- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hsiu-Ju Chang, PhD
- Phone Number: 67096 +88628267000
- Email: hsiuju26@nycu.edu.tw
Study Locations
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Taiwan
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Taipei, Taiwan, Taiwan, 155
- National Yang Ming Chiao Tung University
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Contact:
- Lin
- Phone Number: +886983720209
- Email: l314202018.ns14@nycu.edu.tw
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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.
|
|
No Intervention: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Stigmatizing Attitudes toward Depression
Time Frame: Baseline (1 week prior to intervention) and Immediate Post-test (within 1-2 weeks after the 4-week intervention).
|
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).
|
|
Change in Depression Literacy
Time Frame: 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.
|
Baseline (1 week prior to intervention) and Immediate Post-test (within 1-2 weeks after the 4-week intervention).
|
|
Change in Attitudes Toward Seeking Professional Psychological Help
Time Frame: Baseline (1 week prior to intervention) and Immediate Post-test (within 1-2 weeks after the 4-week intervention).
|
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.
|
Baseline (1 week prior to intervention) and Immediate Post-test (within 1-2 weeks after the 4-week intervention).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depressive Symptom Severity
Time Frame: Baseline (1 week prior to the intervention) and Immediate Post-test (within 1-2 weeks after the 4-week intervention).
|
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).
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
System Usability of the AI Chatbot
Time Frame: Immediate Post-test (within 1-2 weeks after the 4-week intervention).
|
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).
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NYCU115068AF
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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