Enhancing the Outcomes of a Behavioral Parent Training Intervention
2018年9月13日 更新者：Christina Studts
This study is a feasibility trial, testing the hypothesis that among sedentary mothers of behaviorally at-risk preschool-aged children, those who receive behavioral parent training (BPT) programs and concurrently increase their physical activity levels will demonstrate improved parenting and child behavior outcomes compared to those who receive BPT but remain sedentary.
研究概览
地位
完全的
详细说明
The investigators will randomly assign 20 participants to two groups: behavioral parent training plus contingency management to increase steps (BPT+CM) or behavioral parent training alone (BPT). Contingency management procedures will involve monetary rewards for meeting weekly step-count goals.
The specific aims of the proposed project are to: 1) assess the feasibility of the study design and procedures, 2) assess the acceptability of the BPT+CM condition to participants, and 3) determine whether a signal of an effect of increased physical activity exists (via preliminary comparisons of measures of fatigue, perceived energy, parenting behaviors, parenting sense of competence, parenting stress, and child behavior ratings between participants in the two conditions).
This innovative pilot study will prepare us for a fully powered trial to test the efficacy of this approach.
研究类型
介入性
注册 (实际的)
24
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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Kentucky
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Lexington、Kentucky、美国、40536
- University of Kentucky General Pediatrics Clinic
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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
18年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
女性
描述
Inclusion Criteria:
- Female
- Age 18 years or older
- Custodial caregiver of a child aged 2-5 years who lives full-time in the caregiver's home
- Reports that her child has behavioral problems
- Never or rarely engages in regular physical activity
- Able to understand, speak, and read English
Exclusion Criteria:
- The child has been diagnosed with a severe developmental condition (e.g., extreme developmental delay, severe autism, debilitating neurological conditions)
- Participant reports a condition that may contraindicate physical activity (e.g., asthma)
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 |
|---|---|
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有源比较器：Behavioral Parent Training (BPT)
The control group will include 10 participants who will 1) wear Fitbit activity trackers daily for 12 weeks and 2) attend 12 weekly BPT training sessions.
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Wear a Fitbit daily for 12 weeks and meet with a research assistant once per week to download data
Complete 12 BPT training sessions delivered by supervised clinical child psychology doctoral students, with each session lasting approximately 60 minutes.
The BPT is based upon the existing, evidence-based Everyday Parenting intervention.
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实验性的：BPT + Contingency Management (BPT+CM)
The experimental group will include 10 participants who will 1) wear Fitbit activity trackers daily for 12 weeks, 2) attend 12 weekly BPT training sessions, and 3) receive monetary rewards for achieving weekly step-count goals.
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Wear a Fitbit daily for 12 weeks and meet with a research assistant once per week to download data
Complete 12 BPT training sessions delivered by supervised clinical child psychology doctoral students, with each session lasting approximately 60 minutes.
The BPT is based upon the existing, evidence-based Everyday Parenting intervention.
Set weekly step-count goals based on the previous week's performance and receive monetary rewards for meeting the goals.
The schedule of rewards increases as step-count goals increase.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Proportion of participants who complete study procedures within study timeframe
大体时间：14 months
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14 months
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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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Time required per participant to complete all instruments
大体时间：14 months
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14 months
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Participant satisfaction of both control and experimental arms
大体时间：1 week after completion of final BPT session
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1 week after completion of final BPT session
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Step counts
大体时间：end of 2-week screening period, and once per week for 12 weeks
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end of 2-week screening period, and once per week for 12 weeks
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2-minute step test
大体时间：baseline and 1 week after completion of final BPT session
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baseline and 1 week after completion of final BPT session
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Parenting behaviors
大体时间：baseline and 1 week after completion of final BPT session
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Parenting Young Children instrument
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baseline and 1 week after completion of final BPT session
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Child behaviors
大体时间：baseline and 1 week after completion of final BPT session
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Child Behavior Checklist/1.5-5
instrument
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baseline and 1 week after completion of final BPT session
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Parenting stress
大体时间：baseline and 1 week after completion of final BPT session
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Parenting Stress Index/Short Form instrument
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baseline and 1 week after completion of final BPT session
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Parenting sense of competence
大体时间：baseline and 1 week after completion of final BPT session
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Parenting Sense of Competence Scale
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baseline and 1 week after completion of final BPT session
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Parent depression
大体时间：baseline and 1 week after completion of final BPT session
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Beck Depression Inventory-II
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baseline and 1 week after completion of final BPT session
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Self-reported physical activity level
大体时间：baseline and 1 week after completion of final BPT session
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Godin Leisure-Time Exercise Questionnaire
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baseline and 1 week after completion of final BPT session
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Visual Analog Scale-Fatigue
大体时间：baseline and 1 week after completion of final BPT session
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baseline and 1 week after completion of final BPT session
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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：Christina Studts, PhD, LCSW、University of Kentucky
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
2016年3月1日
初级完成 (实际的)
2017年10月1日
研究完成 (实际的)
2018年9月13日
研究注册日期
首次提交
2016年3月4日
首先提交符合 QC 标准的
2016年3月8日
首次发布 (估计)
2016年3月9日
研究记录更新
最后更新发布 (实际的)
2018年9月17日
上次提交的符合 QC 标准的更新
2018年9月13日
最后验证
2018年9月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 15-0291-P6H
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
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.