Only
Participants receive two in-person training sessions on school-based psychosocial support without additional supervision.
Participants also receive brief follow-up materials via mobile messages.
|
A structured training program designed to improve teachers' ability to recognize and respond to students' mental health needs.
The intervention includes evidence-based content on mental health literacy, identification of emotional and behavioral difficulties, and appropriate support and referral strategies.
The training is delivered in-person in two weekly sessions.
Brief follow-up materials delivered via mobile messaging to reinforce key concepts covered in the training sessions.
|
|
Experimental: Arm 3: Online Training + Supervision
Participants receive two synchronous online training sessions (via videoconference), followed by two supervision sessions (audio-based, small group) focused on case discussion and practical application.
Participants also receive brief follow-up materials via mobile messages.
|
Structured small-group supervision sessions conducted via audio calls, focused on discussion of real-life cases, clarification of concepts, and support for practical application of the training content.
Brief follow-up materials delivered via mobile messaging to reinforce key concepts covered in the training sessions.
A structured training program designed to improve teachers' ability to recognize and respond to students' mental health needs.
The intervention includes evidence-based content on mental health literacy, identification of emotional and behavioral difficulties, and appropriate support and referral strategies.
The training is delivered trough synchronous videoconference in two weekly sessions.
|
|
Experimental: Arm 4: Online Training Only
Participants receive two synchronous online training sessions (via videoconference) without additional supervision.
Participants also receive brief follow-up materials via mobile messages.
|
Brief follow-up materials delivered via mobile messaging to reinforce key concepts covered in the training sessions.
A structured training program designed to improve teachers' ability to recognize and respond to students' mental health needs.
The intervention includes evidence-based content on mental health literacy, identification of emotional and behavioral difficulties, and appropriate support and referral strategies.
The training is delivered trough synchronous videoconference in two weekly sessions.
|
|
Active Comparator: Arm 5: Asynchronous Training (Control Condition)
Participants receive the same training content delivered in a fully asynchronous, self-paced format through digital materials, without live sessions or supervision.
|
A structured training program designed to improve teachers' ability to recognize and respond to students' mental health needs.
The intervention includes evidence-based content on mental health literacy, identification of emotional and behavioral difficulties, and appropriate support and referral strategies.
The training is delivered through an asynchronous self-paced course in a digital platform.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in the score in the Mental health Knowledge & Attitudes Questionnaire
Time Frame: Baseline (T0) to post-intervention at 4 weeks (T2)
|
Psychosocial support skills knowledge and attitudes will be assessed using a multiple choice instrument (Mental health Knowledge & Attitudes Questionnaire) developed for this study and previously piloted in a sample of teachers.
Scores will range from 0 to 100%, reflecting the percentage of correct responses.
|
Baseline (T0) to post-intervention at 4 weeks (T2)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Early and Sustained change in the score in the Mental health Knowledge & Attitudes Questionnaire
Time Frame: Baseline (T0) to 2 weeks (T1); Baseline (T0) to 2-month follow-up (T3)
|
Same instrument used in the primary outcome
|
Baseline (T0) to 2 weeks (T1); Baseline (T0) to 2-month follow-up (T3)
|
|
Change in psychosocial support skills score (clinical vignette-based score)
Time Frame: Baseline (T0) to 2 weeks (T1); Baseline (T0) to post-intervention at 4 weeks (T2); Baseline (T0) to 2-month follow-up (T3)
|
Psychosocial support skills will be assessed using a vignette-based instrument (Psychosocial Support Skills Instrument) developed for this study and previously piloted in a sample of teachers.
Each vignette describes a brief clinical scenario, and participants are asked to select the most appropriate level of support for the student.
Response options include: (1) Observe and be available; (2) Provide school-based support and accommodations ; (3) Link to a mental health professional ; (4) Act immediately due to safety concerns.
Scores will range from 0 to 100%, reflecting the percentage of correct responses.
|
Baseline (T0) to 2 weeks (T1); Baseline (T0) to post-intervention at 4 weeks (T2); Baseline (T0) to 2-month follow-up (T3)
|
|
Changes in helping behaviors toward students
Time Frame: Baseline (T0) to 2 weeks (T1); Baseline (T0) to post-intervention at 4 weeks (T2); Baseline (T0) to 2-month follow-up (T3)
|
Assessed using a retrospective self-report scale developed to capture mental health-related helping behaviors toward students ("Helping Behaviors Scale"), including identifying emotional distress, providing support, and facilitating referral to appropriate services.
The scale includes five items describing specific helping behaviors.
Each item is rated as yes, no, or does not apply.
Higher endorsement indicates a greater number of supportive actions taken by the respondent in the past week.
|
Baseline (T0) to 2 weeks (T1); Baseline (T0) to post-intervention at 4 weeks (T2); Baseline (T0) to 2-month follow-up (T3)
|
|
Change in the levels of teacher burnout
Time Frame: Baseline (T0); 2 weeks (T1); Post-intervention at 4 weeks (T2); 2-month follow-up (T3)
|
Teacher burnout will be assessed using the 12-item version of the Burnout Assessment Tool (BAT-12), a self-report questionnaire developed to assess burnout as a multidimensional psychological syndrome.
It evaluates four core dimensions of burnout: exhaustion, mental distance, cognitive impairment, and emotional impairment.
Each item is rated on a five-point frequency scale ranging from 1 (never) to 5 (always).
A total burnout score will be calculated as the mean of the 12 items, with higher scores indicating greater burnout symptoms.
|
Baseline (T0); 2 weeks (T1); Post-intervention at 4 weeks (T2); 2-month follow-up (T3)
|
|
Training acceptability, satisfaction, and perceived confidence
Time Frame: Post-intervention at 4 weeks (T2)
|
Assessed using a post-training self-report questionnaire developed for this study.
The questionnaire includes one item assessing perceived adequacy of training length, rated as too short, about right, or too long.
Three items assess participants' ratings of the training delivery format, amount of practice, and resources/materials provided, each rated on a five-point scale ranging from very poor to excellent.
One additional item assesses participants' confidence in their ability to identify students with psychosocial and mental health difficulties, rated from not at all confident to extremely confident.
Higher ratings indicate greater satisfaction with the training components and greater perceived confidence.
An optional open-ended item collects additional qualitative feedback about the training.
|
Post-intervention at 4 weeks (T2)
|
|
Cost-effectiveness of the intervention
Time Frame: Baseline (T0) to post-intervention at 4 weeks (T2)
|
Cost-effectiveness will be calculated as the cost per improvement unit in the Mental health Knowledge & Attitudes Questionnaire described previously
|
Baseline (T0) to post-intervention at 4 weeks (T2)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Giovanni A. Salum, MD, PhD, Child Mind Institute
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 95402126.0.0000.5327
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
De-identified individual participant data underlying the results reported in this study (including data dictionaries) will be made available to qualified researchers.
Data will be shared after publication of the primary results, upon reasonable request and subject to approval by the study investigators. Requests will be evaluated based on scientific merit, feasibility, and ethical considerations.
Data will be provided in a de-identified format to ensure participant confidentiality and compliance with applicable data protection regulations.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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