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临床试验/NCT06514326
NCT06514326
已完成
不适用

The Impact of Mechanisms of Action on Adherence and Outcomes in Unguided Digital Mental Health Interventions: A Randomized Controlled Trial

University of Haifa1 个研究点 分布在 1 个国家目标入组 172 人2024年9月15日
适应症DPT-STDDPT-TP
干预措施DPT-TPDPT-STD

概览

阶段
不适用
干预措施
DPT-TP
疾病 / 适应症
DPT-STD
发起方
University of Haifa
入组人数
172
试验地点
1
主要终点
Eyberg Child Behavior Inventory (ECBI)
状态
已完成
最后更新
2个月前

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.

注册库
clinicaltrials.gov
开始日期
2024年9月15日
结束日期
2025年10月30日
最后更新
2个月前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Amit Baumel

Associate Professor

University of Haifa

入排标准

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

DPT-STD

This is the standard intervention arm

干预措施: DPT-STD

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)

研究点 (1)

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