- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07658066
Use of Football in Programs to Reduce Stigma Toward Mental Illness: A Comparison of the Effectiveness of Contact Interaction and Video-Based Approaches
The goal of this clinical trial is to evaluate the effectiveness of football-based interventions in reducing stigma toward mental illness among university students. The main questions it aims to answer are:
- Does participating in a contact-based education program involving football help reduce stigma toward mental illness among university students?
- What are the effects of three different intervention methods on reducing stigma toward mental illness?
Researchers will compare the traditional contact-based education program with the other two interventions to evaluate their differences in effectiveness.
Participants will:
- Be randomly assigned to one of the three intervention groups.
- Complete online assessments to measure attitudes toward mental illness before and after the intervention.
- Participate in qualitative interviews to provide in-depth feedback on their experiences and perceptions.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Ming-De Chen, Ph.D.
- Numero di telefono: 2657 +886-73121101
- Email: mdchen@kmu.edu.tw
Luoghi di studio
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Kaohsiung City, Taiwan
- Reclutamento
- Kaohsiung Medical University Chung-Ho Memorial Hospital
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Contatto:
- Ming-De Chen, Ph.D.
- Numero di telefono: 2657 +886-73121101
- Email: mdchen@kmu.edu.tw
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Descrizione
Inclusion Criteria:
- University students currently enrolled, aged between 18 and 30 years.
- In good physical condition with no contraindications to exercise (i.e., not diagnosed by a physician or advised to avoid physical activity, and with no items selected on the PAR-Q+ [Physical Activity Readiness Questionnaire for Everyone]).
- Able to follow the study procedures and provide signed informed consent.
Exclusion Criteria:
- Individuals who are unable to safely participate in football activities due to intellectual disability, pregnancy, head injury, cardiovascular disease, or other neuromuscular or musculoskeletal disorders.
- Individuals who are unable to effectively participate in the intervention program or complete assessments due to significant emotional disturbances, personality disorders, substance (alcohol) abuse, or severe mental illness.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore attivo: Contact-based education
Mental health education and listening to the stories of individuals with mental illness and interactive sharing.
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A one-time session lasting approximately 1.5 to 2.5 hours, consisting of psychiatric education, storytelling by individuals with mental illness, and interactive discussion.
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Sperimentale: Video and contact-based education
Video viewing, mental health education and listening to the stories of individuals with mental illness and interactive sharing.
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A one-time session lasting approximately 1.5 to 2.5 hours, including football video viewing, psychiatric education, storytelling by individuals with mental illness, and interactive discussion.
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Sperimentale: Football and contact-based education
Football interaction, video viewing, mental health education and listening to the stories of individuals with mental illness and interactive sharing.
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A one-time session lasting approximately 1.5 to 2.5 hours.
The session includes football interactive activities, football video viewing, psychiatric education, storytelling by individuals with mental illness, and interactive discussion.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Knowledge
Lasso di tempo: pre-intervention, immediately post-intervention, and at one- and six-month follow-ups.
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The Mental Health Knowledge Schedule (MAKS), consisting of 12 items, will be used to assess the public's knowledge related to mental health stigma.
The questionnaire is divided into two parts: knowledge about mental illness and agreement with statements regarding mental health conditions.
Responses are rated on a five-point Likert scale (5 = Strongly agree, 4 = Slightly agree, 3 = Neither agree nor disagree / Don't know, 2 = Slightly disagree, 1 = Strongly disagree).
The total score ranges from 12 to 60, with higher scores indicating a greater level of knowledge about mental health.
Items 7 to 12 are designed to assess recognition and familiarity with various mental health conditions, helping to contextualize responses to the earlier items.
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pre-intervention, immediately post-intervention, and at one- and six-month follow-ups.
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Attitudes
Lasso di tempo: pre-intervention, immediately post-intervention, and at one- and six-month follow-ups.
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The Questionnaire on Stigmatizing Attitudes Towards Mental Illness will be used in this study.
After undergoing cultural adaptation and psychometric validation, the final Chinese version consists of 16 items across four dimensions: Negative Stereotypes (5 items), Social Distance (3 items), Negative Evaluation (5 items), and Self-Stigma (3 items).
Responses are measured on a six-point Likert scale (6 = Strongly agree, 5 = Agree, 4 = Slightly agree, 3 = Slightly disagree, 2 = Disagree, 1 = Strongly disagree).
The total score ranges from 16 to 96, with higher scores indicating greater levels of negative stigmatizing attitudes toward mental illness.
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pre-intervention, immediately post-intervention, and at one- and six-month follow-ups.
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Intent
Lasso di tempo: pre-intervention, immediately post-intervention, and at one- and six-month follow-ups.
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The Social Distance Scale will be adopted to assess participants' level of social distance toward individuals with mental illness, serving as an indicator of intent to act.
The scale consists of 8 items, which evaluate willingness to engage with people with mental illness in various situations, such as living in the same community or building, sharing a residence, dining together, forming friendships, working together, employing, or helping them.
Responses are rated on a six-point Likert scale (6 = Strongly agree, 5 = Agree, 4 = Slightly agree, 3 = Slightly disagree, 2 = Disagree, 1 = Strongly disagree).
Higher scores indicate a greater willingness to interact with individuals with mental illness.
This scale is considered to be particularly sensitive to measuring implicit bias.
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pre-intervention, immediately post-intervention, and at one- and six-month follow-ups.
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Collaboratori e investigatori
Investigatori
- Cattedra di studio: Ming-De Chen, Ph.D., Kaohsiung Medical University Chung-Ho Memorial Hospital
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- KMUHIRB-F(I)-20250110
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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