Mental Health Literacy & Academic Performance

Status Not yet recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Mental Health Wellness 1

Clinical Trial Details

NCT number	NCT06217744
Study type	Interventional
Source	University of Bucharest
Contact	Cezar Giosan, PhD
Phone	+1(212)4448577
Email	giosan@outlook.com
Status	Not yet recruiting
Phase	N/A
Start date	May 2024
Completion date	November 2024

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Mental Health Literacy and Academic Performance — MHLAP

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms