Substance UseNCT05273021
Validation of the Dutch Translation of the Tobacco, Alcohol, Prescription Medication and Other Substances (TAPS)-Tool
An observational study of Substance Use and Severe Mental Disorder, run by Birgit Seelen-de Lang at 3 sites in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use, Severe Mental Disorder, Intellectual Disability, Mild
- What is being tested?
- TAPS
- How many people
- 150 participants
- Where
- 3 sitesNetherlands
- Study dates
- 1 Jul 2021to Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: secondary psychiatric care departments and special services for people with intellectual disabilities
Who may be able to join
- 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).
Who cannot join
- If patients do not have sufficient command of the Dutch language or cannot concentrate for 20 minutes, the instruments are not taken
Trial locations and contacts
3 sites in 1 country.
Cor de Jong, Dr contact
Netherlands3 sites, 3 recruiting
- Recruiting
GGZ Oost Brabant - FACT
Boekel, North Brabant, 5427 ZG
Birgit Seelen, MSc, 0031 6 81405847, birgit.seelen-delang2@ru.nl
Cor de Jong, Dr, nispa.dejong@gmail.com
- Recruiting
GGZ Oost Brabant - LVB-P
Boekel, North Brabant, 5427 ZG
Birgit Seelen, MSc, 0031 6 81405847, birgit.seelen-delang2@ru.nl
Jay Arts, MSc, j.arts@ggzoostbrabant.nl
- Recruiting
Stichting ORO
Helmond, North Brabant, 5709 HL
Birgit Seelen, MSc, 0031 6 81405847, birgit.seelen-delang2@ru.nl
Evelien Joosten, Dr, ejoosten@oro.nl
About this study
Official 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 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.
Read the 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.
- Being tested
- TAPS
- Keywords
- TAPS, screener
- Medical subject headings
- Substance-Related Disorders, Mental Disorders, Intellectual Disability, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAPSDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| participants with substance use problems | There are 2 subgroups:
* Participants without intellectual disabilities
* Participants with intellectual disabilities with and without severe mental illness Receives: Diagnostic Test: TAPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
TAPS
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.
Measured: one assessment at the start of the treatment
Measurement of Addiction for Triage and Evaluation (MATE)
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.
Measured: At the start of FACT treatment, only for participants of this study
Substance use measurement for people with intellectual disabilities (SumID-Q)
The SumID-Q is an extensive Dutch assessment instrument (interview) on substance use problems for people with intellectual disabilities. There are no total scores.
Measured: Standard assessment at the start of the treatment, or when substance use problems are suspected
Secondary outcomes (2)
Health of the Nation Outcome Scales (HoNOS)
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)..
Measured: Once at start of FACT treatment
Manchester abbreviated quality of life measure (MANSA)
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.
Measured: Once, at start of FACT treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start1 Jul 2021
- Primary completion31 Dec 2024 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Birgit Seelen-de Lang
- Sponsor type
- University, hospital or other
- Collaborators
- Ggz Oost Brabant
- Responsible party
- Sponsor-investigator, Birgit Seelen-de Lang, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05273021
- Sponsor's protocol ID
- ECSW-2021-051
- Status last verified
- Mar 2024
- First submitted
- 11 Feb 2022
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Seelen-de Lang B, Jong C, Hutschemaekers G, Didden R, Noorthoorn E. TAPS-tool reveals severe under detection of substance use problems in patients with severe mental illness. PLoS One. 2024 Jul 24;19(7):e0305142. doi: 10.1371/journal.pone.0305142. eCollection 2024.
PubMed 39047031
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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 Disability
- ClinicalTrials.gov ID
- NCT05273021
- Acronym / sponsor ID
- ECSW-2021-051
- Keywords
- TAPS, screener
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Birgit Seelen-de LangUniversity, hospital or other
- Collaborators
- Ggz Oost Brabant
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 10 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| participants with substance use problems | – | Diagnostic Test: TAPSThere are 2 subgroups: * Participants without intellectual disabilities * Participants with intellectual disabilities with and without severe mental illness |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- secondary psychiatric care departments and special services for people with intellectual disabilities
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- If patients do not have sufficient command of the Dutch language or cannot concentrate for 20 minutes, the instruments are not taken
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAPSall 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 | Diagnostic test | participants with substance use problems |
Primary outcome
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.
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.
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.
2 secondary outcomes
Health of the Nation Outcome Scales (HoNOS)
Time frame: Once at start of FACT treatment
Manchester abbreviated quality of life measure (MANSA)
Time frame: Once, at start of FACT treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Derived from this study: PubMed 39047031Seelen-de Lang B, Jong C, Hutschemaekers G, Didden R, Noorthoorn E. TAPS-tool reveals severe under detection of substance use problems in patients with severe mental illness. PLoS One. 2024 Jul 24;19(7):e0305142. doi: 10.1371/journal.pone.0305142. eCollection 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cor de Jong, Dr contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Substance Use and Severe Mental Disorder, run by Birgit Seelen-de Lang at 3 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Birgit Seelen, MSc (0031 681405847, birgit.seelen-delang2@ru.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TAPS (time frame: one assessment at the start of the treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05273021, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024.