The goal of this clinical trial is to test the effectiveness of an intervention designed to promote mental health literacy in adolescents. The main questions it aims to answer are: 1. Whether this intervention can have an impact on mental health 2. Whether this intervention can have an impact on fostering academic performance, particularly in disadvantaged students (i.e., academic resilience) 3. Whether this intervention will have differential effectiveness as a function of the delivery format (psychoeducational materials only versus blended) Participants will receive either an online, automated intervention consisting of psychoeducational materials delivered at predetermined intervals (automated), or the same but with the addition of synchronous or asynchronous psychoeducational sessions held by a licensed psychologist (i.e., blended). These two conditions will also be compared to a Waitlist, to test if the interventions perform better than no treatment.
A Randomized Clinical Trial was designed, involving comparisons at three time-points (pre-intervention, post-intervention, and follow-up) between: (a) Automated delivery of the intervention, (b) Blended format of the intervention, (c) Waitlist (matched control group). Participants will be randomly allocated to one of these three arms, with randomization done at the classroom level. Appropriate methods for two-level-designs were used to determine sample size requirements for a cRCT with 4 cluster groups (i.e. classrooms) per experimental condition, 22 participants per cluster. For a linear mixed-effects model, a sample size of approximately 88 participants per experimental condition for a total sample size of 264 was sufficient to achieve 80% power to detect an effect size of Cohen's d = 0.4 at an alpha level of 0.05. Mental health symptomatology (screening items, Attention Deficit/Hyperactivity Disorder (ADHD), depression, anxiety, social anxiety, Posttraumatic Stress Disorder (PTSD), eating disorders), adverse childhood experiences, bullying, social support, mental health stigma, help-seeking, social media engagement, digital addiction, and academic performance will be assessed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
264
Participants will receive 6 psychoeducational modules design to increase mental health literacy: Module 1: The Stigma of Mental Illness, Module 2: Understanding Mental Health and Mental Illness, Module 3: Information on Specific Mental Illnesses, Module 4: Experiences of Mental Illness, Module 5: Seeking Help and Finding Support, Module 6: The Importance of Positive Mental Health.
Participants will receive the same materials as the Automated Intervention, as well as the possibility to attend psychoeducational sessions held by licensed psychologists.
University of Bucharest
Bucharest, Romania
RECRUITINGAcademic Performance - reading
Reading comprehension will be assessed with a standardized test for Romanian language, which were sourced from the pool of items from the Progress in International Reading Literacy Study (PIRLS). The test will consist of 26 items, with difficulties ranging from easy to difficult. Higher scores indicate greater academic performance.
Time frame: up to 3 months
Academic Performance - mathematics
Performance in mathematics will be assessed with a standardized test, sourced from the TIMSS, a platform specializing in standardized educational assessment in Romania. The test will consist of 26 items, with difficulties ranging from easy to difficult. Higher scores indicate greater academic performance.
Time frame: up to 3 months
Depressive symptomatology
The Patient Health Questionnaire-9 Depression Scale (PHQ-A, Johnson et al., 2002) is the adolescent-adapted version of the Patient Health Questionnaire and contains ten items. Scores range from 0 to 30 and a higher score is representative of a worse outcome.
Time frame: up to 3 months
Anxiety symptomatology
The Anxiety Rating scale (Spitzer et al., 2011) consists of eight items, with scores ranging from 0 to 24 and higher scores indicate a worse outcome.
Time frame: up to 3 months
Social anxiety symptomatology
The Severity Measure for Social Anxiety Disorder (SMSAD 11-17) is a ten-item instrument for children and adolescents (Carlton et al., 2022), with scores ranging from 0 to 50, with higher scores being indicative of a worse outcome.
Time frame: up to 3 months
Posttraumatic stress symptomatology
Posttraumatic Stress The Post Traumatic Symptom scale (Nedelcea et al., 2022) consists of 37 items. The first part of the scale presents a series of 17 stressful situations and participants are asked to indicate whether they have been exposed to one or more of these events in their lifetime. The last 20 items refer to the individual's reaction after experiencing a stressful situation. Scores range from 0 to 80, with higher scores indicating a worse outcome.
Time frame: up to 3 months
Eating Disorder symptomatology
The NEDA Eating Disorder Screening Tool (Fitzsimmons-Craft et al., 2019) is composed of 14 items. The first 11 items address different aspects of eating behavior and/or self-image. These contain multiple response options, with participants being guided to choose the one that suits them. The last three items refer to information about height, lowest weight in the last year and current weight. Higher scores indicate higher symptomatology.
Time frame: up to 3 months
Perceived social support
The Perceived Social Support Questionnaire (Kliem et al., 2015) contains six items, measured on a five-point Likert-type scale, where 1 = Does not fit me at all and 5 = Fits me extremely well. Scores range from 6 to 30, with higher scores indicative of a better outcome.
Time frame: up to 3 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.