Reach and Scalability of Digital Therapeutics for Childhood Behavior Problems
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 324
- 试验地点
- 2
- 主要终点
- Knowledge of Effective Parenting Test (KEPT)
研究概览
简要总结
In this project, the investigators aim to test the effectiveness of a mobile health (mHealth) system as a standalone versus coach-assisted intervention with the goal of achieving reach and scalability. Parents of children (ages 5-8) with disruptive behaviors (N = 324 subjects) will be randomly assigned to Group 1 (standalone app), Group 2 (coach-assisted app), or Group 3 (control app).
详细描述
In this project, the investigators aim to test the effectiveness of a mobile health (mHealth) system as a standalone versus coach-assisted intervention with the goal of achieving reach and scalability. Aim 1 is to evaluate the effectiveness of the UseIt! mHealth system as both a standalone and coach-assisted intervention compared to a control app condition. Aim 2 is to assess target (parent management training/cognitive behavioral therapy skill acquisition and use) engagement and validation. Aim 3 is to evaluate the effectiveness of the components of the UseIt! mHealth system. The investigators plan to recruit an anticipated total of 324 families for the study. Families will be randomly assigned to Group 1 (standalone app), Group 2 (coach-assisted), or Group 3 (control app condition). Parents will use the app for four months before the administration of the post-treatment assessment. Parents will be trained to use the UseIt! mHealth system over the phone. The coach for the Group 2 condition will be a bachelor's level paraprofessional with a degree in psychology or an allied discipline (e.g., social work) who will provide support to parents. The system is very user friendly and families can be trained in approximately 30 minutes. Assessments will take place at Baseline, Post (4 months from baseline), and 6-month follow-up. All assessments will be conducted online (Qualtrics survey links sent via email by research staff) and take approximately 1 hour to complete.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 5 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females between the ages of 5-8 years
- •Above the 90th percentile for Oppositional Defiant Disorder (ODD) and/or conduct disorders (CD) on the Vanderbilt Assessment Scale
- •Residence with at least one parent/guardian at least 80% of the time
- •Parent/legal guardian consent for participation
- •Parent/guardian must have a smartphone device with daily internet access
排除标准
- •A known preexisting behavioral or mental health diagnosis requiring alternative treatment (bipolar disorder, major depression, pervasive developmental disorder)
- •Currently in treatment for childhood disruptive behavior
研究组 & 干预措施
Group 2: App plus Coach
Standalone parenting app called UseIt! plus a coach.
干预措施: Coach (Behavioral)
Group 3: Control App
Control condition: mindfulness app called SmilingMind.
干预措施: SmilingMind App (Behavioral)
Group 1: Standalone App
Standalone parenting app called UseIt!
干预措施: UseIt! App (Behavioral)
Group 2: App plus Coach
Standalone parenting app called UseIt! plus a coach.
干预措施: UseIt! App (Behavioral)
结局指标
主要结局
Knowledge of Effective Parenting Test (KEPT)
时间窗: 6-month follow-up (10 months after baseline).
Average scores from the Knowledge of Effective Parenting Test (KEPT). This is a 21-item scale, with higher scores indicating better outcomes.
次要结局
- Conduct Disorder Subscale of the Vanderbilt Assessment(6-month follow-up (10 months after baseline).)
- Parenting Skill Use Diary (PSUD)(6-month follow-up (10 months after baseline).)
- Oppositional Defiant Disorder Subscale of the Vanderbilt Assessment(6-month follow-up (10 months after baseline).)
研究者
Oliver Lindhiem
Associate Professor
University of Pittsburgh