Mental Health Wellness 1 Clinical Trial
— MHLAPOfficial 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: 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.
Status | Not yet recruiting |
Enrollment | 264 |
Est. completion date | November 2024 |
Est. primary completion date | August 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 14 Years to 18 Years |
Eligibility | Inclusion Criteria: - Enrolled in High School Exclusion Criteria: - Younger than 14 or older than 18 |
Country | Name | City | State |
---|---|---|---|
Romania | University of Bucharest | Bucharest |
Lead Sponsor | Collaborator |
---|---|
University of Bucharest |
Romania,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Help seeking | The Attitudes Toward Seeking Professional Psychological Help - Short Form (Fischer & Farina, 1995) instrument assesses attitudes towards seeking specialized psychological help. It consists of ten items and participants are asked to express the extent to which they agree with the statements. Scores range from 0 to 30 and higher scores are indicative of a better outcome. | up to 3 months | |
Other | Mental health stigma | The Peer Mental Health Stigmatization Scale (McKeague et al., 2015) assesses stigmatizing attitudes of people experiencing mental health problems. It is composed of 24 items and participants are asked to express the extent to which they agree with the items. cores range from 0 to 96, with higher scores being indicative of a better outcome. | up to 3 months | |
Other | Bullying | Bullying will assessed with the six items used in the World Mental Health Initiative. The items refer to times when someone is intentionally hurt or scared by a peer in the school setting, on the internet and in close relationships. Scores range from 0 to 24, with higher scores indicative of a worse outcome. | up to 3 months | |
Other | Social media engagement | Social Media engagement will be measured with the Social Media Engagement Questionnaire (SMEQ; Przybylski et al., 2013). The questionnaire contains 5 items measured on an 8-point Likert scale (0 = not one day; 7 = every day). Higher scores represent higher engagement with social media. Scores range from 0 to 35, with higher scores indicative of a worse outcome. | up to 3 months | |
Other | Digital addiction | Digital Addiction will be measured with the Digital Addiction Scale for Teenagers (DAST; Seema et al., 2022). This is a 10-item instrument measured on a 7-point Likert scale ranging from never to very often. Scores range from 0 to 60, with higher scores indicative of a worse outcome. | up to 3 months | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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. | up to 3 months | |
Secondary | 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. | up to 3 months | |
Secondary | 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. | up to 3 months | |
Secondary | 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. | up to 3 months |
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