Intellectual DisabilityPROMPT-IDNCT03558815
Psychotropic Medication and Psychotherapeutic Treatment of Adults With Intellectual Disabilities
An observational study of Intellectual Disability, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
Mental health service provision of adults with intellectual disabilities (ID) is often criticized. There is a lack of empirically studies targeting the psychotropic and psychotherapeutic treatment in this population. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Intellectual Disability
- How many people
- 197 participants
- Where
- 1 siteGermany
- Study dates
- 1 May 2017to 31 May 2019
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population are adults with mild to profound levels of intellectual disability using sheltered working and/or sheltered accommodation services.
Who may be able to join
- Mild to profound levels of ID
- Age of 18 years or older
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Mental health service provision of adults with intellectual disabilities (ID) is often criticized. There is a lack of empirically studies targeting the psychotropic and psychotherapeutic treatment in this population. The PROMPT-ID study therefore aims to assess the prevalence of psychotropic medication and psychotherapeutic treatment in adults with mild to profound ID and the quality of psychotropic medication. It further aims to identify predictors of psychotropic medication, of barriers into psychotherapeutic treatment and of good clinical psychotropic medication prescription practice. It is a cross-sectional, epidemiological study carried out in Saxony, Germany. Approval of the responsible ethics committee was obtained. The inclusion criteria are mild to profound forms of ID and an age of 18 years or older. A representative sample is realized by a two-stage sampling procedure. Sheltered working and accommodation service providers are stratified by type of service provider and workshop size/type of accommodation. The stratified cluster sampling is realized by a random selection of service providing institutions followed by a random selection of adults with ID. An estimated total number of n = 200 study participants via sheltered workshops and n = 400 via residential accommodations need to be contacted to obtain data of approximately n = 131 study participants recruited through sheltered workshops and n = 232 participants through sheltered living institutions. Based on a psychotropic medication prevalence of 30%, in- depth interviews about psychotropic prescription practice of an estimated number of n = 109 adults with ID are carried out. Data collection is realized in interviews with key carers in the living environment and, if applicable, with the prescribing physician. If the adults with ID are currently medicated with psychotropics, basic information e.g. about kind, agent, dosage and treatment duration are obtained and a newly developed interview targeting the quality of the psychotropic medication treatment is conducted with the carers. In addition to the prevalence and quality of psychotropic and psychotherapeutic health care utilisation, other parameters like psychiatric symptomatology, problem behavior, sociodemografic and institutional factors and parameters of the provision area are assessed using well- established instruments. Findings will fill the lack of representative data that is urgently needed in this often criticized health service area.
- Conditions
- Intellectual Disability
- Keywords
- intellectual disability, psychotropic medication, mental health services evaluation
- Medical subject headings
- Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adults with mild, moderate, severe or profound ID | Adults with mild, moderate, severe or profound ID in contact with either a sheltered workshop and/ or sheltered living Institution in Saxony. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of psychotropic medication (Interview for Assessing the Quality of Psychopharmacological Treatment of Adults with Intellectual Disabilities (IQP-ID; Schützwohl et al., 2017)
If the adults with ID had a psychotropic medication prescription of at least one of the following six substance classes in the past three months: neuroleptics, antidepressants, benzodiazepines, lithium, anxiolytics/sedatives and/or antiepileptics, the Interview for Assessing the Quality of Psychopharmacological Treatment of Adults with Intellectual Disabilities (IQP-ID; Schützwohl et al., 2017) is conducted. This interview assesses the prescription practice of psychotropic medication in adults with ID. It is based on current guidelines of psychotropic medication prescription in adults with ID.The interview comprises 13 quality indicators that are assigned to one of 7 domains.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start1 May 2017
- Primary completion31 May 2019
- Study completion31 May 2019
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 Intellectual DisabilityStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthias Schützwohl, Technische Universität Dresden
- Investigators
- Matthias Schützwohl, Prof. Dr., Principal investigator, Department of Psychiatry and Psychoptherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03558815
- Sponsor's protocol ID
- 040_5121
- Acronym
- PROMPT-ID
- Status last verified
- Jul 2019
- First submitted
- 15 May 2018
- Last updated
- 22 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Koch A, Dobrindt J, Schutzwohl M. Psychotropic medication and psychotherapeutic treatment of adults with intellectual disabilities (PROMPT-ID): a cross-sectional, epidemiological study in Saxony, Germany. BMJ Open. 2018 Dec 19;8(12):e025947. doi: 10.1136/bmjopen-2018-025947.
PubMed 30573492
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychotropic Medication and Psychotherapeutic Treatment of Adults With Intellectual Disabilities
- ClinicalTrials.gov ID
- NCT03558815
- Acronym / sponsor ID
- PROMPT-ID / 040_5121
- Conditions
- Intellectual Disability
- Keywords
- intellectual disability, psychotropic medication, mental health services evaluation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 15 Jun 2018 (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.
Mental health service provision of adults with intellectual disabilities (ID) is often criticized. There is a lack of empirically studies targeting the psychotropic and psychotherapeutic treatment in this population. The PROMPT-ID study therefore aims to assess the prevalence of psychotropic medication and psychotherapeutic treatment in adults with mild to profound ID and the quality of psychotropic medication. It further aims to identify predictors of psychotropic medication, of barriers into psychotherapeutic treatment and of good clinical psychotropic medication prescription practice. It is a cross-sectional, epidemiological study carried out in Saxony, Germany. Approval of the responsible ethics committee was obtained. The inclusion criteria are mild to profound forms of ID and an age of 18 years or older. A representative sample is realized by a two-stage sampling procedure. Sheltered working and accommodation service providers are stratified by type of service provider and workshop size/type of accommodation. The stratified cluster sampling is realized by a random selection of service providing institutions followed by a random selection of adults with ID. An estimated total number of n = 200 study participants via sheltered workshops and n = 400 via residential accommodations need to be contacted to obtain data of approximately n = 131 study participants recruited through sheltered workshops and n = 232 participants through sheltered living institutions. Based on a psychotropic medication prevalence of 30%, in- depth interviews about psychotropic prescription practice of an estimated number of n = 109 adults with ID are carried out. Data collection is realized in interviews with key carers in the living environment and, if applicable, with the prescribing physician. If the adults with ID are currently medicated with psychotropics, basic information e.g. about kind, agent, dosage and treatment duration are obtained and a newly developed interview targeting the quality of the psychotropic medication treatment is conducted with the carers. In addition to the prevalence and quality of psychotropic and psychotherapeutic health care utilisation, other parameters like psychiatric symptomatology, problem behavior, sociodemografic and institutional factors and parameters of the provision area are assessed using well- established instruments. Findings will fill the lack of representative data that is urgently needed in this often criticized health service area.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with mild, moderate, severe or profound ID | – | –Adults with mild, moderate, severe or profound ID in contact with either a sheltered workshop and/ or sheltered living Institution in Saxony. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population are adults with mild to profound levels of intellectual disability using sheltered working and/or sheltered accommodation services.
Key inclusion criteria (2 listed)
- Mild to profound levels of ID
- Age of 18 years or older
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quality of psychotropic medication (Interview for Assessing the Quality of Psychopharmacological Treatment of Adults with Intellectual Disabilities (IQP-ID; Schützwohl et al., 2017)
Time frame: 3 months
If the adults with ID had a psychotropic medication prescription of at least one of the following six substance classes in the past three months: neuroleptics, antidepressants, benzodiazepines, lithium, anxiolytics/sedatives and/or antiepileptics, the Interview for Assessing the Quality of Psychopharmacological Treatment of Adults with Intellectual Disabilities (IQP-ID; Schützwohl et al., 2017) is conducted. This interview assesses the prescription practice of psychotropic medication in adults with ID. It is based on current guidelines of psychotropic medication prescription in adults with ID.The interview comprises 13 quality indicators that are assigned to one of 7 domains.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2019.
- Derived from this study: PubMed 30573492Koch A, Dobrindt J, Schutzwohl M. Psychotropic medication and psychotherapeutic treatment of adults with intellectual disabilities (PROMPT-ID): a cross-sectional, epidemiological study in Saxony, Germany. BMJ Open. 2018 Dec 19;8(12):e025947. doi: 10.1136/bmjopen-2018-025947.
- Individual participant dataSharing planned: Undecided
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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.
Matthias Schützwohl, Prof. Dr. principal investigator
Department of Psychiatry and Psychoptherapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intellectual Disability, run by Technische Universität Dresden at 1 site in Germany.
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 2 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: finished, as of the sponsor's last update on 22 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of psychotropic medication (Interview for Assessing the Quality of Psychopharmacological Treatment of Adults with Intellectual Disabilities (IQP-ID; Schützwohl et al., 2017) (time frame: 3 months). 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 NCT03558815, 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 22 Jul 2019.