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临床试验/NCT05344885
NCT05344885已完成不适用

Examining the Impact of Intervention Design in Digital Parent Training for Child's Disruptive Behaviors: A Pilot Randomized Trial

University of Haifa2 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2022年4月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
88
试验地点
2
主要终点
Change from Baseline Eyberg Child Behavior Inventory (ECBI) at 10 weeks

研究概览

简要总结

The purpose of this pilot study is to preliminary examine the impact of a design mechanism aimed at increasing engagement in an unguided digital parent training program for child's behavior problems. Parents will be enrolled into one of two digital parent training intervention arms, dedifferentiated by their level of correspondence with the related deign mechanism.

详细描述

The purpose of this pilot study is to preliminary examine the impact of a design mechanism aimed at increasing engagement in an unguided digital parent training program for child's behavior problems. The design mechanism manipulated in this pilot relates to the extent to which program design promotes a positive behavior change. To achieve these goal two unguided digital parent training interventions, differentiated by their level of design (DPT-Standard vs. DPT-Enhanced), will be tested. This pilot aims to recruit 40-60 parents who report behavior problems in their children who will randomly receive one of the two interventions for 10 weeks.

The impact of DPT-E on user engagement and reported child behavior problems will be assessed based on comparison with DPT-Standard. Parental behaviors and sense of competence will be collected to assess the impact of intervention design on these mechanisms of change. In addition, the role of parents' motivation, and their ability to invest effort in making changes during the intervention will be assessed, to examine whether these variables moderate the impact of intervention's design on the aforementioned relationships. The investigators also aim to explore whether the relationship between usage and clinical outcomes is stronger in those using DPT-E compared with DPT-Standard.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
3 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Parents report they have a child between the ages of 3 and 7, who:
  • Has externalized behavior problems based on A) Parents report at least 1 of the two first criteria of behavior problems to be above 4 (the middle point) & the average of all items ≥ 4, on a screening scale that consists of 9 items (on a Likert scale between 1 and 7) that is based on DSM-V symptoms for ODD.
  • B) Parents report ECBI Problems to be above 14 OR Intensity to be above
  • Parents have access to computer at home with an Internet connection and a smartphone with a mobile data plan.
  • Parents can read and understand Hebrew.

排除标准

  • Parents report that the relevant child has been diagnosed with developmental delay, intellectual disability and/or autism spectrum disorder.
  • Parent and/or child are already receiving therapeutic intervention (for the child) in other setting.
  • The relevant child is treated with psychiatric medication.

结局指标

主要结局

Change from Baseline Eyberg Child Behavior Inventory (ECBI) at 10 weeks

时间窗: 10 weeks

The ECBI specifies 36 behaviors commonly reported by parents of children with behavior problems. For each behavior the parent specifies how often this problem occurs on a 1-7 Likert scale (1=never; 7=always; higher scores mean worse outcome), and whether this behavior is currently a problem (0=no; 1=yes; higher scores mean worse outcome).

次要结局

  • change from Baseline Alabama Parenting Questionnaire (APQ) positive parenting practices at 10 weeks(10 weeks)
  • change from Baseline Me as a Parent (MAAP) self-efficacy at 10 weeks(10 weeks)
  • change from Baseline Parenting Tasks Checklist (PTC) self-efficacy at 10 weeks(10 weeks)
  • Program Usage Time(through program completion, an average of 10 weeks)
  • Program Logins(through program completion, an average of 10 weeks)
  • Number of Modules completed(through program completion, an average of 10 weeks)
  • change from Baseline Behavior and Feelings Survey Externalizing Problems at 10 weeks(10 weeks)
  • change from Baseline Parenting Scale (PS) at 10 weeks(10 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amit Baumel

Senior Lecturer

University of Haifa

研究点 (2)

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