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临床试验/NCT07207850
NCT07207850招募中不适用

Parents Helping Parents for Youth Vaping Cessation (PhP-VX)

University of Nebraska1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年5月18日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
7-day point prevalence abstinence

研究概览

简要总结

The goal of this randomized controlled study is to test if this new intervention works to help adolescents quit vaping. A key feature of the program is the use of peer support for parents, delivered by trained parent coaches. Participants will complete baseline and follow up surveys. Parents in the intervention arm will receive peer support as part of the program.

详细描述

This objective of study is to develop and test the feasibility of a novel Parents-helping-Parents for Youth Vaping Cessation (PhP-VX) program. The investigators will conduct a feasibility pilot test with 100 parent-adolescent dyads recruited from an EHR system. Half of the dyads will receive the "PhP-VX" program for 3 months, and half of the dyads will be assigned to the control (no-treatment) group.

The PhP-VX program consists of two key components: 1) online lessons for participating parents and adolescents and 2) one on one sessions with a coach for parents.

Eligible dyads will be randomly assigned to either the test or control group using a computer-generated randomization list. At baseline, all participants will complete a survey assessing their e-cigarette and tobacco use, vaping knowledge, and exposure to marketing and media. Dyads assigned to the test arm will receive PhP-VX program instructions, and parents will be immediately connected with a coach. Parents will be scheduled to receive six bi-weekly, 30-minute, 1:1 coach-facilitated sessions via Zoom. The coaches will identify the priority needs of the participant, provide support and advocacy (e.g., coach on how to identify own needs and access resources), role model (e.g., share experiences, demonstrate effective decision-making), effective communication with their children, and facilitate change (motivation, facilitate change through goal setting/education/skills building). Parents will also be able to contact the coach as needed for additional support and resources.

All participants in both the control and test arms will be followed up at months 1, 3, and 6 with questions on e-cigarette use, vaping knowledge, and marketing/media literacy. Parents and children in the test arm will also complete an evaluation of the PhP-VX program at the end of the intervention (month 3).

The investigators will offer twenty adolescent participants (10 control, 10 intervention) the option to provide saliva samples at baseline, 3 months, and 6 months. The samples will be collected using the iScreen Oral Fluid Device (OFD) cotinine test, which detects cotinine, a metabolite of nicotine and the recommended biomarker for validating self-reported tobacco abstinence. Cotinine levels will serve as our biochemical verification of participants' self-reported abstinence. Adolescents who agree to participate will receive saliva collection kits by mail. Participants will be instructed to upload a photo of their test result via a REDCap survey.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
15 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Report vaping in the previous 30 days
  • English literacy
  • PARENT INCLUSION:
  • Biological, adoptive, stepparents, or adult guardian of adolescent participating
  • Have face-to-face contact with the adolescent at least one day per week during the study period
  • Access to a computer or mobile phone at home
  • Interested in helping adolescent quit e-cigarette/vape use

排除标准

  • 未提供

研究组 & 干预措施

Control Group

No Intervention

Participants in this arm will not receive the PhP-VX treatment.

Test Group - PHP-VX Program

Experimental

Participants in this arm will receive the PhP-VX program.

干预措施: Parents Helping Parents program (Behavioral)

结局指标

主要结局

7-day point prevalence abstinence

时间窗: Baseline and Follow ups (1 month, 3 months, 6 months)

次要结局

  • Vaping frequency(Baseline and Follow ups (1 month, 3 months, 6 months))
  • Past 7 day Vaping intensity(Baseline and Follow ups (1 month, 3 months, 6 months))
  • Other tobacco use(Baseline and Follow ups (1 month, 3 months, 6 months))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hongying Daisy Dai

Principal Investigator

University of Nebraska

研究点 (1)

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