- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07927387
Health Information Framing, Source Characteristics, and Health Behavior Promotion
Research on Health Information Framework, Information Sources and Promotion of Health Behaviors
This study examines how different ways of presenting health information affect health-related understanding, decision-making, and behavior. It includes two connected research components: one focuses on vaccination-related decisions, and the other focuses on mental health and help-seeking. Participants will complete an online questionnaire and will be randomly assigned to different information conditions that vary in message framing, information source, social norms, and presentation format. The study will compare post-exposure decision intentions and behavioral responses across the assigned conditions. No medicines, vaccines, or medical devices will be administered as part of the study.
Przegląd badań
Status
Interwencja / Leczenie
- Behawioralne: AI-sourced gain-framed message (Component 1)
- Behawioralne: AI-sourced loss-framed message (Component 1)
- Behawioralne: AI-sourced normative message (Component 1)
- Behawioralne: AI-sourced structured message (Component 1)
- Behawioralne: AI-sourced expert-authority message (Component 1)
- Behawioralne: Official gain-framed message (Component 1)
- Behawioralne: Official loss-framed message (Component 1)
- Behawioralne: Official normative message (Component 1)
- Behawioralne: Official structured message (Component 1)
- Behawioralne: Official expert-authority message (Component 1)
- Behawioralne: Gain-framed peer message (Component 2)
- Behawioralne: Gain-framed expert message (Component 2)
- Behawioralne: Loss-framed peer message (Component 2)
- Behawioralne: Loss-framed expert message (Component 2)
- Behawioralne: Social-norm message (Component 2)
Szczegółowy opis
Health information can influence how people understand health risks, evaluate available options, and make health-related decisions. This prospective behavioral study will use an online questionnaire and a randomized parallel-group design to evaluate how different characteristics of health information affect health-related decision intention and behavioral responses.
The study consists of two connected components conducted in different participant populations and regions. The first component examines how the source and framing of vaccination-related information influence participants' evaluation, decision intention, trust, and subsequent behavioral choices. The second component examines how differently framed mental health information, source cues, and social norms influence mental health-related decision-making and help-seeking responses.
In each component, eligible participants will provide informed consent and will be randomly assigned through an online survey platform to one of several pre-specified information conditions or a comparison condition. Outcomes will be assessed through self-reported questionnaire measures and behavioral responses recorded by the survey platform, including the decision to view further information or proceed with an available follow-up action.
The study does not administer or evaluate the safety or efficacy of any drug, biological product, vaccine, or medical device. All study procedures will be conducted using a secure online platform in accordance with the approved study protocol and applicable ethical requirements.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Jing Guo, PhD
- Numer telefonu: 86+18086471505
- E-mail: jing624218@163.com
Lokalizacje studiów
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Beijing Municipality
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Beijing, Beijing Municipality, Chiny, 101118
- Beijing Tongzhou Psychiatric Hospital
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Kontakt:
- jing Guo, PhD
- Numer telefonu: 86+18086471505
- E-mail: jing624218@163.com
-
-
Hunan
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Changsha, Hunan, Chiny
- The Third Xiangya Hospital of Central South University
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Kontakt:
- Xiuhong Yuan, PhD
- Numer telefonu: 86+15308488051
- E-mail: 18483195@qq.com
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Aged 10 years or older.
- Component 1: Young adults entering higher education who meet the age and enrollment requirements specified in the approved protocol.
- Component 2: Adolescents and their primary caregivers who meet the age, grade, recruitment-site, and paired-participation requirements specified in the approved protocol.
- Able to understand the study information and complete the online questionnaire with any assistance permitted by the approved protocol.
- Voluntarily participates and provides electronic informed consent. For minors, guardian consent and participant assent are obtained as required.
Exclusion Criteria:
- Unable to provide informed consent or, where applicable, guardian consent and participant assent.
- Does not meet the eligibility requirements for either study component.
- Component 1: Has already completed the relevant full vaccination schedule, where specified as an exclusion criterion in the approved protocol.
- Questionnaire response is invalid because of severe missingness, an implausible completion time, failed quality-control items, or clear logical inconsistency.
- Any additional component-specific exclusion criterion specified in the approved protocol.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Badania usług zdrowotnych
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Brak interwencji: No-information control (Component 1)
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Eksperymentalny: AI-sourced gain-framed message (Component 1)
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Participants view an AI-sourced message emphasizing the benefits of vaccination. |
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Eksperymentalny: AI-sourced loss-framed message (Component 1)
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Participants view an AI-sourced message emphasizing the risks of not being vaccinated. |
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Eksperymentalny: AI-sourced normative message (Component 1)
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Participants view an AI-sourced message emphasizing social or public-health approval of vaccination. |
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Eksperymentalny: AI-sourced structured message (Component 1)
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Participants view an AI-sourced message explaining vaccination and booking procedures in a structured format. |
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Eksperymentalny: AI-sourced expert-authority message (Component 1)
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Participants view an AI-sourced message attributed to professional or expert authority. |
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Eksperymentalny: Official gain-framed message (Component 1)
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Participants view an official message emphasizing the benefits of vaccination. |
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Eksperymentalny: Official loss-framed message (Component 1)
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Participants view an official message emphasizing the risks of not being vaccinated. |
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Eksperymentalny: Official normative message (Component 1)
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Participants view an official message emphasizing social or public-health approval of vaccination. |
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Eksperymentalny: Official structured message (Component 1)
|
Participants view an official message explaining vaccination and booking procedures in a structured format. |
|
Eksperymentalny: Official expert-authority message (Component 1)
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Participants view an official message attributed to professional or expert authority. |
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Eksperymentalny: Gain-framed peer message (Component 2)
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Participants view a gain-framed message emphasizing the benefits of mental health help-seeking, with peer social cues. |
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Eksperymentalny: Gain-framed expert message (Component 2)
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Participants view a gain-framed message emphasizing the benefits of mental health help-seeking, attributed to an expert source. |
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Eksperymentalny: Loss-framed peer message (Component 2)
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Participants view a loss-framed message emphasizing the risks of not seeking mental health support, with peer social cues. |
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Eksperymentalny: Loss-framed expert message (Component 2)
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Participants view a loss-framed message emphasizing the risks of not seeking mental health support, attributed to an expert source. |
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Eksperymentalny: Social-norm message (Component 2)
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Participants view a message presenting help-seeking as a common and socially approved behavior. |
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Brak interwencji: Blank-reminder control (Component 2)
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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HPV vaccination intention
Ramy czasowe: Immediately after exposure to the assigned health information condition (post-exposure questionnaire).
|
In the Hunan population, assessed immediately after exposure with one 5-point item: "I am willing to receive the HPV vaccine in the future." Responses range from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicate stronger intention to receive the HPV vaccine. |
Immediately after exposure to the assigned health information condition (post-exposure questionnaire).
|
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Professional mental health help-seeking intention
Ramy czasowe: Immediately after exposure to the assigned health information condition (post-exposure questionnaire).
|
In Tongzhou students and primary caregivers, assessed using three 7-point items asking how likely the participant would be to seek help from a psychologist, a psychiatrist, and another doctor if experiencing persistent emotional distress or thoughts of self-harm. Scores range from 1 (definitely would not) to 7 (definitely would). The mean of the three items will be calculated; higher scores indicate stronger professional help-seeking intention. |
Immediately after exposure to the assigned health information condition (post-exposure questionnaire).
|
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HPV vaccination booking-directed action
Ramy czasowe: During the same online session immediately after exposure to the assigned health information condition.
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In the Hunan population, a binary behavioral outcome recorded by the online questionnaire platform after exposure. A positive response is defined as either selecting direct booking at the first decision point or agreeing to provide contact information for HPV vaccination booking at the end of the booking pathway. Viewing information without proceeding to booking or providing contact information is not counted as a positive response. |
During the same online session immediately after exposure to the assigned health information condition.
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
HPV vaccine trust
Ramy czasowe: Immediately after exposure to the assigned health information condition.
|
In the Hunan population, assessed with five HPV-adapted Vaccine Trust Gauge items covering vaccine safety, protection against serious illness, relative health risk, benefits versus risks, and effectiveness. Responses will be scored in the direction of greater trust using the prespecified VTG scoring and missing response rules. The item mean will be rescaled to 0-100; higher scores indicate greater trust. |
Immediately after exposure to the assigned health information condition.
|
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Trust in HPV vaccine information sources
Ramy czasowe: Immediately after exposure to the assigned health information condition.
|
In the Hunan population, assessed with five Vaccine Trust Gauge-adapted items measuring trust in HPV vaccine recommendations from schools or official institutions, doctors or nurses, family or friends, classmates or peers, and social media. Responses will be scored using the same prespecified VTG rules. The item mean will be rescaled to 0-100; higher scores indicate greater trust. |
Immediately after exposure to the assigned health information condition.
|
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HPV vaccination readiness (7C-based)
Ramy czasowe: Immediately after exposure to the assigned health information condition.
|
In the Hunan population, assessed using seven HPV-adapted 7C vaccination- readiness items covering calculation, collective responsibility, confidence in the system, confidence in vaccine safety, social conformity, convenience or constraints, and complacency. Items will be reverse scored where required and averaged so that higher scores indicate greater vaccination readiness. |
Immediately after exposure to the assigned health information condition.
|
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Perceived susceptibility to HPV infection
Ramy czasowe: Immediately after exposure to the assigned health information condition.
|
In the Hunan population, assessed using the mean of three 5-point Health Belief Model items representing perceived susceptibility to HPV infection. Items will be reverse scored as specified in the analysis plan so that higher scores indicate greater perceived susceptibility. |
Immediately after exposure to the assigned health information condition.
|
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Perceived severity of HPV infection
Ramy czasowe: Immediately after exposure to the assigned health information condition.
|
In the Hunan population, assessed using one reverse-scored 5-point Health Belief Model item concerning whether the health effects of HPV infection are not serious. The score will be transformed so that higher scores indicate greater perceived severity. |
Immediately after exposure to the assigned health information condition.
|
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Perceived barriers to HPV vaccination
Ramy czasowe: Immediately after exposure to the assigned health information condition.
|
In the Hunan population, assessed using the mean of six 5-point Health Belief Model items concerning perceived drawbacks, cost, insufficient information, uncertain long-term side effects, sexual stigma, and sensitivity of the topic. Higher scores indicate greater perceived barriers to HPV vaccination. |
Immediately after exposure to the assigned health information condition.
|
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Cues to action for HPV vaccination
Ramy czasowe: Immediately after exposure to the assigned health information condition.
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In the Hunan population, assessed using the mean of two 5-point Health Belief Model items concerning exposure to media reports promoting HPV vaccination and the influence of a doctor's recommendation. Higher scores indicate stronger cues to action. |
Immediately after exposure to the assigned health information condition.
|
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Help-seeking efficacy attitudes related to mental health
Ramy czasowe: Immediately after exposure to the assigned school-based health message.
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In Tongzhou students and primary caregivers, assessed using the Help-Seeking dimension of the Universal Mental Health Literacy Scale for Adolescents (UMHL-A). Five applicable items are used in students and four in caregivers. Items are scored on a 5-point scale, averaged, and rescaled to 0-100. Higher scores indicate more favorable help-seeking attitudes. |
Immediately after exposure to the assigned school-based health message.
|
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Stigma-related attitudes toward mental health
Ramy czasowe: Immediately after exposure to the assigned school-based health message.
|
In Tongzhou students and primary caregivers, assessed using the three-item Stigma dimension of the Universal Mental Health Literacy Scale for Adolescents (UMHL-A). Items are scored on a 5-point scale, averaged, and rescaled to 0-100 in the direction of less stigmatizing and more favorable attitudes. |
Immediately after exposure to the assigned school-based health message.
|
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Intention to use generative AI for HPV vaccination information
Ramy czasowe: Immediately after exposure to the assigned health information condition.
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In the Hunan population, assessed using two post-exposure 5-point items asking whether the participant is willing to use an AI chatbot to obtain further HPV vaccination information and whether generative AI would be used as one source of HPV vaccination information. Both items will be coded in the direction of greater intention and averaged. |
Immediately after exposure to the assigned health information condition.
|
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Benevolence dimension of trust in generative AI for health information
Ramy czasowe: Immediately after exposure to the assigned health information condition.
|
In Hunan and Tongzhou participants, assessed using the three-item Benevolence dimension of the Human-Generative AI Trust Scale, adapted to HPV vaccination or mental health information. The items assess whether generative AI acts in the participant's best interest, is willing to understand the participant's needs and preferences, and will help to the best of its ability. Items use a 5-point response scale and are averaged; higher scores indicate greater benevolence-based trust. |
Immediately after exposure to the assigned health information condition.
|
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Competence dimension of trust in generative AI for health information
Ramy czasowe: Immediately after exposure to the assigned health information condition.
|
In Hunan and Tongzhou participants, assessed using the three-item Competence dimension of the Human-Generative AI Trust Scale. The items assess whether generative AI can effectively support the participant in understanding health information, performs well in providing health information support, and has the expected functions for that role. Items use a 5-point response scale and are averaged; higher scores indicate greater competence-based trust. |
Immediately after exposure to the assigned health information condition.
|
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Reciprocity or dependency dimension of trust in generative AI for health information
Ramy czasowe: Immediately after exposure to the assigned health information condition.
|
In Hunan and Tongzhou participants, assessed using the three-item Reciprocity or Dependency dimension of the Human-Generative AI Trust Scale. The items assess whether participants believe they can rely on generative AI, whether it can continue to support health decisions, and whether they refer to health information provided by generative AI. Items use a 5-point response scale and are averaged; higher scores indicate greater reciprocity-based trust. |
Immediately after exposure to the assigned health information condition.
|
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Psychological resilience
Ramy czasowe: Immediately after exposure to the assigned school-based health message.
|
In Tongzhou students and primary caregivers, assessed immediately after exposure using the 10-item Connor-Davidson Resilience Scale (CD-RISC-10). Each item is scored from 0 (not true at all) to 4 (true nearly all the time). The 10 item scores are summed to a total score ranging from 0 to 40; higher scores indicate greater psychological resilience. If the online platform stores responses as 1-5, scores will be recoded to 0-4 before summation. |
Immediately after exposure to the assigned school-based health message.
|
Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- E 26964
- E 26964 (Inny identyfikator: Ethics Committee of the Third Xiangya Hospital of Central South University)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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