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临床试验/NCT03281057
NCT03281057已完成不适用

Community Reinforcement and Family Training (CRAFT)

Kjeld Andersen4 个研究点 分布在 1 个国家目标入组 255 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
255
试验地点
4
主要终点
Whether the drinker has sought treatment for her/his alcohol use disorder

研究概览

简要总结

The present study is dedicated to empowering individuals close to an addicted person (i.e. concerned significant others, CSOs) to create changes in their family environment: changes that increase the likelihood of the addicted person seeking treatment.

The Danish National Clinical Guideline for the treatment of alcohol dependence recommends that alcohol treatment centers offer interventions aimed at CSOs, providing them with the support and empowerment that will enable them to motivate the problem drinker to enter treatment. In the US, the Community Reinforcement and Family Training (CRAFT) intervention has been shown to offer the most effective support to CSOs. CRAFT has consistently demonstrated a two to three times' higher impact on getting individual with an alcohol use disorder (AUD) to attend treatment, compared to other kinds of interventions. Studies of the intervention so far have, however, been small, and the format used in the delivery of CRAFT has not been fully investigated.

The aim of the present cluster randomized controlled trial is to implement and investigate CRAFT in a Danish context and with sufficient sample size. Consecutive CSOs will through cluster randomization be randomized to receive either CRAFT in a group format, CRAFT in an individual format, or a control condition, consisting of self-help material only. The primary outcome of the study will be the rate of individuals with AUD entering treatment following the intervention targeted at the CSOs within three months from its initiation. Data will be collected from all CSOs at baseline, three, and six months after baseline.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Suffering from dementia or other cognitive disorders
  • Not speaking Danish
  • Being psychotic or otherwise severely mentally ill
  • Suffering from AUD in the last three months
  • Being concerned about a person who, according to the CSO, mainly use illegal substances

结局指标

主要结局

Whether the drinker has sought treatment for her/his alcohol use disorder

时间窗: 3 months after baseline

The proportion of problem drinkers, who enter alcohol treatment centers from baseline and until three months after their CSOs enrolled in the CRAFT study.

次要结局

  • Changes in number of sick leave days for concern significant others from 6 months before to 6 months after enrollment in the study.(6 months after baseline)
  • Changes in quality of life among concern significant others.(3 and 6 months after baseline)
  • Changes in the anxiety, - depression and concern symptoms of concern significant others following CRAFT intervention(3 and 6 months after baseline)
  • Improvement in the relationship between the concern significant other and the drinker before and after CRAFT intervention(3 and 6 months after baseline)

研究者

申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Kjeld Andersen

Professor

University of Southern Denmark

研究点 (4)

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