Mental Health Literacy and Academic Performance (MHLAP)

University of Bucharest

Status: Enrolling

Conditions: Mental Health Wellness 1

Treatments: Behavioral: Automated Intervention; Behavioral: Blended Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06217744

MHEALTHACAD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 264 estimated patients

Sex: All

Ages: 14 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Enrolled in High School

Exclusion criteria

• Younger than 14 or older than 18

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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264 participants in 3 patient groups

Automated Intervention

Experimental group

Description:

The intervention will last for 3 months, with two psychoeducational modules delivered per month.

Treatment:

Behavioral: Automated Intervention

Blended Intervention

Experimental group

Description:

The intervention will last for 3 months, with two psychoeducational modules delivered per month. In addition, regular synchronous or asynchronous psychoeducational sessions conducted by a licensed psychologist will be held with the participants.

Treatment:

Behavioral: Blended Intervention

Waitlist

No Intervention group

Description:

This group will undergo the evaluations on the same schedule like the active groups. No intervention will be done.