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临床试验/NCT02537756
NCT02537756已完成不适用

Developing a Self-persuasion Intervention Promoting Adolescent HPV Vaccination

University of Texas Southwestern Medical Center1 个研究点 分布在 1 个国家目标入组 737 人开始时间: 2016年4月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
737
试验地点
1
主要终点
Survey Items Measuring Parental Intentions to vaccinate

研究概览

简要总结

HPV vaccine coverage among adolescents in the US is suboptimal. This is particularly true among traditionally underserved adolescents. Few parent-targeted interventions have focused on the parental decision-making process. Self-persuasion, generating one's own arguments for engaging in a behavior, may be an effective means to influence parents' motivation to vaccinate their children. In a three-phase study, investigators are using quantitative and qualitative research methods to develop and refine a tablet-based self-persuasion intervention for parents who are undecided about the HPV vaccine. This clinical trial submission focuses on the second phase of the study. The results of the second phase will inform the third phase of the trial (also registered in clinical trials).

详细描述

Despite the fact that HPV vaccination is recommended for male and female adolescents, HPV vaccine 3 dose coverage among adolescents is poor (38% for girls, 14% for boys). HPV-related cancers are a significant burden on the US healthcare system and could be prevented through adolescent vaccination. Rates of vaccination are suboptimal among underserved populations (uninsured, low-income, racial and ethnic minorities) often seen in safety-net clinics. Few interventions have been designed that target decision-making among parents of unvaccinated adolescents. Self-persuasion, generating of one's own arguments for a health behavior, may be an effective means of influencing HPV vaccination behaviors among undecided or ambivalent parents. Through three stages, investigators will identify and develop a self-persuasion intervention strategy to promote adolescent HPV vaccination in safety-net clinics. The current trial, Stage 2, is a four-arm randomized controlled trial (RCT), using a 2x2 factorial design, in which investigators will assign participants to one of four self-persuasion intervention conditions that vary by cognitive processing level (verbalize vs. listen to arguments) and choice of argument topics (parents choose vs. are assigned topics) to identify which intervention condition is optimal. Conducted in a laboratory setting, investigators will identify and select the optimal intervention condition through quantitative analysis of the effects on parents' vaccination intentions and qualitatively by exploring parental experiences with the self-persuasion tasks.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Single (Care Provider)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Undecided parents (18 years and older) whose children are 11-17 year old patients who have not begun the HPV vaccine series.

排除标准

  • •Parents whose child is a pregnant adolescent
  • •Lack telephone access
  • •Having impairing hearing or speech
  • •Participants will be excluded from participation in future stages

研究组 & 干预措施

1- Verbalize, Choice

Experimental

Parents will use a tablet-based application (Project Voice) that directs them to verbalize their own arguments based on topics they choose

干预措施: Project Voice (Behavioral)

2- Listen, Choice

Experimental

Parents will use a tablet-based application (Project Voice) that directs them to listen to peer-generated arguments based on topics they choose

干预措施: Project Voice (Behavioral)

3- Verbalize, Assigned

Experimental

Parents will use a tablet-based application (Project Voice) that directs them to verbalize their own arguments based on topics assigned to them

干预措施: Project Voice (Behavioral)

4- Listen, Assigned

Experimental

Parents will use a tablet-based application (Project Voice) that directs them to listen to peer-generated arguments based on topics assigned to them

干预措施: Project Voice (Behavioral)

结局指标

主要结局

Survey Items Measuring Parental Intentions to vaccinate

时间窗: During the intervention visit (1 hr)

Change in intentions of the parent to vaccinate from baseline survey to exit survey using measures adapted from Gerend \& Shepherd (2012). Intentions Likert Scale responses range from 1-very likely to 5-very unlikely.

次要结局

  • HPV vaccination behavior documented in the electronic medical record, initiation(12 months)
  • Change in Decision Stage(During the intervention visit (1 hr))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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