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临床试验/NCT05273021
NCT05273021招募中不适用

Implementation and Validation of the Dutch Translation of the TAPS-tool: a Screener for Tobacco, Alcohol, Prescription Medication and Other Substances for Patients With Severe Mental Illness With and Without Intellectual Disability

Birgit Seelen-de Lang3 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
150
试验地点
3
主要终点
TAPS

研究概览

简要总结

The aim of the study is to investigate the reliability and validity of the Dutch version of the TAPS-tool.

This will be investigated in 2 groups: patients without intellectual disabilities treated in Flexible Assertive Community Treatment (FACT) teams and patients with intellectual disabilities. For the later group, an adjusted version of the TAPS-tool will be developed.

For both groups the TAPS outcome will be compared to a golden standard.

详细描述

All FACT teams in the participating organization (GGZ Oost Brabant) work through a standardized care pattern which implicates screening and assessment on several areas. At the start of the treatment all patients are assessed for intellectual disabilities, trauma related symptoms, addiction, quality of life, level of psychiatric complaints, social functioning, and phase of recovery. Subsequently quality of life and the level of psychiatric complaints is measured yearly. For this research question a small golden standard instrument was added to the standard screening and assessment.

For people with intellectual disabilities (ID) who get an extensive assessment of substance use problems in their (standard) treatment, permission to participate on the TAPS (version for ID) was asked.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

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

  • All patients treated in the participating FACT teams and for patients treated at the LVB-P (department for patients with intellectual disabilities and psychiatric disorders [Dutch name]) department of the GGZ Oost Brabant or the ORO foundation (ORO is no abbreviation but just a name of the institute).

排除标准

  • If patients do not have sufficient command of the Dutch language or cannot concentrate for 20 minutes, the instruments are not taken

结局指标

主要结局

TAPS

时间窗: one assessment at the start of the treatment

The TAPS-tool is a 2-phase screening instrument to detect substance use problems which can be used as an interview or as a self-administered questionnaire. TAPS 1 has a score from 0-4 (higher is more substance use). For a score of 1 or higher, TAPS 2 is also taken. TAPS 2 has a total score from 0-3 (higher is indication of more problematic use) for all of the 8 substances. Cut off score is +2.

Substance use measurement for people with intellectual disabilities (SumID-Q)

时间窗: Standard assessment at the start of the treatment, or when substance use problems are suspected

The SumID-Q is an extensive Dutch assessment instrument (interview) on substance use problems for people with intellectual disabilities. There are no total scores.

Measurement of Addiction for Triage and Evaluation (MATE)

时间窗: At the start of FACT treatment, only for participants of this study

MATE is an instrument, developed in Europe to determine patient characteristics for the indication of care for people with addiction problems on a valid and reliable way. The MATE will be used for participants without intellectual disabilities. Modules 1, 4, and Q1 are used in this study. Module 1 (interview about substance use) for alcohol, nicotine, cannabis, opiates, cocaine, stimulant drugs, extacy, other drugs, sedative medicines and gambling. For every substance there is a cut off point for excessive use. There are no scores for module 1. Module 4: 11 binary questions (yes/no) about dependency and misuse of the problem area. The scoring range is 0 to 9 (cut off = 8). the higher the score, the worse the dependency. Module Q1: five questions about desire, based on a five point Likert-scale (score 0-4). Cut off = sum score \> 12. higher scores stand for more problematic desire.

次要结局

  • Health of the Nation Outcome Scales (HoNOS)(Once at start of FACT treatment)
  • Manchester abbreviated quality of life measure (MANSA)(Once, at start of FACT treatment)

研究者

发起方
Birgit Seelen-de Lang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Birgit Seelen-de Lang

Psychologist

Radboud University Medical Center

研究点 (3)

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