ACTRN12609000710224招募中未知
Children with Type 1 Diabetes: evaluating the Triple P Positive Parenting Program compared to Standard Diabetes Care for reducing externalising behaviour problems.
Murdoch Children’s Research Institute0 个研究点目标入组 80 人开始时间: 2009年8月17日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 4 Years 至 12 Years(—)
- 性别
- All
入选标准
- •1.Children with diagnosed Type 1 Diabetes (of a minimum of 6 months duration) who attend the Diabetes Clinic at the Royal Children's Hospital Melbourne (RCH).
- •2.Children with clinically significant emotional problems and/or behaviour problems (i.e., Internalising T Score > 60 or Externalising T score > 60) will be eligible to participate and will be allocated on the basis of their Externalising or Internalising behaviour problem T score.
- •3.Children without clinically significant emotional or behaviour problems (i.e., (i.e., Internalising T Score < 60 + Externalising T score < 60).
排除标准
- •1.Children whose mothers exhibit significant psychopathology (cut-off score of 12 for depression; Nieuwenhuijsen, de Boer, Verbeek, Blonk, & van Dijk, 2003) will not be invited to participate further in this study as previous research has shown that the Triple P intervention is less effective when mothers have untreated mental health problems. Children and mothers excluded on this basis will be offered assistance getting appropriate clinical services should they want them.
- •2.Children who commence or significantly modify psychotropic medication regimes (which may affect behaviour) during the research and follow-up periods. These children will continue to receive the Triple P Intervention or Standard Diabetes Care (SDC) but their data will not be included in analysis.
- •3.Children with a developmental disorder (such as Autism Spectrum Disorder) and children currently attending at a Special Education School or who qualify for Integration Aide Assistance. These children represent a special population for which individually tailored programs are required.
- •4.Other exclusion criteria for the study include the following:
- •?non-English speaking families;
- •?children with complex medical disease in addition to Type 1 diabetes (e.g., cystic fibrosis, cancer, Traumatic Brain Injury).
研究者
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