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ID
Source
Brief title
Health condition
Mental health problems
Sponsors and support
Intervention
Outcome measures
Primary outcome
Aberrant Behavior Checklist
Secondary outcome
Behavior Problems Inventory, Quantity and quality of off-label psychotropic drug prescription, Medical diagnoses, Restrictive measures, Implemented interventions, Type, dosage and frequency of psychotropic drugs, The number and nature of side-effects of psychotropic drug use,
Baselin measures: Minimal Data Set (MDS), Personal Outcome Scale (POS), Checklist Life Events (CLE), Psychiatric Assessment Schedule for Adults with a Developmental Disability Checklist (PAS-ADD Checklist), Vragenlijst over Ontwikkeling en Gedrag van kinderen (VOG)
Background summary
This study investigates whether diagnosis and treatment of challenging behaviour, as provided by an integrative team of mental health care specialists and intellectual disability specialists, when optimising the use of off-label psychotropic drugs amongst individuals with a moderate to profound intellectual disability and challenging behaviour, leads to better results as measured with the Aberrant Behavior Checklist than care-as-usual.
Study objective
The hypothesis of this study is that treatment and diagnosis of challenging behavioural symptoms, (which are or have been reason for off-label psychotropic drug prescription), as provided by this integrative team, when optimising the use of off-label psychotropic drugs amongst individuals with a moderate to severe intellectual disability and challenging behaviour, leads to better results as measured with the Aberrant Behavior Checklist than care-as-usual.
Study design
Baseline, 8, 16, 24, 32, 40 and 52 weeks
Intervention
Integrative care provided by a specialist mental health care team
Inclusion criteria
- Person with a moderate to profound intellectual disability (level of cognitive development < 6 years)
- Age > 12 years
- Off-label psychotropic drug use for more than one year
- Informed consent (IC) signed by participant and/or participant representative (depending on the competence of the participant)
Exclusion criteria
- One of the following DSM diagnoses:
- Dementia
- Chronic psychotic disorder
- Schizoaffective disorder
- Bipolar disorder type I
- Significant life event in the past six months
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7868 |
| Other | Medisch Ethische Toetsingscommissie UMC Groningen : 201900479 |