The main objective of this study is:This study investigates whether diagnosis and treatment of challenging behaviour, as provided by an specialist team of mental health care professionals and intellectual disability professionals, when optimising…
ID
Source
Brief title
Condition
- Psychiatric and behavioural symptoms NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
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
Background summary
Challenging behaviour is prevalent in people with intellectual disabilities
(ID). (A prevalence of 18.1% as reported by Bowring, Totsika, Hastings,
Toogood, & Griffith, 2017). Challenging behaviour consists of a heterogeneous
group of behaviours such as aggression, self-injurious behaviour, irritability,
stereotyped behaviour and withdrawn behaviour. Individuals with challenging
behaviour require appropriate and proper treatment.
Challenging behaviour is often treated with psychotropic drugs. Individuals
with challenging behaviour often receive psychotropic drugs for long periods of
time and this in turn can contribute to difficulties in reducing the drugs.
Evidence for positive effects of psychopharmacological treatment, is scarce and
adverse effects are clearly present, negatively affecting the quality of life,
yet its use remains widespread.
Endeavours to reduce the prescription of antipsychotic drugs for challenging
behaviour have been successful in part only, and the occurrences of
unsuccessful reduction have given rise to the exploration of the treatment of
challenging behaviour in a broader scope. The newest Dutch guidelines and
government policies aim towards the reduction of inappropriate psychotropic
drug use and the stimulation of non-pharmaceutical treatment. (The same
development can be seen in the British NICE guidelines.)
However, reducing the use of unfit psychotropic drugs and stimulating
non-pharmaceutical treatment is often difficult in practice due to several
reasons. First of all, the assessment and treatment of challenging behaviour is
complicated. Secondly, stimulating non-drug treatment for behavioural problems
in individuals with an intellectual disability is difficult, because
individuals with ID can be served in two separate health care systems, namely
the care for people with an intellectual disability and mental health care. The
care provided to individuals with ID is specialized in problems occurring with
an intellectual disability (often in a residential setting) but is not
necessarily specialized in the assessment and treatment of psychiatric
problems; psychiatric care, on the other hand, does not necessarily include
knowledge of and experience with providing care to people with ID.
The amount of psychological and psychosocial treatment that people receive in
addition to pharmacological treatment is lower in specialized care for
individuals with ID than in mental health care. This indicates that a proper
and uniform health care offer is needed, to reduce unfit psychotropic drug use,
in which the expertise from mental health care and the expertise from the care
for individuals with ID are integrated.
In this study, the knowledge of patient experts, medical experts, psychiatric
experts and behavioural experts will be integrated into one treatment that is
provided to the client by one team. This study is aimed at testing how
effective the integrative approach is in reducing challenging behaviour, and
reducing unfit psychotropic drug use.
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 specialist 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 objective
The main objective of this study is:
This study investigates whether diagnosis and treatment of challenging
behaviour, as provided by an specialist team of mental health care
professionals and intellectual disability professionals, 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.
The secondary objectives of this study are:
To compare the results of treatment of challenging behaviour when optimising
off-label psychotropic drug use, provided by the integrative health care team
versus care-as-usual, regarding:
a. the effect on behaviour as measured with the Behavior Problems Inventory
(BPI) (Rojahn, Matson, Lott, Esbensen, & Smalls, 2001)
b. the effect on quantity and quality (adherence to guideline
recommendations) of off-label psychotropic drug prescription.
c. the effect on Health-related Quality of Life (HQOL) and daily functioning as
measured with an Outcome Measure *Client*s perspectives on
treatments outcomes of CB* (that is developed in a subproject of the
research project).
d. the number and nature of side-effects of psychotropic drug use.
Study design
The study is a cluster-randomized controlled trial. The outcome of the
intervention group will be compared to a care-as-usual control group, to assess
its possible additional value. This design is chosen because there is no option
for a control group without treatment, since the care-as-usual treatment is
already ongoing, and pausing this would not be ethically justifiable. The
intervention cannot be blinded, because it is obvious which group the
participants are in. The randomization has to be clustered due to the risk of
contamination. (If a participant of the control group lives in the same
department/house as a participant in the intervention group, their
environment-focussed interventions could be interacting.)
Intervention
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 individuals with ID (generally
consisting of a psychiatrist, physician for individuals with ID, psychiatric
nurse/social worker, psychologist and/or behavioural scientist).
The professionals will provide care according to professional standards and
guidelines. The specific diagnostic and treatment interventions are selected by
their professional opinion of the best fit for the situation the participant is
in. The professionals of the specialized mental health care team will be
provided with training about the assessment and treatment of challenging
behaviour, to ensure a unified approach and level of knowledge in each
intervention-team.
A general care path is described here, to give an impression of the general
range of possibilities. This description is not an exhaustive or complete
overview. The care path consists of two parts: the diagnostic phase and the
treatment phase.
The intervention will last 9 months. The first 6-8 weeks are needed for
diagnostic assessment; 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
continued outside of the study setting. The start of intervention is spread
over the first 6 months of the study, so that the last participant will finish
the intervention in month 15.
Diagnostic phase
Initial interview
To assess main problem(s) and direction of further plan
Diagnostic assessment, basic:
- File study (incl. course of the symptoms in the past, comorbidities, previous
psychological and pedagogical evaluations, previous treatments)
- Hetero-anamnesis
- Observation of participants* behaviour and interaction, preferably in
participants* daily environment
- Physical examination.
- Medication review, including the assessment of the efficacy and side-effects
Diagnostic assessment, extended:
- Psychological assessments
- System assessment
- Psychiatric assessment
- Applied behavioural analysis
- Assessment of communication needs
- Assessment of problems and needs related to motor functioning and aids
- Assessment of visual and auditory functioning
- Assessment of problems with eating and swallowing
The diagnostic findings will be discussed in a multidisciplinary meeting of the
specialist team and a treatment options will be identified. The treatment
options will be discussed with participant and legal representatives, as well
as caregiver and when applicable his/her own clinicians. Since treatments may
have advantageous and disadvantageous effects, these effects will be discussed
and balanced (shared decision making with participants* representatives), and
the final plan will be written down as the treatment plan. As usual in health
care, informed consent (as stated by the WGBO) by the participants and/or legal
representatives is required before the treatment can start.
Treatment phase
Some of the possible treatments are listed here:
- treatment (advice) of underlying somatic disorder
- behaviour analysis and treatment by means of a structured method such as ABA
- interventions to improve social interaction and participation
- (non-verbal) psychotherapy
- systemic therapy
- team coaching
- psychoeducation
- psychopharmacologic optimization
- psychomotor therapy
- paramedical interventions (such as supportive communication, physiotherapy,
sensory integration therapy, creative therapy)
Treatment evaluations are part of the treatment phase. They consist of
evaluations of treatment execution, effects and - goals, and if necessary
adaptation of the treatment plan along with the participant and/or legal
representatives.
The outcomes of the physical study parameters will be available to the
professionals, to minimize the impact on the participant and his/her
environment (e.g. prevent double physical examination), and because this could
support good treatment outcomes of the participant, which is more generally the
purpose of this study.
Study burden and risks
With changes in medication there is a chance of physical and psychological
reactions, for example withdrawal symptoms or a (temporary) increase in
challenging behaviour can occur. This is no more the case in this randomised
controlled trial than in usual care. Any unexpected effects of treatments by
medical professionals cannot be foreseen.
The results of the study can lead to an improved treatment for all persons
with an intellectual disability. Therefore, the risk and burden on the subject
are in proportion to the potential value of the study.
The study can also be beneficial for the subjects participating in the study,
because the research may improve their use of psychotropic drugs and / or
challenging behavior. The burden and risks for participants of the study are no
greater than in the usual care.
The research can be regarded as group-related, because it is clear that
optimising the treatment of individuals with an intellectual disability and
challenging behaviour cannot be conducted without the participation of these
individuals.
Middenweg 19
Assen 9404 LL
NL
Middenweg 19
Assen 9404 LL
NL
Listed location countries
Age
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
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
Recruitment
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 |
---|---|
CCMO | NL70909.042.19 |
Other | NL7868 |