NCT07666542

Brief Summary

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:

  1. 1.Do teachers who receive the training improve their knowledge on how to better to identify and support students with mental health difficulties?
  2. 2.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?
  3. 3.Take part in a training program delivered either in-person, online, or through self-paced materials;
  4. 4.In some groups, attend additional supervision sessions to discuss real-life cases;
  5. 5.Receive brief follow-up materials through mobile messages after the training
  6. 6.Complete online questionnaires at multiple time points (before the training, during the program, after completion, and at follow-up).

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,925

participants targeted

Target at P75+ for not_applicable

Timeline
5mo left

Started Jun 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress23%
Jun 2026Dec 2026

First Submitted

Initial submission to the registry

June 1, 2026

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 24, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

June 29, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2026

Last Updated

June 24, 2026

Status Verified

June 1, 2026

Enrollment Period

4 months

First QC Date

June 1, 2026

Last Update Submit

June 22, 2026

Conditions

Keywords

School Mental HealthPsychosocial SupportCluster Randomized Controlled TrialTeacher Professional DevelopmentMental Health PromotionEducation Policy

Outcome Measures

Primary Outcomes (1)

  • Change in the score in the Mental health Knowledge & Attitudes Questionnaire

    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 Outcomes (6)

  • Early and Sustained change in the score in the Mental health Knowledge & Attitudes Questionnaire

    Baseline (T0) to 2 weeks (T1); Baseline (T0) to 2-month follow-up (T3)

  • Change in psychosocial support skills score (clinical vignette-based score)

    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

    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

    Baseline (T0); 2 weeks (T1); Post-intervention at 4 weeks (T2); 2-month follow-up (T3)

  • Training acceptability, satisfaction, and perceived confidence

    Post-intervention at 4 weeks (T2)

  • +1 more secondary outcomes

Study Arms (5)

Arm 1: In-Person Training + Supervision

EXPERIMENTAL

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.

Behavioral: In-person School-Based Psychosocial Support TrainingBehavioral: Supervision SessionsBehavioral: Mobile-Based Reinforcement Materials

Arm 2: In-Person Training Only

EXPERIMENTAL

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.

Behavioral: In-person School-Based Psychosocial Support TrainingBehavioral: Mobile-Based Reinforcement Materials

Arm 3: Online Training + Supervision

EXPERIMENTAL

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.

Behavioral: Online School-Based Psychosocial Support TrainingBehavioral: Supervision SessionsBehavioral: Mobile-Based Reinforcement Materials

Arm 4: Online Training Only

EXPERIMENTAL

Participants receive two synchronous online training sessions (via videoconference) without additional supervision. Participants also receive brief follow-up materials via mobile messages.

Behavioral: Online School-Based Psychosocial Support TrainingBehavioral: Mobile-Based Reinforcement Materials

Arm 5: Asynchronous Training (Control Condition)

ACTIVE COMPARATOR

Participants receive the same training content delivered in a fully asynchronous, self-paced format through digital materials, without live sessions or supervision.

Behavioral: Asynchronous School-Based Psychosocial Support Training

Interventions

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.

Arm 1: In-Person Training + SupervisionArm 2: In-Person Training Only

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.

Arm 3: Online Training + SupervisionArm 4: Online Training Only

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.

Arm 5: Asynchronous Training (Control Condition)

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.

Arm 1: In-Person Training + SupervisionArm 3: Online Training + Supervision

Brief follow-up materials delivered via mobile messaging to reinforce key concepts covered in the training sessions.

Arm 1: In-Person Training + SupervisionArm 2: In-Person Training OnlyArm 3: Online Training + SupervisionArm 4: Online Training Only

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Giovanni A. Salum, MD, PhD

    Child Mind Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Giovanni A. Salum, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: This is a cluster randomized, parallel-group trial with five intervention arms. Schools are grouped into clusters of 5 schools. The unit of randomization are those clusters. Teachers within each school are assigned to the same intervention condition. Nine teachers per school will participate in the trial. The five arms differ based on delivery format (in-person, synchronous online, or asynchronous) and the presence or absence of supervision. Four groups receive synchronous training (either in-person or online), with or without additional supervision sessions, while one group receives the same content delivered in an asynchronous format only. The intervention duration ranges from 2 to 4 weeks depending on the assigned condition. Outcomes are assessed at baseline, during the intervention, post-intervention, and follow-up. The study is designed to compare the effectiveness, acceptability, and feasibility of different delivery formats and supervision components.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry and Behavioral Sciences at the Universidade Federal do Rio Grande do Sul (UFRGS); Senior Vice President of Global Programs at the Child Mind Institute.

Study Record Dates

First Submitted

June 1, 2026

First Posted

June 24, 2026

Study Start

June 29, 2026

Primary Completion (Estimated)

October 16, 2026

Study Completion (Estimated)

December 16, 2026

Last Updated

June 24, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

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.