NCT05703503

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
214

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

January 19, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 30, 2023

Completed
Last Updated

February 3, 2023

Status Verified

February 1, 2023

Enrollment Period

2.2 years

First QC Date

January 19, 2023

Last Update Submit

February 1, 2023

Conditions

Keywords

HealthcareAdultsEmploymentMedicationIntellectual DisabilityNeurodevelopmental Disorders

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline

Secondary Outcomes (2)

  • The Aberrant Behaviour Checklist-Community (ABC-C)

    Baseline

  • Moss Psychiatric Assessement Schedules- Checklist (MPAS- Check)

    Baseline

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • Clinical diagnosis of intellectual disability
  • Age 16 or older and providing consent to participate.

You may not qualify if:

  • Age 15 or younger.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian University of Science and Technology

Trondheim, 7023, Norway

Location

MeSH Terms

Conditions

Intellectual DisabilityNeurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Erik Søndenaa, PhD

    Department of Mental Health, Faculty of Medicine and Health Sciences, NTNU.

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2023

First Posted

January 30, 2023

Study Start

October 1, 2017

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

February 3, 2023

Record last verified: 2023-02

Locations