- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07790731
Using a School-Based Depression Literacy Psychoeducation Program With AI Chatbot to Improve Depression Literacy and Help-Seeking Among High School Students
Effects of an AI Chatbot-Enhanced School-Based Depression Literacy Psychoeducation Intervention on Adolescents' Help-Seeking Attitudes: A Randomized Controlled Trial
The primary purpose of this randomized controlled trial is to evaluate the effectiveness of an AI chatbot enhanced school-based depression literacy psychoeducational program, combined with a resource navigation booklet, on high school students in Taiwan.
Despite the high prevalence of depression among adolescents, the treatment gap remains significantly large due to low mental health literacy and high stigma. This study aims to bridge this gap by implementing a 4-week structured psychoeducational intervention. The investigators hypothesize that participants in the experimental group will demonstrate a significant improvement in depression literacy, a reduction in stigmatizing attitudes toward depression, and more positive attitudes toward seeking professional psychological help compared to those in the control group (regular classes as usual). Outcomes will be assessed at baseline and immediately post-intervention.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Depression is a leading cause of disability among adolescents globally, yet a significant treatment gap remains, with up to 70 to 90 percent of adolescents experiencing depressive symptoms failing to receive adequate professional care. Major barriers to accessing appropriate treatment include a widespread lack of mental health literacy and pervasive public and personal stigma surrounding psychological disorders. This study aims to address these barriers by investigating whether a structured psychoeducational intervention can effectively improve depression literacy, reduce stigma, and enhance positive attitudes toward seeking professional psychological help among high school students.
This study employs a quantitative, randomized controlled trial design to evaluate the effectiveness of the proposed psychoeducation intervention. The study population consists of 15 to 19-year-old students recruited from public and private high schools in Taiwan, who will be randomly assigned to either an experimental group or a control group.
Participants assigned to the experimental group will receive an AI chatbot enhanced structured, school-based depression literacy psychoeducation program consisting of four weekly 50-minute sessions. The curriculum is designed to cover the etiology of depression, symptom recognition, and strategies for stigma reduction, and will conclude with the distribution of a physical resource navigation booklet that serves as an actionable emotional first-aid kit detailing local help-seeking channels. Conversely, participants in the control group will receive regular classed as usual, maintaining their standard school curriculum and routine health education classes without exposure to this specific depression literacy intervention.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Hsiu-Ju Chang, PhD
- Telefonní číslo: 67096 +88628267000
- E-mail: hsiuju26@nycu.edu.tw
Studijní místa
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Taiwan
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Taipei, Taiwan, Tchaj-wan, 155
- National Yang Ming Chiao Tung University
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Kontakt:
- Lin
- Telefonní číslo: +886983720209
- E-mail: l314202018.ns14@nycu.edu.tw
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Students aged 15 to 19 enrolled in participating high schools in Taiwan. Fluent in speaking, reading, and writing traditional Chinese, capable of independently completing self-report questionnaires. Willing to participate and provide signed informed assent, alongside signed informed consent from a parent or legal guardian.
Exclusion Criteria:
- Diagnosed with severe cognitive impairment or developmental delay that prevents understanding the curriculum or completing the questionnaires. Currently experiencing an acute psychiatric crisis or exhibiting high risk for self-harm/suicide (e.g., active suicidal ideation, or scoring >= 15 on the baseline Patient Health Questionnaire-9 [PHQ-9], or scoring >= 1 on item 9 of the PHQ-9). These individuals will be referred to immediate standard psychiatric or school counseling care.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: School-based depression literacy psychoeducation program group
A 4-week AI chatbot enhanced school-based depression literacy psychoeducation program consisting of four weekly 50-minute sessions and the distribution of a resource navigation booklet.
The sessions cover the causes of depression, symptom recognition, and stigma reduction.
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The structured psychoeducational program comprises four weekly 50-minute sessions that target knowledge of depression (causes and symptom recognition) and strategies for stigma reduction.
A physical "Resource Navigation Booklet" is provided to serve as an actionable emotional first-aid kit detailing local help-seeking channels.
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Žádný zásah: control group
Participants did not receive the school-based depression literacy program and continued their standard school curriculum and routine health education classes without additional intervention.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Stigmatizing Attitudes toward Depression
Časové okno: Baseline (1 week prior to intervention) and Immediate Post-test (within 1-2 weeks after the 4-week intervention).
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Assessed by the Depression Stigma Scale (DSS).
The scale measures both personal and perceived stigma.
Lower scores indicate lower levels of stigmatizing attitudes toward depression.
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Baseline (1 week prior to intervention) and Immediate Post-test (within 1-2 weeks after the 4-week intervention).
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Change in Depression Literacy
Časové okno: Baseline (1 week prior to intervention) and Immediate Post-test (within 1-2 weeks after the 4-week intervention).
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Assessed by the Depression Literacy Questionnaire (D-Lit).
Higher scores indicate better mental health literacy and understanding of depression.
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Baseline (1 week prior to intervention) and Immediate Post-test (within 1-2 weeks after the 4-week intervention).
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Change in Attitudes Toward Seeking Professional Psychological Help
Časové okno: Baseline (1 week prior to intervention) and Immediate Post-test (within 1-2 weeks after the 4-week intervention).
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Assessed by the full 29-item Attitudes Toward Seeking Professional Psychological Help Scale (ATSPPHS).
Higher scores indicate more positive attitudes and greater willingness to seek professional mental health services.
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Baseline (1 week prior to intervention) and Immediate Post-test (within 1-2 weeks after the 4-week intervention).
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Depressive Symptom Severity
Časové okno: Baseline (1 week prior to the intervention) and Immediate Post-test (within 1-2 weeks after the 4-week intervention).
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Assessed by the Patient Health Questionnaire-9 (PHQ-9).
The PHQ-9 is a 9-item self-report scale with total scores ranging from 0 to 27.
Higher scores indicate more severe depressive symptoms.
In this study, the PHQ-9 is utilized purely for observational and safety monitoring purposes rather than evaluating treatment efficacy.
The initial measurement serves as a baseline reference covariate and a safety screening tool, while the post-test measurement monitors participants' general psychological status following the educational program.
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Baseline (1 week prior to the intervention) and Immediate Post-test (within 1-2 weeks after the 4-week intervention).
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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System Usability of the AI Chatbot
Časové okno: Immediate Post-test (within 1-2 weeks after the 4-week intervention).
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Assessed by the System Usability Scale (SUS).
The SUS is a 10-item questionnaire evaluated on a 5-point Likert scale, designed to measure the usability, learnability, and user satisfaction of the AI Chatbot integrated into the intervention program.
The item scores are converted and summed to a final score ranging from 0 to 100, where higher scores represent better system usability and user acceptance.
Note: This measure is administered exclusively to participants in the experimental group, as they are the sole users of the AI Chatbot.
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Immediate Post-test (within 1-2 weeks after the 4-week intervention).
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
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