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临床试验/NCT02744118
NCT02744118已完成不适用

Helping Eliminate Marijuana Use Through Pediatric Practice

American Academy of Pediatrics2 个研究点 分布在 1 个国家目标入组 620 人开始时间: 2016年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
620
试验地点
2
主要终点
Change in Adolescent Marijuana Use and Habits at 3-6 Weeks using the Timeline Followback (TLFB) Method

研究概览

简要总结

This study adapts the Public Health Service (PHS) 5As model for use with adolescent marijuana users and pilot the intervention to test feasibility and acceptability in pediatric primary care settings. The specific aims are as follows:

Aim 1: Develop a marijuana screening and brief counseling intervention for adolescents based on the Public Health Service 5As model and previously developed adolescent smoking cessation intervention.

Hypothesis 1: The 5As model can be adapted for use as a marijuana screening and counseling intervention for adolescents.

Aim 2: Test the feasibility and acceptability of the 5As marijuana screening and brief counseling intervention in pediatric primary care practice.

Hypothesis 2a: Pediatric clinicians will find the 5As intervention feasible and acceptable for addressing marijuana use in routine clinical visits with adolescents and their families; and

Hypothesis 2b: Adolescents will find the 5As intervention delivered by their clinicians to be acceptable in the context of routine preventive services delivery.

详细描述

The HEMPP study involves three phases: Researchers will (1) Develop a marijuana screening and brief counseling intervention for adolescents, based on expert input, current literature, and themes gathered from focus groups with adolescents and clinicians; (2) Pilot test the acceptability of the 5As marijuana intervention in 2 pediatric primary care practices, where researchers will test the intervention and determine acceptability via in-depth interviews with clinicians, office staff, adolescents and parents; and (3) Pilot test the feasibility of the 5As marijuana intervention in 8 practices (4 intervention/4 comparable control), wherein each practice will enroll 100 adolescents and conduct baseline/exit interviews with all of them. Twenty percent of adolescents/practice (including identified marijuana users) will complete one follow-up interview 3-6 weeks after their practice visit. These interviews will assess physician-delivery of the intervention and any change in use, attitude or behavioral intentions toward marijuana since their clinical visit. Findings will inform the development of a future large-scale trial of adolescent marijuana use, screening and cessation counseling in pediatric primary care. The long-term goal is to improve clinical preventive services for adolescent marijuana cessation. Conducting this work within the AAP PROS network will lead to rapid dissemination of effective interventions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
13 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Adolescents presenting for regular well or sick visits at their pediatrician's office
  • Must live in a home or apartment with access to a telephone and mailing address
  • Must be cognitively able to consider the risks of marijuana use
  • Must be able to speak English
  • Must be able and willing to give informed consent (if 18 years of age or older) or assent (if 14-17 years of age)
  • In addition: parents/legal guardians of minors must be able and willing to give informed consent

排除标准

  • 未提供

结局指标

主要结局

Change in Adolescent Marijuana Use and Habits at 3-6 Weeks using the Timeline Followback (TLFB) Method

时间窗: Baseline (doctor's visit) and 3-6 weeks after doctor's visit

Via a baseline survey and a phone interview 3-6 weeks later, using the Timeline Followback Method (TLFB), adolescents will be asked to report their current marijuana-use status, and will explore whether receiving the intervention affects motivation, intentions to quit and reduce use, or change in marijuana-use habits. Marijuana use will be defined as smoking or ingestion of any part of the marijuana plant; categories include: ever user, past month (current) user; past week and daily user. Addiction measures will include: compulsive use, psychoactive effects and drug-reinforced behaviors.

次要结局

  • Health and Behavioral Outcomes Related to Adolescent Marijuana Use(3-6 weeks after initial doctor's visit)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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