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评估德国有和没有伴随子女的药物依赖患者康复干预(KontextSucht):一项非随机试验的研究方案。

Evaluating a rehabilitative intervention for substance-dependent patients with and without their accompanying children in Germany (KontextSucht): study protocol for a non-randomised trial.

机构信息

Department Health and Sport Sciences, Technical University of Munich (TUM), Munich, Germany

Department Health and Sport Sciences, Technical University of Munich (TUM), Munich, Germany.

出版信息

BMJ Open. 2024 Mar 14;14(3):e078148. doi: 10.1136/bmjopen-2023-078148.

Abstract

INTRODUCTION

People suffering from substance use disorders often live in social contexts with children or are parents themselves. Addicted parents show specific substance-related problems while raising their children, which often leads to various lifelong consequences for the children. The German rehabilitative treatment system allows bringing children to inpatient treatment centres. This mixed-methods study evaluates a newly developed intervention, called 'KontextSucht' or 'AddictionContext', for parents in rehabilitation treatment centres concerning the effectiveness of the intervention in parenting and abstinence outcome.

METHODS AND ANALYSIS

The study uses a two-stage parallel mixed-methods design. A feasibility study (stage 1) and a benefit assessment (stage 2) will be conducted to evaluate the intervention. Both parts of the study will be carried out with qualitative and quantitative work packages. German-speaking parents of children 0-14 years will be included in this study. Qualitative data will be analysed using qualitative content analyses, whereas quantitative data will be analysed descriptively using regression analysis as well as linear mixed models.

ETHICS AND DISSEMINATION

All participants will receive detailed information on the study and sign informed consent before data collection. The research team has obtained the approval of the Ethical Review Committee at the Technical University of Munich in Germany and will follow all legislation rules regarding data protection. The study results will be published in peer-reviewed national and international journals. Furthermore, the study results will be included in an intervention manual distributed to treatment centres.

TRIAL REGISTRATION NUMBER

DRKS00030950.

摘要

简介

患有物质使用障碍的人经常生活在有儿童的社会环境中,或者自己就是父母。成瘾的父母在抚养孩子时表现出特定的与物质相关的问题,这往往会给孩子带来各种终身后果。德国康复治疗系统允许将儿童带到住院治疗中心。本混合方法研究评估了一种新开发的干预措施,称为“KontextSucht”或“AddictionContext”,针对康复治疗中心的父母,评估该干预措施在育儿和戒断效果方面的有效性。

方法和分析

该研究采用两阶段平行混合方法设计。将进行可行性研究(第 1 阶段)和效益评估(第 2 阶段),以评估干预措施。研究的两个部分都将使用定性和定量工作包进行。该研究将纳入德语国家 0-14 岁儿童的父母。定性数据将使用定性内容分析进行分析,而定量数据将使用回归分析以及线性混合模型进行描述性分析。

伦理和传播

所有参与者将在数据收集前收到关于该研究的详细信息并签署知情同意书。研究团队已获得德国慕尼黑工业大学伦理审查委员会的批准,并将遵守所有关于数据保护的立法规定。研究结果将在同行评议的国内外期刊上发表。此外,研究结果将包含在分发给治疗中心的干预手册中。

注册号

DRKS00030950。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5794/10941178/443982f8fd11/bmjopen-2023-078148f01.jpg

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