Clinical trial NCT06217744: Mental Health Literacy and Academic Performance
Official title: Mental Health Literacy and Academic Performance - A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Health Wellness 1
Keywords: adolescents
randomized clinical trial
mental health
resilience
youth
Lead sponsor: University of Bucharest
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 264
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: cluster RCT, with students nested into classrooms (level of randomization)
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Enrolled in High School

Exclusion Criteria:

* Younger than 14 or older than 18

Primary outcomes:
measure: Academic Performance - reading
timeFrame: up to 3 months
measure: Academic Performance - mathematics
timeFrame: up to 3 months
measure: Depressive symptomatology
timeFrame: up to 3 months
measure: Anxiety symptomatology
timeFrame: up to 3 months
Secondary outcomes:
measure: Social anxiety symptomatology
timeFrame: up to 3 months
measure: Posttraumatic stress symptomatology
timeFrame: up to 3 months
measure: Eating Disorder symptomatology
timeFrame: up to 3 months
measure: Perceived social support
timeFrame: up to 3 months
Other outcomes:
measure: Help seeking
timeFrame: up to 3 months
measure: Mental health stigma
timeFrame: up to 3 months
measure: Bullying
timeFrame: up to 3 months
measure: Social media engagement
timeFrame: up to 3 months
measure: Digital addiction
timeFrame: up to 3 months
Locations:
city: Bucharest
country: Romania
facility: University of Bucharest
Study officials:
affiliation: University of Bucharest
name: Cezar Giosan, PhD
role: PRINCIPAL_INVESTIGATOR
References: