Validation of the Dutch Translation of the Tobacco, Alcohol, Prescription Medication and Other Substances (TAPS)-Tool

March 27, 2024 updated by: Birgit Seelen-de Lang

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

secondary psychiatric care departments and special services for people with intellectual disabilities

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
participants with substance use problems

There are 2 subgroups:

  • Participants without intellectual disabilities
  • Participants with intellectual disabilities with and without severe mental illness
Diagnostic test: TAPS
all participants are investigated by the Dutch TAPS tool (Tobacco, Alcohol, Prescription medication and other Substances-tool). A screener and short assessment of possible substance use problems

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TAPS
Time Frame: 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.
one assessment at the start of the treatment
Measurement of Addiction for Triage and Evaluation (MATE)
Time Frame: 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.
At the start of FACT treatment, only for participants of this study
Substance use measurement for people with intellectual disabilities (SumID-Q)
Time Frame: 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.
Standard assessment at the start of the treatment, or when substance use problems are suspected

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health of the Nation Outcome Scales (HoNOS)
Time Frame: Once at start of FACT treatment
The Health of the Nation Outcome Scales (HONOS] is a scaling device routinely used by the mental health services in Anglo-Saxon countries in order to map a patient's mental state and any changes that may have occurred in it. The 12 questions are scored from 0-4. 0 = no problems; 4 = very serious problems. Psychometric properties of the HoNOS are satisfactory to good (Mulder et al., 2004). There is a total sum score available (and reference group: patients with severe mental illness)..
Once at start of FACT treatment
Manchester abbreviated quality of life measure (MANSA)
Time Frame: Once, at start of FACT treatment
Self administered questionnaire on quality of life. The MANSA is a multi-dimensional questionnaire which consists of 16 items. Twelve items determine patient satisfaction with their life as a whole, employment, financial situation, number and quality of friendships, leisure activities, accommodation, personal safety, social network, sex life, relationship with family, physical health and mental health. Satisfaction on these items is rated on a seven-point rating scale (1 = extremely negative, 7 = extremely positive). Four objective items assess the existence of a 'close friend', whether there was contact with a friend in the last week, accusation of a crime, and victimization of physical violence (yes / no). These objective items do not count in the calculation of the total score. In this research, the summed scores were used.
Once, at start of FACT treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Birgit Seelen-de Lang

Collaborators

Ggz Oost Brabant

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

February 11, 2022

First Submitted That Met QC Criteria

March 4, 2022

First Posted (Actual)

March 10, 2022

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 27, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECSW-2021-051

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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