Pilot Cluster RCT of an Indirect Contact Mental Health Literacy Program for 5th-Grade Students
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-11
SponsorTokyo University
About this trial
This cluster-randomized pilot trial will evaluate the preliminary effects and feasibility of adding an indirect contact component to a school-based mental health literacy (MHL) lesson for 5th-grade students in a public elementary school in Tokyo, Japan. Four 5th-grade classes (approximately 150 students in total) will be randomized by class (two classes per arm). All students will receive a 45-minute lesson that includes an animated video and educational slides. In the intervention arm, teachers will additionally introduce a short story about a well-known soccer player who experienced and recovered from a mental health condition, serving as an indirect contact element. The control arm will receive the standard lesson without this component.
Students will complete questionnaires at baseline (T1), immediately after the lesson (T2), and 2-3 months later (T3). The primary outcome is vignette-based social distance toward a peer with mental health problems. Secondary outcomes include mental health knowledge, help-seeking intentions, perceived need for help, intended sources of help. As a pilot study with only four clusters, the trial is not powered to detect small effects; findings will be used to estimate effect sizes and assess feasibility for a future larger-scale trial.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Students enrolled in 5th grade at one of the eight participating public elementary schools in Kanazawa, Japan.
Aged 10-11 years old.
Passive consent obtained from guardians; verbal assent obtained from children.
Able to complete self-report questionnaires.
Disqualifiers
Students whose parents/guardians opted out of the study.
Trial design
Design model
Parallel
Treatments tested in this trial
Indirect Contact
BehavioralA 45-minute school-based mental health literacy lesson including an animated video, educational slides, and an additional indirect contact component in the form of a teacher-delivered story about a well-known soccer player who experienced and recovered from a mental health condition.
Standard MHL Lesson Only
BehavioralA 45-minute standard mental health literacy lesson including an animated educational video and slides, without the indirect contact story component.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Indirect ContactExperimental treatment 1 intervention
Group B: Standard MHL Lesson OnlyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Social Distance Scale Score (Stigma)
A 5-item scale adapted from the Social Distance Scale using a vignette format. Each item rated on a 4-point scale (1=definitely willing to 4=definitely unwilling), total score range 4-20. Higher scores indicate greater stigma. Cronbach's alpha was 0.88.
Time frame
Baseline (T1), immediately post-intervention (T2), and 3-month follow-up (T3)Secondary outcomes
1
Mental Health Knowledge Score
An 8-item true/false questionnaire developed based on the SMHLP content. Scores range from 0 to 8, with higher scores indicating greater knowledge about mental health and illnesses. Cronbach's alpha was 0.65.
Time frame
Baseline (T1), immediately post-intervention (T2), and 3-month follow-up (T3)2
Help-Seeking Intention
A vignette-based item asking whether students themselves would seek help if they were experiencing similar mental health difficulties. Responses were on a 4-point scale: "Definitely yes", "Probably yes", "Probably not", and "Definitely not". Students were considered to have the intention to seek help if they responded "Definitely yes".
Time frame
Baseline (T1), immediately post-intervention (T2), and 3-month follow-up (T3)3
Recognition of the necessity to seek help
A single vignette-based item asking whether students thought the character in the scenario should seek help from others. Responses were on a 4-point scale: "Definitely yes", "Probably yes", "Probably not", and "Definitely not". Students were considered to recognize the necessity to seek help when they responded "Definitely yes".
Time frame
Baseline (T1), immediately post-intervention (T2), and 3-month follow-up (T3)4
Intention to Help Peers
Students were asked to rate their likelihood of performing various desirable supportive behaviors for a peer in distress. Each item was rated on a 4-point scale. Students were considered to have the intention to help if they selected "Definitely yes" for at least one of the behaviors. An example of a behavior is: "I would ask about or listen to their story to understand their situation in detail."
Time frame
Baseline (T1), immediately post-intervention (T2), and 3-month follow-up (T3)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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