NCT05273021

Brief 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. 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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2021

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2022

Completed
27 days until next milestone

First Posted

Study publicly available on registry

March 10, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

March 28, 2024

Status Verified

March 1, 2024

Enrollment Period

3.5 years

First QC Date

February 11, 2022

Last Update Submit

March 27, 2024

Conditions

Keywords

TAPSscreener

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    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)

    Once at start of FACT treatment

  • Manchester abbreviated quality of life measure (MANSA)

    Once, at start of FACT treatment

Study Arms (1)

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

Interventions

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

participants with substance use problems

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

GGZ Oost Brabant - FACT

Boekel, North Brabant, 5427 ZG, Netherlands

RECRUITING

GGZ Oost Brabant - LVB-P

Boekel, North Brabant, 5427 ZG, Netherlands

RECRUITING

Stichting ORO

Helmond, North Brabant, 5709 HL, Netherlands

RECRUITING

MeSH Terms

Conditions

Substance-Related DisordersMental DisordersIntellectual DisabilityLymphoma, Follicular

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Central Study Contacts

Cor de Jong, Dr

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Psychologist

Study Record Dates

First Submitted

February 11, 2022

First Posted

March 10, 2022

Study Start

July 1, 2021

Primary Completion

December 31, 2024

Study Completion

July 1, 2025

Last Updated

March 28, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations