The Impact of Mechanisms of Action on Adherence and Outcomes in Unguided Digital Mental Health Interventions: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Eyberg Child Behavior Inventory (ECBI)
研究概览
简要总结
This randomized controlled trial (RCT) will compare two interventions that utilize the same evidence-based components of established digital parent training programs (DPTs) aimed at treating child behavior problems, but that differ in terms of the quality of therapeutic persuasiveness (TP) quality (standard: DPT-STD; enhanced TP: DPT-TP). The investigators will recruit parents from 160 families with 3-7-year-old children with behavior problems who will be randomized into one of the two intervention arms. The investigators will measure child behavior problems and related parenting variables before, during, and after the intervention. DPT usage will be passively collected.
The investigators hypothesize that, compared to DPT-STD, parents allocated to the DPT-TP arm will have significantly better module completion rates (adherence to the program) and report better outcomes - measured by improvements in child behavior problems and related parenting variables. The investigators also hypothesize that changes in reported outcomes will be mediated by module completion rates. Therefore, comparing two active interventions that only differ in terms of their TP quality will enable to examine the causal link between this conceptual mechanism of action and beneficial outcomes.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parents having a child between the ages of 3 and 7
- •The parents report high levels of behavior problems demonstrated by their child based on the ECBI Intensity subscale (X ≥ 132)
- •The parents have access to a smartphone device with an Internet connection.
排除标准
- •The child is taking medication for behavioral or emotional problems
- •The child is in regular contact with a professional for behavioral or emotional problems
- •their child has been diagnosed with an intellectual disability or developmental delay
- •The parents are currently accessing parenting support elsewhere
研究组 & 干预措施
DPT-TP
This is the enhanced intervention arm
干预措施: DPT-TP (Behavioral)
DPT-STD
This is the standard intervention arm
干预措施: DPT-STD (Behavioral)
结局指标
主要结局
Eyberg Child Behavior Inventory (ECBI)
时间窗: From baseline to 6 months follow-up
Child behavior problems will be assessed using the Intensity subscale of the 36-item ECBI. For each item, caregivers rate the intensity of the behavior (1 = never to 7 = always).
次要结局
- The Parenting Scale (PS)(From baseline to 6 months follow-up)
- Alabama Parenting Questionnaire (APQ)(From baseline to 6 months follow-up)
- The Parenting Tasks Checklist (PTC)(From baseline to 6 months follow-up)
- Parental Self Efficacy (Me as a Parent [MaaP])(From baseline to 6 months follow-up)
- Specific Parenting Practices (SPP)(From baseline to 6 months follow-up)
- Behavior and Feelings Survey (BFS)(From baseline to 6 months follow-up)
- Program Completion(From baseline to 10 weeks time)
研究者
Amit Baumel
Associate Professor
University of Haifa