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Trial of a Novel Brief Intervention on Health Behaviors for Youth With Chronic Medical Conditions

2020年7月7日 更新者:Sharon Levy、Boston Children's Hospital

Trial of a Novel Brief Intervention on Health Behaviors for Youth With Chronic Medical

The primary goal of this project is to develop a tailored screening, brief intervention and referral to treatment (SBIRT) model for youth with chronic medical conditions (YCMC) for delivery at point of care during a routine healthcare visit, through conducting a rigorous randomized control trial among adolescent patients with type 1 diabetes (TID) or rheumatologic conditions. The secondary goal is to assess the attitudes and knowledge of parents of these same adolescents, to explore links between parent beliefs and adolescent behavior around substance use.

研究概览

详细说明

The proposed project is a randomized control trial to assess the efficacy of an SBIRT model tailored to youth with chronic medical conditions. This trial is being built into a larger, longitudinal cohort study to assess whether a set of brief, substance specific questions can accurately predict adolescent substance use outcomes when compared to more lengthy, criterion standard assessment questions, in cross-sectional and prospective analysis. The first component of the project will consist of pre-testing an assessment battery and brief electronic intervention with a small sample of 14-17 year old youth. In the second component the investigators will randomize consented eligible participants into intervention or control arms of the study and administer the 1) Baseline Assessment Battery and the 2) Brief Intervention OR Treatment as Usual (TAU). In the third component the investigators will follow up with all participants at 6 and then 12 months after study entry to reassess rates of substance use through follow up assessment batteries.

At baseline, the investigators will also attempt to enroll parents of all participants who are present at the time of enrollment. The investigators will separately consent and administer a brief assessment battery to parents to assess their knowledge and attitudes around substance use, as well as opinions and attitudes regarding other health and risk behaviors.

研究类型

介入性

注册 (实际的)

460

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Massachusetts
      • Boston、Massachusetts、美国、02115
        • Boston Children's Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

14年 至 17年 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 14-17 year-old youth presenting for routine medical care in the Rheumatology clinic or Endocrinology clinic at Boston Children's Hospital (BCH)
  • A diagnosis of type 1 diabetes for at least a year or a diagnosis of a Rheumatologic condition for at least a year.
  • Able to read and understand English at a middle school level or greater
  • Consent to participation in the study and consent to the 6 month and 12 month follow up assessments.

Exclusion Criteria:

  • Patients who are medically or emotionally unstable or otherwise unable to provide assent at the time of their appointment as determined by their clinician or the research team
  • Unable to speak/read English at a middle school reading level
  • Unable to use a computer keyboard and/or complete an interviewer-assisted questionnaire
  • Do not consent to 6 month and 12 month re-assessment.
  • Patients who are pregnant at baseline

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Intervention
Those in the intervention arm will receive a computerized brief intervention composed of tailored feedback and psycho-education on substance use. Content in the intervention will focus on health promotion and will deliver positive messages about health.
Participants in the intervention arm will receive a computerized brief intervention composed of tailored feedback and psycho-education specific to their chronic condition.
无干预:Control
Those in the control arm will receive treatment as usual.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Frequency and quantity of alcohol use in the past 12 months, measured using the Screen to Brief Intervention (S2BI) screening tool.
大体时间:12 months post intervention
We will compare changes in frequency and quantity of alcohol use over the past twelve months between the intervention and treatment as usual groups.
12 months post intervention

次要结果测量

结果测量
措施说明
大体时间
Frequency of marijuana use in the past 12 months, measured using the S2BI Screening Tool.
大体时间:12 months post intervention
We will compare changes frequency of marijuana use in the past 12 months between the intervention and treatment as usual groups.
12 months post intervention
Perceived risk of harm of substance use
大体时间:12 months post intervention
We will compare self-reported perceived risk of harm of substance use between intervention and TAU groups using Monitoring the Future questions.
12 months post intervention
Medication Adherence measured by self-report
大体时间:12 months post intervention
12 months post intervention

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Sharon Levy, MD, MPH、Boston Children's Hospital
  • 首席研究员:Elissa Weitzman, ScD, MSc、Boston Children's Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年4月1日

初级完成 (实际的)

2019年11月26日

研究完成 (实际的)

2019年11月26日

研究注册日期

首次提交

2016年3月3日

首先提交符合 QC 标准的

2016年6月14日

首次发布 (估计)

2016年6月17日

研究记录更新

最后更新发布 (实际的)

2020年7月8日

上次提交的符合 QC 标准的更新

2020年7月7日

最后验证

2020年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • P00021649

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

Individual participant data will not be made available. We will provide our findings in aggregate.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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