Integration of medical, psychiatric and behavioural care for the substantiated and appropriate use of psychotropic drugs in individuals with an intellectual disability and challenging behaviour.

Integration of medical, psychiatric and behavioural care for the substantiated and appropriate use of psychotropic drugs in individuals with an intellectual disability and challenging behaviour. - CHALIDIT-CRT

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55155

Enrollment

106

Registered

2019-12-02

Start date

2020-02-20

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Challenging behaviour problem behavior

Interventions

Participants in the intervention group will receive integrative care by a specialized mental health care team, consisting of mental health care professionals and health care professionals for indivi

the remaining months are meant for treatment. Re-evaluating the diagnostic assessment remains an opportunity throughout the intervention. After 9 months, if treatment is still ongoing, this can be

Eligibility

Age

12 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Person with a moderate to profound intellectual disability (level of cognitive development 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

Exclusion criteria: A diagnosis of, classified according to DSM-5 criteria: - Dementia - Chronic psychotic disorder - Schizoaffective disorder - Bipolar disorder type I - Significant life event in the past six months

Design outcomes

Primary

Measure	Time frame
The main parameter of this study is the total score of the Aberrant Behavior Checklist (ABC) (Aman, Singh, Stewart, & Field, 1985). The ABC is a symptom checklist that is used to assess problem behavior of children and adults with developmental disorders. It was initially developed to measure the effects of treatment. The ABC has five subscales: Irritability Lethargy; Stereotypic Behavior; Hyperactivity; and Inappropriate Speech. The checklist can be completed by parents and caregivers that have extensive knowledge of the person being assessed. The estimated time needed to complete the entire Aberrant Behavior Checklist is ten to fifteen minutes.	—

Measure

Time frame

The main parameter of this study is the total score of the Aberrant Behavior Checklist (ABC) (Aman, Singh, Stewart, & Field, 1985). The ABC is a symptom checklist that is used to assess problem behavior of children and adults with developmental disorders. It was initially developed to measure the effects of treatment. The ABC has five subscales: Irritability Lethargy; Stereotypic Behavior; Hyperactivity; and Inappropriate Speech. The checklist can be completed by parents and caregivers that have extensive knowledge of the person being assessed. The estimated time needed to complete the entire Aberrant Behavior Checklist is ten to fifteen minutes.

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Secondary

Measure	Time frame
The secondary study parameters of this study are: - Behavior Problems Inventory (BPI) - The outcome measure 'Clients perspectives on treatments outcomes of challenging behaviour' that is developed in a subproject of this study (METC registration number 2019/178) - Restrictive measures - Medical diagnoses - Implemented interventions - Psychotropic drugs: type, dosage and frequency; quality of the drug prescription through the TIPT (Toetsingsinstrument Psychofarmaca Toepassing); - Anticholinergic cognitive burden scale - Extrapyramidal and autonomous nervous system side effects Other study parameters of this study are: - Minimal Data Set (MDS) - Subscale self-determination of Personal Outcome Scale (POS) - Subscale communicatie en invloed* of the Quality of Life of Persons with Profound Multiple Disabilities (QOL-PMD) - 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) - Analyse processen rondom de zorg en behandeling voor mensen met een verstandelijke beperking en moeilijk verstaanbaar gedrag	—

Measure

Time frame

The secondary study parameters of this study are: - Behavior Problems Inventory (BPI) - The outcome measure 'Client*s perspectives on treatments outcomes of challenging behaviour' that is developed in a subproject of this study (METC registration number 2019/178) - Restrictive measures - Medical diagnoses - Implemented interventions - Psychotropic drugs: type, dosage and frequency; quality of the drug prescription through the TIPT (Toetsingsinstrument Psychofarmaca Toepassing); - Anticholinergic cognitive burden scale - Extrapyramidal and autonomous nervous system side effects Other study parameters of this study are: - Minimal Data Set (MDS) - Subscale self-determination of Personal Outcome Scale (POS) - Subscale *communicatie en invloed* of the Quality of Life of Persons with Profound Multiple Disabilities (QOL-PMD) - 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) - Analyse processen rondom de zorg en behandeling voor mensen met een verstandelijke beperking en moeilijk verstaanbaar gedrag

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)