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
Conditions: Substance Use, Severe Mental Disorder, Intellectual Disability, Mild
Sponsor: Birgit Seelen-de Lang

ECSW-2021-052 / Validation of the Dutch translation of the TAPS-tool 
 
 
 
 
 
 
 
 
 
 
 
 
RESEARCH PROTOCOL 
(February 2022) 
 
 
 
 

ECSW-2021-052 / Validation of the Dutch translation of the TAPS-tool 
 
 
 
PROTOCOL TITLE ‘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 Disabilities’ 
 
Protocol ID
ECSW-2021-052
Short title
Implementation and Validation of the Dutch 
Translation of the TAPS-tool 
Date
22.02.2022
Coordinating investigator/project 
leader 
 
n.a. 
 
Principal investigator(s) (in 
Dutch: hoofdonderzoeker/ 
uitvoerder) 
 
B.L. Seelen-de Lang, MSc 
Birgit.seelen-delang2@ru.nl 
Bl.seelen-delang@ggzoostbrabant.nl 
Tel: 0031 6 81405847 
Sponsor (in Dutch: 
verrichter/opdrachtgever) 
GGZ Oost Brabant 
Subsidising party
OLIM fund GGZ Oost Brabant 
 
 

ECSW-2021-052 / Validation of the Dutch translation of the TAPS-tool 
 
 
 
 
TABLE OF CONTENTS 
 
1. 
INTRODUCTION AND RATIONALE .............................................................................. 6 
2. 
OBJECTIVES ................................................................................................................. 7 
3. 
STUDY DESIGN ............................................................................................................ 8 
4. 
STUDY POPULATION ..................................................................................................10 
4.1 
Population (base) ...................................................................................................10 
4.2 
Inclusion criteria .....................................................................................................10 
4.3 
Exclusion criteria ....................................................................................................10 
4.4 
Sample size calculation ..........................................................................................10 
5. 
TREATMENT OF SUBJECTS .......................................................................................11 
METHODS ...........................................................................................................................12 
5.1 
Study parameters/endpoints ...................................................................................12 
5.1.1 
Main study parameter/endpoint .......................................................................12 
Problematic substance use ...........................................................................................12 
5.1.2 
Secondary study parameters/endpoints (if applicable) ....................................12 
5.2 
Randomisation, blinding and treatment allocation ..................................................12 
5.3 
Study procedures ...................................................................................................12 
5.4 
Withdrawal of individual subjects ............................................................................17 
5.5 
Premature termination of the study .........................................................................17 
6. 
SAFETY REPORTING ..................................................................................................18 
6.1 
Temporary halt for reasons of subject safety ..........................................................18 
6.2 
AEs, SAEs and SUSARs ........................................................................................18 
6.3 
Annual safety report ...............................................................................................18 
6.4 
Follow-up of adverse events ...................................................................................18 
6.5 
[Data Safety Monitoring Board (DSMB) / Safety Committee] ..................................18 
STATISTICAL ANALYSIS ....................................................................................................19 
6.6 
Primary study parameter(s) ....................................................................................19 
6.7 
Secondary study parameter(s) ...............................................................................20 
6.8 
Other study parameters ..........................................................................................20 
6.9 
Interim analysis (if applicable) ................................................................................20 
7. 
ETHICAL CONSIDERATIONS ......................................................................................21 
7.1 
Regulation statement .............................................................................................21 
7.2 
Recruitment and consent........................................................................................21 
7.3 
Objection by minors or incapacitated subjects (if applicable) ..................................21 
7.4 
Benefits and risks assessment, group relatedness .................................................21 
7.5 
Compensation for injury .........................................................................................21 
7.6 
Incentives (if applicable) .........................................................................................21 
8. 
ADMINISTRATIVE ASPECTS, MONITORING AND PUBLICATION .............................22 
8.1 
Handling and storage of data and documents ........................................................22 
8.2 
Monitoring and Quality Assurance ..........................................................................22 
8.3 
Amendments ..........................................................................................................22 

ECSW-2021-052 / Validation of the Dutch translation of the TAPS-tool 
 
 
 
8.4 
Annual progress report ...........................................................................................22 
8.5 
Temporary halt and (prematurely) end of study report ............................................22 
8.6 
Public disclosure and publication policy ..................................................................23 
9. 
STRUCTURED RISK ANALYSIS ..................................................................................24 
10. 
REFERENCES ..........................................................................................................24 

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SUMMARY 
 
Rationale: Substance use problems (misuse and addiction) are common among patients 
with Severe Mental Illness (SMI). Substance use problems are often not recognized and 
therefore not incorporated in the treatment for patients with SMI which leads to more 
admissions, behavioural problems, aggregation of psychiatric and addiction problems and 
poorer treatment outcome. Therefore, early detection by screening and assessment is 
important but this is often omitted in psychiatric departments because there is no suitable 
instrument (short but informative). NIDA (National Institute on Drug and Addiction) developed 
the TAPS (Tobacco, Alcohol, Prescription medication and other Substances)-tool for this 
purpose.  
Objective: 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 FACT (Flexible Assertive Community Treatment) teams and patients 
with intellectual disabilities. For the latter 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 design: observational study 
Study population: adult people with SMI, with or without intellectual disabilities.  
Main study parameters/endpoints: We investigate the suitability of the TAPS-tool to detect 
substance use problems in a quick and accurate way and evaluate the validity. 
Nature and extent of the burden and risks associated with participation, benefit and 
group relatedness: The burden of this research are additional questions about addictive 
behaviour (about 15 – 20 minutes) by patients who get several tests and questionnaires for 
their standard treatment. There are no risks associated with participation. By having a 
suitable instrument to detect substance use problems, these problems will be detected more 
in clinical practice. This leads to a better treatment. 

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1. INTRODUCTION AND RATIONALE 
 
20 to 60% of patients treated within mental health care have dual diagnosis problems; a 
combination and interaction of a psychiatric disorder and substance use. The more severe 
the psychiatric condition, the higher the risk of comorbid addiction problems. A mild 
intellectual disability (LVB) also increases the risk of addiction problems (triple problem). 
Within the target group of patients with severe psychiatric disorders, a significant proportion 
appears to function at the level of a mild intellectual disability (Seelen-de Lang et al., 2019). 
Both serious psychiatric disorders and addiction problems lead to social problems, high 
social (care) costs, poorer treatment results and a poorer prognosis. 
Addiction problems are often overlooked in patients with a serious psychiatric disorder, 
whether or not in combination with MID (Ananth, 1990; Shaner, 1993; Nagel, 2018). 
Incomplete and/or inadequate diagnosis can lead to incomplete and/or inadequate treatment, 
which leads to poorer treatment outcomes such as increased risk of relapse, (re)admissions, 
homelessness, violence, somatic disorders, and higher psychological burden and economic 
costs ( Drake, 1998; Caton, 1994; Lindqvist & Allebeck, 1989; Bartels, 1993; Safer, 1987; 
Shaner, 1995). 
The NIDA (National Institute for Drugs and Additiction, USA) developed the TAPS 
questionnaire in 2016 that provides a screener to address these issues (McNeely et al., 
2016; Gryczynski et al., 2017). Including screening for drug addiction in the TAPS is of added 
value for the GGZ target group. A Dutch translation is now available in collaboration with the 
NIDA (DeJong et al., 2019). However, due to the complicated language, this translation is 
unsuitable for patients with MID. The NIDA has also not developed a version for this target 
group. By implementing the TAPS as a standard screener within mental health care, more 
insight can be gained into problematic alcohol and substance use, so that treatment can be 
adapted accordingly. However, it is important that the validity of the Dutch version is still 
being established. 
The SumID-Q, a structured interview used to investigate addiction problems in patients with 
MID, has a duration of 45-60 minutes. Because of this time investment, the instrument is only 
used if there is already a suspicion of highly problematic substance use. As a result, not 
everyone is screened, which leads to underdiagnosis and undertreatment. We want to be 
able to trace precisely the group of patients who are not immediately suspected of use, but 
who may do so anyway, in order to optimize the treatment. In addition, the SumID-Q only 
asks about alcohol, tobacco, cannabis and “other drugs”. Incorrect medication use is not 
included. The addition of this extra category, together with a greatly shortened administration 
time of the TAPS-LVB, ensures that the group of triple problem patients can be better 
mapped. 

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2. OBJECTIVES 
 
There are two objectives: 
1. Validating and implementing the TAPS in patients with a severe mental disorder and 
problematic substance use. 
2. Developing, validating and implementing the TAPS-ID in patients with a mental disorder, 
intellectual disability (ID) and problematic substance use. 

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3. STUDY DESIGN 
 
This is a descriptive study based on routinely collected data. The FACT teams that 
participate in the study work according to a care program in which screening and 
assessment are part of the standard care. This implies that since 2016, screening has been 
carried out at the start of treatment for: PTSD, a mild intellectual disability, addiction 
problems. The current screening for addiction problems is too limited and lacks a follow-up 
step in the form of structured assessment. In addition, at the start of treatment and annually 
in preparation of the treatment plan, the level of complaints is assessed by the care provider 
involved and the phase of recovery and the patient's quality of life are assessed. We want to 
use this data from patients in whom there is no suspicion of mild intellectual disability in 
anonymised form. In the research into the validity of the TAPS, we want to measure whether 
there is a relationship between the existence of problem substance use and a poorer 
treatment outcome (less decrease in complaints), and a reduced quality of life. 
The TAPS has already been included as a replacement for the previously used screener for 
addiction problems by the various substantive advisory bodies that deal with the content and 
improvement of the care of the GGZ Oost Brabant. 
In order to investigate the concurrent validity of the TAPS, a group of at least 40 patients will 
be asked permission to administer some parts of the MATE in addition to the TAPS. 
 
The TAPS is too difficult for patients with intellectual disabilities. We therefore made 
adjustments to the translated TAPS (see below). The adjusted version for patients with ID is 
called the TAPS-ID. The validity of the TAPS-ID is examined by the comparison of the TAPS-
ID and the SumID-Q (an instrument specially developed to map addiction problems in 
patients with MID). This will be carried out in a special department within secondary 
healthcare for patients with a combination of a severe mental disorder and intellectual 
disability (LVB-P) and in a healthcare setting for people with intellectual disabilities with 
minimal or light mental disorders (ORO). The SumID-Q is part of standard care for both 
departments. Trained employees who administer the SumID-Q also take the TAPS-ID. 
 
We would like to analyze the results of these measurements retrospectively over a period of 
at least 6 months by placing them anonymously and not traceable to individual persons in an 
SPSS database. We would also like to add some very global background data to this, 
namely: sex, age in years and the main psychiatric diagnosis. This data will be added to the 
database without name or other personally identifiable information by a secretary who is 
affiliated with the research line and who has access to this data in that regard. For this 

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reason, this secretary also has temporary access to the secured data from the electronic 
patient file.  

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4. STUDY POPULATION 
4.1 Population (base)  
4.2 Inclusion criteria 
In order to be eligible to participate in this study, a subject must meet all of the following 
criteria: 
All patients treated in the participating FACT teams and for patients treated at the LVB-P 
department of the GGZ Oost Brabant or the ORO foundation. 
 
4.3 Exclusion criteria 
A potential subject who meets any of the following criteria will be excluded from 
participation in this study: 
If patients do not have sufficient command of the Dutch language or cannot concentrate 
for 20 minutes, the instruments are not taken. 
 
4.4 Sample size calculation 
The number of new registrations for FACT teams is between 30 and 40 per year. With a 
minimum of three participating FACT teams, there are approximately 100 new patients per 
year. In the 2.5 years of the planned data collection, there will be 250 new patients. Based on 
the information that approximately 40% of FACT patients function at the level of mild 
intellectual disability, we can include at least 150 patients. A very substantial part could 
refuse to participate in order to obtain the required 40 patients for the validity study. 
 
The SumID-Q is administered at least 20 times a year within the various parts of the LVB-P 
department (ambulatory, part-time, clinic). Most administrations take place at the clinic, 
where SumID-Q administration is standard of care at the start of clinical admission. ORO 
also uses the SumID-Q more than ten times a year. The required 40 patients seems 
achievable within the period of data collection. 
 
For both groups, we stop data collection at 100 participating patients. 
 

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5. TREATMENT OF SUBJECTS 
N.a. because this is an observational study.  
 

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METHODS 
5.1 Study parameters/endpoints 
5.1.1 Main study parameter/endpoint 
Problematic substance use 
5.1.2 
 Secondary study parameters/endpoints (if applicable) 
Quality of Life 
Mental complaints 
 
 
5.2 Randomisation, blinding and treatment allocation 
n.a. 
 
5.3 Study procedures 
 
Objective 1: 
The validation study of the TAPS was incorporated in a broader comprehensive 
screening and assessment procedure that is standard care in FACT teams in this 
mental healthcare institute.  
 
All new patients were screened on intellectual disabilities , trauma-related symptoms 
and substance use problems. Actual psychiatric symptoms, quality of life, phase of 
recovery and the burden of care  for relatives of the patient were also mapped. This 
screening and assessment consisted of one test, four self-report questionnaires for 
the patient, one questionnaire for relatives and one questionnaire for the caregiver. 
The TAPS-tool was used for screening and brief assessment of substance use 
problems. Only when a patient was  incapable of concentrating for more than 15 
minutes, when the Dutch language was a problem or when there was almost no 
cooperation for the FACT treatment at all, the screening and assessment was omitted 
.  
Psychologists or case managers were the assessors. They invite the patient for an 
appointment to take the test and fill out the questionnaires together at home or at the 
office. The screening on possible intellectual disabilities was done first. There was no 
fixed order for the other parts.  
 
For the validation of the TAPS two elements were added to the standard procedure: 
First, the assessor also took the parts of the MATE necessary to investigate the 
severity of the addiction (module 1, 4, and Q1; see description of the MATE above). 
Second, after completing the TAPS and the MATE, but before the scoring of   it, the 
assessor also rated the severity of the substance use problems on a five-point Likert 

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scale by answering the following question: “I rate the addiction problem of the client 
as…”. Possible answers were: absent, mild, moderate, severe, very severe  .  
 
Participants were invited by telephone for the regular appointment that was scheduled 
at least one day later. During this telephone conversation, information was given 
about the validation study of the TAPS and patients were asked if they want to think 
about voluntarily participation. During the appointment, the information about the 
validation study was reviewed again, any additional questions from the patients were 
answered and when the patient agreed for participation, informed consent was 
signed. Patients signed informed consent to use the answers of the TAPS and MATE 
and background information (age, gender, diagnosis, medication, level of education) 
anonymously for this scientific purpose. 
 
To investigate research objective 1, the following measuring instruments are used: 
 
TAPS: 
Tobacco, Alcohol, Prescription medication and other Substances-tool. 
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. According 
to McNeely et al., the diagnostic characteristics of both ways are similar (McNeely et 
al., 2016).  
The TAPS-1 (screener) pretends to detect unhealthy substance use in the past year 
quickly and is based on NIDA’s quickscreen. It contains of four multiple choice 
questions where the patient answers how often they used tobacco, alcohol, other 
drugs, and prescription medication in te past year on a five point Likert-scale. 
Possible answers are: never, less than monthly, monthly, weekly, daily or almost 
daily. For tobacco and drugs, a positive score is given when there is any use in the 
past year. For alcohol a positive score is given when someone drinks more than 4 
(women) or 5 (men) drinks containing alcohol a day. For medication, a positive score 
is obtained when someone uses prescription medication in a higher dose, or uses 
medication from someone else or medication without prescription. If there is a positive 
score on any of the sections, the TAPS-2 is assessed (see below). Dus de TAPS-1 
levert geen scores op zichzelf op, maar de scores dienen ertoe om te beslissen of je 
doorgaat met de TAPS 2 of niet?  For the TAPS-1, the optimal cut-off points for the 
detection of a possible substance use disorder (SUD) are: For tobacco and alcohol a 
frequency of monthly use was a predictor for SUD (sensitivity = 0.92 and 0.71, 
specificity = 0.80 and 0.85, AUC = 0.86 and 0.78, respectively) and for illicit drugs and 
prescription medication misuse any reported use was suspect for SUD (sensitivity = 
0.93 and 0.89, specificity = 0.85 and 0.91, AUC = 0.89 and 0.90, respectively). 
(Gryczynski et al., 2017)  
TAPS-2 (brief risk assessment) is based on the ASSIST-lite (Alcohol, Smoking and 
Substance Involvement Screening Test) which is developed by the World Health 
Organization (Ali, Meena, Eastwood, Richards, & Marsden, 2013). The ASSIST has a 

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good test-retest reliability: substance risk scores from two administrations within 1-4 
weeks has excellent concordance (90–98%) and a high correlation (ICC 0.90–0.97) 
for tobacco, alcohol, and drugs  (McNeely et al., 2014). The ASSIST-Lite  (a 
shortened version of the ASSIST) has a single factor structure on which all 
substances loaded (eigenvalue range, 2.42–3.81). It also has a consistent pattern of 
positive loadings on this factor (all ≥0.303) (Ali et al., 2013). For the TAPS-2, only 
ADHD medication and questions about the failure to reduce or stop the use of 
marihuana, amphetamines and anxiolytics have been added to the ASSIST-Lite.   
There are nine categories on the TAPS-2: tobacco, alcohol, marihuana, stimulant 
drugs, opiates, anxiolytic medication, ADHD medication and ‘other substances’. Only 
the elements with a positive score on the TAPS-1 are further assessed. For every 
category, the assessment with the TAPS-2 contains the usage for the last 3 months 
and two or three additional questions which can detect unhealthy use. For scoring 
both the use for the last 3 months and an affirmative answer on each of the additional 
questions lead to one point. A total score is calculated for each of the categories 
separately by adding the positive answers together. A total score of +2 per category 
induces a risk of a substance use disorder and indicates more assessment.  
Investigation of the TAPS-2 has been done by a comparison with the Composite 
International Diagnostic Interview (CIDI). Problematic use (with a cut off score of +1) 
for tobacco has a sensitivity of 0.93 and specificity of 0.87. Alcohol has a sensitivity of 
0.74 and specificity of 0.79. For problematic use of illicit and prescription drugs, 
sensitivity ranges from 0.82 for marijuana to 0.63 for sedatives, and specificity is 0.93 
or higher. For identifying any SUD, sensitivity was lower, but a cut off score of +2 
greatly increases the likelihood of having a SUD as measured by the CIDI (McNeely 
et al., 2016). 
 
HoNOS: 
The course of the complaints is mapped out annually using the HoNOS (Health of the 
Nation Scale). This is an observation list that is completed by the practitioner. The 
outcome of the HoNOS reflects the mental and social functioning of a client in mental 
health care at a given moment. The HoNOS can be completed at several moments 
before, during or after a treatment, so that the change in complaints is mapped out. 
The aim of the HoNOS is therefore to evaluate the treatment or supervision. The 
score for the 12 items that make up the instrument always ranges from 0 (no 
problem) to 4 (very serious problem). These are issues that have occurred in the past 
two weeks. Psychometric properties of the HoNOS are satisfactory to good (Mulder et 
al., 2004). 
 
MANSA: 
The quality of life, as experienced by the patient, is mapped with the MANSA: the 
Manchester abbreviated quality of life measure (Van Nieuwenhuizen, Schene & 
Koeter, 2000), the 16 item version. The MANSA is a multidimensional questionnaire 

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designed to assess quality of life. The closed questions refer to job satisfaction, 
housing, general health and social relationships. 
 
MATE: 
MATE is the Dutch abbreviation of “Measurement of Addiction for Triage and 
Evaluation”. It 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 has ten modules (eight interview modules and two self-
report questionnaires) which take about one hour to assess totally. These modules 
are: 1. substance use, 2. substance abuse and dependence, 3. craving, 4. 
depression, anxiety and stress, 5. psychotic symptoms, suicidality and current 
psychiatric treatment, 6. personality disorders, 7. physical complaints and symptoms 
8. personal and societal functioning, 9. environmental factors influencing recovery, 
and 10. history of substance abuse treatment. The MATE comprises a set of existing, 
well-developed and widely accepted instruments to investigate the ten module-
themes: for example the CIDI (Composite International Diagnostic Interview) to 
investigate ICD criteria, the DASS (Depression Anxiety Stress Scales) to investigate 
depression and anxiety, and the SAPA (Standard Assessment of Personality 
Abbreviated scale) to investigate personality disorders.  
The modular design of the MATE can be used in a flexible way which gives service 
delivery institutions the freedom to select their intake and evaluation tools individually 
from the MATE modules. The original Dutch version is translated into English, 
German and Spanish.   
The factor structure of the ICF-related modules has revealed a three-factor model 
with an acceptable fit. Inter-rater reliability ranges between 0.75 and 0.92  which is 
satisfactory, but interviewer reliability only ranges between 0.34 and 0.73, indicating 
that some of subscales need to be improved. Concurrent validity is indicated by 
significant correlations (>0.50) between the ICF-related modules and the WHO 
Disability Assessment Schedule II (WHODAS II) and WHO Quality of Life brief 
version (WHOQOL-BREF) (Schippers, Broekman, Buchholz, Koeter, & Van Den 
Brink, 2010). A combination of the ten MATE modules can be used in an algorithm to 
determine the severity of the addiction, severity of other psychopathology, social 
disintegration and treatment history.  
The modules to be used in the present study are: 
Module 1 is an interview about substance use of the last month and the total years of 
regular use during life. The number of days the past month and the amount of use on 
an average day are asked about for alcohol, nicotine, cannabis, opiates, cocaine, 
stimulant drugs, XTC, other drugs, sedative medicines and gambling. For the rest of 
the interview, it is decided with the patient which is the main problem area. For every 
substance, excessive use can be calculated by specific criteria (e.g. more than 240 
units of alcohol for the last month or more than one year of regular use and actual use 
of 28 out of 30 days for marihuana).  

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Module 4 contains of 11 binary questions (yes/no) about dependency and misuse of 
the problem area. Every ‘yes’ on question 2 to 9 and 11 (so without question 1 and 
10) gets one point. The scoring range is 0 to 9. A score of 8 or more indicates a high 
severity. 
Module Q1 contains of five questions about desire, based on a five point Likert-scale 
(score 0-4). The score of the five questions is added for the total score of this module 
(range 0-20). A score of 12 or more is an indication for a high severity.  
A high severity of the addiction is a binary variable  which is computed by following 
the algorithm below:  
1) excessive use of three out of five substances in the last year (alcohol, nicotine,  
cannabis, opiates, cocaine / stimulant drugs) or, 
2) A score of 8 or 9 out of 9 questions about dependency / misuse, or 
3) A total score of 12 or more (range 0-20) on questions about desire 
 
Objective 2: 
 
SumID-Q is part of standard care for both departments (LVB-P and ORO). For the 
purpose of the validation of the TAPS-ID, patients are asked if the are voluntary 
willing to participate on the study by adding the TAPS-ID to the SumID-Q. Second, 
after completing the TAPS-ID and the SumID-Q, but before the scoring it, the 
assessor also rated the severity of the substance use problems on a five-point Likert 
scale by answering the following question: “I rate the addiction problem of the client 
as…”. Possible answers were: absent, mild, moderate, severe, very severe.  
 
Psychologists or psychiatric nurses are the assessors. They invite the patient for an 
appointment to take the SumID-Q. Participants were invited by telephone for the 
regular appointment that was scheduled at least one day later. During this telephone 
conversation, information was given about the validation study of the TAPS and 
patients were asked if they want to think about voluntarily participation. During the 
appointment, the information about the validation study was reviewed again, any 
additional questions from the patients were answered and when the patient agreed 
for participation, informed consent was signed. Patients signed informed consent to 
use the answers of the TAPS-ID and SumID-Q and background information (age, 
gender, diagnosis, medication) anonymously for this scientific purpose. 
 
The answers from the TAPS-ID and SumID-Q are recorded on paper. Papers are 
stored in a locked closet at the department of care (GGZ or ORO). 
 
To investigate research objective 2, the following measuring instruments are used: 
 
SumID-Q: 
The SumID-Q maps out what the client knows about psychoactive substances, what 
he/she knows, thinks about them, what is used in his/her environment, what he/she 

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may use and what the consequences of use and motivation are. to change. The 
structure of the interview makes it possible to discuss use in an open and pleasant 
way. It thus lays a foundation for any further diagnostics, interviews, interventions and 
preventive measures. The SumID-Q is designed to be administered to adults with a 
Slight Intellectual Disability, but also appears to be suitable for young people or 
people with a slightly lower or higher level. The SumID-Q can be administered by 
counselors and behavioral experts who have undergone training in the SumID-Q (Van 
der Nagel, Kiewik, De Jong, Van Dijk, Didden, 2011). 
 
TAPS-ID: 
The TAPS will be adapted for the target group of patients with MID. For this, pictures  
are added to the TAPS, questions are divided into sub-questions, and difficult words 
are replaced by a simpler alternative. We test the first version on several patients with 
ID and with various assessors. On basis of their recommendations, we make de 
definitive TAPS-ID.  
 
This procedure was  approved by the institutional scientific board named CWOI of the 
mental health care institute (GGZ Oost Brabant) and the Ethics Committee of Social 
Sciences of the Radboud University Nijmegen (number of approval: ECSW-2021-
051). 
 
 
5.4 Withdrawal of individual subjects 
Subjects can leave the study at any time for any reason if they wish to do so without 
any consequences. The investigator can decide to withdraw a subject from the study 
for urgent medical reasons. 
 
5.5 Premature termination of the study 
The only reason to end the study prematurely is because we can’t get enough 
participants. If this is the case, we will use the gathered data for a brief report.   
 
 

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6. SAFETY REPORTING 
6.1 Temporary halt for reasons of subject safety 
This is not applicable because it is a retrospective observational study with one moment 
of data collection.   
 
6.2 AEs, SAEs and SUSARs 
 
This is not applicable because it is a retrospective observational study with one moment of 
data collection.   
 
 
6.3 Annual safety report 
 
N.a.  
 
6.4 Follow-up of adverse events 
N.a. 
 
6.5 [Data Safety Monitoring Board (DSMB) / Safety Committee] 
 
The data were gathered in routine treatment procedures. For the purpose of the study, 
after merging several sources in full database case numbers were anonymized in a way 
no cases could be traced back. Fully anonymized and corrected data were handed over to 
the research team. The authors assert that all procedures contributing to this work comply 
with the ethical standards of the relevant national and institutional committees on human 
experimentation and with the Helsinki Declaration of 1975, as revised in 2008. The Ethical 
Commission of the Radboud University, Social Sciences, the Netherlands, reviewed the 
procedure used in this study and decided that, because no actions or behaviours are 
imposed on the participants, there was no need for further ethical review. 
 

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STATISTICAL ANALYSIS 
 
This study will not test any intervention. It will focus on the level of agreement between 
patients responses on the newly used instrument for screening and brief assessment of 
addiction problems (TAPS/TAPS-ID) and the golden standard (MATE / SumID-Q).  
 
Research goal 1: 
- With regard to the reliability of the TAPS, the internal consistency is determined 
(Cronbach's alpha and item-total correlation). To determine the convergent validity, first 
the correlation is determined between the outcome of the TAPS (indications of 
problematic use) and the outcome of the severity of the addiction on the MATE (degree of 
severity). 
- To investigate the influence of addiction problems on treatment outcomes and quality of 
life, the correlation with the outcomes of the Honos and Mansa is calculated. The 
hypothesis is that a higher score on the TAPS correlates with a higher score on the 
Honos and a lower score on the Mansa. 
- The optimal cut-off point of the TAPS is determined by means of ROC analyses. 
 
Research goal 2: 
- For the development of the TAPS-ID, the feasibility (by the interviewers) and feasibility 
(with the target group) will first be estimated on the basis of a few interviews with the 
interviewers involved. 
- With regard to the reliability of the TAPS, the internal consistency is determined 
(Cronbach's alpha and item-total correlation). To determine the convergent validity, the 
correlation is determined between the outcome of the TAPS and the outcome of the 
SumID-Q. 
 
6.6 Primary study parameter(s) 
 
Statistical analysis will examine agreement between different measures of substance use 
(sensitivity, specificity and AUC value) to evaluate the level of classification accuracy for 
each items or candidate combination of items.  
This study will not include follow up assessments. We expect a number of patients who 
don’t want the assessment at all or don’t want to sign informed consent. The extent of 
missing data will be analyzed and explore differences in missing data by age, gender, 
and diagnosis. 

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On objective 1 the primary study parameters are TAPS and MATE outcomes. The total 
TAPS-score is used as  
 
 
6.7 Secondary study parameter(s)  
The analysis of size and content of addiction problems will be done by an overview of 
descriptive statistics of the whole patient population, sorted by different substances being 
used.  
For objective 1 the correlation with quality of life (MANSA) and amount of mental 
complains and social functioning (HoNOS) is also calculated for the divergent validity.  
 
6.8 Other study parameters 
 
 
6.9 Interim analysis (if applicable) 
Na. 

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7. ETHICAL CONSIDERATIONS 
7.1 Regulation statement 
This study will be conducted in compliance with the appropriate protocol, current Good 
Clinical Practice (GCP), the principles of the Declaration of Helsinki 2008 and all other 
applicable regulatory requirements. 
 
7.2 Recruitment and consent 
See above (procedure) 
 
7.3 Objection by minors or incapacitated subjects (if applicable) 
Not applicable 
 
7.4 Benefits and risks assessment, group relatedness 
<Please give a justification of the proposed study.> 
 
7.5 Compensation for injury 
The sponsor/investigator has a liability insurance which is in accordance with article 7 of 
the WMO. 
  
The sponsor (also) has an insurance which is in accordance with the legal requirements 
in the Netherlands (Article 7 WMO). This insurance provides cover for damage to 
research subjects through injury or death caused by the study. 
The insurance applies to the damage that becomes apparent during the study or within 4 
years after the end of the study. 
 
7.6 Incentives (if applicable) 
N.a. 

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8. ADMINISTRATIVE ASPECTS, MONITORING AND PUBLICATION 
8.1 Handling and storage of data and documents 
The anonymous data will be saved on an SPSS-file which is placed in a file where only 
the investigators and research assistant from the specific research area of FACT patients 
within the GGZ Oost Brabant have access to.   
 
8.2 Monitoring and Quality Assurance  
This research is part of a PhD study. The progress of this research is monitored every 6 
weeks by professors involved in the PhD project. In addition to that, the progress is yearly 
monitored by the commission for scientific research (CWO) at the GGZ Oost Brabant. 
The  main researcher (B.S.) yearly gives the CWO an update and progression will be 
tested.   
 
8.3 Amendments  
All amendments will be notified to the ECSW that gave a favourable opinion.  
 
8.4 Annual progress report 
The sponsor/investigator will submit a summary of the progress of the trial to the CWO of 
GGZ Oost Brabant once a year. Information will be provided on the date of inclusion of 
the first subject, numbers of subjects included and numbers of subjects that have 
completed the trial, serious adverse events/ serious adverse reactions, other problems, 
and amendments.  
 
8.5 Temporary halt and (prematurely) end of study report 
The investigator/sponsor will notify the CWO and ECSW of the end of the study within a 
period of 8 weeks. The end of the study is defined as the last patient’s last visit.  
 
The sponsor will notify the CWO and ECSW immediately of a temporary halt of the study, 
including the reason of such an action.  
    
In case the study is ended prematurely, the sponsor will notify the CWO and ECSW 
within 15 days, including the reasons for the premature termination. 
 
 Within one year after the end of the study, the investigator/sponsor will submit a final 
study report with the results of the study, including any publications/abstracts of the study, 

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to the CWO and ECSW.  
 
 
8.6 Public disclosure and publication policy 
The outcome data of this two objectives are sent to a scientific journal. 

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9. STRUCTURED RISK ANALYSIS  
N.a. (No product of risk is used) 
 
 
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