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临床试验/ACTRN12609000710224
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

发起方
Murdoch Children’s Research Institute

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