A Family Centered Intervention to Promote Optimal Child Development
2016年8月30日 更新者:Children's Hospital of Philadelphia
A Family Centered Intervention to Promote Optimal Child Development at the Interface of the Health System and Community
This is a randomized controlled trial aimed at assessing the effectiveness of a patient decision aid (PDA) and text message reminder in promoting early intervention referral completion when infants and toddlers are identified with a developmental concern in the pediatric medical home.
Subjects will be randomized to one of two study arms- (1) intervention (2) control condition.
Subjects in the intervention arm will watch a video PDA and will receive a text message reminder approximately 7 to 14 business days after enrollment if they agree to the early intervention referral.
研究概览
研究类型
介入性
注册 (实际的)
64
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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Pennsylvania
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Philadelphia、Pennsylvania、美国、19104
- Children's Hospital of Philadelphia
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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
2天 至 3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:
- Parent-child dyads in which the child is age 0 to 36 months screening positive for developmental concern and receiving care at a practice within Children's Hospital of Philadelphia Pediatric Research Consortium (PeRC).
- Caregivers able to give permission (informed consent).
Exclusion Criteria:
- Primary language other than English
- Children already enrolled in early intervention
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
- 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 |
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实验性的:Patient Decision Aid
After positive screen for a developmental concern the intervention group will receive the Patient Decision Aid (PDA), as well as, a text message reminder to follow up with Early Intervention.
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Short informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services.
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无干预:Routine Care
After screening positive for a potential development delay those in the control arm will receive routine care, in this case, a handout explaining Early Intervention services.
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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 |
---|---|---|
Difference in the Number of Participants Who Completed Early Intervention Intake and Evaluation Visits Between Treatment Groups
大体时间:Up to 1 year after randomization
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Completed intake and evaluation by the early intervention (EI) agency was assessed by parent report and by chart review.
A member of the study team contacted parents within 6 months of the first study visit to obtain this information.
Additionally, a chart review seeking written feedback information regarding referral disposition from the EI agency was completed.
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Up to 1 year after randomization
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention
大体时间:Up to 7 days
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Pre and post knowledge and attitudes regarding developmental delay and early intervention (EI) were assessed by asking participants to respond to 14 statements using a 6 point Likert scale that ranged from strongly disagree to strongly agree.
Questions mapped to the video decision aid content viewed by participants.
Participants in the intervention arm completed the questions before and after watching the video and participants in the control arm completed the questions sequentially.
Secondary outcome measures assessed in the survey included Parent Uncertainty About Early Intervention and Parental Predisposition for Early Intervention.
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Up to 7 days
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
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Parent Uncertainty About Early Intervention
大体时间:Up to 7 days
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Parental uncertainty about whether to enroll their child in Early Intervention will be evaluated using a survey.
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Up to 7 days
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Parental Predisposition for Early Intervention
大体时间:Up to 7 days
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Parental predisposition for early intervention services will be measured using surveys.
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Up to 7 days
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Feasibility of the Patient Decision Aid
大体时间:Up to 7 days
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The feasibility of the patient decision aid (PDA) will be measured by calculating the number of individuals who refuse to participate, time that it takes to complete the PDA, and the number of patients who complete the Early Intervention referral.
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Up to 7 days
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Acceptability of the Patient Decision Aid for Early Intervention Referral
大体时间:Up to 7 days
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The acceptability of using the patient decision aid for early intervention will be assessed by having patients and providers complete surveys on the intervention.
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Up to 7 days
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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:Alexander Fiks, MD, MSCE、Children's Hospital of Philadelphia
- 首席研究员:Manuel Jimenez, MD, MS、Children's Hospital of Philadelphia
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
2013年12月1日
初级完成 (实际的)
2015年7月1日
研究完成 (实际的)
2016年7月1日
研究注册日期
首次提交
2013年9月9日
首先提交符合 QC 标准的
2013年9月9日
首次发布 (估计)
2013年9月13日
研究记录更新
最后更新发布 (估计)
2016年10月21日
上次提交的符合 QC 标准的更新
2016年8月30日
最后验证
2016年8月1日
更多信息
与本研究相关的术语
其他研究编号
- 13-010441
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
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.
Patient Decision Aid的临床试验
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Sykehuset i Vestfold HFHospital Pharmacy Enterprise, South Eastern Norway完全的
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Brigham and Women's HospitalGordon and Betty Moore Foundation完全的
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University of Alabama at BirminghamNational Cancer Institute (NCI)招聘中
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Fondazione Poliambulanza Istituto Ospedaliero完全的