Computerized Intervention of Parental Involvement in Diabetes Care of Their Child
2017年6月1日 更新者：Deborah Ellis, Ph.D.、Wayne State University
Computer-Delivered Motivational Intervention to Improve Teen Diabetes Management
The purpose of this study is to develop an intervention to increase parental motivation for supervision and monitoring youth diabetes care behavior.
The intervention will be tested in three brief session in conjunction with regularly scheduled diabetes clinic visits and delivered through a computer program based in the principles of Motivational Interviewing.
研究概览
地位
完全的
条件
详细说明
The study includes a development phase (Phase 1: development of the intervention followed by feasibility testing with 10 youth and 10 parents) and a pilot validation phase [Phase 2: pilot randomized clinical trial (RCT)] using a sample of 90 African American youth transitioning to independent diabetes care and their parents.
In this phase, families will be randomly assigned to one of three study arms: parent motivation for monitoring and youth motivation for diabetes care (arm 1), parent motivation for monitoring and youth information (arm 2) or parent and youth information (arm 3).
In phase 1 (development), youth and their caregivers will complete a one-time research visit where they use the program and provide feedback via a semi-structured interview regarding the usefulness of the content, its user-friendliness and make suggestions for changes to enhance acceptability.
In phase 2 ( RCT), families will complete three intervention plus data collection visits and one additional data collection only visit.
Research visits will be scheduled to coincide with appointments in the diabetes clinic to maximize convenience for families.
研究类型
介入性
注册 (实际的)
145
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
-
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Michigan
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Detroit、Michigan、美国、48201
- Wayne State University
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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
10年 至 13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:
- African American race/ethnicity
- Age: 10 years 0 months - 12 years, 11 months
- Type 1 diabetes mellitus
- Diagnosed at least 6 months
- Patient of Children's Hospital of Michigan Diabetes Clinics
- English fluency, both verbal and written
Exclusion Criteria:
- Psychiatry/psychological diagnoses including cognitive impairment that would prevent the participant from understanding the data collection measures, (i.e. moderate or severe mental retardation) or the following psychiatric diagnoses: autism and schizophrenia. Youth with current suicidal intent are not enrolled until psychiatrically stable.
- Medical diagnoses that would result in atypical diabetes management i.e. cystic fibrosis. Other medical conditions that would not affect diabetes management, such as asthma, do not exclude the participant from study participation.
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：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Active Caregiver and Active Child
Parent & Child Computer-Delivered Motivational Intervention will be delivered to participants.
A brief computer delivered behavior change counseling intervention for parents of children with diabetes to improve monitoring of diabetes care and a brief computer delivered behavior change counseling intervention for children with diabetes to improve completion of daily diabetes care.
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Motivational Interviewing (MI) is a client-centered, directive method for enhancing intrinsic motivation to change by exploring & resolving ambivalence, with a strong evidence for improving adolescent & adult health behaviors.
Three motivational sessions will be provided by an animated character who delivers the intervention with high fidelity to MI principles.
Small amounts of psychoeducation about potential improvements illness management that can result from monitoring/completing diabetes care will be integrated with more purely motivational elements.
Mailings will be sent to participants to remind them of the reasons they gave as motivation & goals they set regarding diabetes care.
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实验性的：Active Caregiver and Child Education
Parent Computer-Delivered Motivational Intervention will be delivered to the parents only.
A brief computer delivered behavior change counseling intervention for parents of children with diabetes to improve monitoring of diabetes care and a brief computer delivered informational session about diabetes related topics for their child with diabetes.
|
Motivational Interviewing (MI) is a client-centered, directive method for enhancing intrinsic motivation to change by exploring & resolving ambivalence, with a strong evidence for improving adolescent & adult health behaviors.
Three motivational sessions will be provided by an animated character who delivers the intervention with high fidelity to MI principles.
Small amounts of psychoeducation about potential improvements illness management that can result from parental monitoring of diabetes care will be integrated with more purely motivational elements.
Mailings will be sent to participants to remind them of the reasons they gave as motivation & goals they set regarding monitoring diabetes care.
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有源比较器：Education Caregiver/Education Child
Participants will receive computer-delivered information.
A brief computer delivered information session about diabetes related topics for both the caregiver and the child with diabetes.
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Computer-Delivered Information about issues related to living with diabetes that do not directly impact completing diabetes care.
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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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Diabetes Management Scale
大体时间：Each of 3 intervention session, 3-4 month apart
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The Diabetes Management Scale (DMS) (Frey, Ellis, Naar-King et al., 2004) is a self-report questionnaire used to measure a broad range of diabetes management behaviors, such as insulin management, dietary management, blood glucose monitoring, symptom response, and parent assistance/supervision.
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Each of 3 intervention session, 3-4 month apart
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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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Treatment Regulation Questionnaire
大体时间：Each of 3 intervention session, 3-4 month apart
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Parental motivation to monitor the youth is measured by the Treatment Self-Regulation Questionnaire (TSRQ; Ryan & Connell (1989).
The TSRQ evaluates why people engage in a health-relevant behavior and assesses the degree to which one's motivation for a particular behavior or set of behaviors is relatively autonomous or self-determined as compared to derived from external pressures or constraints.
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Each of 3 intervention session, 3-4 month apart
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Readiness Ruler
大体时间：Each of 3 intervention session, 3-4 month apart
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Parent motivation to monitor the youth is also measured by the Readiness Ruler (Stott, Rollnick, & Pill, 1995).
Since readiness to change behaviors is behavior specific, the items will be tailored to assess the behaviors most critical to parental monitoring of diabetes management.
The response format is a visual analog scale (VAS) 10 mm in length.
Written cues anchor the ends and middle of the scale.
Respondents mark their "readiness" on the scale and the position on the line is measured in millimeters.
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Each of 3 intervention session, 3-4 month apart
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HbA1C Blood Test
大体时间：Each of 3 intervention session, 3-4 month apart
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Metabolic control will be measured via hemoglobin A1c (HbA1c).
HbA1c is an indirect and retrospective measure of average blood glucose levels over the previous two to three month period.
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Each of 3 intervention session, 3-4 month apart
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Parental Monitoring of Diabetes Care
大体时间：Each of 3 intervention session, 3-4 month apart
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The Parental Monitoring of Diabetes Care scale (PMDC) is an 18 item, investigator-developed questionnaire that measures the frequency of parental monitoring and direct supervision of diabetes care tasks such as insulin administration, blood glucose testing, and dietary management.
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Each of 3 intervention session, 3-4 month apart
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Twenty-four Hour Recall Interview
大体时间：Each of 3 intervention session, 3-4 month apart
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The Twenty-four Hour Recall Interview, developed by Johnson and colleagues (Freund, Johnson, Silverstein et al., 1991), has been used extensively in pediatric diabetes research for the assessment of illness management.
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Each of 3 intervention session, 3-4 month apart
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Blood Glucose Testing Frequency
大体时间：Each of 3 intervention session, 3-4 month apart
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Objective data on mean daily frequency of blood glucose testing during the 14-day period prior to data collection will be obtained directly from blood glucose meters.
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Each of 3 intervention session, 3-4 month apart
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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：Deborah A Ellis, Ph.D.、Wayne State University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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
2011年4月1日
初级完成 (实际的)
2014年3月3日
研究完成 (实际的)
2014年9月9日
研究注册日期
首次提交
2012年1月18日
首先提交符合 QC 标准的
2012年1月23日
首次发布 (估计)
2012年1月24日
研究记录更新
最后更新发布 (实际的)
2017年6月2日
上次提交的符合 QC 标准的更新
2017年6月1日
最后验证
2017年6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.