NCT06217744

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. 1.Whether this intervention can have an impact on mental health
  2. 2.Whether this intervention can have an impact on fostering academic performance, particularly in disadvantaged students (i.e., academic resilience)
  3. 3.Whether this intervention will have differential effectiveness as a function of the delivery format (psychoeducational materials only versus blended)

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
264

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 22, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

May 10, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

June 18, 2024

Status Verified

June 1, 2024

Enrollment Period

6 months

First QC Date

December 18, 2023

Last Update Submit

June 15, 2024

Conditions

Keywords

adolescentsrandomized clinical trialmental healthresilienceyouth

Outcome Measures

Primary Outcomes (4)

  • Academic 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.

    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.

    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.

    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.

    up to 3 months

Secondary Outcomes (4)

  • Social anxiety symptomatology

    up to 3 months

  • Posttraumatic stress symptomatology

    up to 3 months

  • Eating Disorder symptomatology

    up to 3 months

  • Perceived social support

    up to 3 months

Other Outcomes (5)

  • Help seeking

    up to 3 months

  • Mental health stigma

    up to 3 months

  • Bullying

    up to 3 months

  • +2 more other outcomes

Study Arms (3)

Automated Intervention

EXPERIMENTAL

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

Behavioral: Automated Intervention

Blended Intervention

EXPERIMENTAL

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.

Behavioral: Blended Intervention

Waitlist

NO INTERVENTION

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

Interventions

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.

Automated Intervention

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

Blended Intervention

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Enrolled in High School

You may not qualify if:

  • Younger than 14 or older than 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bucharest

Bucharest, 050663, Romania

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Cezar Giosan, PhD

    University of Bucharest

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cezar Giosan, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: cluster RCT, with students nested into classrooms (level of randomization)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychology

Study Record Dates

First Submitted

December 18, 2023

First Posted

January 22, 2024

Study Start

May 10, 2024

Primary Completion

November 1, 2024

Study Completion

December 1, 2024

Last Updated

June 18, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations