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出境医 / 临床实验 / A Message Framing Intervention for Increasing Parental Acceptance of Human Papillomavirus Vaccination
A Message Framing Intervention for Increasing Parental Acceptance of Human Papillomavirus Vaccination
Study Description
Brief Summary:
The goal of this study is to determine the effects of message framing (gain vs. loss) on African American parents' acceptance of the HPV vaccine and how such effects are moderated by parents' salient beliefs prior to message exposure. Participants are randomized into gain and loss conditions in which they view either gain-framed or loss-framed HPV vaccination messages. Key outcome variables include parents' attitudes and intentions toward vaccinating their children against HPV.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cervical Cancer Anal Cancer Penile Cancer | Behavioral: Framed HPV vaccination messages | Not Applicable |
Detailed Description:
The goal of this study is to determine the effects of message framing (gain vs. loss) on African American parents' acceptance of the HPV vaccine and how such effects are moderated by parents' salient beliefs prior to message exposure. Participants recruited from local communities and online panels will complete a computer-assisted survey. In the survey participants will first answer questions related to their beliefs about HPV and the HPV vaccine (e.g., perceived susceptibility, perceived severity, perceived efficacy, perceived safety, etc.), as well as other background information. Then they will be presented with either a gain-framed or loss-framed human papillomavirus vaccination message. After the message exposure, they will answer questions related to their attitudes toward HPV vaccination, intentions to vaccinate their children, as well as other message response measures. Eligible participants are at least 21 years old, self-identify as African American, and are custodial parents or caretakers of at least one child ages 9-17 who has not initiated the HPV vaccine series.
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 2000 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | A Message Framing Intervention for Increasing Parental Acceptance of Human Papillomavirus Vaccination |
| Estimated Study Start Date : | December 7, 2020 |
| Estimated Primary Completion Date : | May 31, 2021 |
| Estimated Study Completion Date : | May 31, 2021 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Gain-framed messages
Participants in this arm receive gain-framed HPV vaccination messages.
|
Behavioral: Framed HPV vaccination messages
Digital multimedia messages consisting of text and imagery conveying the benefits of being vaccinated against HPV or the costs of not being vaccinated against HPV.
|
|
Experimental: Loss-framed messages
Participants in this arm receive loss-framed HPV vaccination messages.
|
Behavioral: Framed HPV vaccination messages
Digital multimedia messages consisting of text and imagery conveying the benefits of being vaccinated against HPV or the costs of not being vaccinated against HPV.
|
Outcome Measures
Primary Outcome Measures :
- Attitudes [ Time Frame: baseline posttest ]Attitudes toward HPV vaccination will be assessed by three semantic differential items adapted from previous research. Participants will be presented with a statement (i.e., vaccinating my child against HPV would be ____) followed by adjectives such as "Bad/Good," "Stupid/Wise," and "A bad idea/A good idea."
- Attitudes [ Time Frame: 1-month follow up ]Attitudes toward HPV vaccination will be assessed by three semantic differential items adapted from previous research. Participants will be presented with a statement (i.e., vaccinating my child against HPV would be ____) followed by adjectives such as "Bad/Good," "Stupid/Wise," and "A bad idea/A good idea."
- Intentions [ Time Frame: baseline posttest ]Behavioral intentions toward HPV vaccination will be assessed with three questions adapted from previous research. Participants will be asked questions such as "how likely would you be to get your child vaccinated with the HPV vaccine sometime soon?" Since cost of the vaccine is a potential barrier, all participants will be asked to indicate their intentions to get their children vaccinated for two scenarios: 1) if they have to purchase the vaccine for the full retail price at the time and 2) if the vaccine is offered to them free of cost. The two measures will be kept separate as outcome variables.
- Intentions [ Time Frame: 1-month follow up ]Behavioral intentions toward HPV vaccination will be assessed with three questions adapted from previous research. Participants will be asked questions such as "how likely would you be to get your child vaccinated with the HPV vaccine sometime soon?" Since cost of the vaccine is a potential barrier, all participants will be asked to indicate their intentions to get their children vaccinated for two scenarios: 1) if they have to purchase the vaccine for the full retail price at the time and 2) if the vaccine is offered to them free of cost. The two measures will be kept separate as outcome variables.
Secondary Outcome Measures :
- Thoughts [ Time Frame: baseline posttest ]Participants will be asked to list the thoughts they had while viewing the message. They will categorize the thoughts into positive (in support of the message), negative (in opposition to the message), and irrelevant.
- Emotions [ Time Frame: baseline posttest ]Participants will report how they felt while viewing the message. Anger, Guilt, Fear, Sadness, and Happiness will be measured by an established scale.
- Perceived argument strength [ Time Frame: baseline posttest ]Perceived argument strength will be measured by an established scale.
Eligibility Criteria
| Ages Eligible for Study: | 21 Years to 99 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 21 years or older
- Self-identify as African American
- Custodial parent or caretaker of at least one child ages 9-17 who has not initiated the HPV vaccine series
- Has access to Internet to complete the study
Exclusion Criteria:
- Younger than 21 years
- Does not self-identify as African American
- Not a custodial parent or caretaker of at least one child ages 9-17 who has not initiated the HPV vaccine series
- Has no access to Internet to complete the study
Contacts and Locations
Contacts
| Contact: Xiaoli Nan | 3014050640 | nan@umd.edu | |
| Contact: Cheryl Holt | 3014056659 | cholt14@umd.edu |
Sponsors and Collaborators
University of Maryland, College Park
Investigators
| Principal Investigator: | Xiaoli Nan | University of Maryland, College Park |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | December 17, 2018 | ||||||||
| First Posted Date ICMJE | February 27, 2019 | ||||||||
| Last Update Posted Date | December 2, 2020 | ||||||||
| Estimated Study Start Date ICMJE | December 7, 2020 | ||||||||
| Estimated Primary Completion Date | May 31, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | A Message Framing Intervention for Increasing Parental Acceptance of Human Papillomavirus Vaccination | ||||||||
| Official Title ICMJE | A Message Framing Intervention for Increasing Parental Acceptance of Human Papillomavirus Vaccination | ||||||||
| Brief Summary | The goal of this study is to determine the effects of message framing (gain vs. loss) on African American parents' acceptance of the HPV vaccine and how such effects are moderated by parents' salient beliefs prior to message exposure. Participants are randomized into gain and loss conditions in which they view either gain-framed or loss-framed HPV vaccination messages. Key outcome variables include parents' attitudes and intentions toward vaccinating their children against HPV. | ||||||||
| Detailed Description | The goal of this study is to determine the effects of message framing (gain vs. loss) on African American parents' acceptance of the HPV vaccine and how such effects are moderated by parents' salient beliefs prior to message exposure. Participants recruited from local communities and online panels will complete a computer-assisted survey. In the survey participants will first answer questions related to their beliefs about HPV and the HPV vaccine (e.g., perceived susceptibility, perceived severity, perceived efficacy, perceived safety, etc.), as well as other background information. Then they will be presented with either a gain-framed or loss-framed human papillomavirus vaccination message. After the message exposure, they will answer questions related to their attitudes toward HPV vaccination, intentions to vaccinate their children, as well as other message response measures. Eligible participants are at least 21 years old, self-identify as African American, and are custodial parents or caretakers of at least one child ages 9-17 who has not initiated the HPV vaccine series. | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Framed HPV vaccination messages
Digital multimedia messages consisting of text and imagery conveying the benefits of being vaccinated against HPV or the costs of not being vaccinated against HPV.
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE |
2000 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | May 31, 2021 | ||||||||
| Estimated Primary Completion Date | May 31, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 21 Years to 99 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Not Provided | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03856437 | ||||||||
| Other Study ID Numbers ICMJE | 1322177-1.1 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||||||
| Responsible Party | University of Maryland, College Park | ||||||||
| Study Sponsor ICMJE | University of Maryland, College Park | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| PRS Account | University of Maryland, College Park | ||||||||
| Verification Date | November 2020 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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