An e-Parenting Skills Intervention to Decrease Injured Adolescents' Alcohol Use (e-Parenting)
2018年4月10日 更新者：Michael J. Mello, MD, MPH
The objective of this trial is to test feasibility and acceptability of an e-parenting skills intervention with parents of injured adolescent alcohol users (12-17 years old) as compared to standard care at three pediatric trauma centers.
To examine these questions, the investigators will randomly assign adolescent and parent dyads (up to 75) to one of two groups.
One group will continue to receive the institutional standard care of a brief alcohol intervention delivered by clinical staff to the adolescent with no parenting skills intervention.
The second group will continue to receive the same institutional standard care plus the parent will receive an e-parenting skills intervention consisting of: the online parent training program, Parenting Wisely(PW), plus text messaging and a web-based message board.
Study participants will be injured adolescents, 12-17 years old, admitted to the inpatient service of the trauma center, and with a positive CRAFFT (mnemonic acronym of first letters of key words in the screening tool) screen for alcohol use.
Adolescents' alcohol use will be measured at study enrollment and at 3 and 6 months after discharge.
Adolescents' alcohol related negative consequences will be measured at study enrollment for the 6 months prior to hospitalization and again at 6 months after hospital discharge.
Parenting skills will also be assessed at 3 and 6 months.
研究概览
详细说明
This study seeks to test the feasibility and acceptability of an e-parenting skills intervention at three pediatric trauma centers.
The investigators will randomize up to 75 dyads of injured adolescents (12-17 years old) who screen positive for alcohol use and their parent to receive either standard trauma center care (a brief intervention with the adolescent) or standard trauma center care (a brief intervention with the adolescent) plus an e-parenting skills intervention consisting of a computerized intervention for parent skill building, a series of text messages and a web-based message board.
The primary aim of this study is to determine the feasibility and acceptability of conducting the e-parenting intervention protocol across three pediatric trauma centers in preparation for a larger fully power trial.
The central hypothesis for our future fully powered randomized control trial is that adolescents whose parents receive the e-parenting skills intervention will decrease their alcohol use and alcohol-related negative consequences over the 6 months following the intervention more than adolescents who receive only standard trauma center care.
Therefore, a secondary aim of this proposal is to calculate a preliminary effect size that could be used, along with other relevant data, such as the acceptability data and findings in the literature, to calculate sample size in a future fully powered randomized control trial.
The investigators will also examine adolescent's conjoint use of marijuana.
This project advances translational research in collecting preliminary data on an e-parenting skills intervention that can be easily adopted with high fidelity across pediatric trauma centers.
Its findings have the potential to directly impact best clinical practices for intervening with alcohol using injured adolescents
研究类型
介入性
注册 (实际的)
36
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
-
-
Rhode Island
-
Providence、Rhode Island、美国、02903
- Rhode Island 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
12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:
- adolescents, age 12-17, admitted to the trauma service
- medically stable
- a positive CRAFFT screen or lab screen for alcohol use or drug use
- ability to assent to study and have one parent consent
- adolescent and parent are English speaking
Exclusion Criteria:
- the adolescent is cognitively or emotionally unable to participate as determined by a trauma clinician
- the adolescent is suspected by the clinical staff of being a victim of child abuse (and referred to child protective services)
- the adolescent is being evaluated following a suicide attempt
- prior to admission, the adolescent is being treated for an alcohol or drug dependency
- adolescent is currently incarcerated
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：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预：Standard Care
All enrolled adolescents will continue to receive standard trauma center care, a brief intervention during their hospitalization by a trauma center social worker which is required by institutional policy.
|
|
|
实验性的：Standard Care plus e-Parenting Group
The second group will continue to receive the same institutional standard care plus the parent will receive an e-parenting skills intervention consisting of: the online parent training program, Parenting Wisely (PW), plus text messaging and a web-based message board.
|
The second group will continue to receive the same institutional standard care plus the parent will receive an e-parenting skills intervention consisting of: the online parent training program, Parenting Wisely (PW), plus text messaging and a web-based message board.
|
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 |
|---|---|---|
|
Feasibility and Acceptability of an e-Parenting Skills Intervention
大体时间：Up to 3 months
|
Feasibility will be measured by parent data (number of Parenting Wisely logins and activities completed).
Acceptability will be measured by the Systems Usability Scale (SUS) which rates parent ease of use of the program and the Consumer Satisfaction Questionnaire (CSQ) which rates level of parent satisfaction with treatment delivery and ability to manage child's behavior.
|
Up to 3 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Effects on Alcohol Use as assessed by Adolescent Drug Questionnaire (ADQ).
大体时间：Up to 6 months
|
Alcohol use will be measured by Adolescent Drug Questionnaire (number of drinking days and heavy drinking days in the past 3 months) among teen participants.
|
Up to 6 months
|
|
Effects on Drug use as assessed by Drug Use Questionnaire (DUQ).
大体时间：Up to 6 months
|
Drug use will be measured by Drug Use Questionnaire (number of days in the past 3 months teen participants used nicotine, marijuana, cocaine and other drugs).
|
Up to 6 months
|
|
Effects on Alcohol and Drug Related Problems as assessed by Add Health measures.
大体时间：Up to 6 months
|
Alcohol and drug related problems will be measured by the 9 questions from the Add Health survey (frequency of psychosocial and health consequences associated with alcohol and drug use over the prior 3 month period).
|
Up to 6 months
|
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。
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)
2015年9月1日
初级完成 (实际的)
2017年8月1日
研究完成 (实际的)
2018年2月1日
研究注册日期
首次提交
2016年3月2日
首先提交符合 QC 标准的
2016年3月23日
首次发布 (估计)
2016年3月24日
研究记录更新
最后更新发布 (实际的)
2018年4月11日
上次提交的符合 QC 标准的更新
2018年4月10日
最后验证
2018年4月1日
更多信息
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.