Mental Health Literacy and Academic Performance

NCT ID: NCT06217744

Last Updated: 2024-06-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 264 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-10
• Study Completion Date: 2024-12-31

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.

Conditions

Mental Health Wellness 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Automated Intervention

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

Group Type: EXPERIMENTAL

Automated Intervention

Intervention Type: BEHAVIORAL

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.

Blended Intervention

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.

Group Type: EXPERIMENTAL

Blended Intervention

Intervention Type: BEHAVIORAL

Participants will receive the same materials as the Automated Intervention, as well as the possibility to attend psychoeducational sessions held by licensed psychologists.

Waitlist

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Automated Intervention

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.

Intervention Type: BEHAVIORAL

Blended Intervention

Participants will receive the same materials as the Automated Intervention, as well as the possibility to attend psychoeducational sessions held by licensed psychologists.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Enrolled in High School

Exclusion Criteria

• Younger than 14 or older than 18

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Bucharest

OTHER

Sponsor Role: lead

Responsible Party

Cezar Giosan

Associate Professor of Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cezar Giosan, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Bucharest

Locations

University of Bucharest

Bucharest, , Romania

Site Status: RECRUITING

Countries

Romania

Central Contacts

Cezar Giosan, PhD

Role: CONTACT

giosan@outlook.com

+1(212)4448577

Facility Contacts

Cezar Giosan, PhD

Role: primary

giosan@outlook.com

+40730908050

References

Giosan C, Pana A, Cosmoiu A, Chira AM, Toma AM, Papasteri CC, Nedelcea C, Popoviciu C. Mental health literacy and academic performance (MHLAP) in high school students: a randomized clinical trial protocol. Trials. 2024 Jun 27;25(1):419. doi: 10.1186/s13063-024-08270-y.

Reference Type: DERIVED

PMID: 38937769 (View on PubMed)

Other Identifiers

MHEALTHACAD

Identifier Type: -

Identifier Source: org_study_id