Mental Health Wellness 1MHLAPNCT06217744
Mental Health Literacy and Academic Performance
A study testing Automated Intervention and Blended Intervention in people with Mental Health Wellness 1, run by University of Bucharest at 1 site in Romania.
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. Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness 1
- What is being tested?
- Automated Intervention and Blended Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 siteRomania
- Study dates
- 10 May 2024to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Enrolled in High School
Who cannot join
- Younger than 14 or older than 18
Trial locations and contacts
1 site in 1 country.
Romania1 site, 1 recruiting
- Recruiting
University of Bucharest
Bucharest, 050663
Cezar Giosan, PhD, +40730908050, giosan@outlook.com
About this study
Official title: Mental Health Literacy and Academic Performance - A Randomized Clinical Trial
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:
- Whether this intervention can have an impact on mental health
- Whether this intervention can have an impact on fostering academic performance, particularly in disadvantaged students (i.e., academic resilience)
- Whether this intervention will have differential effectiveness as a function of the delivery format (psychoeducational materials only versus blended)
Read more
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.
Read the 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
- Being tested
- Automated Intervention, Blended Intervention
- Keywords
- adolescents, randomized clinical trial, mental health, resilience, youth
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated InterventionBehavioural
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 InterventionBehavioural
Participants will receive the same materials as the Automated Intervention, as well as the possibility to attend psychoeducational sessions held by licensed psychologists.
| Study group | Role | What they receive |
|---|---|---|
| Automated Intervention | Experimental | The intervention will last for 3 months, with two psychoeducational modules delivered per month. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 3 months
Secondary outcomes (4)
Social anxiety symptomatology
The Severity Measure for Social Anxiety Disorder (SMSAD 11-17) is a ten-item instrument for children and adolescents (Carlton et al., 2022), with scores ranging from 0 to 50, with higher scores being indicative of a worse outcome.
Measured: up to 3 months
Posttraumatic stress symptomatology
Posttraumatic Stress The Post Traumatic Symptom scale (Nedelcea et al., 2022) consists of 37 items. The first part of the scale presents a series of 17 stressful situations and participants are asked to indicate whether they have been exposed to one or more of these events in their lifetime. The last 20 items refer to the individual's reaction after experiencing a stressful situation. Scores range from 0 to 80, with higher scores indicating a worse outcome.
Measured: up to 3 months
Eating Disorder symptomatology
The NEDA Eating Disorder Screening Tool (Fitzsimmons-Craft et al., 2019) is composed of 14 items. The first 11 items address different aspects of eating behavior and/or self-image. These contain multiple response options, with participants being guided to choose the one that suits them. The last three items refer to information about height, lowest weight in the last year and current weight. Higher scores indicate higher symptomatology.
Measured: up to 3 months
Perceived social support
The Perceived Social Support Questionnaire (Kliem et al., 2015) contains six items, measured on a five-point Likert-type scale, where 1 = Does not fit me at all and 5 = Fits me extremely well. Scores range from 6 to 30, with higher scores indicative of a better outcome.
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start10 May 2024
- Primary completionNov 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental Health Wellness 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- cluster RCT, with students nested into classrooms (level of randomization)
- Masking
- None (open label)
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bucharest
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cezar Giosan, University of Bucharest
- Investigators
- Cezar Giosan, PhD, Principal investigator, University of Bucharest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06217744
- Sponsor's protocol ID
- MHEALTHACAD
- Acronym
- MHLAP
- Status last verified
- Jun 2024
- First submitted
- 18 Dec 2023
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38937769
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental Health Literacy and Academic Performance - A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06217744
- Acronym / sponsor ID
- MHLAP / MHEALTHACAD
- Conditions
- Mental Health Wellness 1
- Keywords
- adolescents, randomized clinical trial, mental health, resilience, youth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- University of BucharestUniversity, hospital or other
- Study start
- 10 May 2024 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Whether this intervention can have an impact on mental health
- Whether this intervention can have an impact on fostering academic performance, particularly in disadvantaged students (i.e., academic resilience)
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- cluster RCT, with students nested into classrooms (level of randomization)
| Arm | Type | Receives |
|---|---|---|
| Automated Intervention | Experimental | Behavioral: Automated InterventionThe intervention will last for 3 months, with two psychoeducational modules delivered per month. |
| Blended Intervention | Experimental | Behavioral: Blended InterventionThe 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. |
| Waitlist | No intervention | –This group will undergo the evaluations on the same schedule like the active groups. No intervention will be done. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Enrolled in High School
Key exclusion criteria (1 listed)
- Younger than 14 or older than 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automated InterventionParticipants 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. | Behavioural | Automated Intervention |
| Blended InterventionParticipants will receive the same materials as the Automated Intervention, as well as the possibility to attend psychoeducational sessions held by licensed psychologists. | Behavioural | Blended Intervention |
Primary outcome
Academic Performance - reading
Time frame: up to 3 months
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.
Academic Performance - mathematics
Time frame: up to 3 months
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.
Depressive symptomatology
Time frame: up to 3 months
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.
Anxiety symptomatology
Time frame: up to 3 months
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.
4 secondary outcomes
Social anxiety symptomatology
Time frame: up to 3 months
Posttraumatic stress symptomatology
Time frame: up to 3 months
Eating Disorder symptomatology
Time frame: up to 3 months
Perceived social support
Time frame: up to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Derived from this study: PubMed 38937769Giosan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cezar Giosan, PhD principal investigator
University of Bucharest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automated Intervention and Blended Intervention in people with Mental Health Wellness 1, run by University of Bucharest at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cezar Giosan, PhD (+1(212)4448577, giosan@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Academic Performance - reading (time frame: up to 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06217744, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2024.