Intellectual Disabilities (F70-F79)NCT05703503
Mental Health and Healthcare in Adults With Intellectual Disabilities
An observational study of Intellectual Disabilities (F70-F79) and Problem;Behaviour;Adult, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
Intellectual disability (ID) is a diagnosis characterized by significant limitations both in intellectual functioning and in adaptive behavior as expressed in conceptual, social and practical adaptive skills. The disability originates before age 18 years. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intellectual Disabilities (F70-F79), Problem;Behaviour;Adult, Mental Health Issue
- How many people
- 214 participants
- Where
- 1 siteNorway
- Study dates
- 1 Oct 2017to 1 Dec 2019
- How long will I take part?
- 1 Day
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Persons with intellectual disabilities and registered services in the municipalities in two regions localised in the north and middle of Norway will be invited to participate in the study.
Who may be able to join
- Clinical diagnosis of intellectual disability
- Age 16 or older and providing consent to participate.
Who cannot join
- Age 15 or younger.
Trial locations and contacts
1 site in 1 country.
About this study
Intellectual disability (ID) is a diagnosis characterized by significant limitations both in intellectual functioning and in adaptive behavior as expressed in conceptual, social and practical adaptive skills. The disability originates before age 18 years. The prevalence of mental ill-health among adults with intellectual disabilities is higher than the general population. Individuals with ID use psychotropic medication extensively, but studies indicate that less than one out of three who use psychotropic drugs have a psychiatric diagnosis. The drugs are usually prescribed by a regular general practitioner. People with IDs will often require health- and social services throughout their lifetimes. Studies report worse mental and physical health among people with IDs compared to the general population, in addition to more unmet healthcare needs and more difficulty accessing healthcare.
General health surveys in Norway do not include people with intellectual disabilities, and studies of health indicators in this group are largely lacking. Further, the unique organization of services for this group in Norway calls for specific research efforts. This project will use multinational health indicators for youths and adults with IDs in a biopsychosocial context in attempt to identify unmet health care needs to improve services. The project will focus on mental health and challenging behavior and how the related healthcare needs are met. We will also look at the relationship between mental health, behavioral problems and workforce employment amongst people with intellectual disabilities.
Read the detailed description
Intellectual disability (ID) is a diagnosis characterized by significant limitations both in intellectual functioning and in adaptive behavior as expressed in conceptual, social and practical adaptive skills. The disability originates before age 18 years. The prevalence of mental ill-health among adults with intellectual disabilities is higher than the general population. Individuals with ID use psychotropic medication extensively, but studies indicate that less than one out of three who use psychotropic drugs have a psychiatric diagnosis. The drugs are usually prescribed by a regular general practitioner. People with IDs will often require health- and social services throughout their lifetimes. Studies report worse mental and physical health among people with IDs compared to the general population, in addition to more unmet healthcare needs and more difficulty accessing healthcare.
General health surveys in Norway do not include people with intellectual disabilities, and studies of health indicators in this group are largely lacking. Further, the unique organization of services for this group in Norway calls for specific research efforts. This project will use multinational health indicators for youths and adults with IDs in a biopsychosocial context in attempt to identify unmet health care needs to improve services. The project will focus on mental health and challenging behavior and how the related healthcare needs are met. We will also look at the relationship between mental health, behavioral problems and workforce employment amongst people with intellectual disabilities.
The following articles will be published as part of this project:
- "The relationship between symptoms of mental health problems, diagnoses and medication in adults with intellectual disabilities"
- "The contact between individuals with intellectual disabilities with mental health problems, and mental health professionals: characteristics of the patients and the professionals.
- "Mental health, behavioral problems and workforce employment amongst people with intellectual disabilities".
- Conditions
- Intellectual Disabilities (F70-F79), Problem;Behaviour;Adult, Mental Health Issue, Employment, Delivery of Health Care
- Keywords
- Healthcare, Adults, Employment, Medication, Intellectual Disability, Neurodevelopmental Disorders
- Medical subject headings
- Intellectual Disability, Neurodevelopmental Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Health indicators in a Norwegian population of youths and adults with intellectual disabilities.
Health indicators as measured by The POMONA Checklist of Health Indicators (P15). The health indicators include measures of socio-demographics, Health status, Health determinants and Health systems.Physical Activity is defined as a Health determinant in this study in accordance With the POMONA Health indicator classification.
Measured: Baseline
Secondary outcomes (2)
The Aberrant Behaviour Checklist-Community (ABC-C)
The Aberrant Behaviour Checklist-Community (ABC-C) is a rating scale with 58 items for the assessment of behavioural problems in people with intellectual disabilities. The items are grouped into five subscales: (I) Irritability (15 items), (II) Social Withdrawal (16 items), (III) Stereotypic Behaviour (7 items), (IV) Hyperactivity/Non-compliance (16 items) and (V) Inappropriate Speech (4 items).
Measured: Baseline
Moss Psychiatric Assessement Schedules- Checklist (MPAS- Check)
The checklist is a screening instrument specifically designed to help staff recognize mental health problems in the people with intellectual disability for whom they care, and to make informed referral decisions. The instrument consists of a life-events checklist and 29 symptom items scored on a four-point scale
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start1 Oct 2017
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intellectual Disabilities (F70-F79)Studies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 214 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- The Dam Foundation, University of Tromso, University Hospital of North Norway, The Norwegian Association for Persons with Developmental Disabilities
- Responsible party
- Sponsor
- Investigators
- Erik Søndenaa, PhD, Study chair, Department of Mental Health, Faculty of Medicine and Health Sciences, NTNU.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05703503
- Sponsor's protocol ID
- 493747
- Other IDs
- 2022/FO387091
- Status last verified
- Feb 2023
- First submitted
- 19 Jan 2023
- Last updated
- 3 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental Health and Healthcare in Adults With Intellectual Disabilities
- ClinicalTrials.gov ID
- NCT05703503
- Acronym / sponsor ID
- 493747
- Conditions
- Intellectual Disabilities (F70-F79), Problem;Behaviour;Adult, Mental Health Issue, Employment, Delivery of Health Care
- Keywords
- Healthcare, Adults, Employment, Medication, Intellectual Disability, Neurodevelopmental Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- The Dam Foundation, University of Tromso, University Hospital of North Norway, The Norwegian Association for Persons with Developmental Disabilities
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 30 Jan 2023 (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.
Intellectual disability (ID) is a diagnosis characterized by significant limitations both in intellectual functioning and in adaptive behavior as expressed in conceptual, social and practical adaptive skills. The disability originates before age 18 years. The prevalence of mental ill-health among adults with intellectual disabilities is higher than the general population. Individuals with ID use psychotropic medication extensively, but studies indicate that less than one out of three who use psychotropic drugs have a psychiatric diagnosis. The drugs are usually prescribed by a regular general practitioner. People with IDs will often require health- and social services throughout their lifetimes. Studies report worse mental and physical health among people with IDs compared to the general population, in addition to more unmet healthcare needs and more difficulty accessing healthcare.
General health surveys in Norway do not include people with intellectual disabilities, and studies of health indicators in this group are largely lacking. Further, the unique organization of services for this group in Norway calls for specific research efforts. This project will use multinational health indicators for youths and adults with IDs in a biopsychosocial context in attempt to identify unmet health care needs to improve services. The project will focus on mental health and challenging behavior and how the related healthcare needs are met. We will also look at the relationship between mental health, behavioral problems and workforce employment amongst people with intellectual disabilities.
Detailed description
Intellectual disability (ID) is a diagnosis characterized by significant limitations both in intellectual functioning and in adaptive behavior as expressed in conceptual, social and practical adaptive skills. The disability originates before age 18 years. The prevalence of mental ill-health among adults with intellectual disabilities is higher than the general population. Individuals with ID use psychotropic medication extensively, but studies indicate that less than one out of three who use psychotropic drugs have a psychiatric diagnosis. The drugs are usually prescribed by a regular general practitioner. People with IDs will often require health- and social services throughout their lifetimes. Studies report worse mental and physical health among people with IDs compared to the general population, in addition to more unmet healthcare needs and more difficulty accessing healthcare.
General health surveys in Norway do not include people with intellectual disabilities, and studies of health indicators in this group are largely lacking. Further, the unique organization of services for this group in Norway calls for specific research efforts. This project will use multinational health indicators for youths and adults with IDs in a biopsychosocial context in attempt to identify unmet health care needs to improve services. The project will focus on mental health and challenging behavior and how the related healthcare needs are met. We will also look at the relationship between mental health, behavioral problems and workforce employment amongst people with intellectual disabilities.
The following articles will be published as part of this project:
- "The relationship between symptoms of mental health problems, diagnoses and medication in adults with intellectual disabilities"
- "The contact between individuals with intellectual disabilities with mental health problems, and mental health professionals: characteristics of the patients and the professionals.
- "Mental health, behavioral problems and workforce employment amongst people with intellectual disabilities".
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Persons with intellectual disabilities and registered services in the municipalities in two regions localised in the north and middle of Norway will be invited to participate in the study.
Key inclusion criteria (2 listed)
- Clinical diagnosis of intellectual disability
- Age 16 or older and providing consent to participate.
Key exclusion criteria (1 listed)
- Age 15 or younger.
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
Health indicators in a Norwegian population of youths and adults with intellectual disabilities.
Time frame: Baseline
Health indicators as measured by The POMONA Checklist of Health Indicators (P15). The health indicators include measures of socio-demographics, Health status, Health determinants and Health systems.Physical Activity is defined as a Health determinant in this study in accordance With the POMONA Health indicator classification.
2 secondary outcomes
The Aberrant Behaviour Checklist-Community (ABC-C)
Time frame: Baseline
Moss Psychiatric Assessement Schedules- Checklist (MPAS- Check)
Time frame: Baseline
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 3 Feb 2023.
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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.
Erik Søndenaa, PhD study chair
Department of Mental Health, Faculty of Medicine and Health Sciences, NTNU.
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 Disabilities (F70-F79) and Problem;Behaviour;Adult, run by Norwegian University of Science and Technology at 1 site in Norway.
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 3 Feb 2023. 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 Norway. 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?
Health indicators in a Norwegian population of youths and adults with intellectual disabilities. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Feb 2023.