Trial of a Novel Brief Intervention on Health Behaviors for Youth With Chronic Medical Conditions
Trial of a Novel Brief Intervention on Health Behaviors for Youth With Chronic Medical
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
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Massachusetts
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Boston、Massachusetts、美国、02115
- Boston Children's Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
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
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 |
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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.
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Participants in the intervention arm will receive a computerized brief intervention composed of tailored feedback and psycho-education specific to their chronic condition.
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无干预:Control
Those in the control arm will receive treatment as usual.
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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 |
|---|---|---|
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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
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We will compare changes in frequency and quantity of alcohol use over the past twelve months between the intervention and treatment as usual groups.
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12 months post intervention
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Frequency of marijuana use in the past 12 months, measured using the S2BI Screening Tool.
大体时间:12 months post intervention
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We will compare changes frequency of marijuana use in the past 12 months between the intervention and treatment as usual groups.
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12 months post intervention
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Perceived risk of harm of substance use
大体时间:12 months post intervention
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We will compare self-reported perceived risk of harm of substance use between intervention and TAU groups using Monitoring the Future questions.
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12 months post intervention
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Medication Adherence measured by self-report
大体时间:12 months post intervention
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12 months post intervention
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合作者和调查者
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
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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