Digital Parent Training for Disruptive Behaviors in Children
追踪信息 | |||
---|---|---|---|
首次提交日期 ICMJE | September 25, 2018 | ||
首次发布日期e ICMJE | October 5, 2018 | ||
最后更新发布日期 | October 5, 2018 | ||
预计研究开始日期 ICMJE | September 18, 2018 | ||
预计主要完成日期 | November 1, 2019 (主要结果测量的最终数据收集日期) | ||
目前主要观察指标 ICMJE |
Feasibility measured by Program completion[ Time Frame: Endpoint- Week 6 ] Measured by completion of 80% or more of the modules Feasibility measured by Attendance[ Time Frame: Endpoint- Week 6 ] Attendance to two of the three videoconferencing sessions Acceptability measured by Patient Satisfaction Questionnaires[ Time Frame: Endpoint- Week 6 ] 15-item scale measuring satisfaction of participants with clinical intervention |
||
原始主要观察测量 ICMJE | 与当前相同 | ||
目前的二级观察 ICMJE |
|
||
描述性信息 | |||
简略标题 ICMJE | Digital Parent Training for Disruptive Behaviors in Children | ||
正式标题 ICMJE | Cognitive-Behavioral Therapy for Disruptive Behavior in Children and Adolescents | ||
简要概况 | This is an open pilot trial of web-based parent training for tantrums and disruptive behavior in children. Parents will be asked to complete a battery of tests to assess their children' behaviors before and after the intervention. Children will undergo a psychiatric evaluation as part of screening. The intervention will be delivered online via an app over a period of 6 weeks. It consists of 8 self-guided courses that take approximately 10 minutes to complete and include text and animated parent-child simulations. Parents will also complete 3 one-hour videoconferencing sessions with a study clinician. During the intervention, parents will be taught various strategies for managing situations that can be anger provoking for their child. This study is conducted to examine whether a digitally-delivered version of parent-management training can be used to reduce behavioral problems including anger outbursts, irritability, aggression and noncompliance. |
||
详细说明 | |||
研究类型 ICMJE | Interventional | ||
研究阶段 | N/A | ||
研究设计 ICMJE | 分配: 干预模型: Single Group Assignment 干预模型描述: Open feasibility trial 盲法: Interventional 盲法描述: 主要目的: Treatment |
||
适用条件 ICMJE | |||
干预项目 ICMJE |
|
||
研究工具 |
|
||
招募信息 | |||
招募状态 ICMJE | Recruiting | ||
预计入组 ICMJE |
32 | ||
原始预计入组 ICMJE | 与当前相同 | ||
预计研究完成日期 | November 1, 2019 | ||
预计主要完成日期 | November 1, 2019 (主要结果测量的最终数据收集日期) | ||
合格标准 ICMJE | Inclusion Criteria: - Parents have access to a mobile device and/or computer device - Parents speak English as native language - Families agree not to initiate new mental health treatments for the duration of this study. - Child meets diagnostic criteria for one of the Disruptive Behavior Disorders - Affective Reactivity Index parent-report score is above 3.6, which is the mean for children with severe irritability Exclusion Criteria: - Parents have previously received parent-training by a licensed provider. - Untreated medical or psychiatric disorder that requires immediate intervention - Child is non-verbal or minimally verbal | ||
性别 |
|
||
年龄 | 最小年龄:3 Years ,最大年龄:9 Years | ||
接受健康的志愿者 | 没有 | ||
可入组国家 ICMJE | United States | ||
管理信息 | 数据检测委员会 | ||
研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
||
IPD 共享声明 |
|
||
责任方 | , | ||
研究赞助商 ICMJE | Yale University | ||
合作者 ICMJE | |||
研究员 ICMJE |
|
||
PRS 账户 | |||
验证日期 | October 2018 | ||
ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |